Pet Drug Reports

Drugs by active ingredient

Drug · single active ingredient

Gentamicin Sulfate: adverse event reports

All products with this active ingredient · 29 FDA-approved applications in the Green Book

353reports naming this ingredient, 1987–20260% of all reports · about 9 a year
17reports, 12 months to March 202617 in the 12 months before
40.3%classed serious, as reportedof 191 reports stating it
13.9%record death or euthanasia, as reported49 reports
50.1%of reports concern dogs0% of all dog reports

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

Dog30 · peak 3
Oct 2021: 1Dec 2021: 1Feb 2022: 1Sep 2022: 2Mar 2023: 1Jul 2023: 1Aug 2023: 1Sep 2023: 3Oct 2023: 1Feb 2024: 2May 2024: 1Sep 2024: 1Dec 2024: 1Jan 2025: 2May 2025: 1Jul 2025: 1Aug 2025: 1Oct 2025: 2Nov 2025: 1Dec 2025: 2Jan 2026: 1Mar 2026: 22022202320242025
Cat5 · peak 2
Sep 2022: 1Feb 2024: 1May 2024: 1Sep 2025: 22022202320242025
Horse9 · peak 1
Jun 2021: 1Aug 2021: 1Feb 2022: 1May 2022: 1Jan 2023: 1Feb 2023: 1Dec 2023: 1Feb 2024: 1Oct 2024: 12022202320242025
Other34 · peak 3
Feb 2022: 1May 2022: 1Jun 2022: 1Aug 2022: 1Nov 2022: 2Feb 2023: 2Mar 2023: 1May 2023: 1Jun 2023: 2Aug 2023: 1Sep 2023: 1Oct 2023: 1Nov 2023: 1Dec 2023: 1Jan 2024: 1Mar 2024: 2Apr 2024: 2May 2024: 1Jun 2024: 1Aug 2024: 1Sep 2024: 1Oct 2024: 3Dec 2024: 1Apr 2025: 1May 2025: 1Jul 2025: 1Aug 2025: 12022202320242025

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

015291987: 319871988: 21989: 11990: 21991: 119911992: 41993: 41994: 11995: 119951996: 31997: 91998: 61999: 1519992000: 62001: 132002: 62003: 1120032005: 32006: 142007: 92008: 120082009: 22010: 12011: 92012: 2920122013: 212014: 92015: 112016: 2920162017: 202018: 112019: 62020: 820202021: 82022: 122023: 212024: 2220242025: 162026: 3

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

  1. Lethargy[unusually tired or inactive]9.6%34
  2. Vomiting9.3%33
  3. Death9.1%32
  4. Emesis[vomiting]6.2%22
  5. Anorexia[not eating]5.9%21
  6. Other abnormal test result NOS[abnormal laboratory result, type not specified]5.9%21
  7. Ataxia[unsteady, uncoordinated movement]5.4%19
  8. Lack of efficacy - NOS[the product did not have the expected effect]5.4%19
  9. Diarrhoea[diarrhea]5.1%18
  10. Depression[dull, quiet or withdrawn]4.2%15
  11. Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]4.2%15
  12. Elevated creatinine[a kidney value above the normal range]4.2%15
  13. Death by euthanasia[the animal was euthanized]3.7%13
  14. Behavioural disorder NOS[behaviour change, type not specified]3.4%12
  15. Colic3.1%11
  16. Shaking3.1%11
  17. Elevated serum alkaline phosphatase (SAP)[a liver and bone enzyme above the normal range]2.8%10
  18. Fever2.8%10
  19. Solution, Abnormal[a product quality report, not a sign in an animal]2.8%10
  20. Tachycardia[fast heart rate]2.8%10
  21. Anaemia NOS[low red blood cell count]2.5%9
  22. Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]2.5%9
  23. 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

Recovered/Normal21.5%76
Recovered with Sequela1.4%5
Ongoing12.2%43
Died11.6%41
Euthanized2.3%8
Outcome Unknown13.3%47

What kind of report it was

Safety issue73.9%261
Lack of expected effectiveness3.4%12
Both safety and lack of expected effectiveness3.4%12
Manufacturing or product defect17.3%61
Other2%7

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

Species

Dog50.1%177
Horse22.1%78
Cat7.9%28
Cattle1.1%4
Pig1.1%4
Rat0.6%2

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

Under 1 year7.9%28
1 to 3 years15.6%55
4 to 7 years16.7%59
8 to 11 years15.9%56
12 years and over11.6%41
Age not given32.3%114

Weight of the animal

Under 5 kg (11 lb)12.2%43
5 to 9.9 kg (11–22 lb)13%46
10 to 24.9 kg (22–55 lb)10.8%38
25 to 44.9 kg (55–99 lb)11.6%41
45 kg and over (99 lb+)19.5%69
Weight not given32.9%116

Route of administration stated in reports: intravenous (59), topical (51), auricular (otic) (28), intramuscular (19), ophthalmic (16), subcutaneous (14).

In context

MeasureGentamicin SulfateAll drugs containing gentamicin sulfateAll dog reportsAll reports
Reports3536,391985,6751,357,245
Share of that pool's reports naming this drug—5.5%0%0%
Classed serious, of reports stating it40.3%53.2%38.3%38.6%
Death or euthanasia recorded, per 1,000 reports138.8285563.8
Filed as lack of expected effectiveness (wholly or partly)6.8%——23%
Top term, share of reportsLethargy 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

Active ingredientsReportsLatest 12 months
Betamethasone Valerate + Clotrimazole + Gentamicin Sulfate2,32912
Gentamicin Sulfate + Hydrocortisone aceponate + Miconazole Nitrate1,841220
Clotrimazole + Gentamicin Sulfate + Mometasone Furoate Monohydrate1,3278
Betamethasone Valerate + Gentamicin Sulfate3786
Clotrimazole + Gentamicin Sulfate + Mometasone furoate145121
Clotrimazole + Gentamicin Sulfate222

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 nameActive ingredientsSponsorApproved forApplication
Gentocin SolutionGentamicin SulfateIntervet, Inc.Dogs, CatsNADA 038-292
Gentocin SolutionGentamicin SulfateIntervet, Inc.HorsesNADA 046-724
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
Garacin Pig Pump Oral SolutionGentamicin SulfateIntervet, Inc.SwineNADA 130-464
Gentocin Pink Eye SprayGentamicin SulfateIntervet, Inc.CattleNADA 130-952
Garacin Soluble PowderGentamicin SulfateIntervet, Inc.SwineNADA 133-836
Gentamicin Sulfate Inj. Sol.Gentamicin SulfateCronus Pharma Specialities India Private Ltd.DogsNADA 137-310
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
Gentamicin Piglet InjectionGentamicin SulfateSparhawk Laboratories, Inc.SwineANADA 200-394
Gentamicin Sulfate SolutionGentamicin SulfateSparhawk Laboratories, Inc.HorsesANADA 200-395
GentaMed-PGentamicin SulfateBimeda Animal Health Ltd.Chickens, TurkeysANADA 200-468
GentaMedGentamicin SulfateBimeda Animal Health Ltd.SwineANADA 200-494
Gentamicin Sulfate Ophthalmic SolutionGentamicin SulfateDomes Pharma S.A.Dogs, CatsANADA 200-576
Garasol Injectionapproval voluntarily withdrawnGentamicin SulfateIntervet, Inc.TurkeysNADA 047-486
Gentoralapproval voluntarily withdrawnGentamicin SulfateMed-Pharmex, Inc.SwineANADA 200-190
Gentasolapproval voluntarily withdrawnGentamicin SulfateMed-Pharmex, Inc.TurkeysANADA 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.