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
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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.
Emesis (multiple)Not eatingLethargy (see also Central nervous system depression in Neurological)Reluctant to moveSeizure NOS
Body systems
DigestiveOtherNeurologic
Outcomes
Ongoing
USA-USFDACVM-2025-US-074895
Received 2025-12-19
· MSK
· MSK
Serious
Species
Dog
Breed
Bloodhound
Size / weight
50-99 lb (41.28 Kilogram)
Age
4-7 years (5 Year)
Sex
Female Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)Stiffness NOSWalking difficultyGeneralised weaknessNeutropeniaLow platelet countPain NOSDecreased appetiteVomitingElevated liver enzymes NOSFluid in abdomen NOSLiver disorder NOSOther immune system disorder NOSFeverLeucopenia NOSDistension of abdomenHypoglycaemiaAnaemia NOSIndigestion
Body systems
NeurologicOtherDigestive
Outcomes
Ongoing
USA-USFDACVM-2025-US-072729
Received 2025-12-05
· MSK
· MSK
Non-serious
Species
Dog
Breed
Terrier - Bull
Size / weight
25-49 lb (17.6 Kilogram)
Age
4-7 years (7 Year)
Sex
Female Neutered
Region
USA
Reactions
Leucopenia NOSAnaemia NOSHypoalbuminaemiaNeutropeniaPyodermaReduced globulinsHypophosphataemiaNon-regenerative anaemiaLow serum alkaline phosphatase (ALP)Pale mucous membraneElevated alanine aminotransferase (ALT)Decreased packed cell volume (PCV)Lethargy (see also Central nervous system depression in Neurological)HypocalcaemiaElevated aspartate aminotransferase (AST)HypoproteinaemiaProteinuriaElectrolyte disorderDisorder of red blood cell NOSElevated creatine-kinase (CK)Other coagulation investigation abnormalityIncreased band neutrophiliaElevated mean corpuscular volume (MCV)LymphopeniaOther abnormal test result NOSDiarrhoeaPanleucopeniaEosinopeniaDecreased haematocritIncreased percentage reticulocytes
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing
USA-USFDACVM-2025-US-072504
Received 2025-12-04
· MSK
· MSK
Serious
Species
Dog
Breed
Terrier - Bull - American Pit
Size / weight
50-99 lb (29.03 Kilogram)
Age
1-3 years (2 Year)
Sex
Male Neutered
Region
USA
Reactions
Otitis externaTrigeminus paralysisVomitingCoughMuscle atrophy (see also Muscle wasting)Elevated serum alkaline phosphatase (ALP)Elevated alanine aminotransferase (ALT)HypersalivationUnusual stool colourErythema (for urticaria see Immune SOC)Elevated gamma-glutamyl transferase (GGT)Elevated total bilirubinAbnormal ultrasound findingHepatic fibrosisHepatitisLethargy (see also Central nervous system depression in Neurological)AngioedemaGeneralised rashDyspnoeaIncreased lung soundsLeucocytosis NOSIcterusAbnormal radiograph findingJaw disorder
Body systems
OtherDigestiveSkin & allergyNeurologic
Outcomes
Ongoing
USA-USFDACVM-2025-US-072463
Received 2025-12-01
· MSK
· MSK
Non-serious
Species
Dog
Breed
['Rottweiler', 'Retriever - Labrador']
Size / weight
50-99 lb (27.76 Kilogram)
Age
8+ years (14 Year)
Sex
Male Neutered
Region
USA
Reactions
Proprioception deficitMusculoskeletal disorder NOSLethargy (see also Central nervous system depression in Neurological)AnorexiaReluctant to moveBradycardiaArrhythmiaPyrexiaLymphocytosisLeucocytosis NOSLow thyroxine (T4)Elevated symmetrical dimethylarginine (SDMA)Urinary tract infection
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing
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
Body systems
OtherDigestiveEffectivenessBehaviorNeurologic
Outcomes
Euthanized
USA-USFDACVM-2025-US-070121
Received 2025-11-21
· MSK
· MSK
Non-serious
Species
Dog
Breed
['Shepherd Dog - German', 'Dog (unknown)']
Size / weight
50-99 lb (36.015 Kilogram)
Age
8+ years (12 Year)
Sex
Male Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)Decreased appetiteWobblinessNot himself/herself
Body systems
NeurologicDigestiveOther
Outcomes
Ongoing
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
Body systems
DigestiveNeurologicOther
Outcomes
Ongoing
USA-USFDACVM-2025-US-068234
Received 2025-11-12
· MSK
· MSK
Serious
Species
Cat
Breed
Cat (unknown)
Sex
Mixed Unknown
Region
USA
Reactions
DeathHaematocheziaDecreased appetiteRegurgitationLethargy (see also Central nervous system depression in Neurological)DiarrhoeaDeath by euthanasia
Body systems
OtherDigestiveNeurologic
Outcomes
DiedEuthanizedOutcome Unknown
Tap or hover a reaction to see what it means in plain language.
Tracked signals
32
Reported cases
32
Serious reports
25
Species represented
2
Grouped by Body System
Digestive (3)
· Loss of appetite, Bloody diarrhoea, Blood in vomit
Skin & allergy (3)
· Hair loss, Application site hair loss, Alopecia NOS
Neurologic (1)
· Unsteady walking (ataxia)
Behavior (3)
· Biting -aggression, Behavioral disorder (unspecified), Anxiety
Other (22)
· Blood in urine, Bladder distension, Balance problem
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.