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Roxee Medication Guide

Dexmedetomidine

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

Dexmedetomidine

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

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
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
Needs review
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 (USA) restricts this drug to use by or on the order of a licensed veterinarian.

  • 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 (USA) restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Lack of efficacy - NOS, Vomiting, Injection site swelling, Death, Bradycardia, Diarrhoea.

FAQ

Both, Dog, Cat

Yes. Roxee shows this as prescription-only.

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

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
  • Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian
  • wobbly/unsteady walking (1 reports)
  • Loss of appetite (1 reports)
  • Basophilia (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

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; 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; 21 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), Basophilia (1 reports), Balance problem (1 reports), Bacterial skin infection NOS (1 reports)

Body systems represented Signal grouping

Digestive (1), Skin & allergy (3), Neurologic (1), Behavior (2)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Cat (17 reports), Dog (15 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 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, Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian, wobbly/unsteady walking, Loss of appetite, Basophilia

Call sooner if Escalation

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

Bottom line: Use this Dexmedetomidine 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: April 15, 2026, 10:04 AM 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
  • Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian
  • wobbly/unsteady walking
  • Loss of appetite
  • Basophilia

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Loss of appetite (1 reports)
  • Basophilia (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.

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: 54771-1050-1 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
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. Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.

  • 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. Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.
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
1
Active filters
2
Selected filters
Reaction: Intentional misuse Clear Body system: Skin & allergy Clear
Reset
Showing up to 50 matching reports.

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

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

Tracked signals
32
Reported cases
32
Serious reports
21
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 (2) · Anxiety, Aggression Other (25) · Basophilia, Balance problem, Bacterial skin infection NOS
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Dog 1
Digestive 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Cat (17) Dog (15)

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
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Skin & allergy Cat Non-serious - 1
Other Cat Non-serious - 1
Other Dog 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 Dog 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 Dog Non-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.

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

PI SILEO N141456G0022.pdf

Official label / PI · Labeling

DEXVETRA™

SPL · SPL

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

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

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

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

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

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

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

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

FOI · FOI

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

FOI · FOI

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

FOI · FOI

UCM436647.pdf

FOI · FOI

UCM475135.pdf

FOI · FOI

UCM504535.pdf

FOI · FOI

ucm062318.pdf

FOI · FOI

ucm062316.pdf

FOI · FOI

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. Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Unsteady walking (ataxia) (1) Loss of appetite (1) Basophilia (1) Balance problem (1) Bacterial skin infection NOS (1) Azotaemia (1) Arthritis (1) Application site pain (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: 54771-1050-1 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
Package NDC Product NDC Form / Route Status
11695-6967-1 11695 -
17033-005-10 17033 -
46066-088-13 46066 -
54771-1050-1 54771 -
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 122 Clinical 9 Manufacturer 0 Marketing 0
Current Field Facts
  • 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… (Clinical, 2026-04-15)
  • 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… (Clinical, 2026-04-15)
  • 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… (Clinical, 2026-04-11)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Vomiting, Injection site swelling, Death, Bradycardia, Diarrhoea. (Clinical, 2026-04-11)
  • usage: For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. For use a… (Clinical, 2026-04-15)
  • usage: For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. For use a… (Clinical, 2026-04-15)
  • usage: For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. For use a… (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, 2026-04-22)
  • 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)
Recent Revisions
  • side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-16 13:28 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-16 13:28 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-16 13:28 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-16 13:28 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-16 13:28 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-16 13:28 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-15 10:07 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-15 10:07 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-15 10:07 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-15 10:07 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-15 10:07 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-15 10:07 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-15 10:07 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-15 10:07 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-15 10:07 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-15 10:04 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
Parnell Technologies Pty. Ltd. ANADA 200-699 Approved Jan 8, 2026
Dexmedetomidine Hydrochloride
RX
Dexmedetomidine hydrochloride
Sterile Injectable Solution Intravenous, Intramuscular
Felix Pharmaceuticals Pvt. Ltd. ANADA 200-824 Approved Oct 1, 2025
DexmedVet™
RX
Dexmedetomidine hydrochloride
Sterile Injectable Solution Intramuscular, Intravenous
Cronus Pharma Specialities India Private Ltd. ANADA 200-752 Approved Aug 1, 2023
Dexmedetomidine Hydrochloride
RX
Dexmedetomidine hydrochloride
Injectable Solution Intravenous, Intramuscular
ZyVet Animal Health, Inc. ANADA 200-735 Approved Feb 1, 2023
Dexmedesed®
RX
Dexmedetomidine hydrochloride
Sterile Solution Intramuscular, Intravenous
Dechra Veterinary Products LLC ANADA 200-573 Approved Dec 16, 2021
SILEO®
RX
Dexmedetomidine
Oromucosal Gel Oromucosal
Orion Corp. NADA 141-456 Approved May 17, 2021
Dexdomitor®
RX
Dexmedetomidine hydrochloride
Liquid (Solution) Intravenous, Intramuscular
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. Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.

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
Anxiety (1) • Cat Aggression (1) • Cat

Showing top 5 for Behavior.

Other
Basophilia (1) • Cat Balance problem (1) • Dog Bacterial skin infection NOS (1) • Dog Azotaemia (1) • Cat Arthritis (1) • Dog
Show more (20)
Application site reddening (1) • Cat Application site pain (1) • Dog Application site lesion (1) • Cat Application site discharge NOS (1) • Cat Application site bleeding (1) • Dog Anisocoria (1) • Cat Angioedema (1) • Dog Anaemia NOS (1) • Cat Agitation (1) • Cat Acting tense (1) • Cat Acid-base disorder (1) • Dog 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 electrocardiogram (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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Let others know your experience or advice regarding this medication.

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