Roxee Medication Guide
Terbinafine
Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
Veterinary professional?
Data freshness
Roxee is still reviewing source support for this medication profile.
Roxee has safety or ingredient evidence for this medication, but a regulatory product/application match is still pending.
openFDA reaction terms and case summaries are supporting evidence, not proof of causality.
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.
- 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
Terbinafine
Drug type: Generic ingredient • Generic profile • Regulatory linkage incomplete
Species: Both
Approval status: Official document linked, regulatory match incomplete. An official source document is available, but Roxee has not linked this row to a confirmed FDA animal-drug application or product record yet.
Medication Snapshot
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
Terbinafine
For the treatment of otitis externa in dogs associated with susceptible strains of bacteria ( Staphylococcus pseudintermedius ) and yeast ( Malassezia pachydermatis ). CLARO™ is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ). For the treatment of otitis externa associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ) in dogs. Species commonly shown: Both.
Indications / Uses
For the treatment of otitis externa in dogs associated with susceptible strains of bacteria ( Staphylococcus pseudintermedius ) and yeast ( Malassezia pachydermatis ). CLARO™ is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ). For the treatment of otitis externa associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ) in dogs.
Warnings / Contraindications
Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
- Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Side Effects
Top reported reactions (openFDA): Lack of efficacy - NOS, Ear discharge, Vomiting, Loss of hearing, Deafness, Head shake - ear disorder.
FAQ
Related Conditions
Source Transparency
- Verified source: https://www.roxee.ai/meds/
- Verified source: https://animaldrugsatfda.fda.gov
- Verified source: https://api.fda.gov/animalandveterinary/event.json
- Verified source: https://www.roxee.ai/conditions/
- Verified source: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/17828
- Verified source: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/18375
- Last refreshed: Jun 22, 2026, 10:45 a.m.
- Last verified: Apr 15, 2026, 10:04 a.m.
- Validation status: Incomplete
Add to My Pet's Medications
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Sign in to continuePet Owner Quick Guide
Start here first for the safest next-step summary before the deeper medication detail.
Used for:
For the treatment of otitis externa in dogs associated with susceptible strains of bacteria ( Staphylococcus pseudintermedius ) and yeast ( Malassezia pachydermatis ). CLARO™ is indicated for the treatment of otitis exte...
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:
- For otic use in dogs only
- wobbly/unsteady walking (1 reports)
- Head tilt - ear disorder (1 reports)
- Head shake - ear disorder (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.
Regulatory restrictions are shown in Vet View.
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?
Medication Research Insights
A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.
What to know
Roxee has limited cited overview evidence for Terbinafine; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 23 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.
Evidence tension
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.
Reaction signal map
Unsteady walking (ataxia) (1 reports), Head tilt - ear disorder (1 reports), Head shake - ear disorder (1 reports), Flaking skin (1 reports), Falling (1 reports)
Digestive (4), Skin & allergy (3), Neurologic (1), Behavior (2)
Species and breed lens
Dog (20 reports), Cat (12 reports)
Terrier - Yorkshire (1), ['Terrier (unspecified)', 'Dog (unknown)'] (1). These are report metadata, not proof that a breed is at higher risk.
What your vet may verify
Verify whether Terbinafine 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.
What to watch next
For otic use in dogs only, wobbly/unsteady walking, Head tilt - ear disorder, Head shake - ear disorder
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Vet source depth
- openFDA case USA-USFDACVM-2025-US-072174 · adverse_reaction · adverse reactions
- Medication contraindications · safety_warning · warnings contraindications
- FOI summary · document · documents
- FOI summary · document · documents
- FOI summary · document · documents
- FOI summary · document · documents
- FOI summary · document · documents
- FOI summary · document · documents
Evidence
Review status / Updated / Sources
Review status: Clinical reviewer not listed
Updated: April 15, 2026, 10:04 AM UTC
- Medication contraindications · safety_warning
- openFDA case USA-USFDACVM-2025-US-072174 · adverse_reaction
- FOI summary · document
- FOI summary · document
- FOI summary · document
Safety & side effects
Side effects to monitor:
- For otic use in dogs only
- wobbly/unsteady walking
- Head tilt - ear disorder
- Head shake - ear disorder
Most reported reactions:
- Unsteady walking (ataxia) (1 reports)
- Head tilt - ear disorder (1 reports)
- Head shake - ear disorder (1 reports)
Emergency warning signs:
- Repeated vomiting or diarrhea.
- Severe lethargy (hard to wake, very low energy).
- Collapse or fainting.
- Trouble breathing.
Vet Fast Scan
Source-backed clinical checkpoints for quick review.
- High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federa…
Quick Facts
Official label facts first, then secondary summaries. Marketing content is separated below.
Warnings / Contraindications
Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
- High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
- https://animaldrugsatfda.fda.gov · safety_warning · Medication contraindications
Adverse Reactions
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Reported case explorer
Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.
Tap or hover a reaction to see what it means in plain language.
Grouped by Body System
Most Reported Reactions
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Neurologic | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Skin & allergy | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 |
Species coverage: Dog (20) Cat (12)
View detailed reaction table
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Digestive | Dog | Non-serious | - | 1 | |
| Neurologic | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Skin & allergy | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Skin & allergy | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Behavior | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Behavior | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Skin & allergy | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Digestive | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-072174
Source Documents
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.
Owner handouts
0Official label / PI
0SPL
0FOI
6FOI Summary oA 200-848 Approved April 8, 2026.pdf
FOI · FOI summary
FOI Summary oA 200-829 Approved December 22, 2025.pdf
FOI · FOI summary
FOI Summary oN 141-598 Approved April 10 2025_ceg_ef.pdf
FOI · FOI summary
FOI Summary oA 200-719 Approved September 28, 2022.pdf
FOI · FOI summary
UCM465253.pdf
FOI · FOI summary
UCM436650.pdf
FOI · FOI summary
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/18375 · document · FOI summary
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/17828 · document · FOI summary
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/16805 · document · FOI summary
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/12934 · document · FOI summary
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/931 · document · FOI summary
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/928 · document · FOI summary
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.
-
Reference facts:
Source Roxee
| Refreshed Jun 22, 2026, 10:45 AM UTC
The reference fact projection used for browse cards and quick facts.
- 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
Counseling and Monitoring Highlights
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
- Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 17030-001-10 | 17030 | - | |
| 17033-277-02 | 17033 | - | |
| 17033-277-20 | 17033 | - | |
| 17033-283-02 | 17033 | - | |
| 17033-283-20 | 17033 | - | |
| 51072-122-00 | 51072 | - | |
| 51072-122-01 | 51072 | - | |
| 51072-122-02 | 51072 | - | |
| 58198-0027-1 | 58198 | - | |
| 58198-0027-2 | 58198 | - | |
| 58198-0027-3 | 58198 | - | |
| 58198-0027-4 | 58198 | - | |
| 86032-057-01 | 86032 | - | |
| 86136-125-67 | 86136 | - |
Enriched Documents
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
-
FOI Summary oA 200-848 Approved April 8, 2026.pdf
• FOI summary • Official
• April 30, 2026
FDA FOI summary for application 200848
-
FOI Summary oA 200-829 Approved December 22, 2025.pdf
• FOI summary • Official
• Jan. 5, 2026
FDA FOI summary for application 200829
-
FOI Summary oN 141-598 Approved April 10 2025_ceg_ef.pdf
• FOI summary • Official
• June 3, 2025
FDA FOI summary for application 141598
-
FOI Summary oA 200-719 Approved September 28, 2022.pdf
• FOI summary • Official
• Oct. 3, 2022
FDA FOI summary for application 200719
-
UCM465253.pdf
• FOI summary • Official
• Aug. 3, 2021
FDA FOI summary for application 141440
-
UCM436650.pdf
• FOI summary • Official
• Aug. 11, 2020
FDA FOI summary for application 141437
Data Sources & Change Log
Every non-trivial field is expected to include provenance and update timestamps.
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-06-22)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-06-22)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-06-21)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-06-20)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-06-13)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-06-12)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-06-12)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-06-11)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-06-11)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-06-10)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-06-08)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-06-07)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-06-06)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-06-05)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-06-04)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-06-03)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-06-02)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-06-01)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-06-01)
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-05-31)
- side_effects updated 2026-06-22 10:45 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-06-22 10:45 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-06-22 10:45 by etl_backfill • Backfilled from existing medication fields
- side_effects updated 2026-06-22 10:04 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-06-22 10:04 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-06-22 10:04 by etl_backfill • Backfilled from existing medication fields
- side_effects updated 2026-06-21 05:18 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-06-21 05:18 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-06-21 05:18 by etl_backfill • Backfilled from existing medication fields
- side_effects updated 2026-06-20 20:58 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-06-20 20:58 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-06-20 20:58 by etl_backfill • Backfilled from existing medication fields
- side_effects updated 2026-06-13 11:33 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-06-13 11:33 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-06-13 11:33 by etl_backfill • Backfilled from existing medication fields
- side_effects updated 2026-06-12 10:42 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-06-12 10:42 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-06-12 10:42 by etl_backfill • Backfilled from existing medication fields
- side_effects updated 2026-06-12 10:04 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-06-12 10:04 by etl_backfill • Backfilled from existing medication fields
Usage
For the treatment of otitis externa in dogs associated with susceptible strains of bacteria ( Staphylococcus pseudintermedius ) and yeast ( Malassezia pachydermatis ). CLARO™ is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ). For the treatment of otitis externa associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ) in dogs.
Contraindications
Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Top Reported Reactions (openFDA)
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 Skin & allergy.
Showing top 5 for Neurologic.
Showing top 5 for Behavior.
Show more (17)
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.
Dog, Terrier - Yorkshire, Female, 13 year, 6.12 kilogram • Drug: MSK, Unknown • Reactions: Partial lack of efficacy, Hair loss, Erythema, Papule, Excoriation… • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-072174
- Serious AE: No
- Treated For AE: Yes
- Sex: Female
- Age: 13.00 Year
- Weight: 6.120 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Dog, ['Terrier (unspecified)', 'Dog (unknown)'], Female, 5 month, 5.987 kilogram • Drug: MSK, Unknown • Reactions: Hair loss, Bacterial skin infection NOS, Ringworm, Vomiting, Cough… • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-070191
- Serious AE: No
- Treated For AE: Yes
- Sex: Female
- Age: 5.00 Month
- Weight: 5.987 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
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
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
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Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.