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Roxee Meds Catalog

Phenobarbital

Medication catalog facts with explicit FDA-approval, off-label, source-limited, and safety context.

Both Catalog complete FDA data linked Rx required Tablet Genus Lifesciences Official label facts Owner quick guide first
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Data freshness

Storefront facts
Catalog refreshed
May 5, 2026, 10:00 a.m.

These are the storefront facts Roxee uses on browse cards and quick facts.

FDA applications
FDA application data refreshed
May 5, 2026, 10:00 a.m.

Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports
Safety data refreshed
May 5, 2026, 10:01 a.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:00 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: February 12, 2026

Updated: February 12, 2026, 7:40 PM UTC

Sources:
Image coming soon
Phenobarbital

Phenobarbital

Drug type: Generic ingredient • Branded profile • FDA branded products available

Both Tablet Rx required 100% storefront ready

Species: Both

Manufacturer: Genus Lifesciences

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Phenobarbital

Anti-seizure medication used for epilepsy and seizure disorders. Species commonly shown: Both, Dog, No Use Class Stated Or Implied.

Generic name
Phenobarbital
Brand names
FIDOQUEL™-CA1, FIDOQUEL-CA1
Manufacturer
Genus Lifesciences
Species
Both, Dog, No Use Class Stated Or Implied
Dosage forms
Tablet
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
FIDOQUEL™-CA1 FIDOQUEL-CA1
Dosage forms
Tablet

Indications / Uses

Anti-seizure medication used for epilepsy and seizure disorders.

Administration / How To Give

Oral

Storage

Store at room temperature; keep secured.

Warnings / Contraindications

Use caution with liver disease.

  • Use caution with liver disease.

Side Effects

Sedation, increased thirst/urination, increased appetite. Long-term: liver enzyme changes.

FAQ

Both, Dog, No Use Class Stated Or Implied

Yes. Roxee shows this as prescription-only.

Tablet

Store at room temperature; keep secured.

Related Medications

Cyclosporine Same category: Allergies / Itching Diphenhydramine Same category: Allergies / Itching Lokivetmab Same category: Allergies / Itching Oclacitinib Same category: Allergies / Itching Oclacitinib Maleate Same category: Allergies / Itching Prednisone Same category: Allergies / Itching

Related Conditions

Seizures (idiopathic/structural)

Source Transparency

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

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:

  • Use caution with liver disease
  • Panting (1 reports)
  • Pancreatitis NOS (1 reports)
  • Mental impairment NOS (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

What to tell or ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?
Major cautions & emergency warning signs

Side effects to monitor:

  • Use caution with liver disease
  • Panting
  • Pancreatitis NOS
  • Mental impairment NOS

Most reported reactions:

  • Panting (1 reports)
  • Pancreatitis NOS (1 reports)
  • Mental impairment NOS (1 reports)

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Genus Lifesciences
Form: Tablet
Identifiers:
NADA: 141578 NDC Package: 64950-541-01 NDC Package: 64950-541-10 NDC Package: 64950-542-01 NDC Package: 64950-542-10 NDC Package: 64950-543-01 NDC Package: 64950-543-10 NDC Package: 64950-544-01 NDC Package: 64950-544-10 NDC Package: 64950-560-01 NDC Package: 64950-560-10 NDC Package: 64950-561-01 NDC Package: 64950-561-10 NDC Package: 64950-562-01 NDC Package: 64950-562-10 NDC Package: 64950-563-01 NDC Package: 64950-563-10 NDC Product: 64950
Source metadata:

Warnings / Contraindications

Use caution with liver disease.

  • High: Use caution with liver disease.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
32
Serious reports
15
Species represented
2
Grouped by Body System
Digestive (3) · Vomiting, Diarrhea, Blood in vomit Neurologic (1) · Tiredness (lethargy) Effectiveness (2) · Partial lack of efficacy, Lack of efficacy - NOS Other (26) · Panting, Pancreatitis NOS, Not eating
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Effectiveness 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1

Species coverage: Cat (21) Dog (11)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Digestive Cat Non-serious - 1
Neurologic Dog Non-serious - 1
Effectiveness Cat Non-serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Non-serious - 1
Other Cat Serious - 1
Other Cat Non-serious - 1
Other Cat Non-serious - 1
Effectiveness Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Non-serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Non-serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Cat Non-serious - 1
Digestive Cat 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
Other Cat Non-serious - 1
Other Cat Serious - 1
Other Dog Non-serious - 1
Source metadata:

Storage & Handling

Store at room temperature; keep secured.

Documents

Owner handouts and official technical documents open on-page first, with the original source still one click away.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

2

FOI

1

FIDOQUEL™-CA1

SPL · SPL

Open original
FDA Structured Product Label

FIDOQUEL™-CA1

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Genus Lifesciences Inc.
C
141-578
Status
RX
Form
Tablet
Route
Oral
Species
Dog, No Use Class Stated Or Implied
Composition / specifications
15, 16.2, 30, 32.4, 60, 64.8, 97.2, or 100 mg per tablet

Dogs

Indication

Conditionally approved for the control of seizures associated with idiopathic epilepsy in dogs.

Dosage

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.

FIDOQUEL-CA1 SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for FIDOQUEL-CA1. Use the source link for the full official labeling record.

FOI Summary 141-578 Approved September 6, 2023.pdf

FOI · FOI

Open original
Source metadata:
Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:00 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: FIDOQUEL-CA1
Manufacturer mapping: Genus Lifesciences
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Tablet • Oral
Applications: C 141-578
NDC: Packages 64950-541-01 64950-541-10 64950-542-01 64950-542-10 64950-543-01 64950-543-10 • Products 64950
Documents: 1 (FOI: 1) • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 3 • Cat 18 • View
Case summaries: 7 (showing 7) • View
openFDA reports are unverified and do not prove causation.
Explore
Related conditions: Seizures (idiopathic/structural)
Linked using: Fda_Label (0.95)
Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • Use caution with liver disease. (Contraindication, High)
Top reaction signals
Panting (1) Pancreatitis NOS (1) Mental impairment NOS (1) Lack of efficacy - NOS (1) Ketosis (1) Intentional misuse (1) Inappetence (1) Hypotension (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
NADA: 141578 NDC Package: 64950-541-01 NDC Package: 64950-541-10 NDC Package: 64950-542-01 NDC Package: 64950-542-10 NDC Package: 64950-543-01 NDC Package: 64950-543-10 NDC Package: 64950-544-01 NDC Package: 64950-544-10 NDC Package: 64950-560-01 NDC Package: 64950-560-10 NDC Package: 64950-561-01 NDC Package: 64950-561-10 NDC Package: 64950-562-01 NDC Package: 64950-562-10 NDC Package: 64950-563-01 NDC Package: 64950-563-10 NDC Product: 64950
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 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 37 Clinical 4 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Sedation, increased thirst/urination, increased appetite. Long-term: liver enzyme changes. (Clinical, 2026-04-11)
  • storage_handling: Store at room temperature; keep secured. (Clinical, 2026-04-12)
  • storage_handling: Store at room temperature; keep secured. (Clinical, 2026-04-11)
  • storage_handling: Store at room temperature; keep secured. (Clinical, 2026-02-12)
  • contraindications: Use caution with liver disease. (Official, 2026-04-12)
  • contraindications: Use caution with liver disease. (Official, 2026-04-11)
  • contraindications: Use caution with liver disease. (Official, 2026-02-12)
  • indications: Conditionally approved for the control of seizures associated with idiopathic epilepsy in dogs (Official, 2026-05-05)
  • indications: Conditionally approved for the control of seizures associated with idiopathic epilepsy in dogs (Official, 2026-05-03)
  • indications: Conditionally approved for the control of seizures associated with idiopathic epilepsy in dogs (Official, 2026-05-02)
  • indications: Conditionally approved for the control of seizures associated with idiopathic epilepsy in dogs (Official, 2026-04-29)
  • indications: Conditionally approved for the control of seizures associated with idiopathic epilepsy in dogs (Official, 2026-04-28)
  • indications: Conditionally approved for the control of seizures associated with idiopathic epilepsy in dogs (Official, 2026-04-27)
  • indications: Conditionally approved for the control of seizures associated with idiopathic epilepsy in dogs (Official, 2026-04-26)
  • indications: Conditionally approved for the control of seizures associated with idiopathic epilepsy in dogs (Official, 2026-04-25)
  • indications: Conditionally approved for the control of seizures associated with idiopathic epilepsy in dogs (Official, 2026-04-22)
  • manufacturer_name: Genus Lifesciences (Official, 2026-05-05)
  • manufacturer_name: Genus Lifesciences (Official, 2026-05-03)
  • manufacturer_name: Genus Lifesciences (Official, 2026-05-02)
  • manufacturer_name: Genus Lifesciences (Official, 2026-04-29)
Recent Revisions
  • side_effects updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
FIDOQUEL™-CA1
RX
Phenobarbital
Tablet • Oral
Label highlights
Official documents
Genus Lifesciences Inc. C 141-578 Approved Jun 3, 2024

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
15, 16.2, 30, 32.4, 60, 64.8, 97.2, or 100 mg per tablet
Dogs
Indication

Conditionally approved for the control of seizures associated with idiopathic epilepsy in dogs.

Dosage

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.

Limitations

FDA page: Open in Animal Drugs @ FDA

Usage

Anti-seizure medication used for epilepsy and seizure disorders.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Use caution with liver disease.

Side Effects

Sedation, increased thirst/urination, increased appetite. Long-term: liver enzyme changes.

Source: FDA openFDA • Reference

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Vomiting (1) • Cat Diarrhea (1) • Cat Blood in vomit (1) • Cat

Showing top 5 for Digestive.

Neurologic
Tiredness (1) • Dog

Showing top 5 for Neurologic.

Effectiveness
Partial lack of efficacy (1) • Cat Lack of efficacy - NOS (1) • Dog

Showing top 5 for Effectiveness.

Other
Panting (1) • Dog Pancreatitis NOS (1) • Cat Not eating (1) • Cat Mental impairment NOS (1) • Cat Low sodium-potassium ratio (1) • Cat
Show more (21)
Limping (1) • Cat Ketosis (1) • Cat Intentional misuse (1) • Dog Inappetence (1) • Cat Hypotension (1) • Cat Hyperglycaemia (1) • Cat High ionized calcium (1) • Cat Heart murmur (1) • Cat Hard stool (1) • Cat Gait abnormality (1) • Dog Fever (1) • Dog Elevated serum alkaline phosphatase (1) • Dog Elevated alanine aminotransferase (1) • Cat Decreased red blood cell count (1) • Dog Decreased packed cell volume (1) • Cat Decreased haemoglobin (1) • Dog Decreased haematocrit (1) • Dog Cyst NOS (1) • Cat Arthritis (1) • Cat Aortic mineralisation (1) • Cat Anaemia 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.

Cat, Domestic Shorthair, Female, 10 year, 4.85 kilogram • Drug: MSK, Unknown • Reactions: Heart murmur, High ionized calcium, Cyst NOS, Aortic mineralisation, Not eating… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075006
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 10.00 Year
  • Weight: 4.850 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Heart murmur High ionized calcium Cyst NOS Aortic mineralisation Not eating Third eyelid protrusion Pawing Mental impairment NOS Hypotension Decreased packed cell volume
Outcomes: Ongoing

Dog, Terrier - Boston, Male, 3 year, 10.886 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Seizure NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074340
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 3.00 Year
  • Weight: 10.886 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Seizure NOS
Outcomes: Ongoing

Dog, Dog (unknown), Unknown • Drug: MSK, Unknown • Reactions: Tiredness (lethargy) • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-072427
  • Serious AE: No
  • Treated For AE: No
  • Sex: Unknown
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Tiredness (lethargy)
Outcomes: Outcome Unknown

Dog, Deutsche Dogge, Great Dane, Female, 3 year • Drug: MSK, Tablet, Oral • Reactions: Urinary incontinence • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-073386
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 3.00 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
Reactions Reported:
Urinary incontinence
Outcomes: Recovered/Normal

Dog, ['Hound - Basset', 'Collie (unspecified)'], Male, 11 year, 27.488 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Seizure NOS • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-071469
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 11.00 Year
  • Weight: 27.488 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Seizure NOS
Outcomes: Recovered/Normal

Dog, Retriever - Labrador, Male, 7 year, 36.3 kilogram • Drug: MSK, Unknown • Reactions: Seizure NOS • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-071530
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 7.00 Year
  • Weight: 36.300 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Seizure NOS
Outcomes: Recovered/Normal

Cat, Domestic Mediumhair, Male, 14.6 year, 5 kilogram • Drug: MSK, Unknown • Reactions: Not eating, Limping, Low sodium-potassium ratio, Elevated alanine aminotransferase, Gait abnormality… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-066416
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 14.60 Year
  • Weight: 5.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Not eating Limping Low sodium-potassium ratio Elevated alanine aminotransferase Gait abnormality Hard stool Skin inflammation NOS Arthritis Swelling NOS
Outcomes: Ongoing

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

Store at room temperature; keep secured.

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Let others know your experience or advice regarding this medication.

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