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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 use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. For use as a preanesthetic to general anesthesia. For use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. Species commonly shown: Both, Dog, Cat.
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. For use as a preanesthetic to general anesthesia. For use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue. Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.
Top reported reactions (openFDA): Lack of efficacy - NOS, Vomiting, Injection site swelling, Death, Bradycardia, Diarrhoea.
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Used for:
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.
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 Dexmedetomidine; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 27 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.
Loss of appetite (1 reports), Decreased activity (1 reports), Death by euthanasia (1 reports), Death (1 reports), Cough, productive (1 reports)
Digestive (2), Skin & allergy (1), Neurologic (1), Behavior (2)
Cat (17 reports), Dog (15 reports)
Domestic Shorthair (3), Terrier - Bull - Staffordshire (1), Terrier - Bull - American Pit (1), Maine Coon (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Dexmedetomidine 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 DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or k, Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian, Loss of appetite, Decreased activity, Death by euthanasia
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.
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue. Federal law (USA) 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 2025-11-25 · MSK · MSK
Received 2025-11-14 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Digestive | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 |
Species coverage: Cat (17) Dog (15)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Neurologic | Dog | Non-serious | - | 1 | |
| Digestive | Cat | Serious | - | 1 | |
| Skin & allergy | Cat | Non-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 | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Digestive | 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 | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Non-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.
Owner handouts · Labeling
Official label / PI · Labeling
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 use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.
Administer 375 micrograms (mcg) per square meter (/m2) of body surface area by intravenous injection or 500 mcg/m2 of body surface area by intramuscular injection.
For use as a preanesthetic to general anesthesia.
Administer 125 mcg/m2 of body surface area or 375 mcg/m2 of body surface area by intramuscular injection.
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.
40 mcg/kg by intramuscular injection
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 use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.
Administer 375 micrograms (µg) per square meter (/m2) of body surface area by intravenous injection or 500 µg/m2 of body surface area by intramuscular injection.
For use as a preanesthetic to general anesthesia.
Administer 125 µg/m2 of body surface area or 375 µg/m2 of body surface area by intramuscular injection.
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.
40 µg/killogram by intramuscular injection.
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 use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.
Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 IM.
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.
Sedation, Analgesia and Preanesthesia: 40 mcg/kg IM.
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 use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.
Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 IM.
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.
Sedation, Analgesia and Preanesthesia: 40 mcg/kg intramuscularly (IM)
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.
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 |
|---|---|---|---|
| 11695-6967-1 | 11695 | - | |
| 17033-005-10 | 17033 | - | |
| 46066-088-13 | 46066 | - | |
| 54771-1050-1 | 54771 | - | |
| 54771-2805-1 | 54771 | - | |
| 54771-2806-1 | 54771 | - | |
| 64189-8502-0 | 64189 | - | |
| 64189-8502-1 | 64189 | - | |
| 68504-006-10 | 68504 | - | |
| 69043-038-10 | 69043 | - | |
| 86101-061-41 | 86101 | - | |
| 86136-105-31 | 86136 | - | |
| 86136-152-31 | 86136 | - |
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 |
|---|---|---|---|---|
|
DEXVETRA™
RX
Dexmedetomidine hydrochloride
Injectable Solution
• Intravenous, Intramuscular
|
Parnell Technologies Pty. Ltd. | ANADA 200-699 | Approved | Jan 8, 2026 |
|
Dexmedetomidine Hydrochloride
RX
Dexmedetomidine hydrochloride
Sterile Injectable Solution
• Intravenous, Intramuscular
|
Felix Pharmaceuticals Pvt. Ltd. | ANADA 200-824 | Approved | Oct 1, 2025 |
|
DexmedVet™
RX
Dexmedetomidine hydrochloride
Sterile Injectable Solution
• Intramuscular, Intravenous
|
Cronus Pharma Specialities India Private Ltd. | ANADA 200-752 | Approved | Aug 1, 2023 |
|
Dexmedetomidine Hydrochloride
RX
Dexmedetomidine hydrochloride
Injectable Solution
• Intravenous, Intramuscular
|
ZYVET AH, Inc. | ANADA 200-735 | Approved | Feb 1, 2023 |
|
Dexmedesed®
RX
Dexmedetomidine hydrochloride
Sterile Solution
• Intramuscular, Intravenous
|
Dechra Veterinary Products LLC | ANADA 200-573 | Approved | Dec 16, 2021 |
|
SILEO®
RX
Dexmedetomidine
Oromucosal Gel
• Oromucosal
|
Orion Corp. | NADA 141-456 | Approved | May 17, 2021 |
|
Dexdomitor®
RX
Dexmedetomidine hydrochloride
Liquid (Solution)
• Intravenous, Intramuscular
|
Orion Corp. | NADA 141-267 | 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 use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.
Administer 375 micrograms (mcg) per square meter (/m2) of body surface area by intravenous injection or 500 mcg/m2 of body surface area by intramuscular injection.
For use as a preanesthetic to general anesthesia.
Administer 125 mcg/m2 of body surface area or 375 mcg/m2 of body surface area by intramuscular injection.
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.
40 mcg/kg by intramuscular injection
FDA page: Open in Animal Drugs @ FDA
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.
Administer 375 micrograms (µg) per square meter (/m2) of body surface area by intravenous injection or 500 µg/m2 of body surface area by intramuscular injection.
For use as a preanesthetic to general anesthesia.
Administer 125 µg/m2 of body surface area or 375 µg/m2 of body surface area by intramuscular injection.
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.
40 µg/killogram by intramuscular injection.
FDA page: Open in Animal Drugs @ FDA
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.
Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 IM.
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.
Sedation, Analgesia and Preanesthesia: 40 mcg/kg IM.
FDA page: Open in Animal Drugs @ FDA
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.
Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 IM.
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.
Sedation, Analgesia and Preanesthesia: 40 mcg/kg intramuscularly (IM)
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
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. For use as a preanesthetic to general anesthesia. For use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.
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 DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue. Federal law (USA) 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, Unknown • Reactions: Fever, Cough, productive, Weight loss, Breathing difficulty, Abnormal radiograph finding… • Outcome: Recovered/Normal
Dog, Terrier - Bull - Staffordshire, Male, 7.5 year, 28.486 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Injection site oedema • Outcome: Recovered/Normal
Dog, Terrier - Bull - American Pit, Male, 7 year, 37 kilogram • Drug: MSK, Injection, Intramuscular, Dose: 0.40 mL per animal • Reactions: Loose stool, Vomiting, Decreased appetite, Decreased drinking, Medication error NOS… • Outcome: Ongoing
Cat, Domestic Shorthair, Female, 6 month, 3.084 kilogram • Drug: MSK, Unknown, Dose: 0.70 Milligram per animal • Reactions: Elevated temperature, Breathing difficulty, Quiet • Outcome: Ongoing
Cat, Maine Coon, Male, 13 year, 6.58 kilogram • Drug: MSK, Unknown • Reactions: Twitching, Focal seizure, Death, Tiredness (lethargy) • Outcome: Died
Dog, Bulldog - French, Female, 11 year, 12.066 kilogram • Drug: MSK, Injection, Intravenous, Dose: 0.12 mL per dose, Frequency: 1 per day • Reactions: Lack of efficacy, Swollen limb, Wound, Local erythema, Bruising • Outcome: Outcome Unknown
Cat, Domestic Shorthair, Female, 4 month, 2.5 kilogram • Drug: MSK, Injection, solution, Intramuscular, Dose: 0.05 mL per animal • Reactions: Drooling, Tachypnoea, Abnormal radiograph finding, Hypothermia, Hyperactivity… • Outcome: Ongoing
Dog, Pug, Female, 6 year, 9.344 kilogram • Drug: MSK, Injection, Intramuscular, Dose: 0.05 mL per dose, Frequency: 1 per day • Reactions: Swollen limb, Limb non-weight bearing, Pain NOS, Bruising, Local erythema… • 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.