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
Jun 22, 2026, 10:45 a.m.
Roxee has a partial reference profile for this medication. Some primary facts still need verification.
FDA applications
FDA application data refreshed
Jun 22, 2026, 10:41 a.m.
Sponsor, product, and application records imported from Animal Drugs @ FDA.
Safety reports
Safety data refreshed
Jun 22, 2026, 10:42 a.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 Jun 22, 2026, 10:45 AM UTC
The reference fact projection used for browse cards and quick facts.
Animal Drug Product Listing Directory (NDC):Source FDA| Refreshed Jun 22, 2026, 10:41 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
openFDA reaction terms:Source FDA openFDA| Refreshed Jun 22, 2026, 10:45 AM UTC
openFDA case summaries:Source FDA openFDA| Refreshed Jun 22, 2026, 10:45 AM 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
SolutitionKits, Gabapentin
Manufacturer
Multiple FDA labelers
Species
Both
Completeness
86%
Validation
Incomplete
Brand names
SolutitionKitsGabapentin
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 case USA-USFDACVM-2025-US-070810
Safety signal coverageReported signals
32 tracked reaction signals; 32 reported cases; 25 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.
Source: openFDA case USA-USFDACVM-2025-US-070810
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 case USA-USFDACVM-2025-US-070810
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.
Reaction signal map
Most reported reactionsTop terms
Unsteady walking (ataxia) (1 reports), Loss of appetite (1 reports), Bloody diarrhoea (1 reports), Blood in vomit (1 reports), Blood in urine (1 reports)
Shepherd Dog - German (2), Domestic Shorthair (2), Siamese (1), Siberian Husky (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, wobbly/unsteady walking, Loss of appetite, Bloody diarrhoea
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.
Lack of efficacy - NOSUrinary tract infectionBehavioural disorder NOSDecreased haematocritOliguria
Body systems
EffectivenessOtherBehavior
Outcomes
Outcome Unknown
USA-USFDACVM-2025-US-075291
Received 2025-12-22
· MSK
· MSK
Serious
Species
Dog
Breed
Shepherd Dog - German
Size / weight
50-99 lb (44.45 Kilogram)
Age
8+ years (10.9 Year)
Sex
Female Unknown
Region
USA
Reactions
Lack of efficacy - NOSSeizure NOSOther abnormal test result NOSAtaxiaMusculoskeletal disorder NOSElevated serum alkaline phosphatase (ALP)
Body systems
EffectivenessNeurologicOther
Outcomes
Ongoing
USA-USFDACVM-2025-US-073901
Received 2025-12-19
· MSK
· MSK
Serious
Species
Dog
Breed
Terrier - Bull - American Pit
Size / weight
50-99 lb (37 Kilogram)
Age
4-7 years (7 Year)
Sex
Male Neutered
Region
USA
Reactions
Loose stoolEmesis (multiple)Decreased appetiteDecreased drinkingMedication error NOSLack of efficacy - NOS
Body systems
OtherDigestiveEffectiveness
Outcomes
Ongoing
USA-USFDACVM-2025-US-074070
Received 2025-12-18
· MSK
· MSK
Serious
Species
Dog
Breed
['Retriever - Golden', 'Poodle (unspecified)']
Size / weight
50-99 lb (43.273 Kilogram)
Age
8+ years (12 Year)
Sex
Female Unknown
Region
USA
Reactions
Urinary tract infectionMedication error NOSLack of efficacy - NOS
Body systems
OtherEffectiveness
Outcomes
Ongoing
USA-USFDACVM-2025-US-075245
Received 2025-12-16
· MSK
· MSK
Serious
Species
Dog
Breed
Retriever - Golden
Size / weight
10-24 lb (6.622 Kilogram)
Age
Under 1 year (2 Month)
Sex
Male Intact
Region
USA
Reactions
WeaknessNot eatingLying downInappropriate urinationDifficulty standingWalking slowlyCollapse NOS (see also Cardio-vascular and Neurological disorders)Pain NOSSneezingCough, productiveInvoluntary urinationUnable to walkLeucocytosis NOSAnaemia NOSDecreased blood urea nitrogen (BUN) or creatinineAbdominal painGastric ulcerSeizure NOSDeathLack of efficacy - NOS
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-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
Body systems
OtherDigestiveEffectivenessBehaviorNeurologic
Outcomes
Euthanized
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
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.