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Roxee Medication Guide

Buprenorphine

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 Injectable Solution Multiple FDA labelers Official label facts Owner quick guide first
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Showing simplified owner view. Switch to Vet View for full technical detail.

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.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • 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
Buprenorphine

Buprenorphine

Drug type: Generic ingredient • Branded profile • FDA branded products available

Both Injectable Solution Rx required 100% reference complete

Species: Both

Manufacturer: Multiple FDA labelers

Medication Snapshot

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

Buprenorphine

For the control of postoperative pain associated with surgical procedures in cats. Species commonly shown: Both, Cat.

Generic name
Buprenorphine
Brand names
Simbadol®, Zorbium™, Zorbium, Simbadol
Manufacturer
Multiple FDA labelers
Species
Both, Cat
Dosage forms
Injectable Solution, Transdermal Solution
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Simbadol® Zorbium™ Zorbium Simbadol
Dosage forms
Injectable Solution Transdermal Solution

Indications / Uses

For the control of postoperative pain associated with surgical procedures in cats.

Warnings / Contraindications

Federal law 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.

Side Effects

Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Diarrhoea, Death, Death by euthanasia, Anorexia.

FAQ

Both, Cat

Yes. Roxee shows this as prescription-only.

Injectable Solution, Transdermal Solution

Related Conditions

Pain (acute, chronic) Pica

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 the control of postoperative pain associated with surgical procedures in cats.

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:

  • Loss of appetite (1 reports)
  • Ascites (1 reports)
  • Arthritis (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 Buprenorphine; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-072073
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 20 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-072073
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-2025-US-072073
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

Loss of appetite (1 reports), Ascites (1 reports), Arthritis (1 reports), Arched back (1 reports), Appetite loss (1 reports)

Body systems represented Signal grouping

Digestive (2), Skin & allergy (3), Behavior (2), Other (25)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Cat (27 reports), Dog (5 reports)

Breed metadata in reports Metadata only

Domestic Shorthair (4), Spaniel - King Charles Cavalier (1), Cat (unknown) (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 Buprenorphine 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

Loss of appetite, Ascites, Arthritis

Call sooner if Escalation

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

Bottom line: Use this Buprenorphine 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-2025-US-072073 · 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:

  • Loss of appetite
  • Ascites
  • Arthritis

Most reported reactions:

  • Loss of appetite (1 reports)
  • Ascites (1 reports)
  • Arthritis (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
Indication / use
For the control of postoperative pain associated with surgical procedures in cats.
Form / route / dose
Form: Injectable Solution, Transdermal Solution
Route: Subcutaneous, Topical
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.
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 labelers
Form: Injectable Solution, Transdermal Solution
Identifiers:
NADA: 141434 NADA: 141547 NDC Package: 54771-4131-1 NDC Package: 58198-0078-1 NDC Package: 58198-0078-2 NDC Package: 86084-100-30 NDC Product: 54771 NDC Product: 58198 NDC Product: 86084
Source metadata:

Warnings / Contraindications

Federal law 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.
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
104
Matching reports
104
Active filters
0
Reset
Drill into common report signals
Not eating (23) Lethargy (see also Central nervous system depression in Neurological) (20) Behavioural disorder NOS (17) Dilated pupils (13) Other (96) Neurologic (32) Digestive (23) Behavior (22)
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-014468

Received 2026-03-26 · MSK · MSK

Serious
Species
Dog
Breed
Spaniel - King Charles Cavalier
Size / weight
10-24 lb (9.48 Kilogram)
Age
4-7 years (7 Year)
Sex
Female Unknown
Region
USA
Reactions
CyanosisRespiratory arrestPremature ventricular contractionsDeath
Body systems
Other
Outcomes
Died

USA-USFDACVM-2026-US-014253

Received 2026-03-24 · MSK · MSK

Non-serious
Species
Cat
Breed
Cat (unknown)
Sex
Unknown Unknown
Region
USA
Reactions
HidingUnclassifiable adverse event
Body systems
Other
Outcomes
Recovered/Normal

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-014109

Received 2026-03-23 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (1.8 Kilogram)
Age
Under 1 year (6 Month)
Sex
Female Intact
Region
USA
Reactions
Tongue ulcerationNot eatingDroolingStomatitis
Body systems
OtherDigestive
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-014093

Received 2026-03-23 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (2.22 Kilogram)
Age
Under 1 year (19.7 Week)
Sex
Female Neutered
Region
USA
Reactions
Not himself/herselfBehavioural disorder NOSDisorientationDilated pupilsLethargy (see also Central nervous system depression in Neurological)AtaxiaNot eating
Body systems
OtherBehaviorNeurologic
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-013871

Received 2026-03-23 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (2.72 Kilogram)
Age
Under 1 year (6 Month)
Sex
Female Intact
Region
USA
Reactions
Tongue ulceration
Body systems
Other
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-013856

Received 2026-03-23 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Mediumhair
Size / weight
Under 10 lb (2.95 Kilogram)
Age
Under 1 year (6 Month)
Sex
Female Intact
Region
USA
Reactions
Tongue ulceration
Body systems
Other
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-013464

Received 2026-03-23 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6.169 Kilogram)
Age
8+ years (16 Year)
Sex
Female Unknown
Region
USA
Reactions
Injection site mass NOSAbnormal radiograph findingFibrosarcoma
Body systems
Other
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-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-013262

Received 2026-03-19 · MSK · MSK

Serious
Species
Cat
Breed
Persian
Size / weight
Under 10 lb (4.08 Kilogram)
Age
4-7 years (4 Year)
Sex
Male Neutered
Region
USA
Reactions
Laboured breathingAnorexia
Body systems
OtherDigestive
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-014257

Received 2026-03-17 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (4.53 Kilogram)
Age
1-3 years (2 Year)
Sex
Female Neutered
Region
USA
Reactions
Limb amputationInjection site sarcomaBehavioural disorder NOSLethargy (see also Central nervous system depression in Neurological)Localised pain NOS (see other SOCs for specific pain)VocalisationLimpingInjection site mass NOS
Body systems
OtherBehaviorNeurologic
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-013220

Received 2026-03-17 · MSK · MSK

Non-serious
Species
Dog
Breed
['Terrier - Bull - American Pit', 'Dog (unknown)']
Age
8+ years (13 Year)
Sex
Male Neutered
Region
USA
Reactions
Head downWalking difficulty
Body systems
Other
Outcomes
Ongoing

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-014358

Received 2026-03-16 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.37 Kilogram)
Age
1-3 years (2 Year)
Sex
Female Neutered
Region
USA
Reactions
VomitingLethargy (see also Central nervous system depression in Neurological)High pancreatic-specific lipaseDehydrationNeutrophiliaPancreatitis NOSNot eatingLeukocytosis NOSDepressionElevated gamma-glutamyl transferase (GGT)AzotaemiaAnaemia NOSHypoalbuminaemiaAbdominal effusionHyperglycaemiaElevated symmetrical dimethylarginine (SDMA)Elevated blood urea nitrogen (BUN)Elevated creatinineHyponatremiaHypochloraemiaLow serum alkaline phosphatase (ALP)Decreased red blood cell countDecreased haemoglobinProteinuria
Body systems
DigestiveNeurologicOther
Outcomes
Recovered/Normal

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-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-012294

Received 2026-03-16 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6.26 Kilogram)
Age
8+ years (11 Year)
Sex
Male Neutered
Region
USA
Reactions
Not eatingHypersalivationHypoglycaemiaHypotensionAbnormal ultrasound findingHidingBehavioural disorder NOSLethargy (see also Central nervous system depression in Neurological)HypothermiaDehydrationNeutropeniaDiarrhoeaSoft stool
Body systems
OtherDigestiveBehaviorNeurologic
Outcomes
Ongoing

USA-USFDACVM-2026-US-014081

Received 2026-03-13 · MSK · MSK

Serious
Species
Dog
Breed
Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog)
Size / weight
50-99 lb (23.2 Kilogram)
Age
4-7 years (5 Year)
Sex
Male Neutered
Region
USA
Reactions
Sudden death
Body systems
Other
Outcomes
Died

USA-USFDACVM-2026-US-012855

Received 2026-03-13 · MSK · MSK

Serious
Species
Dog
Breed
Pug
Sex
Unknown
Region
USA
Reactions
DeathCardiac arrest
Body systems
Other
Outcomes
Died

USA-USFDACVM-2026-US-012843

Received 2026-03-13 · MSK · MSK

Serious
Species
Dog
Breed
Bulldog - French
Sex
Unknown
Region
USA
Reactions
DeathCardiac arrest
Body systems
Other
Outcomes
Died

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-011414

Received 2026-03-13 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (4.54 Kilogram)
Age
8+ years (17 Year)
Sex
Female Neutered
Region
USA
Reactions
HyperactivityUrinary retentionConstipationRestlessnessDysphoriaNot sleeping
Body systems
Other
Outcomes
Recovered/Normal

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-011402

Received 2026-03-11 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (7.529 Kilogram)
Age
8+ years (11 Year)
Sex
Male Neutered
Region
USA
Reactions
Dilated pupilsNot sleepingBehavioural disorder NOSRestlessness
Body systems
OtherBehavior
Outcomes
Outcome Unknown

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-010873

Received 2026-03-04 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (4.98 Kilogram)
Age
8+ years (9.91 Year)
Sex
Female Neutered
Region
USA
Reactions
Sedation prolongedIncreased respiratory rateOpen mouth breathingDeath by euthanasiaCardiac enlargementAdministration error NOS
Body systems
Other
Outcomes
Euthanized

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-009572

Received 2026-03-03 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (1.8 Kilogram)
Age
Under 1 year (6 Month)
Sex
Male Intact
Region
USA
Reactions
Decreased appetiteListlessDehydrationNot himself/herselfStumbling gaitArched backAbnormal postureSpinal pain NOSKnucklingDysphoriaSlow reflexesReduced responsesDilated pupilsStaringElevated temperatureStiff gaitBehavioural disorder NOS
Body systems
DigestiveOtherBehavior
Outcomes
Ongoing

USA-USFDACVM-2026-US-008769

Received 2026-02-28 · MSK · MSK

Serious
Species
Cat
Breed
Russian
Size / weight
Under 10 lb (4.3 Kilogram)
Age
8+ years (19 Year)
Sex
Male Neutered
Region
USA
Reactions
Not drinkingNot eatingDullnessAnaemia NOSCardiac disorder NOSHeart murmurPale mucous membraneAtaxiaOliguriaRenal failureDeath by euthanasiaInappetenceLethargy (see also Central nervous system depression in Neurological)AscitesThird eyelid protrusionLateral recumbencyAcute renal failureDehydrationProlonged capillary refill timeHyperglycaemiaSplenic neoplasm NOSHead bobbingElevated blood urea nitrogen (BUN)Elevated creatinineAbnormal radiograph findingAzotaemiaDecreased packed cell volume (PCV)DullHypernatraemia
Body systems
OtherNeurologic
Outcomes
Euthanized

USA-USFDACVM-2026-US-009973

Received 2026-02-27 · MSK · MSK

Serious
Species
Dog
Breed
Crossbred Canine/dog
Size / weight
50-99 lb (34.019 Kilogram)
Age
8+ years (10.5 Year)
Sex
Male Neutered
Region
USA
Reactions
Not eatingWalking difficultyPantingSeizure NOSDeathIntentional misuse
Body systems
OtherNeurologic
Outcomes
Died

USA-USFDACVM-2026-US-009570

Received 2026-02-26 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (7.87 Kilogram)
Age
8+ years (11.8 Year)
Sex
Male Neutered
Region
USA
Reactions
FeverNot urinatingElevated aspartate aminotransferase (AST)Decreased blood urea nitrogen (BUN) or creatinineLow creatinineHypocalcaemiaHypoproteinaemia
Body systems
Other
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-008768

Received 2026-02-25 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (4.536 Kilogram)
Age
8+ years (14.5 Year)
Sex
Female Unknown
Region
USA
Reactions
Open mouth breathingUnable to walkBalance impairedDilated pupilsAbnormal posture NOSArthritisTwitchingLethargy (see also Central nervous system depression in Neurological)Unresponsive to stimuli
Body systems
OtherSkin & allergyNeurologic
Outcomes
Ongoing

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-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-007430

Received 2026-02-19 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (4.98 Kilogram)
Age
8+ years (8 Year)
Sex
Female Neutered
Region
USA
Reactions
Dilated pupilsHyperactivityQuiet
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-007434

Received 2026-02-18 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.44 Kilogram)
Age
1-3 years (3 Year)
Sex
Male Neutered
Region
USA
Reactions
Application site alopecia
Body systems
Skin & allergy
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-006824

Received 2026-02-16 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.63 Kilogram)
Age
Under 1 year (6 Month)
Sex
Male Intact
Region
USA
Reactions
HyperactivityNot sleeping
Body systems
Other
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-011611

Received 2026-02-14 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6.3 Kilogram)
Age
4-7 years (6 Year)
Sex
Male Neutered
Region
USA
Reactions
DeathDullNot himself/herselfHead pressingHypotensionUnresponsive to stimuli
Body systems
Other
Outcomes
Died

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-007418

Received 2026-02-09 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (8.7 Kilogram)
Age
1-3 years (2.8 Year)
Sex
Male Neutered
Region
USA
Reactions
Lack of efficacy - NOSNot eatingLethargy (see also Central nervous system depression in Neurological)General pain (see other SOCs for specific pain)Facial oedemaTrigeminus paralysisOral ulcerationIntentional misuse
Body systems
EffectivenessOtherNeurologic
Outcomes
Ongoing

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-004923

Received 2026-02-04 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (4.33 Kilogram)
Age
Under 1 year (6 Month)
Sex
Male Neutered
Region
USA
Reactions
HallucinationHyperactivityFallingLocomotor disturbance
Body systems
Other
Outcomes
Ongoing

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

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

Tracked signals
32
Reported cases
32
Serious reports
20
Species represented
2
Grouped by Body System
Digestive (2) · Loss of appetite, Appetite loss Skin & allergy (3) · Hair loss at application site, Application site pruritus, Application site hair loss Behavior (2) · Anxiety, Aggression Other (25) · Ascites, Arthritis, Arched back
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Digestive 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1

Species coverage: Cat (27) Dog (5)

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

Simbadol® SPL · SPL Zorbium™ SPL · SPL Simbadol SPL SPL · Structured Product Label

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

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

4

FOI

2

Simbadol®

SPL · SPL

Open original
FDA Structured Product Label

Simbadol®

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

Sponsor
Zoetis Inc.
NADA
141-434
Status
RX
Form
Injectable Solution
Route
Subcutaneous
Species
Cat
Composition / specifications
Each milliliter of solution contains 1.8 milligrams buprenorphine.

Cats

Indication
For the control of postoperative pain associated with surgical procedures in cats.
Dosage
Administer 0.24 mg/kg (0.11 mg/lb) by subcutaneous injection once daily for up to 3 days. Administer the first dose approximately 1 hour prior to surgery.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Zorbium™

SPL · SPL

Open original
FDA Structured Product Label

Zorbium™

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

Sponsor
Elanco US Inc.
NADA
141-547
Status
RX
Form
Transdermal Solution
Route
Topical
Species
Cat
Composition / specifications
20mg/mL

Cats

Indication

For the control of postoperative pain associated with surgical procedures in cats.

Dosage

Administer topically to the dorsal cervical area at the base of the skull a single dose of 1.2 to 3.1 mg/lb (2.7 to 6.7 mg/kg) approximately 1 to 2 hours before surgery.

Simbadol SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Simbadol. Use the source link for the full official labeling record.

Zorbium SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Zorbium. Use the source link for the full official labeling record.

UCM408852.pdf

FOI · FOI

Open original

FOI Summary oN 141-547 Approved January 20, 2022.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.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • 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 • FDA branded products available
Official FDA brands: Simbadol Zorbium
Manufacturer mapping: Multiple FDA labelers
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Cat
Rx/OTC: RX
Form/route: Injectable Solution, Transdermal Solution • Subcutaneous, Topical
Applications: NADA 141-434 • NADA 141-547
NDC: Packages 54771-4131-1 58198-0078-1 58198-0078-2 • Products 54771 58198
Documents: 2 (FOI: 2) • SPL: 2 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 136 • Cat 269 • View
Case summaries: 104 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Related conditions: Pain (acute, chronic) Pica
Linked using: Fda_Label (0.95), 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. (Contraindication, High)
Top reaction signals
Loss of appetite (1) Ascites (1) Arthritis (1) Arched back (1) Appetite loss (1) Anisocoria (1) Angioedema (1) Anaemia NOS (1)

Identifiers & Packages

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

Identifiers
NADA: 141434 NADA: 141547 NDC Package: 54771-4131-1 NDC Package: 58198-0078-1 NDC Package: 58198-0078-2 NDC Package: 86084-100-30 NDC Product: 54771 NDC Product: 58198 NDC Product: 86084
Package NDC Product NDC Form / Route Status
54771-4131-1 54771 -
58198-0078-1 58198 -
58198-0078-2 58198 -
86084-100-30 86084 -

Enriched Documents

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

  • Simbadol SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Zorbium SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • UCM408852.pdf • FOI summary • Official • Feb. 8, 2023
    FDA FOI summary for application 141434
  • FOI Summary oN 141-547 Approved January 20, 2022.pdf • FOI summary • Official • Feb. 1, 2022
    FDA FOI summary for application 141547

Data Sources & Change Log

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

Official 123 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Diarrhoea, Death, Death by euthanasia, Ano… (Clinical, 2026-04-11)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Official, 2026-04-12)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Official, 2026-04-11)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Official, 2026-02-12)
  • indications: For the control of postoperative pain associated with surgical procedures in cats For the control of postoperative pain associated with surgical procedures in … (Official, 2026-08-06)
  • indications: For the control of postoperative pain associated with surgical procedures in cats For the control of postoperative pain associated with surgical procedures in … (Official, 2026-08-05)
  • indications: For the control of postoperative pain associated with surgical procedures in cats For the control of postoperative pain associated with surgical procedures in … (Official, 2026-08-04)
  • indications: For the control of postoperative pain associated with surgical procedures in cats For the control of postoperative pain associated with surgical procedures in … (Official, 2026-08-03)
  • indications: For the control of postoperative pain associated with surgical procedures in cats For the control of postoperative pain associated with surgical procedures in … (Official, 2026-08-02)
  • indications: For the control of postoperative pain associated with surgical procedures in cats For the control of postoperative pain associated with surgical procedures in … (Official, 2026-08-01)
  • indications: For the control of postoperative pain associated with surgical procedures in cats For the control of postoperative pain associated with surgical procedures in … (Official, 2026-07-31)
  • indications: For the control of postoperative pain associated with surgical procedures in cats For the control of postoperative pain associated with surgical procedures in … (Official, 2026-07-30)
  • indications: For the control of postoperative pain associated with surgical procedures in cats For the control of postoperative pain associated with surgical procedures in … (Official, 2026-07-29)
  • indications: For the control of postoperative pain associated with surgical procedures in cats For the control of postoperative pain associated with surgical procedures in … (Official, 2026-07-28)
  • indications: For the control of postoperative pain associated with surgical procedures in cats For the control of postoperative pain associated with surgical procedures in … (Official, 2026-07-27)
  • indications: For the control of postoperative pain associated with surgical procedures in cats For the control of postoperative pain associated with surgical procedures in … (Official, 2026-07-26)
  • indications: For the control of postoperative pain associated with surgical procedures in cats For the control of postoperative pain associated with surgical procedures in … (Official, 2026-07-25)
  • indications: For the control of postoperative pain associated with surgical procedures in cats For the control of postoperative pain associated with surgical procedures in … (Official, 2026-07-25)
  • indications: For the control of postoperative pain associated with surgical procedures in cats For the control of postoperative pain associated with surgical procedures in … (Official, 2026-07-22)
  • indications: For the control of postoperative pain associated with surgical procedures in cats For the control of postoperative pain associated with surgical procedures in … (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
Simbadol®
RX
Buprenorphine
Injectable Solution • Subcutaneous
Label highlights
Official documents
Zoetis Inc. NADA 141-434 Approved Feb 8, 2023
Zorbium™
RX
Buprenorphine
Transdermal Solution • Topical
Label highlights
Official documents
Elanco US Inc. NADA 141-547 Approved Feb 1, 2022

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: Cat
Composition / specifications
Each milliliter of solution contains 1.8 milligrams buprenorphine.
Cats
Indication
For the control of postoperative pain associated with surgical procedures in cats.
Dosage
Administer 0.24 mg/kg (0.11 mg/lb) by subcutaneous injection once daily for up to 3 days. Administer the first dose approximately 1 hour prior to surgery.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Cat
Composition / specifications
20mg/mL
Cats
Indication

For the control of postoperative pain associated with surgical procedures in cats.

Dosage

Administer topically to the dorsal cervical area at the base of the skull a single dose of 1.2 to 3.1 mg/lb (2.7 to 6.7 mg/kg) approximately 1 to 2 hours before surgery.

Limitations

FDA page: Open in Animal Drugs @ FDA

Usage

For the control of postoperative pain associated with surgical procedures in cats.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Federal law 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) • Dog Appetite loss (1) • Cat

Showing top 5 for Digestive.

Skin & allergy
Hair loss at application site (1) • Cat Application site pruritus (1) • Cat Application site hair loss (1) • Cat

Showing top 5 for Skin & allergy.

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

Showing top 5 for Behavior.

Other
Ascites (1) • Cat Arthritis (1) • Cat Arched back (1) • Cat Application site skin scaling (1) • Cat Application site reddening (1) • Cat
Show more (20)
Application site lesion (1) • Cat Application site irritation (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 Acute renal failure (1) • Cat Acting tense (1) • Cat Abnormal ultrasound finding (1) • Dog Abnormal radiograph finding (1) • Cat Abnormal pupil light reflex (1) • Cat Abnormal posture NOS (1) • Cat Abnormal posture (1) • Cat Abnormal movement NOS (1) • Cat Abnormal cytology (1) • Dog Abdominal pain (1) • Cat Abdominal effusion (1) • Cat Abdominal discomfort (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, Solution, Topical, Dose: 1 tube per animal • 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: Topical
  • Form: Solution
  • Dose: 1 tube per animal
Reactions Reported:
Seizure NOS
Outcomes: Recovered/Normal

Dog, Spaniel - King Charles Cavalier, Female, 7 year, 9.48 kilogram • Drug: MSK, Injection, solution, Unknown • Reactions: Cyanosis, Respiratory arrest, Premature ventricular contractions, Death • Outcome: Died

  • Report ID: USA-USFDACVM-2026-US-014468
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 7.00 Year
  • Weight: 9.480 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Injection, solution
Reactions Reported:
Cyanosis Respiratory arrest Premature ventricular contractions Death
Outcomes: Died

Cat, Cat (unknown), Unknown • Drug: MSK, Solution, Topical • Reactions: Hiding, Unclassifiable adverse event • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2026-US-014253
  • Serious AE: No
  • Treated For AE: No
  • Sex: Unknown
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Topical
  • Form: Solution
Reactions Reported:
Hiding Unclassifiable adverse event
Outcomes: Recovered/Normal

Cat, Ragdoll, Male, 10 year, 5.498 kilogram • Drug: MSK, Solution, Topical, Dose: 1 tube per animal • 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: Topical
  • Form: Solution
  • Dose: 1 tube per animal
Reactions Reported:
Head tilt - neurological disorder Unsteady walking (ataxia)
Outcomes: Outcome Unknown

Cat, Domestic Longhair, Male, 5 month, 2.781 kilogram • Drug: MSK, Unassigned, Unknown • 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: Unknown
  • Form: Unassigned
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

Cat, Domestic Shorthair, Female, 6 month, 1.8 kilogram • Drug: MSK, Solution, Topical, Dose: 1 tube per animal • Reactions: Tongue ulceration, Not eating, Drooling, Stomatitis • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-014109
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 6.00 Month
  • Weight: 1.800 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Topical
  • Form: Solution
  • Dose: 1 tube per animal
Reactions Reported:
Tongue ulceration Not eating Drooling Stomatitis
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Female, 19.7 week, 2.22 kilogram • Drug: MSK, Solution, Topical, Dose: 1 tube per animal • Reactions: Not himself/herself, Behavioral disorder (unspecified), Disorientation, Dilated pupils, Tiredness (lethargy)… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-014093
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 19.70 Week
  • Weight: 2.220 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Topical
  • Form: Solution
  • Dose: 1 tube per animal
Reactions Reported:
Not himself/herself Behavioral disorder (unspecified) Disorientation Dilated pupils Tiredness (lethargy) Unsteady walking (ataxia) Not eating
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Female, 6 month, 2.72 kilogram • Drug: MSK, Solution, Topical, Dose: 1 tube per animal • Reactions: Tongue ulceration • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2026-US-013871
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 6.00 Month
  • Weight: 2.720 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Topical
  • Form: Solution
  • Dose: 1 tube per animal
Reactions Reported:
Tongue ulceration
Outcomes: Recovered/Normal

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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This medication has not been reviewed by a veterinarian yet.