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
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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.
Musculoskeletal disorder NOSAggressionUnable to walkUrinary incontinenceMelaenaEmesis (multiple)Lethargy (see also Central nervous system depression in Neurological)Death by euthanasiaNeurological signs NOS
Body systems
OtherBehaviorDigestiveNeurologic
Outcomes
Euthanized
USA-USFDACVM-2026-US-012478
Received 2026-03-16
· MSK
· MSK
Serious
Species
Dog
Breed
['Retriever - Labrador', 'Terrier - Bull - American Pit']
Size / weight
50-99 lb (31.298 Kilogram)
Age
8+ years (14 Year)
Sex
Female Neutered
Region
USA
Reactions
Limb weaknessDecreased appetiteDeath by euthanasiaLethargy (see also Central nervous system depression in Neurological)Panting
Body systems
OtherDigestiveNeurologic
Outcomes
Euthanized
USA-USFDACVM-2026-US-008246
Received 2026-02-24
· MSK
· MSK
Serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
100+ lb (48.08 Kilogram)
Age
4-7 years (7.5 Year)
Sex
Male Neutered
Region
USA
Reactions
Death by euthanasiaNot himself/herselfLethargy (see also Central nervous system depression in Neurological)VomitingHaemorrhage NOSWeight lossSternoabdominal recumbencyDehydrationDiabetic ketoacidosisAcute pancreatitisAzotaemia
Body systems
OtherNeurologicDigestive
Outcomes
Euthanized
USA-USFDACVM-2025-US-074164
Received 2025-12-16
· MSK
· MSK
Serious
Species
Cat
Breed
Cat (unknown)
Size / weight
Under 10 lb (3.63 Kilogram)
Age
8+ years (18 Year)
Sex
Female Neutered
Region
USA
Reactions
UnwellCryingDeath by euthanasiaDehydrationPale mucous membraneAnorexiaNot drinking
Body systems
OtherDigestive
Outcomes
Euthanized
USA-USFDACVM-2025-US-072787
Received 2025-12-15
· MSK
· MSK
Serious
Species
Dog
Breed
Poodle - Standard
Size / weight
25-49 lb (20.412 Kilogram)
Age
1-3 years (2 Year)
Sex
Female Intact
Region
USA
Reactions
Death by euthanasiaConjunctivitisUlceration NOSEar canal erythemaWeltBumps on skinSkin inflammation NOSAnorexiaPain NOSDifficulty to risePyodermaAbnormal histology NOSSeizure NOSNeutropeniaMonocytosisElevated creatinineThrombocytopeniaHyperkeratosisPruritus
Body systems
OtherDigestiveNeurologicSkin & allergy
Outcomes
Euthanized
USA-USFDACVM-2025-US-072107
Received 2025-12-01
· MSK
· MSK
Serious
Species
Dog
Breed
Shepherd Dog - German
Size / weight
50-99 lb (40.1 Kilogram)
Age
8+ years (10.5 Year)
Sex
Male Neutered
Region
USA
Reactions
VocalisationAbnormal tail posturePain NOSWeight lossDecreased appetiteVomitingChewing disorderPantingTremblingLying downAnxietyExcessive chewing, licking and/or groomingMuscle atrophy (see also Muscle wasting)Musculoskeletal disorder NOSAbnormal radiograph findingSpondylosisJoint effusionElevated gamma-glutamyl transferase (GGT)LymphopeniaLethargy (see also Central nervous system depression in Neurological)Thoracic painDeath by euthanasiaMedication error NOS
Body systems
OtherDigestiveBehaviorNeurologic
Outcomes
Euthanized
USA-USFDACVM-2025-US-075182
Received 2025-11-24
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (4.76 Kilogram)
Age
8+ years (11 Year)
Sex
Male Neutered
Region
USA
Reactions
Cold feeling to the touchDecreased appetiteLack of efficacy - NOSBehavioural disorder NOSVomitingRenal disorder NOSLethargy (see also Central nervous system depression in Neurological)Elevated renal parametersArthritisReluctant to moveWeight gainWobblinessDental diseaseRespiratory tract infection NOSAnaemia NOSElevated creatinineHypercalcaemiaFeverDehydrationDiarrhoeaDecreased haematocritDecreased red blood cell countDigestive tract disorder NOSSicknessDistressDiabetesDecreased body temperatureDeath by euthanasia
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.