Terbinafine: adverse event reports in all combinations
Active ingredient, alone and in combinations
Brand names with this ingredient: Osurnia, Claro, DuOtic, Otiserene, Simplera, Klentz, and 1 more.
The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.
Read this first. FDA says this about the data:
An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another. When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event. This dataset should not be the sole source of information for clinical decision-making or other assumptions about the safety or effectiveness of a product. The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.
FDA Center for Veterinary Medicine publishes these words. Source: Adverse Event Reports for Animal Drugs and Devices, read on . The data have the reports that FDA received through .
This page is not veterinary advice. For an animal that is ill, speak to a veterinarian.
Contacting a veterinarianHow to report to FDAFDA reports received through . Counts include this ingredient alone and in combinations. Why brand names have no separate count.
From March 2012 to June 2026, FDA received 8,694 adverse event reports that name a drug with terbinafine, alone or in a combination. 5 sets of active ingredients with terbinafine have a drug page.
Of the 8,694 reports, 6,152 (70.8%) are about dogs. 973 reports are about cats (11.2%). In January to March 2026, FDA received 152 reports that name terbinafine, alone or in a combination. The signs that appear in the largest number of the 8,694 reports are "Lack of efficacy - NOS", "Ataxia" and "Lethargy". A report is not proof that a drug caused a sign.
Reports that name this ingredient fell by 7.4% in the 12 months to June 2026, compared with the 12 months before. Reports for all animal drugs fell by 4.6% in the same periods. The newest months can get more reports in a later update. Reports about dogs are 70.8% of the reports that name this ingredient, and 72.6% of all reports.
Reports in the latest closed quarter
| Species | Jan to Mar 2026 | Oct to Dec 2025 | Jan to Mar 2025 |
|---|---|---|---|
| All species | 152 | 186 | 134 |
| Dog | 121 | 151 | 105 |
| Cat | 22 | 22 | 17 |
| Horse | 0 | 0 | 0 |
| Other or not given | 9 | 13 | 12 |
January to March 2026 is the latest closed quarter in the data.
Drug pages with terbinafine
A report names a drug by its set of active ingredients. Each set with terbinafine that has a drug page is in the table, in order of name. The table has 5 sets.
| Active ingredients | Reports, all years | Reports, latest 12 months |
|---|---|---|
| Betamethasone Acetate + Florfenicol + Terbinafine | 627 | 60 |
| Betamethasone Acetate + Terbinafine | 65 | 61 |
| Florfenicol + Mometasone furoate + Terbinafine | 5,599 | 476 |
| Florfenicol + Terbinafine | 2,282 | 18 |
| Terbinafine | 158 | 20 |
A report can name more than one set, so the counts of the sets can add to more than the count of the page.
An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
Signs that the reports list
A sign is a coded term from the report. The words in brackets are a plain gloss of the term. The percentage is the share of the 8,694 reports that list the sign. One report can list more than one sign and more than one drug.
The sign that is in the largest number of the reports comes first.
- Lack of efficacy - NOS[the product did not have the expected effect]23.2%2,019 reports
- Ataxia[unsteady, uncoordinated movement]9.3%811 reports
- Lethargy[unusually tired or inactive]8%692 reports
- Vomiting7.7%668 reports
- Tubes, Leaking[a product quality report, not a sign in an animal]7.3%636 reports
- Head tilt - ear disorder6.9%598 reports
- Ear discharge5.8%506 reports
- Head shake - ear disorder5.6%483 reports
- Nystagmus[rapid involuntary eye movement]5%431 reports
- Behavioural disorder NOS[behaviour change, type not specified]4.7%407 reports
- Deafness4.4%384 reports
- Anorexia[not eating]4.4%383 reports
- Corneal ulcer4.2%367 reports
- Not eating4.2%367 reports
Show the next 16 signs
- Vestibular disorder NOS[NOS: not otherwise specified]4.1%356 reports
- Horner's syndrome3.3%289 reports
- Loss of hearing3.3%284 reports
- Ocular discharge3.2%279 reports
- Other abnormal test result NOS[abnormal laboratory result, type not specified]3.2%278 reports
- Diarrhoea[diarrhea]3.2%275 reports
- Underfilling, Package[a product quality report, not a sign in an animal]3.1%267 reports
- Decreased appetite3%263 reports
- Ear pain2.8%242 reports
- Ear infection NOS[NOS: not otherwise specified]2.7%238 reports
- Falling2.5%216 reports
- Squinting2.5%214 reports
- Keratoconjunctivitis sicca2.3%201 reports
- Odor, Abnormal[a product quality report, not a sign in an animal]2.3%197 reports
- Weight loss2.3%196 reports
- Third eyelid protrusion2.2%193 reports
Reports by species
Reports for each month, Jul 2021 to Jun 2026
No chart: no month has 5 or more reports.
The month is the month in which FDA received the report. Each chart has its own scale. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.
Reports by year
- Dog
- Cat
- Horse
- Other or not given
| Year | Dog | Cat | Horse | Other or not given | All species |
|---|---|---|---|---|---|
| 2026 | 222 | 29 | 0 | 19 | 270 |
| 2025 | 521 | 75 | 0 | 44 | 640 |
| 2024 | 608 | 85 | 0 | 123 | 816 |
| 2023 | 595 | 87 | 0 | 90 | 772 |
| 2022 | 494 | 104 | 0 | 73 | 671 |
| 2021 | 441 | 116 | 0 | 74 | 631 |
| 2020 | 447 | 103 | 0 | 91 | 641 |
| 2019 | 469 | 125 | 0 | 99 | 693 |
| 2018 | 485 | 112 | 0 | 210 | 807 |
| 2017 | 611 | 75 | 0 | 278 | 964 |
| 2016 | 872 | 58 | 0 | 453 | 1,383 |
| 2015 | 374 | 4 | 0 | 15 | 393 |
| 2014 | 7 | 0 | 0 | 0 | 7 |
| 2013 | 4 | 0 | 0 | 0 | 4 |
| 2012 | 2 | 0 | 0 | 0 | 2 |
2026 has the reports that FDA received through Jun 2026. Download the years (CSV)
What the reports record
Outcome at the time of the report
- Recovered/Normal16.4%1,424
- Recovered with Sequela[recovered, with a lasting effect]1.5%133
- Ongoing19.2%1,670
- Died1.3%110
- Euthanized2%173
- Outcome Unknown43.3%3,768
An outcome in a report is not proof that the drug caused it. The person who sends the report gives the outcome. Each share is of the 8,694 reports that name terbinafine.
Kind of report
- Safety issue64%5,565
- Lack of expected effectiveness14.1%1,222
- Both safety and lack of expected effectiveness4.6%402
- Manufacturing or product defect17.3%1,504
- Otherunder 0.1%1
Age of the animal
- Under 1 year3.2%280
- 1 to 3 years15.9%1,379
- 4 to 7 years20.8%1,806
- 8 to 11 years21.4%1,861
- 12 years and over14.1%1,228
- Age not given24.6%2,140
Each share of kind and age is of the 8,694 reports that name terbinafine.
Approved animal drugs with this active ingredient (FDA Green Book)
This section is reference data. It has no report count.
The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.
Brand names
- Osurnia
- Claro
- DuOtic
- Otiserene
- Simplera
- Klentz
- Florfinasone
What the Green Book records give
- Applications with an approval in force
- 7
- Approved species
- Dogs
- Dose forms
- Solution, Gel, Otic Suspension
- Routes
- Otic
- Sale
- RX (prescription)
- Earliest approval date in the records
The species, dose forms and routes are the words of the Green Book records for all the applications together. One product can have fewer. The label of a product gives its approved use.
| Brand name | Active ingredients | Sponsor | Approved species | Application |
|---|---|---|---|---|
| Osurnia | Betamethasone Acetate, Florfenicol, Terbinafine | Dechra Veterinary Products LLC | Dogs | NADA 141-437 |
| Claro | Florfenicol, Mometasone furoate, Terbinafine | Elanco US Inc. | Dogs | NADA 141-440 |
| DuOtic | Betamethasone Acetate, Terbinafine | Dechra Veterinary Products LLC | Dogs | NADA 141-579 |
| Otiserene | Dexamethasone, Marbofloxacin, Terbinafine | Dechra Veterinary Products LLC | Dogs | NADA 141-598 |
| Simplera | Florfenicol, Mometasone furoate, Terbinafine | Vetoquinol USA, Inc. | Dogs | ANADA 200-719 |
| Klentz | Florfenicol, Mometasone furoate, Terbinafine | Aurora Pharmaceutical, Inc. | Dogs | ANADA 200-829 |
| Florfinasone Otic | Florfenicol, Mometasone furoate, Terbinafine | Cronus Pharma Specialities India Private Ltd. | Dogs | ANADA 200-848 |
FDA pages for this ingredient
- How to Report Animal Drug and Device Side Effects and Product ProblemsThe FDA page that tells an owner or a veterinarian how to send a report.
- Green Book record of NADA 141-437The FDA record of the application for Osurnia.
- Green Book record of NADA 141-440The FDA record of the application for Claro.
- Green Book record of NADA 141-579The FDA record of the application for DuOtic.
- Green Book record of NADA 141-598The FDA record of the application for Otiserene.
- Green Book record of ANADA 200-719The FDA record of the application for Simplera.
- Green Book record of ANADA 200-829The FDA record of the application for Klentz.
- Animal Drugs @ FDAThe search page of the Green Book, the FDA list of approved animal drugs.
The site checked these addresses on . The links open in a new tab.
Cite this page
Pet Drug Reports. Terbinafine, all combinations: adverse event reports that FDA received. https://petdrugreports.com/ingredient/terbinafine/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of . Reports received through .
Where the data come from
The counts come from the openFDA Animal and Veterinary adverse event files, export of 30 Oct 2026. The files have the reports that the FDA Center for Veterinary Medicine received through 26 Jun 2026. The files mask brand and manufacturer names. The site counts a drug by the active ingredients that each record gives, and gives no count to a brand, an application or a company. Ingredient names and the lists of approved products follow the FDA Green Book of 2 Nov 2026. Ingredient names follow the Green Book, with salts and forms as FDA lists them.
The site does not publish report text, lot numbers or details of a reporter. FDA's record is the authority. See how the site counts reports, the data sources and the corrections page.
Questions about these reports
- Which brand are these reports about?
The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand. The Green Book section of this page lists brand names with this active ingredient.
- Do the reports show that the ingredient caused the signs?
No. A report can name more than one drug, and a drug can have more than one active ingredient. FDA states this about the data.
When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event.
The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
- How many reports did FDA receive in the latest 12 months?
FDA received 637 reports in the 12 months to June 2026. It received 688 reports in the 12 months before. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.
- What kinds of report are in the count?
Of the 8,694 reports received from March 2012 to June 2026, 64% are about a safety issue only. 18.7% are about a lack of expected effectiveness, alone or with a safety issue. 17.3% are about a defect of the product or its package.