Florfenicol + Terbinafine: adverse event reports that FDA received

Name: Florfenicol + Terbinafine: adverse event reports that FDA received, by year and species
Creator: Pet Drug Reports
License: https://creativecommons.org/publicdomain/zero/1.0/

Combination of 2 active ingredients

The Green Book lists no brand name for exactly these active ingredients.

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 2 Oct 2026. The data have the reports that FDA received through 26 Jun 2026.

This page is not veterinary advice. For an animal that is ill, speak to a veterinarian.

Contacting a veterinarian How to report to FDA

From February 2015 to April 2026, FDA received 2,282 adverse event reports that name a drug with florfenicol and terbinafine as its active ingredients. Of the 2,282 reports, 2,013 (88.2%) are about dogs. 138 reports are about cats (6%).

In January to March 2026, FDA received 3 reports that name this drug. The signs that appear in the largest number of the 2,282 reports are "Lack of efficacy - NOS" and "Ear discharge". A report is not proof that a drug caused a sign.

Reports that name this drug fell by 18.2% 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 88.2% of the reports that name this drug, and 72.6% of all reports.

Search engines list a drug page with 500 reports or more in all years. The page also needs 30 reports or more in the 12 months to June 2026. This page is under one of these numbers. The site keeps the page and keeps it out of search engines.

Since the last update of the FDA data

The latest update of the FDA data, recorded on 11 Oct 2026, changed no count of this page.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 3 reports that name florfenicol + terbinafine: 3 dog, 0 cat, 0 horse, 0 other or not given.

All updates Feed of updates (RSS)

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 2,282 reports that list the sign. One report can list more than one sign.

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]49.8%1,136 reports
Ear discharge7.1%161 reports
Loss of hearing4.9%112 reports
Vomiting4.8%110 reports
Lethargy[unusually tired or inactive]4.5%102 reports
Head shake - ear disorder3.9%89 reports
Culture/titer data abnormal3.6%82 reports
Deafness3.5%81 reports
Ear pain3.3%75 reports
Hearing decreased3.3%75 reports
Behavioural disorder NOS[behaviour change, type not specified]3.2%74 reports
Other abnormal test result NOS[abnormal laboratory result, type not specified]3.2%74 reports
Other ear disorder NOS[NOS: not otherwise specified]2.9%67 reports
Ataxia[unsteady, uncoordinated movement]2.8%64 reports

Show the next 16 signs

Head tilt - ear disorder2.6%60 reports
Not eating2.6%60 reports
Ear infection NOS[NOS: not otherwise specified]2.6%59 reports
Impaired hearing2.3%53 reports
Anorexia[not eating]2%45 reports
Diarrhoea[diarrhea]2%45 reports
Horner's syndrome1.9%44 reports
External ear disorder NOS[NOS: not otherwise specified]1.9%43 reports
Weight loss1.9%43 reports
Decreased appetite1.8%42 reports
Otitis externa[outer ear inflammation]1.8%41 reports
Partial lack of efficacy[the product worked less well than expected]1.8%41 reports
Corneal ulcer1.7%39 reports
Death by euthanasia[the animal was euthanized]1.4%32 reports
Third eyelid protrusion1.4%32 reports
Otorrhoea1.4%31 reports

The list shows 30 of 776 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

Dog88.2%2,013
Cat6%138
Human exposure0.7%15
Other Cervidsunder 0.1%1

The share is of all 2,282 reports that name florfenicol + terbinafine. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog62 reports

No chart: no month has 5 or more reports.

Cat2 reports

No chart: no month has 5 or more reports.

Horse0 reports

No chart: no month has 5 or more reports.

Other or not given1 report

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

Reports that name florfenicol + terbinafine, by the year in which FDA received them and by species
Year	Dog	Cat	Other or not given	All species
2026	5	0	0	5
2025	21	1	0	22
2024	20	0	1	21
2023	7	0	0	7
2022	5	1	0	6
2021	6	0	0	6
2020	75	12	2	89
2019	207	30	19	256
2018	246	30	27	303
2017	388	31	32	451
2016	677	29	37	743
2015	356	4	13	373

2026 has the reports that FDA received through Apr 2026. Download the years (CSV)

What the reports record

Outcome at the time of the report

Recovered/Normal12%274
Recovered with Sequela[recovered, with a lasting effect]2.4%54
Ongoing22.3%509
Died0.8%18
Euthanized1.4%32
Outcome Unknown56.1%1,280

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 2,282 reports that name florfenicol + terbinafine.

A report about more than one animal can have more than one outcome.

Kind of report

Safety issue50.9%1,162
Lack of expected effectiveness38.4%877
Both safety and lack of expected effectiveness2.9%67
Manufacturing or product defect7.7%176
Other0%0

2,165 reports say if the event was serious. 29.8% of them have the serious flag. The person who sends the report sets the flag.

Show age, weight, breed and route

Age of the animal

Under 1 year3.4%77
1 to 3 years15.3%349
4 to 7 years23%524
8 to 11 years28.2%643
12 years and over13.6%310
Age not given16.6%379

Weight of the animal

Under 5 kg (11 lb)10.3%234
5 to 9.9 kg (11 to 22 lb)17.4%397
10 to 24.9 kg (22 to 55 lb)21.3%487
25 to 44.9 kg (55 to 99 lb)24.6%561
45 kg and over (99 lb and over)5%115
Weight not given21.4%488

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

Auricular (Otic)91.2%2,082
Topical1.1%25
Intraocular0.6%13
Oral0.6%13
Ophthalmic0.1%3
Cutaneous0.1%2

Each bar is on a scale of 0 to 100%.

Approved animal drugs with these active ingredients (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.

No approved product has exactly this set of active ingredients. The ingredient field of a report can be incomplete. The approved products below have all the ingredients of this page and one or more other ingredients.

Applications in the Green Book of 2 Nov 2026, pioneer applications (NADA) first
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
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

Other pages with one of these ingredients

A report names a drug by its set of active ingredients. Each set has its own page. The list is in order of name.

Next in the A to Z list

All drugs by active ingredient. Brand names A to Z

FDA pages for this drug

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.
Animal Drugs @ FDAThe search page of the Green Book, the FDA list of approved animal drugs.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Pet Drug Reports. Florfenicol + Terbinafine: adverse event reports that FDA received. https://petdrugreports.com/drug/florfenicol-terbinafine/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of 30 Oct 2026. Reports received through 26 Jun 2026.

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. The site does not use the application number that a record has.

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 lists no brand name for exactly these active ingredients.
Do the reports show that the drug caused the signs?: No. 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 18 reports in the 12 months to June 2026. It received 22 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 2,282 reports received from February 2015 to April 2026, 50.9% are about a safety issue only. 41.4% are about a lack of expected effectiveness, alone or with a safety issue. 7.7% are about a defect of the product or its package.