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Roxee Medication Guide

Dexmedetomidine Hydrochloride

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Reference complete FDA data linked Rx required Liquid (Solution) Multiple FDA sponsors Official label facts Owner quick guide first
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Data freshness

Reference facts
Reference refreshed
Aug 6, 2026, 7:47 p.m.

These are the reference facts Roxee uses on browse cards and quick facts.

FDA applications
FDA application data refreshed
Aug 6, 2026, 7:47 p.m.

Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports
Safety data refreshed
Aug 6, 2026, 7:49 p.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Aug 6, 2026, 7:47 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Illustration placeholder
Dexmedetomidine Hydrochloride

Dexmedetomidine Hydrochloride

Drug type: Generic ingredient • Generic profile • No FDA branded products linked

Both Liquid (Solution) Rx required 100% reference complete

Species: Both

Manufacturer: Multiple FDA sponsors

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Dexmedetomidine Hydrochloride

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. For use as a preanesthetic to general anesthesia. For use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. Species commonly shown: Both, Dog, Cat.

Generic name
Dexmedetomidine Hydrochloride
Brand names
Dexdomitor®, SILEO®, Dexmedesed®, DEXVETRA™
Manufacturer
Multiple FDA sponsors
Species
Both, Dog, Cat
Dosage forms
Liquid (Solution), Oromucosal Gel, Sterile Solution, Injectable Solution
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Dexdomitor® SILEO® Dexmedesed® DEXVETRA™ Dexmedetomidine Hydrochloride DexmedVet™
Dosage forms
Liquid (Solution) Oromucosal Gel Sterile Solution Injectable Solution Sterile Injectable Solution

Indications / Uses

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. For use as a preanesthetic to general anesthesia. For use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.

  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.

Side Effects

Top reported reactions (openFDA): Lack of efficacy - NOS, Bradycardia, INEFFECTIVE, SEDATION, Vomiting, Sedation, Lethargy (see also Central nervous system depression in 'Neurological').

FAQ

Both, Dog, Cat

Yes. Roxee shows this as prescription-only.

Liquid (Solution), Oromucosal Gel, Sterile Solution, Injectable Solution

Related Conditions

Shock (hypovolemic, septic, cardiogenic, anaphylactic)

Source Transparency

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

  • Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue
  • wobbly/unsteady walking (1 reports)
  • Loss of appetite (1 reports)
  • Bladder distension (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

Regulatory restrictions are shown in Vet View.

What to tell or ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence
Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Dexmedetomidine Hydrochloride; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2026-US-014066
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 22 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2026-US-014066
Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case USA-USFDACVM-2026-US-014066
Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Unsteady walking (ataxia) (1 reports), Loss of appetite (1 reports), Bladder distension (1 reports), Biting -aggression (1 reports), Bilirubinuria (1 reports)

Body systems represented Signal grouping

Digestive (1), Skin & allergy (3), Neurologic (1), Behavior (4)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Cat (22 reports), Dog (10 reports)

Breed metadata in reports Metadata only

Domestic Shorthair (2), Pug (1), ['Mastiff (unspecified)', 'Crossbred Canine/dog'] (1), Ragdoll (1). These are report metadata, not proof that a breed is at higher risk.

What your vet may verify

Fit for this patient Vet check

Verify whether Dexmedetomidine Hydrochloride fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or k, wobbly/unsteady walking, Loss of appetite, Bladder distension

Call sooner if Escalation

Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.

Bottom line: Use this Dexmedetomidine Hydrochloride brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA case USA-USFDACVM-2026-US-014066 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. FDA application profile · official_label · quick facts
  5. Medication usage source · fda_animal_drugs · quick facts
  6. FOI · document · documents
  7. SPL · document · documents
  8. FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: February 12, 2026, 10:44 PM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue
  • wobbly/unsteady walking
  • Loss of appetite
  • Bladder distension

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Loss of appetite (1 reports)
  • Bladder distension (1 reports)
Explore reported case details

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Cat, Dog
Indication / use
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.
Form / route / dose
Form: Injectable Solution, Liquid (Solution), Oromucosal Gel, Sterile Injectable Solution, Sterile Solution
Route: Intramuscular, Intravenous, Oromucosal
Confirm product label and patient-specific plan.
Warnings
  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or …
Adverse-event caveat
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Source docs

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Multiple FDA sponsors
Form: Injectable Solution, Liquid (Solution), Oromucosal Gel, Sterile Injectable Solution, Sterile Solution
Identifiers:
ANADA: 200573 ANADA: 200699 ANADA: 200735 ANADA: 200752 ANADA: 200824 NADA: 141267 NADA: 141456 NDC Package: 11695-6967-1 NDC Package: 17033-005-10 NDC Package: 46066-088-13 NDC Package: 54771-2805-1 NDC Package: 54771-2806-1 NDC Package: 64189-8502-0 NDC Package: 64189-8502-1 NDC Package: 68504-006-10 NDC Package: 69043-038-10 NDC Package: 86101-061-41 NDC Package: 86136-105-31 NDC Package: 86136-152-31 NDC Product: 11695
Source metadata:

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.

  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Reported case explorer

Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.

Clear filters
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Stored reports
86
Matching reports
86
Active filters
0
Reset
Drill into common report signals
Lethargy (see also Central nervous system depression in Neurological) (13) Behavioural disorder NOS (12) Intentional misuse (11) Not eating (11) Other (79) Neurologic (27) Digestive (21) Skin & allergy (15)
Showing up to 50 matching reports. Narrow filters to inspect the remaining reports.

USA-USFDACVM-2026-US-014624

Received 2026-03-26 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5 Kilogram)
Age
Under 1 year (1 Month)
Sex
Male Intact
Region
USA
Reactions
Seizure NOS
Body systems
Neurologic
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-014105

Received 2026-03-25 · MSK · MSK

Non-serious
Species
Dog
Breed
Pug
Size / weight
25-49 lb (12.7 Kilogram)
Age
1-3 years (3.75 Year)
Sex
Male Neutered
Region
USA
Reactions
Neurogenic keratoconjunctivitis sicca (KCS)Corneal ulcerNasal cavity disorder NOSAbnormal Schirmer tear test
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-014066

Received 2026-03-25 · MSK · MSK

Serious
Species
Dog
Breed
['Mastiff (unspecified)', 'Crossbred Canine/dog']
Size / weight
50-99 lb (29.574 Kilogram)
Age
1-3 years (1 Year)
Sex
Male Neutered
Region
USA
Reactions
HypotensionNot eatingNauseaDrowsiness - systemic disorderPain NOSVomitingRegurgitationDiscoloured urineCoughCrustHyperproteinaemiaHypoalbuminaemiaLeukocytosis NOSNeutrophiliaFluid in abdomen NOSSepticaemiaIntestinal disorder NOSAbdominal cavity disorder NOSElevated lactateAbnormal cytologyDuodenal ulcerIntestinal perforationDeath by euthanasiaLack of efficacy - NOSIntentional misuse
Body systems
OtherDigestiveEffectiveness
Outcomes
Euthanized

USA-USFDACVM-2026-US-014107

Received 2026-03-24 · MSK · MSK

Non-serious
Species
Cat
Breed
Ragdoll
Size / weight
10-24 lb (5.498 Kilogram)
Age
8+ years (1 Year)
Sex
Male Neutered
Region
USA
Reactions
Head tilt - neurological disorder (see also Head tilt - ear disorder)Ataxia
Body systems
Neurologic
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-013761

Received 2026-03-24 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Longhair
Size / weight
Under 10 lb (2.781 Kilogram)
Age
Under 1 year (5 Month)
Sex
Male Neutered
Region
USA
Reactions
Increased respiratory rateBreathing difficultyCrackles on auscultationAbnormal ultrasound findingPulmonary disorder NOSIntentional misuseDecreased pulse oxygenationPale mucous membrane
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-013479

Received 2026-03-24 · MSK · MSK

Serious
Species
Dog
Breed
Terrier - Bull - Staffordshire
Size / weight
50-99 lb (33.611 Kilogram)
Age
1-3 years (2 Year)
Sex
Female Unknown
Region
USA
Reactions
Facial swelling (see also Skin)Hypersensitivity reactionEmesis (multiple)Bloody diarrhoeaAtaxiaElevated total bilirubinElevated alanine aminotransferase (ALT)Elevated blood urea nitrogen (BUN)Lethargy (see also Central nervous system depression in Neurological)Intentional misuse
Body systems
Skin & allergyOtherDigestiveNeurologic
Outcomes
Ongoing

USA-USFDACVM-2026-US-013840

Received 2026-03-20 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.89 Kilogram)
Age
4-7 years (6 Year)
Sex
Male Neutered
Region
USA
Reactions
Gastrointestinal foreign body NOS
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-012798

Received 2026-03-20 · MSK · MSK

Serious
Species
Dog
Breed
Crossbred Canine/dog
Size / weight
25-49 lb (14.969 Kilogram)
Age
1-3 years (1 Year)
Sex
Female Unknown
Region
USA
Reactions
VocalisationRestlessnessIntentional misuse
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-013836

Received 2026-03-19 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (2.94 Kilogram)
Age
Under 1 year (1 Month)
Sex
Female Intact
Region
USA
Reactions
Behavioural disorder NOSRestlessnessNot sleepingHyperactivity
Body systems
BehaviorOther
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-013633

Received 2026-03-19 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.33 Kilogram)
Age
8+ years (11 Year)
Sex
Female Neutered
Region
USA
Reactions
DysphoriaBehavioural disorder NOSDilated pupilsAnorexiaSkin and tissue infection NOSLethargy (see also Central nervous system depression in Neurological)
Body systems
OtherBehaviorDigestiveNeurologic
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-012422

Received 2026-03-17 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6.98 Kilogram)
Age
4-7 years (7.58 Year)
Sex
Male Neutered
Region
USA
Reactions
Application site hair loss
Body systems
Skin & allergy
Outcomes
Ongoing

USA-USFDACVM-2026-US-014092

Received 2026-03-16 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (4.354 Kilogram)
Age
4-7 years (7 Year)
Sex
Female Neutered
Region
USA
Reactions
DroolingReluctant to moveNot eatingDilated pupilsNot himself/herselfHypothermiaTachypnoeaIntentional misuseLeukopenia NOSHypoglycaemiaElevated symmetrical dimethylarginine (SDMA)AzotaemiaLow ionized calcium (Ca; Hypocalcaemia, ionized)ObtundedWeak pulseLateral recumbencyRegurgitationCardiac arrestDeath
Body systems
DigestiveOther
Outcomes
Died

USA-USFDACVM-2026-US-013278

Received 2026-03-16 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Mediumhair
Size / weight
10-24 lb (6.8 Kilogram)
Age
8+ years (9 Year)
Sex
Male Neutered
Region
USA
Reactions
Injection site cystInjection site sarcomaInjection site lumpInjection site discharge NOSInjection site irritationLethargy (see also Central nervous system depression in Neurological)Elevated symmetrical dimethylarginine (SDMA)HypoalbuminaemiaThrombocytosisHyperkalaemiaAbnormal radiograph findingConstipationPain NOSAbnormal cytologyDecreased appetiteLicking at injection site
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing

USA-USFDACVM-2026-US-012576

Received 2026-03-16 · MSK · MSK

Serious
Species
Dog
Breed
Bulldog - French
Size / weight
25-49 lb (12.791 Kilogram)
Age
4-7 years (7 Year)
Sex
Female Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)Decreased appetiteLimpingFeverSwollen lymph nodeWeight lossPolyuriaPolydipsiaEmesis (multiple)Nasal dischargeLaboured breathingStridor (Upper respiratory; for lower respiratory see also Bronchial rale)Gait abnormalityJoint painJoint effusionImmune-mediated polyarthritisLymphopeniaHypoalbuminaemiaElevated globulinsElevated aspartate aminotransferase (AST)Elevated serum alkaline phosphatase (ALP)
Body systems
NeurologicDigestiveOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-012565

Received 2026-03-16 · MSK · MSK

Non-serious
Species
Cat
Breed
['Siberian', 'Crossbred Feline/cat']
Size / weight
10-24 lb (4.85 Kilogram)
Age
4-7 years (4.83 Year)
Sex
Female Neutered
Region
USA
Reactions
Application site discharge NOSApplication site reddeningApplication site hair lossApplication site lesion
Body systems
OtherSkin & allergy
Outcomes
Ongoing

USA-USFDACVM-2026-US-014084

Received 2026-03-13 · MSK · MSK

Serious
Species
Dog
Breed
Dog (unknown)
Sex
Unknown Unknown
Region
USA
Reactions
Lack of efficacy - NOS
Body systems
Effectiveness
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-014083

Received 2026-03-13 · MSK · MSK

Serious
Species
Dog
Breed
American Pit Bull Terrier
Size / weight
50-99 lb (26.4 Kilogram)
Age
4-7 years (4 Year)
Sex
Male Neutered
Region
USA
Reactions
Cardiac arrestDeath
Body systems
Other
Outcomes
Died

USA-USFDACVM-2026-US-014082

Received 2026-03-13 · MSK · MSK

Serious
Species
Dog
Breed
Shih Tzu
Size / weight
10-24 lb (6.4 Kilogram)
Age
1-3 years (3 Year)
Sex
Female Neutered
Region
USA
Reactions
Cardiac arrestDeath by euthanasiaNeurological symptoms NOS
Body systems
OtherNeurologic
Outcomes
Euthanized

USA-USFDACVM-2026-US-013584

Received 2026-03-13 · MSK · MSK

Non-serious
Species
Dog
Breed
Crossbred Canine/dog
Size / weight
25-49 lb (15.876 Kilogram)
Age
8+ years (1 Year)
Sex
Female Neutered
Region
USA
Reactions
ItchingLicking
Body systems
Skin & allergyOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-012217

Received 2026-03-13 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Longhair
Size / weight
Under 10 lb (1.992 Kilogram)
Age
Under 1 year (5 Month)
Sex
Female Intact
Region
USA
Reactions
Elevated temperatureDecreased body temperature
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-011996

Received 2026-03-13 · MSK · MSK

Serious
Species
Dog
Breed
Terrier - Bull - American Pit
Size / weight
50-99 lb (29.937 Kilogram)
Age
4-7 years (5 Year)
Sex
Male Neutered
Region
USA
Reactions
Injection site painAnorexiaFeverInjection site swellingInjection site abscessLethargy (see also Central nervous system depression in Neurological)
Body systems
OtherDigestiveSkin & allergyNeurologic
Outcomes
Ongoing

USA-USFDACVM-2026-US-014171

Received 2026-03-12 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.715 Kilogram)
Age
4-7 years (5 Year)
Sex
Male Neutered
Region
USA
Reactions
Behavioural disorder NOSGait abnormalityHyperthermiaMonoparesis (paralysis of limb)
Body systems
BehaviorOther
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-011403

Received 2026-03-11 · MSK · MSK

Serious
Species
Dog
Breed
['Shepherd Dog (unspecified)', 'Dog (unknown)']
Size / weight
50-99 lb (25.62 Kilogram)
Age
8+ years (8 Year)
Sex
Female Neutered
Region
USA
Reactions
DehiscenceIntestinal perforationPleural effusionPeritonitisDeath by euthanasiaPeriodontal disorderOral cavity disorder NOSSurgical site disorderAbdominal discomfortAbnormal radiograph finding
Body systems
Other
Outcomes
Euthanized

USA-USFDACVM-2026-US-011407

Received 2026-03-09 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Longhair
Size / weight
Under 10 lb (4.17 Kilogram)
Age
1-3 years (2 Year)
Sex
Female Intact
Region
USA
Reactions
Not drinkingOliguriaNeutrophiliaReluctant to moveBehavioural disorder NOSNot eatingElevated temperatureHypophosphataemiaLow creatinineHypocalcaemiaLow blood urea nitrogen (BUN)
Body systems
OtherBehavior
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-010196

Received 2026-03-09 · MSK · MSK

Serious
Species
Dog
Breed
['Schnauzer - Miniature', 'Dog (unknown)']
Size / weight
25-49 lb (12.701 Kilogram)
Age
4-7 years (5 Year)
Sex
Female Unknown
Region
USA
Reactions
BradycardiaHypotensionPremature ventricular contractionsHypoventilationHeart block NOSLack of efficacy - NOSIntentional misuse
Body systems
OtherEffectiveness
Outcomes
Ongoing

USA-USFDACVM-2026-US-009874

Received 2026-03-05 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (2.522 Kilogram)
Age
8+ years (13 Year)
Sex
Female Unknown
Region
USA
Reactions
DeathIntentional misuse
Body systems
Other
Outcomes
Died

USA-USFDACVM-2026-US-012200

Received 2026-03-04 · MSK · MSK

Serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (33.566 Kilogram)
Age
4-7 years (4 Year)
Sex
Male Intact
Region
USA
Reactions
FeverPantingElevated temperature
Body systems
Other
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-009881

Received 2026-03-03 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Longhair
Size / weight
Under 10 lb (3.175 Kilogram)
Age
1-3 years (2 Year)
Sex
Male Neutered
Region
USA
Reactions
HyperthermiaAnxiety
Body systems
OtherBehavior
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-010730

Received 2026-02-25 · MSK · MSK

Serious
Species
Dog
Breed
['Retriever - Labrador', 'Dog (unknown)']
Size / weight
50-99 lb (25.265 Kilogram)
Age
8+ years (11 Year)
Sex
Female Neutered
Region
USA
Reactions
SpondylosisGait abnormalityHead tilt - neurological disorder (see also Head tilt - ear disorder)Balance problemHorizontal nystagmusPacingStrokeDeath by euthanasiaBrain tumourUnable to walk
Body systems
OtherNeurologic
Outcomes
Euthanized

USA-USFDACVM-2026-US-009390

Received 2026-02-23 · MSK · MSK

Non-serious
Species
Dog
Breed
Terrier - Bull - Staffordshire
Size / weight
50-99 lb (30.617 Kilogram)
Age
8+ years (8 Year)
Sex
Male Neutered
Region
USA
Reactions
Swollen limbInjection site inflammationLack of efficacy (neoplasia, no remission)
Body systems
OtherEffectiveness
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-008346

Received 2026-02-23 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (4.4 Kilogram)
Age
4-7 years (4 Year)
Sex
Female Neutered
Region
USA
Reactions
MonocytosisLow creatinineGait abnormalityMuscle atrophy (see also Muscle wasting)Unkempt hair coatPlantigrade postureSedationGreasy skin
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-009436

Received 2026-02-19 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (4.2 Kilogram)
Age
Under 1 year (5 Month)
Sex
Male Intact
Region
USA
Reactions
Vomiting
Body systems
Digestive
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-007819

Received 2026-02-19 · MSK · MSK

Serious
Species
Dog
Breed
Shepherd (unspecified)
Size / weight
50-99 lb (28.576 Kilogram)
Age
4-7 years (4 Year)
Sex
Male Neutered
Region
USA
Reactions
Bloody diarrhoeaVomitingDehydrationIncreased packed cell volume (PCV)DiarrhoeaWeight loss
Body systems
DigestiveOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-010895

Received 2026-02-18 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.688 Kilogram)
Age
Under 1 year (8 Month)
Sex
Male Neutered
Region
USA
Reactions
Not sleepingHyperactivityBehavioural disorder NOS
Body systems
OtherBehavior
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-010894

Received 2026-02-18 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (2.495 Kilogram)
Age
Under 1 year (7 Month)
Sex
Female Neutered
Region
USA
Reactions
RestlessnessAgitationDifficulty standingStumbling gaitNot sleepingBehavioural disorder NOS
Body systems
OtherBehavior
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-006579

Received 2026-02-13 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (2.495 Kilogram)
Age
Under 1 year (7 Month)
Sex
Female Neutered
Region
USA
Reactions
RestlessnessAgitationDifficulty standingStumbling gaitNot sleepingBehavioural disorder NOS
Body systems
OtherBehavior
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-006576

Received 2026-02-13 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.688 Kilogram)
Age
Under 1 year (8 Month)
Sex
Male Neutered
Region
USA
Reactions
Not sleepingHyperactivityBehavioural disorder NOS
Body systems
OtherBehavior
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-010643

Received 2026-02-12 · MSK · MSK

Non-serious
Species
Dog
Breed
Retriever - Golden
Size / weight
50-99 lb (30.844 Kilogram)
Age
4-7 years (6 Year)
Sex
Female Unknown
Region
USA
Reactions
Localised pain NOS (see other SOCs for specific pain)Limb non-weight bearingSwollen limbWhiningUncomfortablePain NOSReluctant to moveInappropriate urinationAbnormal urine odourInjection site bleedingAnorexiaInjection site itchingInjection site irritationInjection site self traumaLimpingInjection site discharge NOSSkin irritationReddening of the skinAlopecia localInjection site scratchingInjection site swellingInjection site hair loss
Body systems
OtherDigestiveSkin & allergy
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-009550

Received 2026-02-08 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6.894 Kilogram)
Age
4-7 years (6.42 Year)
Sex
Male Neutered
Region
USA
Reactions
Open mouth breathingRespiratory distressFeverNot eating
Body systems
Other
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-005986

Received 2026-02-04 · MSK · MSK

Serious
Species
Dog
Breed
Terrier - Boston
Size / weight
25-49 lb (12.3 Kilogram)
Age
1-3 years (3.6 Year)
Sex
Female Neutered
Region
USA
Reactions
Hives (see also Skin)AngioedemaFacial swelling (see also Skin)
Body systems
Skin & allergyOther
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-004873

Received 2026-02-03 · MSK · MSK

Serious
Species
Dog
Breed
['Spaniel - King Charles Cavalier', 'Poodle (unspecified)']
Size / weight
10-24 lb (5.4 Kilogram)
Age
4-7 years (4 Year)
Sex
Female Unknown
Region
USA
Reactions
Emesis (multiple)Not eatingDehydrationQuietLeukocytosis NOSNeutrophiliaHyponatremiaHypokalaemiaHypochloraemiaMelaenaGastric dilationIleusGastric ulcerAbnormal ultrasound findingLack of efficacy - NOSBloody diarrhoea
Body systems
DigestiveOtherEffectiveness
Outcomes
Ongoing

USA-USFDACVM-2026-US-004494

Received 2026-02-03 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Mediumhair
Size / weight
10-24 lb (6.804 Kilogram)
Age
8+ years (9 Year)
Sex
Male Neutered
Region
USA
Reactions
Injection site cystInjection site sarcomaInjection site lumpInjection site discharge NOSInjection site irritationLethargy (see also Central nervous system depression in Neurological)Elevated symmetrical dimethylarginine (SDMA)HypoalbuminaemiaThrombocytosisHyperkalaemiaAbnormal radiograph findingConstipationPain NOSAbnormal cytologyDecreased appetiteLicking at injection site
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing

USA-USFDACVM-2026-US-008917

Received 2026-01-29 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6.53 Kilogram)
Age
1-3 years (1.33 Year)
Sex
Male Neutered
Region
USA
Reactions
PtyalismTremorSeizure NOSAggressionLeukocytosis NOSNeutrophiliaEosinopeniaHypernatraemiaElevated cholesterol (total)Eyes rolling backHyperactivityElevated haematocritDisorientationUrinary tract obstruction/blockageAnaemia NOSOther abnormal test result NOSMydriasisActing tenseMental confusionTwitchingBradycardiaDecreased heart rateBehavioural disorder NOSHaematuriaProteinuria
Body systems
OtherNeurologicBehaviorSkin & allergy
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-003960

Received 2026-01-27 · MSK · MSK

Serious
Species
Dog
Breed
Terrier - Bull - Staffordshire
Size / weight
50-99 lb (43.091 Kilogram)
Age
8+ years (9 Year)
Sex
Male Unknown
Region
USA
Reactions
General illnessDeath by euthanasiaMedication error NOS
Body systems
Other
Outcomes
Euthanized

USA-USFDACVM-2026-US-003352

Received 2026-01-27 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.992 Kilogram)
Age
8+ years (13 Year)
Sex
Female Neutered
Region
USA
Reactions
DiarrhoeaDecreased appetiteLethargy (see also Central nervous system depression in Neurological)Bloody diarrhoeaDry mucous membraneOpen mouth breathingUnresponsive to stimuliDecreased haematocritIncreased percentage reticulocytesRegenerative anaemiaIntentional misuseThrombocytopeniaHypersalivationHeart murmur
Body systems
DigestiveNeurologicOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-002947

Received 2026-01-20 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.901 Kilogram)
Age
1-3 years (3 Year)
Sex
Male Neutered
Region
USA
Reactions
AnisocoriaTwitchingTachypnoeaHypothermia
Body systems
OtherSkin & allergy
Outcomes
Ongoing

USA-USFDACVM-2026-US-003528

Received 2026-01-19 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (4 Kilogram)
Age
8+ years (13 Year)
Sex
Female Neutered
Region
USA
Reactions
Unresponsive to stimuliOpen mouth breathingAnorexiaLethargy (see also Central nervous system depression in Neurological)DiarrhoeaDry mucous membraneBloody diarrhoeaIncreased percentage reticulocytesDecreased haematocritRegenerative anaemiaThrombocytopeniaHypersalivationMurmur
Body systems
OtherDigestiveNeurologic
Outcomes
Ongoing

USA-USFDACVM-2026-US-003253

Received 2026-01-16 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6.53 Kilogram)
Age
1-3 years (1.33 Year)
Sex
Male Neutered
Region
USA
Reactions
PtyalismTremorSeizure NOSAggressionLeukocytosis NOSNeutrophiliaEosinopeniaHypernatraemiaElevated cholesterol (total)Eyes rolling backHyperactivityElevated haematocritDisorientationUrinary tract obstruction/blockageAnaemia NOSOther abnormal test result NOSMydriasisActing tenseMental confusionTwitchingBradycardiaDecreased heart rateBehavioural disorder NOSHaematuriaProteinuria
Body systems
OtherNeurologicBehaviorSkin & allergy
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-001079

Received 2026-01-16 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (4.395 Kilogram)
Age
4-7 years (4 Year)
Sex
Female Unknown
Region
USA
Reactions
LimpingWobblinessMonocytosisLow creatinineSedationUnkempt hair coatGreasy skinPlantigrade postureMuscle atrophy (see also Muscle wasting)Medication error NOS
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-005684

Received 2026-01-14 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Sex
Male Unknown
Region
USA
Reactions
Focal seizureDilated pupilsLow blood pressureBradycardiaIncorrect route of drug administration
Body systems
NeurologicOther
Outcomes
Recovered/Normal

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
32
Serious reports
22
Species represented
2
Grouped by Body System
Digestive (1) · Loss of appetite Skin & allergy (3) · Hair loss at application site, Application site hair loss, Alopecia local Neurologic (1) · Unsteady walking (ataxia) Behavior (4) · Biting -aggression, Behavioral disorder (unspecified), Anxiety Other (23) · Bladder distension, Bilirubinuria, Basophilia
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Dog 1
Digestive 1 Cat 1
Other 1 Cat 1
Behavior 1 Dog 1
Other 1 Cat 1
Behavior 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1

Species coverage: Cat (22) Dog (10)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Neurologic Dog Serious - 1
Digestive Cat Serious - 1
Skin & allergy Cat Non-serious - 1
Other Cat Serious - 1
Behavior Dog Serious - 1
Other Cat Serious - 1
Behavior Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Non-serious - 1
Other Cat Non-serious - 1
Skin & allergy Cat Non-serious - 1
Other Cat Non-serious - 1
Behavior Cat Non-serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Skin & allergy Dog Non-serious - 1
Other Cat Non-serious - 1
Behavior Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Non-serious - 1
Other Cat Serious - 1
Other Dog Non-serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Source metadata:

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

CIS SILEO N141456G0022-2.pdf Owner handouts · Labeling PI SILEO N141456G0022.pdf Official label / PI · Labeling DEXVETRA™ SPL · SPL

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

1

Official label / PI

1

SPL

7

FOI

9

CIS SILEO N141456G0022-2.pdf

Owner handouts · Labeling

Open original

PI SILEO N141456G0022.pdf

Official label / PI · Labeling

Open original

DEXVETRA™

SPL · SPL

Open original
FDA Structured Product Label

DEXVETRA™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Parnell Technologies Pty. Ltd.
ANADA
200-699
Status
RX
Form
Injectable Solution
Route
Intravenous, Intramuscular
Species
Dog • Cat
Composition / specifications
0.5 mg/mL

Dogs

Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.

Dosage

Administer 375 micrograms (mcg) per square meter (/m2) of body surface area by intravenous injection or 500 mcg/m2 of body surface area by intramuscular injection.

Indication

For use as a preanesthetic to general anesthesia.

Dosage

Administer 125 mcg/m2 of body surface area or 375 mcg/m2 of body surface area by intramuscular injection.

Cats

Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.

Dosage

40 mcg/kg by intramuscular injection

Dexmedetomidine Hydrochloride

SPL · SPL

Open original
FDA Structured Product Label

Dexmedetomidine Hydrochloride

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Felix Pharmaceuticals Pvt. Ltd.
ANADA
200-824
Status
RX
Form
Sterile Injectable Solution
Route
Intravenous, Intramuscular
Composition / specifications
0.5 mg/mL

Dogs

Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.

Dosage

Administer 375 micrograms (µg) per square meter (/m2) of body surface area by intravenous injection or 500 µg/m2 of body surface area by intramuscular injection.

Indication

For use as a preanesthetic to general anesthesia.

Dosage

Administer 125 µg/m2 of body surface area or 375 µg/m2 of body surface area by intramuscular injection.

Cats

Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.

Dosage

40 µg/killogram by intramuscular injection.

DexmedVet™

SPL · SPL

Open original
FDA Structured Product Label

DexmedVet™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Cronus Pharma Specialities India Private Ltd.
ANADA
200-752
Status
RX
Form
Sterile Injectable Solution
Route
Intramuscular, Intravenous
Species
Dog • Cat
Composition / specifications
0.5 mg/mL

Dogs

Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.

Dosage

Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 IM.

Cats

Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.


Dosage

Sedation, Analgesia and Preanesthesia: 40 mcg/kg IM.

Dexmedetomidine Hydrochloride

SPL · SPL

Open original
FDA Structured Product Label

Dexmedetomidine Hydrochloride

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
ZyVet Animal Health, Inc.
ANADA
200-735
Status
RX
Form
Injectable Solution
Route
Intravenous, Intramuscular
Species
Dog • Cat
Composition / specifications
0.5 mg/mL

Dogs

Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.

Dosage

Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 IM.

Cats

Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.

Dosage

Sedation, Analgesia and Preanesthesia: 40 mcg/kg intramuscularly (IM)

Dexmedesed®

SPL · SPL

Open original
FDA Structured Product Label

Dexmedesed®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Dechra Veterinary Products LLC
ANADA
200-573
Status
RX
Form
Sterile Solution
Route
Intramuscular, Intravenous
Species
Dog • Cat
Composition / specifications
0.5 mg/mL

<strong>Dogs</strong>

Dosage
For sedative and analgesic administer 375 mcg/m2 by intravenous (IV) injection or 500 mcg/m2 by intramuscular (IM) injection; for preanesthesia administer 125 or 375 mcg/m2 by IM injection

<strong>Cats</strong>

Indication
For use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. Dexmedetomidine HCl is also indicated for use as a preanesthetic to general anesthesia in dogs and cats
Dosage
For sedation, analgesia, or preanesthesia administer 40 mcg/kg IM

SILEO®

SPL · SPL

Open original
FDA Structured Product Label

SILEO®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Orion Corp.
NADA
141-456
Status
RX
Form
Oromucosal Gel
Route
Oromucosal
Species
Dog
Composition / specifications
Each mL contains 0.09 mg dexmedetomidine (equivalent to 0.1 mg dexmedetomidine hydrochloride)

Dogs

Indication
For the treatment of noise aversion in dogs.
Dosage
Administer onto the oral mucosa between the dog’s cheek and gum at the dose of 125 micrograms per square meter.
Limitations
Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.

Dexdomitor®

SPL · SPL

Open original
FDA Structured Product Label

Dexdomitor®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Orion Corp.
NADA
141-267
Status
RX
Form
Liquid (Solution)
Route
Intravenous, Intramuscular
Species
Dog • Cat
Composition / specifications
Each mL contains 0.5 mg dexmedetomidine hydrochloride

Cats

Indication
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.
Dosage
40 mcg/kg by intramuscular (IM) injection.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.
Indication
For use as a preanesthetic to general anesthesia.
Dosage
40 mcg/kg by intramuscular (IM) injection.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.

Dogs

Indication
For use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.
Dosage
Administer 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 of body surface area by intravenous (IV) injection. Note that the mcg/kg dosage decreases as body weight increases.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.
Indication
For use as a preanesthetic to general anesthesia.
Dosage
Administer 125 mcg/m2 of body surface area or 375 mcg/m2 of body surface area by intramuscular injection. Note that the mcg/kg dosage decreases as body weight increases.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.

FOI Summary oA 200-699 Approved March 11, 2021.pdf

FOI · FOI

Open original

FOI Summary oA 200-824 Approved September 19, 2025.pdf

FOI · FOI

Open original

FOI Summary oA 200-752 Approved July 6, 2023.pdf

FOI · FOI

Open original

FOI Summary oA 200-735 Approved January 13, 2023.pdf

FOI · FOI

Open original

UCM436647.pdf

FOI · FOI

Open original

UCM475135.pdf

FOI · FOI

Open original

UCM504535.pdf

FOI · FOI

Open original

ucm062318.pdf

FOI · FOI

Open original

ucm062316.pdf

FOI · FOI

Open original
Source metadata:
Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Reference facts: Source Roxee | Refreshed Aug 6, 2026, 7:47 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Cat, Dog
Rx/OTC: RX
Form/route: Injectable Solution, Liquid (Solution), Oromucosal Gel, Sterile Injectable Solution, Sterile Solution • Intramuscular, Intravenous, Oromucosal
Applications: ANADA 200-699 • ANADA 200-824 • ANADA 200-752 • ANADA 200-735 • ANADA 200-573 • NADA 141-456 • NADA 141-267
Documents: 11 (FOI: 9) • SPL: 7 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 157 • Cat 178 • View
Case summaries: 86 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95)
Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue. (Contraindication, High)
Top reaction signals
Unsteady walking (ataxia) (1) Loss of appetite (1) Bladder distension (1) Biting -aggression (1) Bilirubinuria (1) Behavioral disorder (unspecified) (1) Basophilia (1) Balance problem (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
ANADA: 200573 ANADA: 200699 ANADA: 200735 ANADA: 200752 ANADA: 200824 NADA: 141267 NADA: 141456 NDC Package: 11695-6967-1 NDC Package: 17033-005-10 NDC Package: 46066-088-13 NDC Package: 54771-2805-1 NDC Package: 54771-2806-1 NDC Package: 64189-8502-0 NDC Package: 64189-8502-1 NDC Package: 68504-006-10 NDC Package: 69043-038-10 NDC Package: 86101-061-41 NDC Package: 86136-105-31 NDC Package: 86136-152-31 NDC Product: 11695 NDC Product: 17033 NDC Product: 46066 NDC Product: 54771 NDC Product: 64189
Package NDC Product NDC Form / Route Status
11695-6967-1 11695 -
17033-005-10 17033 -
46066-088-13 46066 -
54771-2805-1 54771 -
54771-2806-1 54771 -
64189-8502-0 64189 -
64189-8502-1 64189 -
68504-006-10 68504 -
69043-038-10 69043 -
86101-061-41 86101 -
86136-105-31 86136 -
86136-152-31 86136 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 125 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Bradycardia, INEFFECTIVE, SEDATION, Vomiting, Sedation, Lethargy (see also Central nervous system dep… (Clinical, 2026-04-11)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respir… (Official, 2026-04-12)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respir… (Official, 2026-04-11)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respir… (Official, 2026-02-12)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-08-06)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-08-05)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-08-04)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-08-03)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-08-02)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-08-01)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-07-31)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-07-30)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-07-29)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-07-28)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-07-27)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-07-26)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-07-25)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-07-25)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-07-22)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-07-22)
Recent Revisions
  • side_effects updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
DEXVETRA™
RX
Dexmedetomidine hydrochloride
Injectable Solution • Intravenous, Intramuscular
Label highlights
Official documents
Parnell Technologies Pty. Ltd. ANADA 200-699 Approved Jan 8, 2026
Dexmedetomidine Hydrochloride
RX
Dexmedetomidine hydrochloride
Sterile Injectable Solution • Intravenous, Intramuscular
Label highlights
Official documents
Felix Pharmaceuticals Pvt. Ltd. ANADA 200-824 Approved Oct 1, 2025
DexmedVet™
RX
Dexmedetomidine hydrochloride
Sterile Injectable Solution • Intramuscular, Intravenous
Label highlights
Official documents
Cronus Pharma Specialities India Private Ltd. ANADA 200-752 Approved Aug 1, 2023
Dexmedetomidine Hydrochloride
RX
Dexmedetomidine hydrochloride
Injectable Solution • Intravenous, Intramuscular
Label highlights
Official documents
ZyVet Animal Health, Inc. ANADA 200-735 Approved Feb 1, 2023
Dexmedesed®
RX
Dexmedetomidine hydrochloride
Sterile Solution • Intramuscular, Intravenous
Label highlights
Official documents
Dechra Veterinary Products LLC ANADA 200-573 Approved Dec 16, 2021
SILEO®
RX
Dexmedetomidine
Oromucosal Gel • Oromucosal
Label highlights
Official documents
Orion Corp. NADA 141-456 Approved May 17, 2021
Dexdomitor®
RX
Dexmedetomidine hydrochloride
Liquid (Solution) • Intravenous, Intramuscular
Label highlights
Official documents
Orion Corp. NADA 141-267 Approved Jun 1, 2016

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Dog • Cat
Composition / specifications
0.5 mg/mL
Dogs
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.

Dosage

Administer 375 micrograms (mcg) per square meter (/m2) of body surface area by intravenous injection or 500 mcg/m2 of body surface area by intramuscular injection.

Limitations
Indication

For use as a preanesthetic to general anesthesia.

Dosage

Administer 125 mcg/m2 of body surface area or 375 mcg/m2 of body surface area by intramuscular injection.

Limitations
Cats
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.

Dosage

40 mcg/kg by intramuscular injection

Limitations

FDA page: Open in Animal Drugs @ FDA

Composition / specifications
0.5 mg/mL
Dogs
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.

Dosage

Administer 375 micrograms (µg) per square meter (/m2) of body surface area by intravenous injection or 500 µg/m2 of body surface area by intramuscular injection.

Limitations
Indication

For use as a preanesthetic to general anesthesia.

Dosage

Administer 125 µg/m2 of body surface area or 375 µg/m2 of body surface area by intramuscular injection.

Limitations
Cats
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.

Dosage

40 µg/killogram by intramuscular injection.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog • Cat
Composition / specifications
0.5 mg/mL
Dogs
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.

Dosage

Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 IM.

Limitations
Cats
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.


Dosage

Sedation, Analgesia and Preanesthesia: 40 mcg/kg IM.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog • Cat
Composition / specifications
0.5 mg/mL
Dogs
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.

Dosage

Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 IM.

Limitations
Cats
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.

Dosage

Sedation, Analgesia and Preanesthesia: 40 mcg/kg intramuscularly (IM)

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog • Cat
Composition / specifications
0.5 mg/mL
<strong>Dogs</strong>
Indication
Dosage
For sedative and analgesic administer 375 mcg/m2 by intravenous (IV) injection or 500 mcg/m2 by intramuscular (IM) injection; for preanesthesia administer 125 or 375 mcg/m2 by IM injection
Limitations
<strong>Cats</strong>
Indication
For use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. Dexmedetomidine HCl is also indicated for use as a preanesthetic to general anesthesia in dogs and cats
Dosage
For sedation, analgesia, or preanesthesia administer 40 mcg/kg IM
Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog
Composition / specifications
Each mL contains 0.09 mg dexmedetomidine (equivalent to 0.1 mg dexmedetomidine hydrochloride)
Dogs
Indication
For the treatment of noise aversion in dogs.
Dosage
Administer onto the oral mucosa between the dog’s cheek and gum at the dose of 125 micrograms per square meter.
Limitations
Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dog • Cat
Composition / specifications
Each mL contains 0.5 mg dexmedetomidine hydrochloride
Cats
Indication
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.
Dosage
40 mcg/kg by intramuscular (IM) injection.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.
Indication
For use as a preanesthetic to general anesthesia.
Dosage
40 mcg/kg by intramuscular (IM) injection.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.
Dogs
Indication
For use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.
Dosage
Administer 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 of body surface area by intravenous (IV) injection. Note that the mcg/kg dosage decreases as body weight increases.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.
Indication
For use as a preanesthetic to general anesthesia.
Dosage
Administer 125 mcg/m2 of body surface area or 375 mcg/m2 of body surface area by intramuscular injection. Note that the mcg/kg dosage decreases as body weight increases.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.

FDA page: Open in Animal Drugs @ FDA

Usage

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. For use as a preanesthetic to general anesthesia. For use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Loss of appetite (1) • Cat

Showing top 5 for Digestive.

Skin & allergy
Hair loss at application site (1) • Cat Application site hair loss (1) • Cat Alopecia local (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog

Showing top 5 for Neurologic.

Behavior
Biting -aggression (1) • Dog Behavioral disorder (1) • Cat Anxiety (1) • Cat Aggression (1) • Cat

Showing top 5 for Behavior.

Other
Bladder distension (1) • Cat Bilirubinuria (1) • Cat Basophilia (1) • Cat Balance problem (1) • Dog Azotaemia (1) • Cat
Show more (18)
Application site reddening (1) • Cat Application site lesion (1) • Cat Application site discharge NOS (1) • Cat Anisocoria (1) • Cat Angioedema (1) • Dog Anaemia NOS (1) • Cat Agitation (1) • Cat Administration error NOS (1) • Cat Acting tense (1) • Cat Accidental exposure (1) • Cat Abnormal urine odour (1) • Dog Abnormal ultrasound finding (1) • Cat Abnormal Schirmer tear test (1) • Dog Abnormal radiograph finding (1) • Cat Abnormal posture NOS (1) • Dog Abnormal cytology (1) • Cat Abdominal discomfort (1) • Dog Abdominal cavity disorder NOS (1) • Dog

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Cat, Domestic Shorthair, Male, 10 month, 5 kilogram • Drug: MSK, Unknown • Reactions: Seizure NOS • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2026-US-014624
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 10.00 Month
  • Weight: 5.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Seizure NOS
Outcomes: Recovered/Normal

Dog, Pug, Male, 3.75 year, 12.7 kilogram • Drug: MSK, Unknown • Reactions: Neurogenic keratoconjunctivitis sicca, Corneal ulcer, Nasal cavity disorder NOS, Abnormal Schirmer tear test • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-014105
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 3.75 Year
  • Weight: 12.700 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Neurogenic keratoconjunctivitis sicca Corneal ulcer Nasal cavity disorder NOS Abnormal Schirmer tear test
Outcomes: Ongoing

Dog, ['Mastiff (unspecified)', 'Crossbred Canine/dog'], Male, 1 year, 29.574 kilogram • Drug: MSK, Injection, Intramuscular, Dose: 0.30 mL per animal • Reactions: Hypotension, Not eating, Nausea, Drowsiness - systemic disorder, Pain NOS… • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2026-US-014066
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 1.00 Year
  • Weight: 29.574 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Injection
  • Dose: 0.30 mL per animal
Reactions Reported:
Hypotension Not eating Nausea Drowsiness - systemic disorder Pain NOS Vomiting Regurgitation Discoloured urine Cough Crust Hyperproteinaemia Hypoalbuminaemia Leukocytosis NOS Neutrophilia Fluid in abdomen NOS Septicaemia Intestinal disorder NOS Abdominal cavity disorder NOS Elevated lactate Abnormal cytology Duodenal ulcer Intestinal perforation Death by euthanasia Lack of efficacy - NOS Intentional misuse
Outcomes: Euthanized

Cat, Ragdoll, Male, 10 year, 5.498 kilogram • Drug: MSK, Unknown • Reactions: Head tilt - neurological disorder, Unsteady walking (ataxia) • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-014107
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 5.498 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Head tilt - neurological disorder Unsteady walking (ataxia)
Outcomes: Outcome Unknown

Cat, Domestic Longhair, Male, 5 month, 2.781 kilogram • Drug: MSK, Injection, Intramuscular, Dose: 0.16 mL per animal • Reactions: Increased respiratory rate, Breathing difficulty, Crackles on auscultation, Abnormal ultrasound finding, Pulmonary disorder NOS… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-013761
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 5.00 Month
  • Weight: 2.781 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Injection
  • Dose: 0.16 mL per animal
Reactions Reported:
Increased respiratory rate Breathing difficulty Crackles on auscultation Abnormal ultrasound finding Pulmonary disorder NOS Intentional misuse Decreased pulse oxygenation Pale mucous membrane
Outcomes: Ongoing

Dog, Terrier - Bull - Staffordshire, Female, 2 year, 33.611 kilogram • Drug: MSK, Injection, Intramuscular • Reactions: Facial swelling (possible allergy), Hypersensitivity reaction, Vomiting, Bloody diarrhoea, Unsteady walking (ataxia)… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-013479
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 2.00 Year
  • Weight: 33.611 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Injection
Reactions Reported:
Facial swelling (possible allergy) Hypersensitivity reaction Vomiting Bloody diarrhoea Unsteady walking (ataxia) Elevated total bilirubin Elevated alanine aminotransferase Elevated blood urea nitrogen Tiredness (lethargy) Intentional misuse
Outcomes: Ongoing

Cat, Domestic Shorthair, Male, 6 year, 5.89 kilogram • Drug: MSK, Unknown • Reactions: Gastrointestinal foreign body NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-013840
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 6.00 Year
  • Weight: 5.890 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Gastrointestinal foreign body NOS
Outcomes: Ongoing

Dog, Crossbred Canine/dog, Female, 1 year, 14.969 kilogram • Drug: MSK, Injection, Intramuscular • Reactions: Vocalisation, Restlessness, Intentional misuse • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-012798
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 1.00 Year
  • Weight: 14.969 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Injection
Reactions Reported:
Vocalisation Restlessness Intentional misuse
Outcomes: Ongoing

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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