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Roxee Medication Guide
Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
Veterinary professional?
These are the reference facts Roxee uses on browse cards and quick facts.
Sponsor, product, and application records imported from Animal Drugs @ FDA.
openFDA reaction terms and case summaries are supporting evidence, not proof of causality.
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: Multiple FDA labelers
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
For the control of postoperative pain associated with surgical procedures in cats. Species commonly shown: Both, Cat.
For the control of postoperative pain associated with surgical procedures in cats.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Diarrhoea, Death, Death by euthanasia, Anorexia.
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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:
When to call the vet:
Regulatory restrictions are shown in Vet View.
What to tell or ask your vet today:
A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.
Roxee has limited cited overview evidence for Buprenorphine; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 22 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.
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.
Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.
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.
Unsteady walking (ataxia) (1 reports), Loss of appetite (1 reports), Cardiac enlargement (1 reports), Burn (1 reports), Bruising (1 reports)
Digestive (3), Skin & allergy (3), Neurologic (1), Behavior (3)
Cat (21 reports), Dog (11 reports)
Domestic Shorthair (3), Siamese (2), ['Great Pyrenees', 'Retriever - Labrador'] (1), Cat (unknown) (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Buprenorphine fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.
Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.
wobbly/unsteady walking, Loss of appetite, Cardiac enlargement
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Review status / Updated / Sources
Review status: Clinical reviewer not listed
Updated: February 12, 2026, 10:44 PM UTC
Side effects to monitor:
Most reported reactions:
Emergency warning signs:
Source-backed clinical checkpoints for quick review.
Official label facts first, then secondary summaries. Marketing content is separated below.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.
Received 2025-12-17 · MSK · MSK
Received 2025-11-24 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| 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 | Cat | 1 | |
| Digestive | 1 | Dog | 1 |
Species coverage: Cat (21) Dog (11)
| 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 | Cat | Serious | - | 1 | |
| Digestive | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Behavior | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Behavior | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Skin & allergy | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Skin & allergy | Cat | Non-serious | - | 1 | |
| Digestive | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Behavior | Cat | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 |
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.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
For the control of postoperative pain associated with surgical procedures in cats.
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.
SPL · Structured Product Label
SPL · Structured Product Label
FOI · FOI
FOI · FOI
Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.
Quick facts and links to official labeling and safety signals.
Diagnosis-code mappings are not available for this medication yet.
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 54771-4131-1 | 54771 | - | |
| 58198-0078-1 | 58198 | - | |
| 58198-0078-2 | 58198 | - | |
| 86084-100-30 | 86084 | - |
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
Every non-trivial field is expected to include provenance and update timestamps.
Official sponsor/proprietary-name/application-status records linked by active ingredient.
| Product | Sponsor | Application | Status | Published |
|---|---|---|---|---|
|
Simbadol®
RX
Buprenorphine
Injectable Solution
• Subcutaneous
|
Zoetis Inc. | NADA 141-434 | Approved | Feb 8, 2023 |
|
Zorbium™
RX
Buprenorphine
Transdermal Solution
• Topical
|
Elanco US Inc. | NADA 141-547 | Approved | Feb 1, 2022 |
Data source: FDA Animal Drugs @ FDA (public search export).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
FDA page: Open in Animal Drugs @ FDA
For the control of postoperative pain associated with surgical procedures in cats.
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.
FDA page: Open in Animal Drugs @ FDA
For the control of postoperative pain associated with surgical procedures in cats.
Source: FDA Animal Drugs @ FDA • Reference
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).
Showing top 5 for Digestive.
Showing top 5 for Skin & allergy.
Showing top 5 for Neurologic.
Showing top 5 for Behavior.
Showing top 5 for Other.
Data source: FDA openFDA Animal & Veterinary adverse event reports.
These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.
Cat, Domestic Shorthair, Female, 7 month, 3.08 kilogram • Drug: MSK, Solution, Topical, Dose: 1 mL per animal • Reactions: Fever, Cough, productive, Weight loss, Breathing difficulty, Abnormal radiograph finding… • Outcome: Recovered/Normal
Cat, Siamese, Male, 15 year, 3.88 kilogram • Drug: MSK, Solution, Topical, Dose: 0.40 mL per animal • Reactions: Lack of efficacy - NOS, Urinary tract infection, Behavioral disorder (unspecified), Decreased haematocrit, Oliguria • Outcome: Outcome Unknown
Cat, Domestic Shorthair, Male, 12 year, 6.8 kilogram • Drug: MSK, Solution, Topical, Dose: 1 mL per animal, Frequency: 1 per day • Reactions: Behavioral disorder (unspecified), Application site irritation, Application site pruritus, Application site hair loss • Outcome: Ongoing
Cat, Siamese, Female, 11.75 year, 3.73 kilogram • Drug: MSK, Solution, Topical, Dose: 1 mL per animal • Reactions: Application site hair loss, Skin lesion NOS • Outcome: Ongoing
Cat, Domestic Shorthair, Female, 4 month, 2.4 kilogram • Drug: MSK, Solution, Topical, Dose: 0.40 mL per animal • Reactions: Head shake - behavioural disorder, Unable to walk, Not drinking, Not eating, Unsteady walking (ataxia)… • Outcome: Ongoing
Dog, ['Great Pyrenees', 'Retriever - Labrador'], Female, 31.661 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Vomiting • Outcome: Ongoing
Cat, Cat (unknown), Unknown, 3.49 kilogram • Drug: MSK, Solution, Unknown, Dose: 1 tube per animal • Reactions: Pulmonary congestion, Decreased body temperature, Drowsiness - systemic disorder, Disorientation, Unable to stand… • Outcome: Recovered/Normal
Cat, Persian, Male, 10.83 year, 4.67 kilogram • Drug: MSK, Solution, Topical, Dose: 1 mL per animal • Reactions: Hair loss at application site, Defect Unknown/Not Specified • Outcome: Ongoing
Data source: FDA openFDA Animal & Veterinary adverse event reports.
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.