Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
BothReference completeFDA data linkedRx requiredInjectable SolutionMultiple FDA labelers
Official label facts
Owner quick guide first
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™ZorbiumSimbadol
Dosage forms
Injectable SolutionTransdermal 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.
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 contextLimited
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 coverageReported 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 guardrailNot 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 signalLabel / review
Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.
Source: openFDA case USA-USFDACVM-2025-US-072073
Weaker signalReported 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 reactionsTop terms
Loss of appetite (1 reports), Ascites (1 reports), Arthritis (1 reports), Arched back (1 reports), Appetite loss (1 reports)
Body systems representedSignal grouping
Digestive (2), Skin & allergy (3), Behavior (2), Other (25)
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 patientVet check
Verify whether Buprenorphine fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.
Evidence limitationsEvidence review
Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.
What to watch next
Watch listOwner-safe
Loss of appetite, Ascites, Arthritis
Call sooner ifEscalation
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.
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-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
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-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
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-002976
Received 2026-01-20
· MSK
· MSK
Serious
Species
Dog
Breed
Shih Tzu
Size / weight
Under 10 lb (2.449 Kilogram)
Age
Under 1 year (2 Month)
Sex
Male Intact
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)VomitingBloody diarrhoeaDiarrhoeaReluctant to moveDecreased body temperaturePale mucous membraneHypoglycaemiaFluid in abdomen NOSFeverDistension of abdomenNeutropeniaLeukocytosis NOSDecreased haematocritNot eatingObtundedHypersalivationAbdominal discomfortDecreased skin turgorBreathing difficultyFlaccid musclesProlonged capillary refill timeRegurgitationLack of efficacy - NOSLymphopeniaMonocytosisLeukopenia NOSHyponatremiaHypercalcaemiaIncreased band neutrophiliaIleusAbnormal radiograph findingIntestinal thickeningHypokalaemiaNasal dischargeIncreased respiratory rateLymphocytosisAbnormal ultrasound findingLateral recumbencyWeak pulseIntentional misuse
Body systems
NeurologicDigestiveOtherEffectiveness
Outcomes
Ongoing
USA-USFDACVM-2025-US-075148
Received 2025-12-19
· MSK
· MSK
Serious
Species
Dog
Breed
['Great Pyrenees', 'Retriever - Labrador']
Size / weight
50-99 lb (31.661 Kilogram)
Sex
Female Neutered
Region
USA
Reactions
Emesis (multiple)
Body systems
Digestive
Outcomes
Ongoing
USA-USFDACVM-2025-US-074533
Received 2025-12-17
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (2.5 Kilogram)
Age
Under 1 year (4 Month)
Sex
Female Neutered
Region
USA
Reactions
HypersalivationTachypnoeaAbnormal radiograph findingHypothermiaHyperactivityNot eatingLethargy (see also Central nervous system depression in Neurological)Hiding
Body systems
DigestiveOtherNeurologic
Outcomes
Ongoing
USA-USFDACVM-2025-US-074164
Received 2025-12-16
· MSK
· MSK
Serious
Species
Cat
Breed
Cat (unknown)
Size / weight
Under 10 lb (3.63 Kilogram)
Age
8+ years (18 Year)
Sex
Female Neutered
Region
USA
Reactions
UnwellCryingDeath by euthanasiaDehydrationPale mucous membraneAnorexiaNot drinking
Body systems
OtherDigestive
Outcomes
Euthanized
USA-USFDACVM-2025-US-073547
Received 2025-12-15
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Mediumhair
Size / weight
Under 10 lb (2.404 Kilogram)
Age
8+ years (18 Year)
Sex
Female Neutered
Region
USA
Reactions
Behavioural disorder NOSTrismusDysphoriaDilated pupilsTwitchingAppetite lossConstipationNot sleepingAtaxiaNot drinkingBlood in urineCystitisHyperactivitySniffingDecreased appetite
Otitis externaTrigeminus paralysisVomitingCoughMuscle atrophy (see also Muscle wasting)Elevated serum alkaline phosphatase (ALP)Elevated alanine aminotransferase (ALT)HypersalivationUnusual stool colourErythema (for urticaria see Immune SOC)Elevated gamma-glutamyl transferase (GGT)Elevated total bilirubinAbnormal ultrasound findingHepatic fibrosisHepatitisLethargy (see also Central nervous system depression in Neurological)AngioedemaGeneralised rashDyspnoeaIncreased lung soundsLeucocytosis NOSIcterusAbnormal radiograph findingJaw disorder
Body systems
OtherDigestiveSkin & allergyNeurologic
Outcomes
Ongoing
USA-USFDACVM-2025-US-072073
Received 2025-12-01
· MSK
· MSK
Non-serious
Species
Dog
Breed
Shih Tzu
Size / weight
10-24 lb (4.536 Kilogram)
Age
1-3 years (1 Year)
Sex
Female Neutered
Region
USA
Reactions
Necrotic woundSkin lesion NOSLocal erythemaAnorexiaDiarrhoeaAbdominal discomfortDehydrationBacterial skin infection NOS
Body systems
OtherDigestive
Outcomes
Ongoing
USA-USFDACVM-2025-US-071209
Received 2025-11-25
· MSK
· MSK
Serious
Species
Dog
Breed
Portuguese Water Dog
Size / weight
50-99 lb (23.406 Kilogram)
Age
4-7 years (6 Year)
Sex
Female Neutered
Region
USA
Reactions
AnorexiaInjection site itchingSwelling NOSLethargy (see also Central nervous system depression in Neurological)Injection site mucopurulent dischargeInjection site swellingInjection site skin discolourationInjection site bruisingInjection site abscessInjection site necrosisSicknessInjection site skin change NOSOther abnormal test result NOS
Body systems
DigestiveSkin & allergyNeurologicOther
Outcomes
Ongoing
USA-USFDACVM-2025-US-069596
Received 2025-11-24
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6.2 Kilogram)
Age
8+ years (13 Year)
Sex
Male Neutered
Region
USA
Reactions
Not eatingVomitingCardiac enlargementSplenomegalyAbnormal ultrasound findingHaematuriaPyuriaNon-regenerative anaemiaDecreased haematocritHypokalaemiaBladder distensionDehydrationElevated creatinineNot urinatingIntentional misuseUrinary tract disorder NOS
DeathHaematocheziaDecreased appetiteRegurgitationLethargy (see also Central nervous system depression in Neurological)DiarrhoeaDeath by euthanasia
Body systems
OtherDigestiveNeurologic
Outcomes
DiedEuthanizedOutcome Unknown
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
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.
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.
Every non-trivial field is expected to include provenance and update timestamps.
Official 123Clinical 1Manufacturer 0Marketing 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.
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.
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.
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.
Medical Disclaimer: The medication details provided on Roxee are for informational purposes only and are not a substitute for professional veterinary advice. Always consult your veterinarian about your pet's specific needs.