Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
BothReference partialNot FDA-approved for animalsMultiple FDA labelers
Official label facts
Owner quick guide first
Showing simplified owner view. Switch to Vet View for full technical detail.
Some reference facts for this medication are still being verified.
Not FDA-approved as an animal drug.
No FDA-approved animal-drug application is linked for this record. It may represent extra-label, human-drug, bulk-compounding, export-only, or otherwise unapproved animal-use source data; use only under veterinarian direction.
Do not start, stop, or change treatment without your veterinarian.
Data freshness
Reference facts
Reference refreshed
Aug 6, 2026, 7:47 p.m.
Roxee has a partial reference profile for this medication. Some primary facts still need verification.
FDA applications
FDA application data refreshed
Aug 6, 2026, 7:47 p.m.
Sponsor, product, and application records imported from Animal Drugs @ FDA.
Safety reports
Safety data refreshed
Aug 6, 2026, 7:49 p.m.
openFDA reaction terms and case summaries are supporting evidence, not proof of causality.
Source timing details
Source timing details
Reference facts:Source Roxee| Refreshed Aug 6, 2026, 7:47 PM UTC
The reference fact projection used for browse cards and quick facts.
Animal Drug Product Listing Directory (NDC):Source FDA| Refreshed Aug 6, 2026, 7:47 PM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
openFDA reaction terms:Source FDA openFDA| Refreshed Aug 6, 2026, 7:52 PM UTC
openFDA case summaries:Source FDA openFDA| Refreshed Aug 6, 2026, 7:52 PM UTC
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Gabapentin
Gabapentin
Drug type: Generic ingredient
• Branded profile • Not FDA-approved for animals
Both86% reference complete
Species: Both
Approval status: Not FDA-approved as an animal drug. No FDA-approved animal-drug application is linked for this record. It may represent extra-label, human-drug, bulk-compounding, export-only, or otherwise unapproved animal-use source data; use only under veterinarian direction.
Medication Snapshot
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
Gabapentin
Used for neuropathic pain and as an adjunct for seizure control; also used for situational anxiety/sedation in some cases. Species commonly shown: Both.
Generic name
Gabapentin
Brand names
GABAPENTIN, SolutitionKits
Manufacturer
Multiple FDA labelers
Species
Both
Completeness
86%
Validation
Incomplete
Brand names
GABAPENTINSolutitionKits
Indications / Uses
Used for neuropathic pain and as an adjunct for seizure control; also used for situational anxiety/sedation in some cases.
Administration / How To Give
Oral
Storage
Store at room temperature.
Warnings / Contraindications
Use caution with kidney disease; dose adjustments may be needed.
Use caution with kidney disease; dose adjustments may be needed.
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 Gabapentin; use the official documents and your veterinarian's instructions for product-specific decisions.
Source: openFDA reaction aggregate term
Safety signal coverageReported signals
32 tracked reaction signals; 60 reported cases; 7 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.
Source: openFDA reaction aggregate term
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 reaction aggregate term
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.
Domestic Shorthair (2), Retriever - Labrador (2), Schnauzer - Miniature (1), Crossbred Canine/dog (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 Gabapentin 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
Use caution with kidney disease, dose adjustments may be needed, Thrombocytopenia, Elevated symmetrical dimethylarginine, Conjunctivitis
Call sooner ifEscalation
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Bottom line: Use this Gabapentin brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Skin lumpSurgical site disorderSkin inflammation NOSReddening of the skinIntentional misuseApplication site irritationApplication site reddeningApplication site inflammationContamination NOS
Body systems
Other
Outcomes
Ongoing
USA-USFDACVM-2026-US-009973
Received 2026-02-27
· MSK
· MSK
Serious
Species
Dog
Breed
Crossbred Canine/dog
Size / weight
50-99 lb (34.019 Kilogram)
Age
8+ years (10.5 Year)
Sex
Male Neutered
Region
USA
Reactions
Not eatingWalking difficultyPantingSeizure NOSDeathIntentional misuse
Lethargy (see also Central nervous system depression in Neurological)InappetenceSwollen lip (see also Skin)Localised pain NOS (see other SOCs for specific pain)Ocular dischargeNot drinkingSmelly breathLip smackingWalking difficultyAbdominal painDrooping eyelidReluctant to moveOral ulcerationTongue ulcerationIntentional misuse
Body systems
NeurologicOther
Outcomes
Ongoing
USA-USFDACVM-2026-US-007418
Received 2026-02-09
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (8.7 Kilogram)
Age
1-3 years (2.8 Year)
Sex
Male Neutered
Region
USA
Reactions
Lack of efficacy - NOSNot eatingLethargy (see also Central nervous system depression in Neurological)General pain (see other SOCs for specific pain)Facial oedemaTrigeminus paralysisOral ulcerationIntentional misuse
Body systems
EffectivenessOtherNeurologic
Outcomes
Ongoing
USA-USFDACVM-2026-US-003352
Received 2026-01-27
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.992 Kilogram)
Age
8+ years (13 Year)
Sex
Female Neutered
Region
USA
Reactions
DiarrhoeaDecreased appetiteLethargy (see also Central nervous system depression in Neurological)Bloody diarrhoeaDry mucous membraneOpen mouth breathingUnresponsive to stimuliDecreased haematocritIncreased percentage reticulocytesRegenerative anaemiaIntentional misuseThrombocytopeniaHypersalivationHeart murmur
Body systems
DigestiveNeurologicOther
Outcomes
Ongoing
USA-USFDACVM-2025-US-072888
Received 2025-12-11
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Longhair
Size / weight
10-24 lb (5.715 Kilogram)
Age
8+ years (14 Year)
Sex
Male Neutered
Region
USA
Reactions
SyncopeCollapse NOS (see also Cardio-vascular and Neurological disorders)AnorexiaHidingLow blood pressureHepatomegalyHepato-biliary disorder NOSIntentional misuse
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing
USA-USFDACVM-2025-US-072814
Received 2025-12-10
· MSK
· MSK
Serious
Species
Dog
Breed
Pinscher - Miniature
Size / weight
Under 10 lb (4.037 Kilogram)
Age
8+ years (1 Year)
Sex
Female Unknown
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)TremblingLimpingHead downWalking difficultyFeverLack of efficacy - NOSElevated globulinsBlood in urineImmune-mediated polyarthropathyElevated protein:creatinine ratioProteinuriaIntentional misuse
Body systems
NeurologicOtherEffectiveness
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
Body systems
OtherDigestive
Outcomes
Ongoing
USA-USFDACVM-2025-US-067364
Received 2025-11-14
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6.804 Kilogram)
Age
8+ years (14 Year)
Sex
Female Unknown
Region
USA
Reactions
DehydrationEmesis (multiple)Elevated cholesterol (total)Abnormal radiograph findingLack of efficacy - NOSWeaknessUrinary incontinenceAtaxiaDullRecumbencyIncreased coagulation timeElevated aspartate aminotransferase (AST)Elevated creatinineHypokalaemiaElevated gamma-glutamyl transferase (GGT)Elevated triglycerideBlood in urineHypothermiaDisseminated intravascular coagulationCardiorespiratory arrestDeathIntentional misuseShockDistension of abdomen
Body systems
OtherDigestiveEffectivenessNeurologic
Outcomes
Died
USA-USFDACVM-2025-US-067000
Received 2025-11-14
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.992 Kilogram)
Age
8+ years (13 Year)
Sex
Female Unknown
Region
USA
Reactions
DiarrhoeaDecreased appetiteLethargy (see also Central nervous system depression in Neurological)Bloody diarrhoeaDry mucous membraneOpen mouth breathingUnresponsive to stimuliDecreased haematocritIncreased percentage reticulocytesRegenerative anaemiaIntentional misuseUnderdoseThrombocytopeniaHeart murmurHypersalivation
De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).
Effectiveness
Lack of efficacy (endoparasite) - tapeworm (2) • Dog
Showing top 5 for Effectiveness.
Other
Thrombocytopenia (4) • Dog
Elevated symmetrical dimethylarginine (4) • Dog
Conjunctivitis (3) • Dog
Urolithiasis (2) • Dog
Unclassifiable adverse event (2) • Dog
Show more (26)
Trembling (2) • Dog
Skin lesion NOS (2) • Dog
Respiratory tract infection NOS (2) • Dog
Regurgitation (2) • Dog
Reduced globulins (2) • Dog
Pyoderma (2) • Dog
Proprioception deficit (2) • Dog
Knuckling (2) • Dog
Hypophosphataemia (2) • Dog
Hypokalaemia (2) • Cat
Hepatomegaly (2) • Cat
Fracture (2) • Dog
Erythema (2) • Dog
Elevated alanine aminotransferase (2) • Cat
Decreased activity (2) • Cat
Death (2) • Cat
Confusion (2) • Dog
Abnormal radiograph finding (1) • Cat
Abnormal movement NOS (1) • Dog
Abnormal menace reflex test (1) • Cat
Abnormal histology NOS (1) • Dog
Abnormal cytology (1) • Dog
Abdominal pain (1) • Dog
Abdominal effusion (1) • Dog
Abdominal discomfort (1) • Dog
Abdominal cavity disorder NOS (1) • Dog
Showing top 5 for Other.
Data source: FDA openFDA Animal & Veterinary adverse event reports.
Adverse Event Case Summaries (openFDA)
These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.
Data source: FDA openFDA Animal & Veterinary adverse event reports.
Overdose Information
Overdose can cause severe sedation, loss of coordination, muscle tremors, and respiratory depression. Emergency care: IV fluids, monitoring.
Storage & Handling
Store at room temperature.
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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.