Pet Drug Reports

Florfenicol + Mometasone furoate + Terbinafine (Claro, Simplera)adverse event reports that FDA received

Combination of 3 active ingredients

Also sold as: Claro, Simplera, Klentz, Florfinasone.

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 FDA

From November 2015 to June 2026, FDA received 5,599 adverse event reports that name this drug. Its active ingredients are florfenicol, mometasone furoate and terbinafine. Of the 5,599 reports, 3,503 (62.6%) are about dogs. 692 reports are about cats (12.4%).

In January to March 2026, FDA received 119 reports that name this drug. The signs that appear in the largest number of the 5,599 reports are "Lack of efficacy - NOS", "Ataxia" and "Tubes, Leaking". A report is not proof that a drug caused a sign.

Reports that name this drug fell by 17.2% 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 62.6% of the reports that name this drug, and 72.6% of all reports.

Since the last update of the FDA data

The site recorded an update of the FDA data on . FDA changed these counts for January to March 2026:

  • All species: from 101 to 119.
  • Dog: from 78 to 95.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 119 reports that name florfenicol + mometasone furoate + terbinafine: 95 dog, 16 cat, 0 horse, 8 other or not given.

All updatesFeed 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 5,599 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.

  1. Lack of efficacy - NOS[the product did not have the expected effect]14%784 reports
  2. Ataxia[unsteady, uncoordinated movement]12.5%701 reports
  3. Tubes, Leaking[a product quality report, not a sign in an animal]11.3%633 reports
  4. Lethargy[unusually tired or inactive]9.1%507 reports
  5. Head tilt - ear disorder8.9%498 reports
  6. Vomiting8.6%481 reports
  7. Nystagmus[rapid involuntary eye movement]6.8%383 reports
  8. Head shake - ear disorder6.1%340 reports
  9. Ear discharge5.5%309 reports
  10. Vestibular disorder NOS[NOS: not otherwise specified]5.5%309 reports
  11. Behavioural disorder NOS[behaviour change, type not specified]5.5%308 reports
  12. Anorexia[not eating]5.4%305 reports
  13. Corneal ulcer5.3%295 reports
  14. Underfilling, Package[a product quality report, not a sign in an animal]4.5%254 reports
Show the next 16 signs
  1. Not eating4.4%248 reports
  2. Ocular discharge4.1%229 reports
  3. Deafness3.8%214 reports
  4. Horner's syndrome3.8%212 reports
  5. Odor, Abnormal[a product quality report, not a sign in an animal]3.5%197 reports
  6. Diarrhoea[diarrhea]3.4%188 reports
  7. Falling3.3%187 reports
  8. Decreased appetite3.3%185 reports
  9. Squinting3.2%181 reports
  10. Keratoconjunctivitis sicca3.2%177 reports
  11. Other abnormal test result NOS[abnormal laboratory result, type not specified]3.1%176 reports
  12. Ear infection NOS[NOS: not otherwise specified]2.8%159 reports
  13. Schirmer tear test2.8%157 reports
  14. Ear pain2.7%153 reports
  15. Dry eye2.6%146 reports
  16. Ear canal erythema2.5%140 reports

The list shows 30 of 1,329 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

  • Dog62.6%3,503
  • Cat12.4%692
  • Human exposure2.2%121
  • Rabbitunder 0.1%2

The share is of all 5,599 reports that name florfenicol + mometasone furoate + terbinafine. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog2,156 reports. Largest count in one month: 69 (Sep 2024)
Cat330 reports. Largest count in one month: 11 (May 2022)
Horse0 reports

No chart: no month has 5 or more reports.

Other or not given354 reports. Largest count in one month: 31 (Aug 2024)

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 + mometasone furoate + terbinafine, by the year in which FDA received them and by species
YearDogCatHorseOther or not givenAll species
202617422018214
202538859036483
2024503640117684
202350068083651
202242177069567
202132888067483
202031775087479
201925092080422
2018233800183496
2017203400246489
2016176270416619
20151000212

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/Normal16.9%949
  • Recovered with Sequela[recovered, with a lasting effect]0.9%51
  • Ongoing18.1%1,015
  • Died1.3%75
  • Euthanized2.1%117
  • Outcome Unknown37.8%2,115

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 5,599 reports that name florfenicol + mometasone furoate + terbinafine.

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

Kind of report

  • Safety issue66.9%3,746
  • Lack of expected effectiveness5.3%299
  • Both safety and lack of expected effectiveness4.6%255
  • Manufacturing or product defect23.2%1,298
  • Otherunder 0.1%1

4,318 reports say if the event was serious. 59.4% 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%167
  • 1 to 3 years15.4%865
  • 4 to 7 years19.6%1,098
  • 8 to 11 years18.4%1,032
  • 12 years and over13.6%760
  • Age not given30%1,677

Weight of the animal

  • Under 5 kg (11 lb)11.3%634
  • 5 to 9.9 kg (11 to 22 lb)19.6%1,098
  • 10 to 24.9 kg (22 to 55 lb)16.5%925
  • 25 to 44.9 kg (55 to 99 lb)15.3%855
  • 45 kg and over (99 lb and over)3.3%182
  • Weight not given34%1,905

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

  • Auricular (Otic)41%2,298
  • Topical3.4%191
  • Other1.3%71
  • Intraocular0.6%32
  • Ophthalmic0.6%31
  • Oral0.1%6

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.

Brand names

  • Claro
  • Simplera
  • Klentz
  • Florfinasone

What the Green Book records give

Applications with an approval in force
4
Approved species
Dogs
Dose forms
Solution
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.

Applications in the Green Book of 2 Nov 2026, pioneer applications (NADA) first
Brand nameActive ingredientsSponsorApproved speciesApplication
ClaroFlorfenicol, Mometasone furoate, TerbinafineElanco US Inc.DogsNADA 141-440
SimpleraFlorfenicol, Mometasone furoate, TerbinafineVetoquinol USA, Inc.DogsANADA 200-719
KlentzFlorfenicol, Mometasone furoate, TerbinafineAurora Pharmaceutical, Inc.DogsANADA 200-829
Florfinasone OticFlorfenicol, Mometasone furoate, TerbinafineCronus Pharma Specialities India Private Ltd.DogsANADA 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

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

Cite this page

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

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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 section of this page lists the brand names with 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 476 reports in the 12 months to June 2026. It received 575 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 5,599 reports received from November 2015 to June 2026, 66.9% are about a safety issue only. 9.9% are about a lack of expected effectiveness, alone or with a safety issue. 23.2% are about a defect of the product or its package.