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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 • Branded profile • FDA branded products available
Species: Both
Manufacturer: Genus Lifesciences
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
Anti-seizure medication used for epilepsy and seizure disorders. Species commonly shown: Both, Dog.
Anti-seizure medication used for epilepsy and seizure disorders.
Oral
Store at room temperature; keep secured.
Use caution with liver disease.
Sedation, increased thirst/urination, increased appetite. Long-term: liver enzyme changes.
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Used for:
Conditionally approved for the control of seizures associated with idiopathic epilepsy in dogs.
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:
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 Phenobarbital; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 18 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.
Unsteady walking (ataxia) (1 reports), Falling (1 reports), Eyes rolling back (1 reports), Eosinopenia (1 reports), Elevated symmetrical dimethylarginine (1 reports)
Digestive (3), Neurologic (1), Behavior (2), Other (26)
Cat (21 reports), Dog (11 reports)
Domestic Shorthair (3), Shepherd Dog - German (1), ['Retriever - Golden', 'Dog (unknown)'] (1), Dog (unknown) (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Phenobarbital 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.
Use caution with liver disease, wobbly/unsteady walking, Falling, Eyes rolling back
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: February 12, 2026, 7:40 PM 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.
Use caution with liver disease.
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 2026-03-19 · MSK · MSK
Received 2026-03-17 · MSK · MSK
Received 2026-03-11 · MSK · MSK
Received 2026-03-09 · MSK · MSK
Received 2026-03-06 · MSK · MSK
Received 2026-03-04 · MSK · MSK
Received 2026-03-02 · MSK · MSK
Received 2026-02-23 · MSK · MSK
Received 2026-01-30 · MSK · MSK
Received 2026-01-29 · MSK · MSK
Received 2026-01-16 · MSK · MSK
Received 2025-12-24 · MSK · MSK
Received 2025-12-16 · MSK · MSK
Received 2025-12-09 · MSK · MSK
Received 2025-12-08 · MSK · MSK
Received 2025-12-05 · MSK · MSK
Received 2025-12-03 · MSK · MSK
Received 2025-10-28 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Neurologic | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 |
Species coverage: Cat (21) Dog (11)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Digestive | Cat | Non-serious | - | 1 | |
| Neurologic | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Digestive | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Digestive | Cat | Non-serious | - | 1 | |
| Behavior | Cat | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Behavior | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 |
Store at room temperature; keep secured.
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.
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.
Conditionally approved for the control of seizures associated with idiopathic epilepsy in dogs.
Administer phenobarbital as tablets given orally twice a day at the minimum dosage of 2.5 mg per kilogram of body weight (mg/kg) and may be titrated to effect to a maximum dosage of 5 mg/kg. The dosage of phenobarbital tablets should be adjusted based on monitoring the clinical response of the individual patient.
SPL · Structured Product Label
SPL · Structured Product Label
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 |
|---|---|---|---|
| 64950-541-01 | 64950 | - | |
| 64950-541-10 | 64950 | - | |
| 64950-542-01 | 64950 | - | |
| 64950-542-10 | 64950 | - | |
| 64950-543-01 | 64950 | - | |
| 64950-543-10 | 64950 | - | |
| 64950-544-01 | 64950 | - | |
| 64950-544-10 | 64950 | - | |
| 64950-560-01 | 64950 | - | |
| 64950-560-10 | 64950 | - | |
| 64950-561-01 | 64950 | - | |
| 64950-561-10 | 64950 | - | |
| 64950-562-01 | 64950 | - | |
| 64950-562-10 | 64950 | - | |
| 64950-563-01 | 64950 | - | |
| 64950-563-10 | 64950 | - |
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 |
|---|---|---|---|---|
|
FIDOQUEL™-CA1
RX
Phenobarbital
Tablet
• Oral
|
Genus Lifesciences Inc. | C 141-578 | Approved | Jun 3, 2024 |
Data source: FDA Animal Drugs @ FDA (public search export).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
Conditionally approved for the control of seizures associated with idiopathic epilepsy in dogs.
Administer phenobarbital as tablets given orally twice a day at the minimum dosage of 2.5 mg per kilogram of body weight (mg/kg) and may be titrated to effect to a maximum dosage of 5 mg/kg. The dosage of phenobarbital tablets should be adjusted based on monitoring the clinical response of the individual patient.
FDA page: Open in Animal Drugs @ FDA
Anti-seizure medication used for epilepsy and seizure disorders.
Source: FDA Animal Drugs @ FDA • Reference
Use caution with liver disease.
Sedation, increased thirst/urination, increased appetite. Long-term: liver enzyme changes.
Source: FDA openFDA • Reference
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 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.
Dog, Shepherd Dog - German, Male, 9 year, 43.318 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Lack of efficacy (ectoparasite) - flea, Tiredness (lethargy), Unable to walk, Falling, Grand mal seizure • Outcome: Ongoing
Dog, ['Retriever - Golden', 'Dog (unknown)'], Male, 13 year, 26.036 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Partial lack of efficacy • Outcome: Ongoing
Dog, Dog (unknown), Male • Drug: MSK, Unknown • Reactions: Nausea, Difficulty to rise, Difficulty standing, Collapse NOS, Limb weakness… • Outcome: Outcome Unknown
Dog, Retriever - Labrador, Male, 3.5 year, 29.48 kilogram • Drug: MSK, Unknown • Reactions: Seizure NOS • Outcome: Recovered/Normal
Dog, Spaniel - King Charles Cavalier, Female, 7.6 year, 13.15 kilogram • Drug: MSK, Unassigned, Oral, Dose: 32.40 Milligram per animal • Reactions: Excessive thirst, Cough, Swallowing difficult, Oral cavity disorder NOS, Drooping eyelid • Outcome: Ongoing
Cat, Domestic Shorthair, Male, 17 year, 5.806 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Anaemia NOS, Hypercalcaemia, Elevated symmetrical dimethylarginine, Seizure NOS, Lack of efficacy - NOS… • Outcome: Outcome Unknown
Cat, Domestic Shorthair, Male, 18 year, 5.67 kilogram • Drug: MSK, Unassigned, Oral, Dose: 7.50 Milligram per animal, Frequency: 12 per hour • Reactions: Seizure NOS, Unsteady walking (ataxia) • Outcome: Ongoing
Cat, Domestic Shorthair, Male, 14 year, 5.443 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Seizure NOS, Unsteady walking (ataxia) • 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.
Store at room temperature; keep secured.
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.