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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 • Generic profile • No FDA branded products linked
Species: Both
Manufacturer: Multiple FDA sponsors
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
For reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride or medetomidine hydrochloride. For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs. Species commonly shown: Both, Dog.
For reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride or medetomidine hydrochloride. For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
For intramuscular use only. Not recommended for use in pregnant or lactating animals, or animals intended for breeding. Atipamezole has not been evaluated in breeding animals. 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.
Top reported reactions (openFDA): Lack of efficacy - NOS, Vomiting, INEFFECTIVE, REVERSAL, Bradycardia, Death, Diarrhoea.
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Used for:
For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
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 Atipamezole Hydrochloride; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 21 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.
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), Death (1 reports), Cough, productive (1 reports), Constipation (1 reports), Conjunctivitis (1 reports)
Digestive (2), Skin & allergy (2), Neurologic (1), Behavior (3)
Cat (20 reports), Dog (12 reports)
Domestic Shorthair (3), Pug (1), Terrier - Bull - Staffordshire (1), Domestic Mediumhair (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Atipamezole Hydrochloride 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.
For intramuscular use only, Not recommended for use in pregnant or lactating animals, or animals intended for breeding, Atipamezole has not been evaluated in breeding animals, wobbly/unsteady walking, Death
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: April 15, 2026, 10:04 AM 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.
For intramuscular use only. Not recommended for use in pregnant or lactating animals, or animals intended for breeding. Atipamezole has not been evaluated in breeding animals. 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.
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 2026-03-09 · MSK · MSK
Received 2026-02-23 · MSK · MSK
Received 2025-12-19 · MSK · MSK
Received 2025-12-17 · MSK · MSK
Received 2025-11-25 · MSK · MSK
Received 2025-11-20 · MSK · MSK
Received 2025-11-19 · MSK · MSK
Received 2025-11-17 · MSK · MSK
Received 2025-11-04 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Neurologic | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 |
Species coverage: Cat (20) Dog (12)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Neurologic | Cat | Serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Skin & allergy | Cat | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Digestive | Dog | Serious | - | 1 | |
| Behavior | Cat | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Behavior | Cat | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Behavior | Cat | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Skin & allergy | Dog | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | 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.
For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
Administer 3,750 mcg/m2 intramuscularly for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride and 5,000 mcg/m2 intramuscularly for the reversal of intramuscular dexmedetomidine hydrochloride or medetomidine hydrochloride.
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 reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
Administer intramuscularly (IM) for reversal of sedation and analgesia regardless of the route used for dexmedetomidine hydrochloride or medetomidine hydrochloride. The atipamezole dose for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride is 3750 mcg/m2. The atipamezole dose for the reversal of IM dexmedetomidine hydrochloride or medetomidine hydrochloride is 5000 mcg/m2.
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 reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
Administer 3750 mcg/m2 intramuscularly for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride and 5000 mcg/m2 intramuscularly for the reversal of intramuscular dexmedetomidine hydrochloride or medetomidine hydrochloride.
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 reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
REVERTIDINE™ is administered intramuscularly (IM) for reversal of sedation and analgesia regardless of the route used for dexmedetomidine or medetomidine. The atipamezole dose for the reversal of IV dexmedetomidine or medetomidine is 3750 mcg/m2.
The atipamezole dose for the reversal of IM dexmedetomidine or medetomidine is 5000 mcg/m2.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
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.
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 |
|---|---|---|---|
| 11695-7020-1 | 11695 | - | |
| 15914-008-01 | 15914 | - | |
| 43744-021-01 | 43744 | - | |
| 46066-109-13 | 46066 | - | |
| 54771-6293-1 | 54771 | - | |
| 64189-0001-0 | 64189 | - | |
| 64189-0001-1 | 64189 | - | |
| 68504-007-01 | 68504 | - | |
| 69043-039-10 | 69043 | - | |
| 71052-191-10 | 71052 | - | |
| 71052-191-25 | 71052 | - | |
| 71052-191-50 | 71052 | - | |
| 86101-068-41 | 86101 | - | |
| 86136-106-31 | 86136 | - | |
| 86136-115-31 | 86136 | - | |
| 86136-151-31 | 86136 | - | |
| 86184-006-01 | 86184 | - | |
| 86197-002-01 | 86197 | - | |
| 86197-002-02 | 86197 | - | |
| 86225-019-06 | 86225 | - |
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 |
|---|---|---|---|---|
|
Atipamezole Hydrochloride Injection
RX
Atipamezole Hydrochloride
Sterile Injectable Solution
• Intramuscular
|
Felix Pharmaceuticals Pvt. Ltd. | ANADA 200-838 | Approved | Mar 2, 2026 |
|
CONTRASED™
RX
Atipamezole Hydrochloride
Sterile Injectable Solution
• Intramuscular
|
Parnell Technologies Pty. Ltd. | ANADA 200-772 | Approved | Nov 26, 2024 |
|
Cropamezole™
RX
Atipamezole Hydrochloride
Sterile Injectable Solution
• Intramuscular
|
Cronus Pharma Specialities India Private Ltd. | ANADA 200-753 | Approved | Aug 1, 2023 |
|
REVERTIDINE™
RX
Atipamezole Hydrochloride
Sterile Injectable Solution
• Intramuscular
|
Modern Veterinary Therapeutics, LLC | ANADA 200-624 | Approved | Aug 2, 2018 |
|
Antisedan®
RX
Atipamezole Hydrochloride
Liquid (Solution)
• Intramuscular
|
Orion Corp. | NADA 141-033 | Approved | Jun 1, 2016 |
Data source: FDA Animal Drugs @ FDA (public search export).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
Administer 3,750 mcg/m2 intramuscularly for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride and 5,000 mcg/m2 intramuscularly for the reversal of intramuscular dexmedetomidine hydrochloride or medetomidine hydrochloride.
FDA page: Open in Animal Drugs @ FDA
For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
Administer intramuscularly (IM) for reversal of sedation and analgesia regardless of the route used for dexmedetomidine hydrochloride or medetomidine hydrochloride. The atipamezole dose for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride is 3750 mcg/m2. The atipamezole dose for the reversal of IM dexmedetomidine hydrochloride or medetomidine hydrochloride is 5000 mcg/m2.
FDA page: Open in Animal Drugs @ FDA
For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
Administer 3750 mcg/m2 intramuscularly for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride and 5000 mcg/m2 intramuscularly for the reversal of intramuscular dexmedetomidine hydrochloride or medetomidine hydrochloride.
FDA page: Open in Animal Drugs @ FDA
For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
REVERTIDINE™ is administered intramuscularly (IM) for reversal of sedation and analgesia regardless of the route used for dexmedetomidine or medetomidine. The atipamezole dose for the reversal of IV dexmedetomidine or medetomidine is 3750 mcg/m2.
The atipamezole dose for the reversal of IM dexmedetomidine or medetomidine is 5000 mcg/m2.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
For reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride or medetomidine hydrochloride. For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
Source: FDA Animal Drugs @ FDA • Reference
For intramuscular use only. Not recommended for use in pregnant or lactating animals, or animals intended for breeding. Atipamezole has not been evaluated in breeding animals. 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.
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.
Dog, Pug, Male, 3.75 year, 12.7 kilogram • Drug: MSK, Unknown • Reactions: Neurogenic keratoconjunctivitis sicca, Corneal ulcer, Nasal cavity disorder NOS, Abnormal Schirmer tear test • Outcome: Ongoing
Dog, Terrier - Bull - Staffordshire, Female, 2 year, 33.611 kilogram • Drug: MSK, Solution, Intramuscular • Reactions: Facial swelling (possible allergy), Hypersensitivity reaction, Vomiting, Bloody diarrhoea, Unsteady walking (ataxia)… • Outcome: Ongoing
Cat, Domestic Shorthair, Female, 11 year, 5.33 kilogram • Drug: MSK, Unknown • Reactions: Dysphoria, Behavioral disorder (unspecified), Dilated pupils, Loss of appetite, Skin and tissue infection NOS… • Outcome: Recovered/Normal
Cat, Domestic Shorthair, Female, 7 year, 4.354 kilogram • Drug: MSK, Intramuscular • Reactions: Drooling, Reluctant to move, Not eating, Dilated pupils, Not himself/herself… • Outcome: Died
Cat, Domestic Mediumhair, Male, 9 year, 6.8 kilogram • Drug: MSK, Unknown, Dose: 0.15 mL per animal • Reactions: Injection site cyst, Injection site sarcoma, Injection site lump, Injection site discharge NOS, Injection site irritation… • Outcome: Ongoing
Cat, Domestic Longhair, Female, 2 year, 4.17 kilogram • Drug: MSK, Parenteral • Reactions: Not drinking, Oliguria, Neutrophilia, Reluctant to move, Behavioral disorder (unspecified)… • Outcome: Recovered/Normal
Dog, ['Schnauzer - Miniature', 'Dog (unknown)'], Female, 5 year, 12.701 kilogram • Drug: MSK, Solution, Intravenous, Dose: 0.05 mL per animal • Reactions: Bradycardia, Hypotension, Premature ventricular contractions, Hypoventilation, Heart block NOS… • Outcome: Ongoing
Cat, Domestic Shorthair, Female, 13 year, 2.522 kilogram • Drug: MSK, Solution, Intramuscular, Dose: 0.10 mL per animal • Reactions: Death, Intentional misuse • Outcome: Died
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.