Pet Drug Reports

Gentamicin Sulfate: adverse event reports in all combinations

Active ingredient, alone and in combinations

Brand names with this ingredient: Gentocin, Topagen, Otomax, Mometamax, Easotic, Vetro-Gen Veterinary, and 15 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 FDA

FDA reports received through . Counts include this ingredient alone and in combinations. Why brand names have no separate count.

From January 1987 to June 2026, FDA received 6,453 adverse event reports that name a drug with gentamicin sulfate, alone or in a combination. 7 sets of active ingredients with gentamicin sulfate have a drug page.

Of the 6,453 reports, 4,480 (69.4%) are about dogs. 203 reports are about cats (3.1%). In January to March 2026, FDA received 74 reports that name gentamicin sulfate, alone or in a combination. The signs that appear in the largest number of the 6,453 reports are "Deafness", "Dispenser, Abnormal" and "Loss of hearing". A report is not proof that a drug caused a sign.

Reports that name this ingredient rose by 44.2% 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 cats are 3.1% of the reports that name this ingredient, and 11% of all reports.

Reports in the latest closed quarter

Reports that name gentamicin sulfate, by the quarter in which FDA received them
SpeciesJan to Mar 2026Oct to Dec 2025Jan to Mar 2025
All species7411466
Dog708147
Cat210
Horse000
Other or not given23219

January to March 2026 is the latest closed quarter in the data.

All updatesFeed of updates (RSS)

Drug pages with gentamicin sulfate

A report names a drug by its set of active ingredients. Each set with gentamicin sulfate that has a drug page is in the table, in order of name. The table has 7 sets.

Drug pages with gentamicin sulfate, in order of name, with the reports of each page
Active ingredientsReports, all yearsReports, latest 12 months
Betamethasone Valerate + Clotrimazole + Gentamicin Sulfate2,33417
Betamethasone Valerate + Gentamicin Sulfate38612
Clotrimazole + Gentamicin Sulfate222
Clotrimazole + Gentamicin Sulfate + Mometasone furoate163114
Clotrimazole + Gentamicin Sulfate + Mometasone Furoate Monohydrate1,33312
Gentamicin Sulfate35819
Gentamicin Sulfate + Hydrocortisone aceponate + Miconazole Nitrate1,861197

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 6,453 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.

  1. Deafness31.3%2,020 reports
  2. Dispenser, Abnormal[a product quality report, not a sign in an animal]10.1%649 reports
  3. Loss of hearing6.2%402 reports
  4. Partial deafness5.6%362 reports
  5. Uncoded sign[a sign with no matching dictionary term]4.8%312 reports
  6. Difficulty of Use[a product quality report, not a sign in an animal]4.8%308 reports
  7. Lack of efficacy - NOS[the product did not have the expected effect]3.8%243 reports
  8. Vomiting3.6%234 reports
  9. Missing Cap3.2%208 reports
  10. Lethargy[unusually tired or inactive]2.6%168 reports
  11. Hearing affected2.6%165 reports
  12. Product defect, product difficult to use/handle[a product quality report, not a sign in an animal]2.5%160 reports
  13. Product Defect, General[a product quality report, not a sign in an animal]2.3%146 reports
  14. Accidental exposure[exposure that was not intended]2.1%138 reports
Show the next 16 signs
  1. Administration device NOS, priming issue2%130 reports
  2. Diarrhoea[diarrhea]2%130 reports
  3. Applicator, Abnormal[a product quality report, not a sign in an animal]1.8%116 reports
  4. Ataxia[unsteady, uncoordinated movement]1.8%113 reports
  5. Depression[dull, quiet or withdrawn]1.7%111 reports
  6. Anorexia[not eating]1.6%105 reports
  7. Death by euthanasia[the animal was euthanized]1.6%101 reports
  8. Emesis[vomiting]1.5%96 reports
  9. Pinnal erythema1.3%82 reports
  10. Behavioural disorder NOS[behaviour change, type not specified]1.2%78 reports
  11. Death1.1%74 reports
  12. Other abnormal test result NOS[abnormal laboratory result, type not specified]1.1%72 reports
  13. Application site erythema[reddened skin where the product was applied]1%62 reports

Download all signs (CSV)

Reports by species

Reports for each month, Jul 2021 to Jun 2026

Dog663 reports. Largest count in one month: 32 (Oct 2025)
Cat18 reports

No chart: no month has 5 or more reports.

Horse9 reports

No chart: no month has 5 or more reports.

Other or not given494 reports. Largest count in one month: 21 (Sep 2025)

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 gentamicin sulfate, by the year in which FDA received them and by species
YearDogCatHorseOther or not givenAll species
20261204010134
202525040125379
20241154389211
20237723100182
20225922120183
20217755119206
20201014188194
201940211053
2018901014105
2017121594139
2016156799181
201518460132322
2014265110119395
2013381162183582
2012347171106471
20111822137222
20101853020208
20092378049294
20081543045202
200718213647248
200616361236217
20051322140175
2004756042123
2003964040140
2002707236115
2001261053677
2000626033101
19991181092139
19988872198
19978382194
19966520067
19954600147
19945901060
19934731354
1992910010
199112003
199030025
198950005
198840026
198751006

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/Normal9.3%597
  • Recovered with Sequela[recovered, with a lasting effect]2.2%142
  • Ongoing6.8%442
  • Died2%132
  • Euthanized0.8%52
  • Outcome Unknown13.2%854

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 6,453 reports that name gentamicin sulfate.

Kind of report

  • Safety issue70.7%4,563
  • Lack of expected effectiveness1.9%123
  • Both safety and lack of expected effectiveness1.5%100
  • Manufacturing or product defect25.7%1,659
  • Other0.1%8

Age of the animal

  • Under 1 year3%196
  • 1 to 3 years9.3%600
  • 4 to 7 years12.3%796
  • 8 to 11 years22.7%1,465
  • 12 years and over21.3%1,376
  • Age not given31.3%2,020

Each share of kind and age is of the 6,453 reports that name gentamicin sulfate.

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

  • Gentocin
  • Topagen
  • Otomax
  • Mometamax
  • Easotic
  • Vetro-Gen Veterinary
  • Vetro-Max
  • GBC
  • GB
  • Mometavet
  • Garacin
  • Garasol

The Green Book has 9 more brand names with this active ingredient. Brand names A to Z

What the Green Book records give

Applications with an approval in force
39
Approved species
Dogs, Equids, Swine, Cats, Turkeys, Chickens, Cattle
Dose forms
Liquid (Solution), Ointment, Spray, Soluble Powder, Injection, Liquid (Suspension), Ophthalmic Solution, Oral Concentrate Solution, Otic Suspension, Solution, Suspension
Routes
Topical, Intrauterine, Oral, Ophthalmic, Subcutaneous, Intramuscular, Otic, Immersion, Intrasynovial
Sale
RX (prescription), OTC (over the counter)
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
Gentocin DurafilmBetamethasone Acetate, Gentamicin SulfateIntervet, Inc.DogsNADA 034-267
Gentocin SolutionGentamicin SulfateIntervet, Inc.Dogs, CatsNADA 038-292
Gentocin SolutionGentamicin SulfateIntervet, Inc.HorsesNADA 046-724
Gentocin Otic SolutionBetamethasone Valerate, Gentamicin SulfateIntervet, Inc.Dogs, CatsNADA 046-821
GaracinGentamicin SulfateIntervet, Inc.SwineNADA 091-191
Garasol SolutionGentamicin SulfateIntervet, Inc.TurkeysNADA 092-523
Gentocin Ophthalmic OintmentGentamicin SulfateIntervet, Inc.Dogs, CatsNADA 098-989
Gentocin Ophthalmic SolutionGentamicin SulfateIntervet, Inc.Dogs, CatsNADA 099-008
GarasolGentamicin SulfateIntervet, Inc.Chickens, TurkeysNADA 101-862
Garacin Piglet InjectionGentamicin SulfateIntervet, Inc.SwineNADA 103-037
Topagen OintmentBetamethasone Valerate, Gentamicin SulfateIntervet, Inc.DogsNADA 113-231
Garacin Pig Pump Oral SolutionGentamicin SulfateIntervet, Inc.SwineNADA 130-464
Gentocin Pink Eye SprayGentamicin SulfateIntervet, Inc.CattleNADA 130-952
Gentocin Topical SprayBetamethasone Valerate, Gentamicin SulfateIntervet, Inc.DogsNADA 132-338
Garacin Soluble PowderGentamicin SulfateIntervet, Inc.SwineNADA 133-836
Gentamicin Sulfate Inj. Sol.Gentamicin SulfateCronus Pharma Specialities India Private Ltd.DogsNADA 137-310
OtomaxBetamethasone Valerate, Clotrimazole, Gentamicin SulfateIntervet, Inc.DogsNADA 140-896
Mometamax Otic SuspensionClotrimazole, Gentamicin Sulfate, Mometasone Furoate MonohydrateIntervet, Inc.DogsNADA 141-177
EasoticGentamicin Sulfate, Hydrocortisone aceponate, Miconazole NitrateVirbac AH, Inc.DogsNADA 141-330
Gentamicin Sulfate Solution 100 mg/mlGentamicin SulfateCronus Pharma Specialities India Private Ltd.HorsesANADA 200-023
Gentamicin Sulfate Solution; Legacy Sterile SolutionGentamicin SulfateHuvepharma EOODHorsesANADA 200-037
Gentaglyde SolutionGentamicin SulfateZoetis Inc.HorsesANADA 200-102
Gentamex 100Gentamicin SulfateBimeda Animal Health Ltd.HorsesANADA 200-115
GentaMax 100Gentamicin SulfateElanco US Inc.HorsesANADA 200-137
Genta-Ject; GentaPoultGentamicin SulfateHuvepharma EOODChickens, TurkeysANADA 200-147
Gentamicin Sulfate Pig Pump Oral SolutionGentamicin SulfateHuvepharma EOODSwineANADA 200-174
GEN-GARDGentamicin SulfateHuvepharma EOODSwineANADA 200-185
Vetro-Gen Veterinary Ophthalmic OintmentGentamicin SulfateDechra Veterinary Products LLCDogs, CatsANADA 200-273
Vetro-MaxBetamethasone Valerate, Clotrimazole, Gentamicin SulfateFougera Pharmaceuticals, LLCDogsANADA 200-283
GBC OintmentBetamethasone Valerate, Clotrimazole, Gentamicin SulfateCronus Pharma Specialities India Private Ltd.DogsANADA 200-287
GB Topical SprayBetamethasone Valerate, Gentamicin SulfateDechra Veterinary Products LLCDogsANADA 200-388
Gentamicin Piglet InjectionGentamicin SulfateSparhawk Laboratories, Inc.SwineANADA 200-394
Gentamicin Sulfate SolutionGentamicin SulfateSparhawk Laboratories, Inc.HorsesANADA 200-395
Gentamicin Sulfate Topical SprayBetamethasone Valerate, Gentamicin SulfateFirst Priority, Inc.DogsANADA 200-415
Gentamicin Topical SprayBetamethasone Valerate, Gentamicin SulfateSparhawk Laboratories, Inc.DogsANADA 200-416
GentaMed-PGentamicin SulfateBimeda Animal Health Ltd.Chickens, TurkeysANADA 200-468
GentaMedGentamicin SulfateBimeda Animal Health Ltd.SwineANADA 200-494
MometavetClotrimazole, Gentamicin Sulfate, Mometasone furoateDechra Veterinary Products LLCDogsANADA 200-536
Gentamicin Sulfate Ophthalmic SolutionGentamicin SulfateDomes Pharma S.A.Dogs, CatsANADA 200-576
Garasol Injectionapproval withdrawnGentamicin SulfateIntervet, Inc.TurkeysNADA 047-486
VET BETA-GENapproval withdrawnBetamethasone Valerate, Gentamicin SulfateMed-Pharmex, Inc.Dogs, CatsANADA 200-183
Betagen Topical Sprayapproval withdrawnBetamethasone Valerate, Gentamicin SulfateMed-Pharmex, Inc.DogsANADA 200-188
Gentoralapproval withdrawnGentamicin SulfateMed-Pharmex, Inc.SwineANADA 200-190
Gentasolapproval withdrawnGentamicin SulfateMed-Pharmex, Inc.TurkeysANADA 200-191
Tri-Otic Ointmentapproval withdrawnBetamethasone Valerate, Clotrimazole, Gentamicin SulfateMed-Pharmex, Inc.DogsANADA 200-229

FDA pages for this ingredient

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

Cite this page

Pet Drug Reports. Gentamicin Sulfate, all combinations: adverse event reports that FDA received. https://petdrugreports.com/ingredient/gentamicin-sulfate/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of . Reports received through .

Embed this card on your site

Copy this code into your page. The card shows the figures above with their source. A line under the card links to this page.

How embedding works. It is free. Keep the link in the card and the link line under it.

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 372 reports in the 12 months to June 2026. It received 258 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 6,453 reports received from January 1987 to June 2026, 70.7% are about a safety issue only. 3.5% are about a lack of expected effectiveness, alone or with a safety issue. 25.7% are about a defect of the product or its package.