Active ingredient · pooled across combinations
Gentamicin Sulfate: adverse event reports, pooled
11 ingredient sets in reports · 45 FDA-approved applications in the Green Book
Gentamicin Sulfate appears, alone or combined with other ingredients, in 6,391 reports in FDA's animal adverse event database (January 1987 to March 2026). The figures here pool all 11 ingredient sets that include it.
The Green Book lists 45 FDA-approved applications containing it. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand.
385 reports arrived in the 12 months to March 2026, up 64% from 235 in the 12 months before. FDA posts reports quarterly with a delay of three to six months, so the newest months are incomplete and usually grow in later releases. That is about 163 reports a year over its reporting history and 0.5% of all reports.
Pooled across every set, the terms listed most often are deafness (31.5%), dispenser, Abnormal (10.2%) and loss of hearing (6%). Many drugs combine several ingredients, and many reports list several drugs, so a term on this page may relate to any of them or to none.
Of reports that state seriousness, 53.2% were classed as serious (38.6% across the whole database); 2.8% record a death or euthanasia (6.4% overall). Ingredients used in older or sicker animals, or in anaesthesia and cancer care, carry higher shares for that reason alone.
Ingredient sets that include gentamicin sulfate
| Active ingredients recorded for the drug | Reports | Share of this page's reports | Latest 12 months |
|---|---|---|---|
| Betamethasone Valerate + Clotrimazole + Gentamicin Sulfate | 2,329 | 36.4% | 12 |
| Gentamicin Sulfate + Hydrocortisone aceponate + Miconazole Nitrate | 1,841 | 28.8% | 220 |
| Clotrimazole + Gentamicin Sulfate + Mometasone Furoate Monohydrate | 1,327 | 20.8% | 8 |
| Betamethasone Valerate + Gentamicin Sulfate | 378 | 5.9% | 6 |
| Gentamicin Sulfate | 353 | 5.5% | 17 |
| Clotrimazole + Gentamicin Sulfate + Mometasone furoate | 145 | 2.3% | 121 |
| Clotrimazole + Gentamicin Sulfate | 22 | 0.3% | 2 |
| Betamethasone Valerate + Gentamicin Sulfate + Triamcinolone | 7 | 0.1% | 0 |
| Gentamicin Sulfate + Mometasone Furoate Monohydrate | 1 | 0% | 0 |
| Gentamicin Sulfate + Miconazole Nitrate | 1 | 0% | 0 |
| Gentamicin Sulfate + Hydrocortisone | 1 | 0% | 1 |
Ordered by report count. FDA states that these data "cannot be used to estimate the risk associated with the product or compare one drug or device product with another"; counts follow sales volume and years on the market. A report can list more than one set, so shares can add to more than 100%.
Signs listed in reports, pooled
share of gentamicin sulfate reports listing the termall reports in the database
- Deafness31.5%2,015
- Dispenser, Abnormal[a product quality report, not a sign in an animal]10.2%649
- Loss of hearing6%382
- Partial deafness5.7%362
- Uncoded sign[a sign with no matching dictionary term]4.9%312
- Difficulty of Use[a product quality report, not a sign in an animal]4.8%308
- Lack of efficacy - NOS[the product did not have the expected effect]3.7%235
- Vomiting3.6%230
- Missing Cap3.3%208
- Hearing affected2.6%165
- Lethargy[unusually tired or inactive]2.5%161
- Product defect, product difficult to use/handle[a product quality report, not a sign in an animal]2.5%160
- Product Defect, General[a product quality report, not a sign in an animal]2.3%146
- Accidental exposure[exposure that was not intended]2.2%138
- Administration device NOS, priming issue2%130
- Diarrhoea[diarrhea]2%127
- Applicator, Abnormal[a product quality report, not a sign in an animal]1.8%114
- Depression[dull, quiet or withdrawn]1.7%111
- Ataxia[unsteady, uncoordinated movement]1.7%110
- Anorexia[not eating]1.6%104
- Death by euthanasia[the animal was euthanized]1.5%98
- Emesis[vomiting]1.5%96
- Head tilt - ear disorder1.3%81
- Pinnal erythema1.3%81
- Behavioural disorder NOS[behaviour change, type not specified]1.2%77
- Death1.1%72
- Other abnormal test result NOS[abnormal laboratory result, type not specified]1.1%71
- Application site erythema[reddened skin where the product was applied]1%62
Pooled across every ingredient set and every report that names the ingredient. One report can list several terms and several drugs; a term here may relate to any of them or to none.
Monthly reports by species, five years
By month of receipt; each panel has its own scale. The newest months are incomplete because FDA posts reports with a delay of three to six months.
Outcomes, report types and ages
Outcome recorded in the report
What kind of report it was
Age of the animal
Coloured bar: reports naming gentamicin sulfate. Grey bar: all 1,357,245 reports. Outcomes are as stated by the reporter; FDA has not necessarily determined whether any product played a part.
In context
| Measure | Gentamicin Sulfate | All reports |
|---|---|---|
| Reports | 6,391 | 1,357,245 |
| Latest 12 months against the 12 before | +64% | -5% |
| Classed serious, of reports stating it | 53.2% | 38.6% |
| Death or euthanasia recorded, per 1,000 reports | 28 | 63.8 |
| Filed as lack of expected effectiveness (wholly or partly) | 3.4% | 23% |
Shares of reports, not of animals treated: how many animals receive the ingredient is not public. Ingredients used in anaesthesia, cancer care or in old animals carry more serious outcomes in their reports for that reason alone.
FDA-approved products containing gentamicin sulfate (Green Book)
Reference information, not report statistics. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand. The list below is the FDA Green Book as of 1 Oct 2026; nothing on this page says which of these products, if any, a report concerned.
| Trade name | Active ingredients | Sponsor | Approved for | 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 voluntarily withdrawn | Gentamicin Sulfate | Intervet, Inc. | Turkeys | NADA 047-486 |
| VET BETA-GENapproval voluntarily withdrawn | Betamethasone Valerate, Gentamicin Sulfate | Med-Pharmex, Inc. | Dogs, Cats | ANADA 200-183 |
| Betagen Topical Sprayapproval voluntarily withdrawn | Betamethasone Valerate, Gentamicin Sulfate | Med-Pharmex, Inc. | Dogs | ANADA 200-188 |
| Gentoralapproval voluntarily withdrawn | Gentamicin Sulfate | Med-Pharmex, Inc. | Swine | ANADA 200-190 |
| Gentasolapproval voluntarily withdrawn | Gentamicin Sulfate | Med-Pharmex, Inc. | Turkeys | ANADA 200-191 |
| Tri-Otic Ointmentapproval voluntarily withdrawn | Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate | Med-Pharmex, Inc. | Dogs | ANADA 200-229 |
Species are the major species the Green Book search lists for the application ("—" where it lists another species or none). Approval dates are not part of the Green Book listing files and are not shown. Pioneer applications (NADA) come first, then generics (ANADA).
Questions about gentamicin sulfate reports
How many FDA adverse event reports mention gentamicin sulfate?
6,391 reports through March 2026, 385 of them in the latest 12 months, counting gentamicin sulfate alone and in combinations.
Which brands do these reports concern?
That cannot be known from the public data. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand. The Green Book reference list on this page names approved products containing gentamicin sulfate without any counts.
In which combinations is gentamicin sulfate reported?
Betamethasone Valerate + Clotrimazole + Gentamicin Sulfate (36.4% of these reports), Gentamicin Sulfate + Hydrocortisone aceponate + Miconazole Nitrate (28.8% of these reports), Clotrimazole + Gentamicin Sulfate + Mometasone Furoate Monohydrate (20.8% of these reports), Betamethasone Valerate + Gentamicin Sulfate (5.9% of these reports) and Gentamicin Sulfate (5.5% of these reports).
What reactions are reported for gentamicin sulfate?
deafness (31.5%), dispenser, Abnormal (10.2%), loss of hearing (6%), partial deafness (5.7%) and uncoded sign (4.9%). Shares are of reports naming the ingredient; one report can list several terms.
Which animals are these reports about?
dog (69.3%), cat (3.1%) and horse (1.2%).
Does a high count mean gentamicin sulfate is a problem ingredient?
A count cannot show that. FDA states that "there is no certainty that the reported drug or device caused the adverse event" and that the event "may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources." Widely used ingredients collect more reports because more animals receive them.
How do I report a problem?
Call the drug company using the number on the label, or send Form FDA 1932a to FDA. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Animal & Veterinary adverse event bulk files released 28 Sep 2026, which hold reports FDA's Center for Veterinary Medicine received through 31 Mar 2026. openFDA masks brand and manufacturer names in these files, so drugs are counted by the active ingredients each record discloses and no figure is attributed to a brand, application or company. Ingredient names, and the separate reference lists of approved products, follow the FDA Green Book as of 1 Oct 2026. Ingredient names follow the Green Book; salts and forms are kept as FDA lists them. Drug entries are matched by the active ingredients their unmasked ingredient field discloses. No report text, lot numbers or reporter details are published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.