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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?
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.
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.
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
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.
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.
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): Lack of efficacy - NOS, Ear discharge, Vomiting, Loss of hearing, Deafness, Head shake - ear disorder.
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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:
When to call the vet:
Regulatory restrictions are shown in Vet View.
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 Terbinafine; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 21 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), Elevated blood urea nitrogen (1 reports), Ear pruritus (1 reports), Ear pain (1 reports)
Digestive (4), Skin & allergy (3), Neurologic (1), Behavior (2)
Dog (22 reports), Cat (10 reports)
Shepherd Dog - Australian (1), ['Retriever - Labrador', 'Poodle (unspecified)'] (1), Retriever - Labrador (1), ['Shih Tzu', 'Dog (unknown)'] (1). These are report metadata, not proof that a breed is at higher risk.
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.
For otic use in dogs only, wobbly/unsteady walking, Falling, Elevated blood urea nitrogen
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: April 15, 2026, 10:04 AM 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.
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.
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 2026-03-16 · MSK · MSK
Received 2026-03-04 · MSK · MSK
Received 2025-12-01 · MSK · MSK
Received 2025-11-21 · 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 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Skin & allergy | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 |
Species coverage: Dog (22) Cat (10)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Digestive | Dog | Non-serious | - | 1 | |
| Neurologic | Cat | Serious | - | 1 | |
| Skin & allergy | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Skin & allergy | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Dog | Serious | - | 1 | |
| Other | Dog | Non-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 | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 |
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.
FOI · FOI summary
FOI · FOI summary
FOI · FOI summary
FOI · FOI summary
FOI · FOI summary
FOI · FOI summary
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.
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 |
|---|---|---|---|
| 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 | - |
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
Every non-trivial field is expected to include provenance and update timestamps.
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.
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.
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.
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 - Australian, Male, 5.83 year, 25.85 kilogram • Drug: MSK, Unassigned, Oral, Dose: 361.90 Milligram per animal, Frequency: 24 per hour • Reactions: Partial lack of efficacy, Skin lesion NOS, Inappropriate elimination NOS, Polyuria, Polydipsia… • Outcome: Ongoing
Dog, ['Retriever - Labrador', 'Poodle (unspecified)'], Female, 8.08 year, 11.7 kilogram • Drug: MSK, Auricular (Otic) • Reactions: Hypoalbuminaemia, Neutropenia • Outcome: Outcome Unknown
Dog, Retriever - Labrador, Female, 18 month, 33 kilogram • Drug: MSK, Unknown • Reactions: Ear infection NOS, Dermatitis, Abnormal cytology, Other abnormal test result NOS, Lack of efficacy (endoparasite) - heartworm • Outcome: Ongoing
Dog, ['Shih Tzu', 'Dog (unknown)'], Female, 13 year, 10.16 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Vomiting, Lack of efficacy - NOS • Outcome: Ongoing
Dog, Terrier - Yorkshire, Female, 13 year, 6.12 kilogram • Drug: MSK, Unknown • Reactions: Partial lack of efficacy, Hair loss, Erythema, Papule, Excoriation… • Outcome: Ongoing
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
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.
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.