Meds A-Z
Terbinafine
Detailed information about Terbinafine
Pet Owner Quick Guide
Start here: what this medicine is for, what it does, and when it's usually needed.
Usually used for:
For the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ).
What it does:
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...
When it's needed:
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.
Call your vet sooner if you notice:
- 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.
Commonly reported reactions:
- (2 reports)
- (2 reports)
- (1 reports)
What to 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?
Terbinafine
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: MSK
Quick Facts
Official label facts first, then secondary summaries. Marketing content is separated below.
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200829 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141598 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source
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 · fda_animal_drugs · Contraindication source
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.
Most Reported Reactions
| Reaction | Cases | Species | Serious cases |
|---|---|---|---|
| 2 | Cat, Dog | 2 | |
| 2 | Cat, Dog | 2 | |
| 1 | Dog | 1 | |
| 1 | Cat | 1 | |
| 1 | Cat | 1 | |
| 1 | Cat | 1 | |
| 1 | Dog | 1 | |
| 1 | Cat | 1 |
Species coverage: Cat (17) Dog (15)
View detailed reaction table
| Reaction | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-055162
Storage & Handling
No storage/handling guidance is linked yet.
Documents
Official label facts are separated from secondary summaries.
Official documents: 10 • Secondary summaries: 0
- FOI Summary oA 200-829 Approved December 22, 2025.pdf · FOI
- Klentz™ · SPL
- FOI Summary oN 141-598 Approved April 10 2025_ceg_ef.pdf · FOI
- Otiserene® · SPL
- FOI Summary oA 200-719 Approved September 28, 2022.pdf · FOI
- SIMPLERA™ · SPL
- UCM465253.pdf · FOI
- CLARO™ · SPL
- UCM436650.pdf · FOI
- Osurnia™ · SPL
No source yet.
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/17828 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/18162/Klentz%E2%84%A2 · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/16805 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/17106/Otiserene%C2%AE · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/12934 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/13011/SIMPLERA%E2%84%A2 · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/931 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2303/CLARO%E2%84%A2 · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/928 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2330/Osurnia%E2%84%A2 · document · SPL
Promotional Materials (Marketing)
This content is marketing material and not clinical guidance.
No marketing assets are linked yet.
No source yet.
Technical appendix (vet reference)
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.
- Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 10:44 PM UTC
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Feb 16, 2026, 11:00 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 Feb 16, 2026, 11:00 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Feb 16, 2026, 11:03 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:20 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 200-829 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 & Revision History
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… (Official, 2026-02-12)
- side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Ear discharge, Vomiting, Loss of hearing, Deafness, Head shake - ear disorder. (Official, 2026-02-12)
- usage: For the treatment of otitis externa in dogs associated with susceptible strains of bacteria ( Staphylococcus pseudintermedius ) and yeast ( Malassezia pachyder… (Official, 2026-02-12)
- side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-02-12 22:44 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 |
|---|---|---|---|---|
|
Klentz™
RX
Florfenicol Mometasone furoate Terbinafine
Solution
• Otic
|
Aurora Pharmaceutical, Inc. | ANADA 200-829 | Approved | Jan 5, 2026 |
|
Otiserene®
RX
Dexamethasone Marbofloxacin Terbinafine
Otic Suspension
• Otic
|
Dechra, Ltd. | NADA 141-598 | Approved | Jun 3, 2025 |
|
SIMPLERA™
RX
Florfenicol Mometasone furoate Terbinafine
Solution
• Otic
|
Vetoquinol USA, Inc. | ANADA 200-719 | Approved | Oct 3, 2022 |
|
CLARO™
RX
Florfenicol Mometasone furoate Terbinafine
Solution
• Otic
|
Elanco US Inc. | NADA 141-440 | Approved | Aug 3, 2021 |
|
Osurnia™
RX
Betamethasone Acetate Florfenicol Terbinafine
Gel
• Otic
|
Dechra, Ltd. | NADA 141-437 | Approved | Aug 11, 2020 |
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.
Composition / specifications
For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
Administer one dose (1 dropperette) per affected ear.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius) in dogs.
Administer one dose (1 tube) per affected ear once.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
Administer one dose (1 dropperette) per affected ear.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
CLARO™ is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
-
Summary
For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
- Klentz™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
Summary
For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius) in dogs.
- Otiserene® (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
Summary
For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
- SIMPLERA™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM465253.pdf
Summary
For the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis) and bacteria ( Staphylococcus pseudintermedius).
- CLARO™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM436650.pdf
Summary
For the treatment of otitis externa in dogs associated with susceptible strains of bacteria ( Staphylococcus pseudintermedius) and yeast ( Malassezia pachydermatis).
- Osurnia™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
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.
Source: FDA Animal Drugs @ FDA • Reference
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.
Side Effects
No approved side-effect narrative is linked yet.
openFDA reaction signals are available for Dog 56 and Cat 8 (view top reported reactions).
Top Reported Reactions (openFDA)
Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).
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, Unassigned, Unknown, Frequency: 1 per day • Reactions: Partial lack of efficacy, Hair loss, Erythema, Papule, Excoriation… • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-055162
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Female
- Age: 13.00 Year
- Weight: 6.120 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Unassigned
- Frequency: 1 per day
Dog, ['Hound (unspecified)', 'Crossbred Canine/dog'], Female, 7 year, 21.6 kilogram • Drug: MSK, Unknown • Reactions: Lymphopenia, Increased band neutrophilia, Monocytopenia • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-051640
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Age: 7.00 Year
- Weight: 21.600 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Dog, Schnauzer - Miniature, Male, 5.33 year, 11.2 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 2 tube per animal, Frequency: 1 per year • Reactions: Bumps on skin, Lack of efficacy (fungi) - NOS, Lack of efficacy (bacteria) - NOS, Ear canal inflammation, Flaking skin… • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-051338
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 5.33 Year
- Weight: 11.200 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Auricular (Otic)
- Form: Solution
- Dose: 2 tube per animal
- Frequency: 1 per year
Dog, Bulldog - French, Female, 6 year, 10.795 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Vomiting, Medication error NOS, Overdose • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-050163
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Age: 6.00 Year
- Weight: 10.795 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Unassigned
Dog, Shepherd Dog - German, Male, 19 month, 42.6 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 1 tube per animal, Frequency: 1 per year • Reactions: Malaise, Abnormal posture, Respiratory distress, Appetite loss, Death by euthanasia… • Outcome: Euthanized
- Report ID: USA-USFDACVM-2025-US-048352
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 19.00 Month
- Weight: 42.600 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Auricular (Otic)
- Form: Solution
- Dose: 1 tube per animal
- Frequency: 1 per year
Cat, Domestic Shorthair, Male, 10 year, 3.8 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 2 tube per animal, Frequency: 1 per year • Reactions: Stumbling gait, Neutrophilia, Leucocytosis NOS, Hypokalaemia, Elevated blood urea nitrogen… • Outcome: Euthanized
- Report ID: USA-USFDACVM-2025-US-048340
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 10.00 Year
- Weight: 3.800 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Auricular (Otic)
- Form: Solution
- Dose: 2 tube per animal
- Frequency: 1 per year
Cat, Domestic Shorthair, Male, 10 year, 4.5 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 2 tube per animal, Frequency: 1 per year • Reactions: Head shake - ear disorder, Ear canal inflammation, Application site bleeding, Tympanic rupture, Not eating… • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2025-US-041669
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 10.00 Year
- Weight: 4.500 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Auricular (Otic)
- Form: Solution
- Dose: 2 tube per animal
- Frequency: 1 per year
Cat, Domestic Longhair, Male, 9 week, 1.361 kilogram • Drug: MSK, Tablet, Oral, Dose: 0.25 tablet per animal, Frequency: 12 per hour • Reactions: Unsteady walking (ataxia), Shaking, Stiffness NOS, Vocalisation • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2025-US-054081
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Age: 9.00 Week
- Weight: 1.361 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Tablet
- Dose: 0.25 tablet per animal
- Frequency: 12 per hour
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.
Share Your Thoughts
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.