USA-USFDACVM-2026-US-009864
Received 2026-02-23 · MSK · MSK
- Species
- Cat
- Breed
- Cat (unknown)
- Sex
- Unknown Unknown
- Region
- USA
- Reactions
- NauseaDrooling
- Body systems
- Digestive
- Outcomes
- Recovered/Normal
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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.
To produce sedation, as an analgesic, and as a preanesthetic to local or general anesthesia. To produce sedation, as an analgesic, and as a preanesthetic to local anesthesia. To produce sedation, accompanied by a shorter period of analgesia. May be used to calm and facilitate handling of fractious animals for diagnostic procedures, for minor surgical procedures, for therapeutic medication for sedation and relief of pain following injury or surgery, and as a preanesthetic to local anesthetic. At the recommended dosages, can be used in conjunction with local anesthetics, such as procaine or lidocaine. To produce sedation, as an analgesic, and as a preanesthetic to local or general anesthesia Species commonly shown: Both, Dog, Horse, Not For Meat Production.
To produce sedation, as an analgesic, and as a preanesthetic to local or general anesthesia. To produce sedation, as an analgesic, and as a preanesthetic to local anesthesia. To produce sedation, accompanied by a shorter period of analgesia. May be used to calm and facilitate handling of fractious animals for diagnostic procedures, for minor surgical procedures, for therapeutic medication for sedation and relief of pain following injury or surgery, and as a preanesthetic to local anesthetic. At the recommended dosages, can be used in conjunction with local anesthetics, such as procaine or lidocaine. To produce sedation, as an analgesic, and as a preanesthetic to local or general anesthesia
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption. Do not use in domestic food-producing animals. Do not use in Cervidae less than 15 days before or during the hunting season.
Top reported reactions (openFDA): Death, Lack of efficacy - NOS, Vomiting, Death by euthanasia, Hives (see also 'Skin'), INEFFECTIVE, ANESTHESIA.
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Used for:
To produce sedation, as an analgesic, and as a preanesthetic to local or general anesthesia.
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 Xylazine; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 24 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.
Vomiting (1 reports), Paraparesis (1 reports), Panting (1 reports), Otitis NOS (1 reports), Myelopathy NOS (1 reports)
Digestive (3), Effectiveness (1), Other (28)
Dog (17 reports), Cat (15 reports)
Cat (unknown) (2), Domestic Shorthair (2), Greyhound (1), ['Retriever - Golden', 'Poodle - Standard'] (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Xylazine 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.
Do not use in horses intended for human consumption, Do not use in Cervidae less than 15 days before or during the hunting season, Vomiting, Paraparesis, Panting
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. Do not use in horses intended for human consumption. Do not use in domestic food-producing animals. Do not use in Cervidae less than 15 days before or during the hunting season.
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 2026-02-23 · MSK · MSK
Received 2026-02-04 · MSK · MSK
Received 2025-12-29 · MSK · MSK
Received 2025-12-29 · MSK · MSK
Received 2025-12-29 · MSK · MSK
Received 2025-12-03 · MSK · MSK
Received 2025-12-03 · MSK · MSK
Received 2025-12-01 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Digestive | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 |
Species coverage: Dog (17) Cat (15)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Digestive | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Digestive | Cat | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Effectiveness | Cat | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Cat | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | 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.
Do not use in horses intended for human consumption.
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.
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.
Do not use in horses intended for human consumption.
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.
Do not use in horses intended for human consumption.
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.
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.
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
FOI · FOI
FOI · FOI
FOI · FOI
FOI · FOI
FOI · FOI
FOI · FOI
FOI · FOI
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 |
|---|---|---|---|
| 11695-4024-1 | 11695 | - | |
| 17033-099-05 | 17033 | - | |
| 58597-8582-6 | 58597 | - | |
| 58597-8582-8 | 58597 | - | |
| 62157-373-01 | 62157 | - | |
| 62157-374-01 | 62157 | - | |
| 62991-1624-2 | 62991 | - | |
| 62991-1624-3 | 62991 | - | |
| 62991-1624-4 | 62991 | - | |
| 63537-0091-5 | 63537 | - | |
| 63537-0092-9 | 63537 | - | |
| 64189-9001-0 | 64189 | - | |
| 64189-9001-1 | 64189 | - | |
| 64189-9001-2 | 64189 | - | |
| 64189-9001-3 | 64189 | - | |
| 64189-9002-0 | 64189 | - | |
| 64189-9002-1 | 64189 | - | |
| 64189-9002-2 | 64189 | - | |
| 64189-9002-3 | 64189 | - | |
| 69043-043-05 | 69043 | - |
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 |
|---|---|---|---|---|
|
Rompun® Injectable (100 mg)
RX
Xylazine Hydrochloride
Liquid (Solution)
• Intramuscular, Intravenous, Subcutaneous
|
Dechra Veterinary Products LLC | NADA 47956 | Approved | Jul 14, 2026 |
|
Rompun® Injectable (20 mg)
RX
Xylazine Hydrochloride
Liquid (Solution)
• Intravenous, Intramuscular, Subcutaneous
|
Dechra Veterinary Products LLC | NADA 47955 | W | Jul 14, 2026 |
|
Sedazine™
RX
Xylazine Hydrochloride
Liquid (Solution)
• Intramuscular, Intravenous
|
Boehringer Ingelheim Animal Health USA Inc. | ANADA 200-088 | W | May 12, 2025 |
|
Xylazine HCl Injection AnaSed® Equine Injection
RX
Xylazine Hydrochloride
Injectable Solution
• Intramuscular, Intravenous
|
Cronus Pharma Specialities India Private Ltd. | NADA 140-442 | Approved | Feb 26, 2025 |
|
Anased®
RX
Xylazine Hydrochloride
Liquid (Solution)
• Subcutaneous, Intramuscular, Intravenous
|
Cronus Pharma Specialities India Private Ltd. | NADA 139-236 | Approved | Jun 13, 2024 |
|
XylaMed™
RX
Xylazine
Injectable Solution
|
Bimeda Animal Health Ltd. | ANADA 200-529 | Approved | Feb 27, 2023 |
|
Chanazine®
RX
Xylazine Hydrochloride
Liquid (Solution)
• Intravenous, Intramuscular
|
Chanelle Pharmaceuticals Manufacturing Ltd. | ANADA 200-139 | Approved | Jul 28, 2017 |
|
Chanazine®
RX
Xylazine Hydrochloride
Liquid (Solution)
• Subcutaneous, Intramuscular, Intravenous
|
Chanelle Pharmaceuticals Manufacturing Ltd. | ANADA 200-184 | Approved | May 22, 2017 |
Data source: FDA Animal Drugs @ FDA (public search export).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
Do not use in horses intended for human consumption.
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
Do not use in horses intended for human consumption.
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
To produce sedation, as an analgesic, and as a preanesthetic to local or general anesthesia. To produce sedation, as an analgesic, and as a preanesthetic to local anesthesia. To produce sedation, accompanied by a shorter period of analgesia. May be used to calm and facilitate handling of fractious animals for diagnostic procedures, for minor surgical procedures, for therapeutic medication for sedation and relief of pain following injury or surgery, and as a preanesthetic to local anesthetic. At the recommended dosages, can be used in conjunction with local anesthetics, such as procaine or lidocaine. To produce sedation, as an analgesic, and as a preanesthetic to local or general anesthesia
Source: FDA Animal Drugs @ FDA • Reference
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption. Do not use in domestic food-producing animals. Do not use in Cervidae less than 15 days before or during the hunting season.
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 Effectiveness.
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, Cat (unknown), Unknown • Drug: MSK, Unknown • Reactions: Nausea, Drooling • Outcome: Recovered/Normal
Cat, Domestic Shorthair, Male, 6 month, 4.33 kilogram • Drug: MSK, Unknown • Reactions: Hallucination, Hyperactivity, Falling, Locomotor disturbance • Outcome: Ongoing
Dog, Greyhound, Female, 9 year, 27.3 kilogram • Drug: MSK, Solution, Subcutaneous • Reactions: Lack of efficacy - NOS, Unrelated death • Outcome: Euthanized
Dog, ['Retriever - Golden', 'Poodle - Standard'], Male, 5 year, 25.5 kilogram • Drug: MSK, Solution, Subcutaneous • Reactions: Lack of efficacy - NOS, Unrelated death • Outcome: Euthanized
Dog, Crossbred Canine/dog, Male, 14 year, 17.7 kilogram • Drug: MSK, Solution, Subcutaneous • Reactions: Lack of efficacy - NOS, Unrelated death • Outcome: Euthanized
Dog, Dog (unknown), Unknown • Drug: MSK, Injection, Intramuscular, Dose: 1 dose per animal, Frequency: 1 per day • Reactions: Lack of efficacy - NOS • Outcome: Recovered/Normal
Cat, Cat (unknown), Unknown • Drug: MSK, Injection, Intramuscular, Dose: 1 dose per animal, Frequency: 1 per day • Reactions: Lack of efficacy - NOS • Outcome: Recovered/Normal
Cat, Domestic Shorthair, Male, 2 year, 4.536 kilogram • Drug: MSK, Injection, solution, Unknown • Reactions: Seizure NOS, Death by euthanasia • Outcome: Euthanized
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.