Drug · single active ingredient
Gentamicin Sulfate: adverse event reports
All products with this active ingredient · 29 FDA-approved applications in the Green Book
- Mostly dog reports
- Intravenous route most often
- Brands masked by FDA
353 adverse event reports in FDA's database list a drug whose active ingredient is recorded as gentamicin sulfate. The earliest was received in January 1987, the latest in March 2026. The Green Book lists 29 FDA-approved applications with this single active ingredient.
openFDA masks the brand and manufacturer in every report, so these figures describe the ingredient across all products and cannot be attributed to a brand.
In the 12 months to March 2026, 17 reports named it, close to the 17 of the 12 months before. Recent months are provisional: fDA posts reports quarterly with a delay of three to six months, so the newest months are incomplete and usually grow in later releases. Over its whole reporting history that is about 9 reports a year and 0% of all 1,357,245 reports (0% of all dog reports). How many animals received it is not published, so a count says nothing about how often a problem occurs per dose.
The signs named most often are lethargy (9.6%), vomiting (9.3%) and death (9.1%). A report can list several signs, so shares add to more than 100%; 553 different terms appear across these reports. Lethargy appears in 9.6% of these reports, a larger share than in the pooled reports for every drug containing gentamicin sulfate (2.5%).
50.1% of reports concern dogs. Not every report describes illness: 17.3% as product or packaging defects. Of reports that state seriousness, 40.3% were classed as serious, and 13.9% of all reports record a death or euthanasia as an outcome, as reported. FDA has not necessarily determined whether any drug played a part.
Monthly reports by species, five years
Reports by the month FDA received them. Each panel has its own scale; the peak month is printed at the top right. The newest months are incomplete because FDA posts reports with a delay of three to six months.
Reports by year received
2026 covers reports received through March 2026 only.
Signs listed in reports
share of gentamicin sulfate reports listing the termall drugs containing gentamicin sulfateall dog reports
- Lethargy[unusually tired or inactive]9.6%34
- Vomiting9.3%33
- Death9.1%32
- Emesis[vomiting]6.2%22
- Anorexia[not eating]5.9%21
- Other abnormal test result NOS[abnormal laboratory result, type not specified]5.9%21
- Ataxia[unsteady, uncoordinated movement]5.4%19
- Lack of efficacy - NOS[the product did not have the expected effect]5.4%19
- Diarrhoea[diarrhea]5.1%18
- Abdominal pain4.8%17
- Depression[dull, quiet or withdrawn]4.2%15
- Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]4.2%15
- Elevated creatinine[a kidney value above the normal range]4.2%15
- Weight loss4%14
- Corneal ulcer3.7%13
- Death by euthanasia[the animal was euthanized]3.7%13
- Behavioural disorder NOS[behaviour change, type not specified]3.4%12
- Colic3.1%11
- Shaking3.1%11
- Decreased appetite2.8%10
- Elevated serum alkaline phosphatase (SAP)[a liver and bone enzyme above the normal range]2.8%10
- Fever2.8%10
- Loose stool2.8%10
- Solution, Abnormal[a product quality report, not a sign in an animal]2.8%10
- Tachycardia[fast heart rate]2.8%10
- Anaemia NOS[low red blood cell count]2.5%9
- Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]2.5%9
- Increased sweating2.5%9
- Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]2.5%9
Top 30 of 553 coded terms (VeDDRA, the veterinary reporting dictionary; plain-language gloss in brackets). One report can list several terms. The ticks show how often the same term appears in a wider pool of reports; they describe the reports, and FDA cautions that such figures cannot be used to estimate risk or to compare one product with another. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand.
Outcomes and report types
Outcome recorded in the report
What kind of report it was
Coloured bar: reports naming gentamicin sulfate. Grey bar: all 1,357,245 reports in the database. Outcomes are the status at the time of the last report, as stated by the reporter; a report covering several animals can carry more than one outcome. FDA has not necessarily determined whether any drug played a part in any outcome.
Species and breeds in the reports
Single-breed animals
Breed shares follow how common each breed is. Crossbred animals and reports with no breed stay in the species figure only.
Age, weight and route
Age of the animal
Weight of the animal
Route of administration stated in reports: intravenous (59), topical (51), auricular (otic) (28), intramuscular (19), ophthalmic (16), subcutaneous (14).
In context
| Measure | Gentamicin Sulfate | All drugs containing gentamicin sulfate | All dog reports | All reports |
|---|---|---|---|---|
| Reports | 353 | 6,391 | 985,675 | 1,357,245 |
| Share of that pool's reports naming this drug | — | 5.5% | 0% | 0% |
| Classed serious, of reports stating it | 40.3% | 53.2% | 38.3% | 38.6% |
| Death or euthanasia recorded, per 1,000 reports | 138.8 | 28 | 55 | 63.8 |
| Filed as lack of expected effectiveness (wholly or partly) | 6.8% | — | — | 23% |
| Top term, share of reports | Lethargy 9.6% | 2.5% | 7.9% | — |
The gentamicin sulfate pool is every report naming gentamicin sulfate alone or in any combination; this single-ingredient set accounts for 5.5% of it. Shares are of reports, not of animals treated. The number of doses sold is not public, so none of these figures is a rate of occurrence, and differences between columns reflect which animals receive a drug and who reports as much as anything else.
Other ingredient sets sharing an ingredient
Listed for navigation, 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": drugs differ in formulation, in the animals they are given to, in sales volume and in years on the market. A report's ingredient field can be incomplete, so reports about one product may sit under more than one set.
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 Solution | Gentamicin Sulfate | Intervet, Inc. | Dogs, Cats | NADA 038-292 |
| Gentocin Solution | Gentamicin Sulfate | Intervet, Inc. | Horses | NADA 046-724 |
| 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 |
| 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 |
| 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 |
| 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 |
| Gentamicin Piglet Injection | Gentamicin Sulfate | Sparhawk Laboratories, Inc. | Swine | ANADA 200-394 |
| Gentamicin Sulfate Solution | Gentamicin Sulfate | Sparhawk Laboratories, Inc. | Horses | ANADA 200-395 |
| GentaMed-P | Gentamicin Sulfate | Bimeda Animal Health Ltd. | Chickens, Turkeys | ANADA 200-468 |
| GentaMed | Gentamicin Sulfate | Bimeda Animal Health Ltd. | Swine | ANADA 200-494 |
| 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 |
| Gentoralapproval voluntarily withdrawn | Gentamicin Sulfate | Med-Pharmex, Inc. | Swine | ANADA 200-190 |
| Gentasolapproval voluntarily withdrawn | Gentamicin Sulfate | Med-Pharmex, Inc. | Turkeys | ANADA 200-191 |
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 adverse event reports has FDA received for gentamicin sulfate?
353 reports record a drug with gentamicin sulfate as its active ingredient in the openFDA release of 28 Sep 2026, covering reports received through March 2026. 17 of them arrived in the latest 12 months.
Which brand 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 lists 29 approved applications with this ingredient alone; the reference list on this page names them without any counts.
What signs are reported most often?
lethargy (9.6%), vomiting (9.3%), death (9.1%), emesis (6.2%) and anorexia (5.9%). These are the coded terms listed in reports; several can appear in one report, and a term's presence is not a finding that the drug was responsible.
Which species and breeds appear in these reports?
dog (50.1%), horse (22.1%) and cat (7.9%). Among single-breed animals the most frequent labels are Labrador Retriever, Quarter Horse, Domestic Shorthair and Thoroughbred; popular breeds appear often in any drug's reports because there are more of them.
Are reports rising?
17 reports in the 12 months to March 2026, close to the 17 of 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. Counts also move with sales, publicity and time on the market.
Do these reports show that gentamicin sulfate harms pets?
Report counts 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." FDA also notes that commonly used products may have more reports simply because more animals receive them.
Are these the side effects of gentamicin sulfate?
They are signs listed in reports, not an established list of side effects. The adverse reactions observed in studies are printed on each product's FDA-approved label, which a veterinarian can go through with you. This page is a record of what was reported to FDA.
How do I report a problem with an animal drug?
FDA asks owners and veterinarians to call the drug company first (the number is on the label); companies must pass reports to FDA. Reports can also go directly to FDA on Form FDA 1932a. 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. Drug entries are grouped by the active ingredients their unmasked ingredient field discloses; the application number that records also carry is not used. 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.