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 FDAFDA 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
| Species | Jan to Mar 2026 | Oct to Dec 2025 | Jan to Mar 2025 |
|---|---|---|---|
| All species | 74 | 114 | 66 |
| Dog | 70 | 81 | 47 |
| Cat | 2 | 1 | 0 |
| Horse | 0 | 0 | 0 |
| Other or not given | 2 | 32 | 19 |
January to March 2026 is the latest closed quarter in the data.
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.
| Active ingredients | Reports, all years | Reports, latest 12 months |
|---|---|---|
| Betamethasone Valerate + Clotrimazole + Gentamicin Sulfate | 2,334 | 17 |
| Betamethasone Valerate + Gentamicin Sulfate | 386 | 12 |
| Clotrimazole + Gentamicin Sulfate | 22 | 2 |
| Clotrimazole + Gentamicin Sulfate + Mometasone furoate | 163 | 114 |
| Clotrimazole + Gentamicin Sulfate + Mometasone Furoate Monohydrate | 1,333 | 12 |
| Gentamicin Sulfate | 358 | 19 |
| Gentamicin Sulfate + Hydrocortisone aceponate + Miconazole Nitrate | 1,861 | 197 |
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.
- Deafness31.3%2,020 reports
- Dispenser, Abnormal[a product quality report, not a sign in an animal]10.1%649 reports
- Loss of hearing6.2%402 reports
- Partial deafness5.6%362 reports
- Uncoded sign[a sign with no matching dictionary term]4.8%312 reports
- Difficulty of Use[a product quality report, not a sign in an animal]4.8%308 reports
- Lack of efficacy - NOS[the product did not have the expected effect]3.8%243 reports
- Vomiting3.6%234 reports
- Missing Cap3.2%208 reports
- Lethargy[unusually tired or inactive]2.6%168 reports
- Hearing affected2.6%165 reports
- Product defect, product difficult to use/handle[a product quality report, not a sign in an animal]2.5%160 reports
- Product Defect, General[a product quality report, not a sign in an animal]2.3%146 reports
- Accidental exposure[exposure that was not intended]2.1%138 reports
Show the next 16 signs
- Administration device NOS, priming issue2%130 reports
- Diarrhoea[diarrhea]2%130 reports
- Applicator, Abnormal[a product quality report, not a sign in an animal]1.8%116 reports
- Ataxia[unsteady, uncoordinated movement]1.8%113 reports
- Depression[dull, quiet or withdrawn]1.7%111 reports
- Anorexia[not eating]1.6%105 reports
- Death by euthanasia[the animal was euthanized]1.6%101 reports
- Emesis[vomiting]1.5%96 reports
- Pinnal erythema1.3%82 reports
- Head tilt - ear disorder1.3%81 reports
- Behavioural disorder NOS[behaviour change, type not specified]1.2%78 reports
- Administration device NOS, abnormal1.2%75 reports
- Death1.1%74 reports
- Administration device NOS, malfunction1.1%72 reports
- Other abnormal test result NOS[abnormal laboratory result, type not specified]1.1%72 reports
- Application site erythema[reddened skin where the product was applied]1%62 reports
Reports by species
Reports for each month, Jul 2021 to Jun 2026
No chart: no month has 5 or more reports.
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 | 120 | 4 | 0 | 10 | 134 |
| 2025 | 250 | 4 | 0 | 125 | 379 |
| 2024 | 115 | 4 | 3 | 89 | 211 |
| 2023 | 77 | 2 | 3 | 100 | 182 |
| 2022 | 59 | 2 | 2 | 120 | 183 |
| 2021 | 77 | 5 | 5 | 119 | 206 |
| 2020 | 101 | 4 | 1 | 88 | 194 |
| 2019 | 40 | 2 | 1 | 10 | 53 |
| 2018 | 90 | 10 | 1 | 4 | 105 |
| 2017 | 121 | 5 | 9 | 4 | 139 |
| 2016 | 156 | 7 | 9 | 9 | 181 |
| 2015 | 184 | 6 | 0 | 132 | 322 |
| 2014 | 265 | 11 | 0 | 119 | 395 |
| 2013 | 381 | 16 | 2 | 183 | 582 |
| 2012 | 347 | 17 | 1 | 106 | 471 |
| 2011 | 182 | 2 | 1 | 37 | 222 |
| 2010 | 185 | 3 | 0 | 20 | 208 |
| 2009 | 237 | 8 | 0 | 49 | 294 |
| 2008 | 154 | 3 | 0 | 45 | 202 |
| 2007 | 182 | 13 | 6 | 47 | 248 |
| 2006 | 163 | 6 | 12 | 36 | 217 |
| 2005 | 132 | 2 | 1 | 40 | 175 |
| 2004 | 75 | 6 | 0 | 42 | 123 |
| 2003 | 96 | 4 | 0 | 40 | 140 |
| 2002 | 70 | 7 | 2 | 36 | 115 |
| 2001 | 26 | 10 | 5 | 36 | 77 |
| 2000 | 62 | 6 | 0 | 33 | 101 |
| 1999 | 118 | 10 | 9 | 2 | 139 |
| 1998 | 88 | 7 | 2 | 1 | 98 |
| 1997 | 83 | 8 | 2 | 1 | 94 |
| 1996 | 65 | 2 | 0 | 0 | 67 |
| 1995 | 46 | 0 | 0 | 1 | 47 |
| 1994 | 59 | 0 | 1 | 0 | 60 |
| 1993 | 47 | 3 | 1 | 3 | 54 |
| 1992 | 9 | 1 | 0 | 0 | 10 |
| 1991 | 1 | 2 | 0 | 0 | 3 |
| 1990 | 3 | 0 | 0 | 2 | 5 |
| 1989 | 5 | 0 | 0 | 0 | 5 |
| 1988 | 4 | 0 | 0 | 2 | 6 |
| 1987 | 5 | 1 | 0 | 0 | 6 |
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.
| Brand name | Active ingredients | Sponsor | Approved species | Application |
|---|---|---|---|---|
| Gentocin Durafilm | Betamethasone Acetate, Gentamicin Sulfate | Intervet, Inc. | Dogs | NADA 034-267 |
| Gentocin Solution | Gentamicin Sulfate | Intervet, Inc. | Dogs, Cats | NADA 038-292 |
| Gentocin Solution | Gentamicin Sulfate | Intervet, Inc. | Horses | NADA 046-724 |
| Gentocin Otic Solution | Betamethasone Valerate, Gentamicin Sulfate | Intervet, Inc. | Dogs, Cats | NADA 046-821 |
| Garacin | Gentamicin Sulfate | Intervet, Inc. | Swine | NADA 091-191 |
| Garasol Solution | Gentamicin Sulfate | Intervet, Inc. | Turkeys | NADA 092-523 |
| Gentocin Ophthalmic Ointment | Gentamicin Sulfate | Intervet, Inc. | Dogs, Cats | NADA 098-989 |
| Gentocin Ophthalmic Solution | Gentamicin Sulfate | Intervet, Inc. | Dogs, Cats | NADA 099-008 |
| Garasol | Gentamicin Sulfate | Intervet, Inc. | Chickens, Turkeys | NADA 101-862 |
| Garacin Piglet Injection | Gentamicin Sulfate | Intervet, Inc. | Swine | NADA 103-037 |
| Topagen Ointment | Betamethasone Valerate, Gentamicin Sulfate | Intervet, Inc. | Dogs | NADA 113-231 |
| Garacin Pig Pump Oral Solution | Gentamicin Sulfate | Intervet, Inc. | Swine | NADA 130-464 |
| Gentocin Pink Eye Spray | Gentamicin Sulfate | Intervet, Inc. | Cattle | NADA 130-952 |
| Gentocin Topical Spray | Betamethasone Valerate, Gentamicin Sulfate | Intervet, Inc. | Dogs | NADA 132-338 |
| Garacin Soluble Powder | Gentamicin Sulfate | Intervet, Inc. | Swine | NADA 133-836 |
| Gentamicin Sulfate Inj. Sol. | Gentamicin Sulfate | Cronus Pharma Specialities India Private Ltd. | Dogs | NADA 137-310 |
| Otomax | Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate | Intervet, Inc. | Dogs | NADA 140-896 |
| Mometamax Otic Suspension | Clotrimazole, Gentamicin Sulfate, Mometasone Furoate Monohydrate | Intervet, Inc. | Dogs | NADA 141-177 |
| Easotic | Gentamicin Sulfate, Hydrocortisone aceponate, Miconazole Nitrate | Virbac AH, Inc. | Dogs | NADA 141-330 |
| Gentamicin Sulfate Solution 100 mg/ml | Gentamicin Sulfate | Cronus Pharma Specialities India Private Ltd. | Horses | ANADA 200-023 |
| Gentamicin Sulfate Solution; Legacy Sterile Solution | Gentamicin Sulfate | Huvepharma EOOD | Horses | ANADA 200-037 |
| Gentaglyde Solution | Gentamicin Sulfate | Zoetis Inc. | Horses | ANADA 200-102 |
| Gentamex 100 | Gentamicin Sulfate | Bimeda Animal Health Ltd. | Horses | ANADA 200-115 |
| GentaMax 100 | Gentamicin Sulfate | Elanco US Inc. | Horses | ANADA 200-137 |
| Genta-Ject; GentaPoult | Gentamicin Sulfate | Huvepharma EOOD | Chickens, Turkeys | ANADA 200-147 |
| Gentamicin Sulfate Pig Pump Oral Solution | Gentamicin Sulfate | Huvepharma EOOD | Swine | ANADA 200-174 |
| GEN-GARD | Gentamicin Sulfate | Huvepharma EOOD | Swine | ANADA 200-185 |
| Vetro-Gen Veterinary Ophthalmic Ointment | Gentamicin Sulfate | Dechra Veterinary Products LLC | Dogs, Cats | ANADA 200-273 |
| Vetro-Max | Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate | Fougera Pharmaceuticals, LLC | Dogs | ANADA 200-283 |
| GBC Ointment | Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate | Cronus Pharma Specialities India Private Ltd. | Dogs | ANADA 200-287 |
| GB Topical Spray | Betamethasone Valerate, Gentamicin Sulfate | Dechra Veterinary Products LLC | Dogs | ANADA 200-388 |
| Gentamicin Piglet Injection | Gentamicin Sulfate | Sparhawk Laboratories, Inc. | Swine | ANADA 200-394 |
| Gentamicin Sulfate Solution | Gentamicin Sulfate | Sparhawk Laboratories, Inc. | Horses | ANADA 200-395 |
| Gentamicin Sulfate Topical Spray | Betamethasone Valerate, Gentamicin Sulfate | First Priority, Inc. | Dogs | ANADA 200-415 |
| Gentamicin Topical Spray | Betamethasone Valerate, Gentamicin Sulfate | Sparhawk Laboratories, Inc. | Dogs | ANADA 200-416 |
| GentaMed-P | Gentamicin Sulfate | Bimeda Animal Health Ltd. | Chickens, Turkeys | ANADA 200-468 |
| GentaMed | Gentamicin Sulfate | Bimeda Animal Health Ltd. | Swine | ANADA 200-494 |
| Mometavet | Clotrimazole, Gentamicin Sulfate, Mometasone furoate | Dechra Veterinary Products LLC | Dogs | ANADA 200-536 |
| Gentamicin Sulfate Ophthalmic Solution | Gentamicin Sulfate | Domes Pharma S.A. | Dogs, Cats | ANADA 200-576 |
| Garasol Injectionapproval withdrawn | Gentamicin Sulfate | Intervet, Inc. | Turkeys | NADA 047-486 |
| VET BETA-GENapproval withdrawn | Betamethasone Valerate, Gentamicin Sulfate | Med-Pharmex, Inc. | Dogs, Cats | ANADA 200-183 |
| Betagen Topical Sprayapproval withdrawn | Betamethasone Valerate, Gentamicin Sulfate | Med-Pharmex, Inc. | Dogs | ANADA 200-188 |
| Gentoralapproval withdrawn | Gentamicin Sulfate | Med-Pharmex, Inc. | Swine | ANADA 200-190 |
| Gentasolapproval withdrawn | Gentamicin Sulfate | Med-Pharmex, Inc. | Turkeys | ANADA 200-191 |
| Tri-Otic Ointmentapproval withdrawn | Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate | Med-Pharmex, Inc. | Dogs | ANADA 200-229 |
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 034-267The FDA record of the application for Gentocin Durafilm.
- Green Book record of NADA 038-292The FDA record of the application for Gentocin Solution.
- Green Book record of NADA 046-821The FDA record of the application for Gentocin Otic Solution.
- Green Book record of NADA 098-989The FDA record of the application for Gentocin Ophthalmic Ointment.
- Green Book record of NADA 099-008The FDA record of the application for Gentocin Ophthalmic Solution.
- Green Book record of NADA 113-231The FDA record of the application for Topagen Ointment.
- 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. 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 .
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.