Pet Drug Reports

Ingredients

Active ingredient · pooled across combinations

Gentamicin Sulfate: adverse event reports, pooled

11 ingredient sets in reports · 45 FDA-approved applications in the Green Book

6,391reports naming the ingredient, 1987–20260.5% of all reports · about 163 a year
385reports, 12 months to March 2026235 in the 12 months before
53.2%classed serious, as reportedall reports: 38.6%
69.3%of reports concern dogscat 3.1%

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 drugReportsShare of this page's reportsLatest 12 months
Betamethasone Valerate + Clotrimazole + Gentamicin Sulfate2,32936.4%12
Gentamicin Sulfate + Hydrocortisone aceponate + Miconazole Nitrate1,84128.8%220
Clotrimazole + Gentamicin Sulfate + Mometasone Furoate Monohydrate1,32720.8%8
Betamethasone Valerate + Gentamicin Sulfate3785.9%6
Gentamicin Sulfate3535.5%17
Clotrimazole + Gentamicin Sulfate + Mometasone furoate1452.3%121
Clotrimazole + Gentamicin Sulfate220.3%2
Betamethasone Valerate + Gentamicin Sulfate + Triamcinolone70.1%0
Gentamicin Sulfate + Mometasone Furoate Monohydrate10%0
Gentamicin Sulfate + Miconazole Nitrate10%0
Gentamicin Sulfate + Hydrocortisone10%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

  1. Deafness31.5%2,015
  2. Dispenser, Abnormal[a product quality report, not a sign in an animal]10.2%649
  3. Uncoded sign[a sign with no matching dictionary term]4.9%312
  4. Difficulty of Use[a product quality report, not a sign in an animal]4.8%308
  5. Lack of efficacy - NOS[the product did not have the expected effect]3.7%235
  6. Vomiting3.6%230
  7. Lethargy[unusually tired or inactive]2.5%161
  8. Product defect, product difficult to use/handle[a product quality report, not a sign in an animal]2.5%160
  9. Product Defect, General[a product quality report, not a sign in an animal]2.3%146
  10. Accidental exposure[exposure that was not intended]2.2%138
  11. Administration device NOS, priming issue2%130
  12. Diarrhoea[diarrhea]2%127
  13. Applicator, Abnormal[a product quality report, not a sign in an animal]1.8%114
  14. Depression[dull, quiet or withdrawn]1.7%111
  15. Ataxia[unsteady, uncoordinated movement]1.7%110
  16. Anorexia[not eating]1.6%104
  17. Death by euthanasia[the animal was euthanized]1.5%98
  18. Emesis[vomiting]1.5%96
  19. Behavioural disorder NOS[behaviour change, type not specified]1.2%77
  20. Death1.1%72
  21. Other abnormal test result NOS[abnormal laboratory result, type not specified]1.1%71
  22. 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

Dog626 · peak 32
Apr 2021: 5May 2021: 8Jun 2021: 2Jul 2021: 9Aug 2021: 9Sep 2021: 4Oct 2021: 15Nov 2021: 4Dec 2021: 1Jan 2022: 4Feb 2022: 6Mar 2022: 3Apr 2022: 4May 2022: 4Jun 2022: 7Jul 2022: 8Aug 2022: 5Sep 2022: 9Oct 2022: 3Nov 2022: 5Dec 2022: 1Jan 2023: 2Feb 2023: 6Mar 2023: 6Apr 2023: 5May 2023: 9Jun 2023: 1Jul 2023: 11Aug 2023: 10Sep 2023: 8Oct 2023: 8Nov 2023: 5Dec 2023: 6Jan 2024: 7Feb 2024: 7Mar 2024: 7Apr 2024: 10May 2024: 10Jun 2024: 5Jul 2024: 9Aug 2024: 12Sep 2024: 15Oct 2024: 6Nov 2024: 9Dec 2024: 18Jan 2025: 16Feb 2025: 14Mar 2025: 17Apr 2025: 11May 2025: 20Jun 2025: 18Jul 2025: 31Aug 2025: 21Sep 2025: 21Oct 2025: 32Nov 2025: 22Dec 2025: 27Jan 2026: 22Feb 2026: 21Mar 2026: 252022202320242025
Cat17 · peak 2
Jun 2021: 1Jul 2021: 1Aug 2021: 1Apr 2022: 1Sep 2022: 1Jul 2023: 1Nov 2023: 1Feb 2024: 1Mar 2024: 1May 2024: 1Jun 2024: 1Apr 2025: 1Sep 2025: 2Dec 2025: 1Jan 2026: 22022202320242025
Horse10 · peak 2
Jun 2021: 1Aug 2021: 1Feb 2022: 1May 2022: 1Jan 2023: 1Feb 2023: 1Dec 2023: 1Feb 2024: 1Oct 2024: 22022202320242025
Other523 · peak 21
Apr 2021: 13May 2021: 12Jun 2021: 12Jul 2021: 9Aug 2021: 10Sep 2021: 10Oct 2021: 8Nov 2021: 9Dec 2021: 4Jan 2022: 15Feb 2022: 12Mar 2022: 12Apr 2022: 14May 2022: 6Jun 2022: 11Jul 2022: 4Aug 2022: 6Sep 2022: 7Oct 2022: 8Nov 2022: 15Dec 2022: 10Jan 2023: 16Feb 2023: 10Mar 2023: 15Apr 2023: 4May 2023: 4Jun 2023: 8Jul 2023: 6Aug 2023: 11Sep 2023: 4Oct 2023: 6Nov 2023: 11Dec 2023: 5Jan 2024: 11Feb 2024: 2Mar 2024: 5Apr 2024: 9May 2024: 7Jun 2024: 9Jul 2024: 7Aug 2024: 5Sep 2024: 9Oct 2024: 10Nov 2024: 7Dec 2024: 8Jan 2025: 4Feb 2025: 4Mar 2025: 11Apr 2025: 11May 2025: 9Jun 2025: 5Jul 2025: 12Aug 2025: 16Sep 2025: 21Oct 2025: 21Nov 2025: 11Jan 2026: 1Feb 2026: 12022202320242025

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.

02915821987: 619871988: 61989: 51990: 51991: 319911992: 101993: 541994: 601995: 4719951996: 671997: 941998: 981999: 13919992000: 1012001: 772002: 1152003: 14020032004: 1232005: 1752006: 2172007: 24820072008: 2022009: 2942010: 2082011: 22220112012: 4712013: 5822014: 3952015: 32220152016: 1812017: 1392018: 1052019: 5320192020: 1942021: 2062022: 1832023: 18220232024: 2112025: 3792026: 72

Outcomes, report types and ages

Outcome recorded in the report

Recovered/Normal9.2%585
Recovered with Sequela2.1%137
Ongoing6.7%429
Died2%130
Euthanized0.8%49
Outcome Unknown13%833

What kind of report it was

Safety issue70.6%4,515
Lack of expected effectiveness1.9%119
Both safety and lack of expected effectiveness1.5%97
Manufacturing or product defect25.8%1,652
Other0.1%8

Species

Dog69.3%4,428
Cat3.1%201
Horse1.2%79
Human exposure0.6%36
Other0.1%5
Cattle0.1%4

Age of the animal

Under 1 year3.1%195
1 to 3 years9.2%589
4 to 7 years12.3%786
8 to 11 years22.7%1,451
12 years and over21.2%1,357
Age not given31.5%2,013

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

MeasureGentamicin SulfateAll reports
Reports6,3911,357,245
Latest 12 months against the 12 before+64%-5%
Classed serious, of reports stating it53.2%38.6%
Death or euthanasia recorded, per 1,000 reports2863.8
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 nameActive ingredientsSponsorApproved forApplication
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 voluntarily withdrawnGentamicin SulfateIntervet, Inc.TurkeysNADA 047-486
VET BETA-GENapproval voluntarily withdrawnBetamethasone Valerate, Gentamicin SulfateMed-Pharmex, Inc.Dogs, CatsANADA 200-183
Betagen Topical Sprayapproval voluntarily withdrawnBetamethasone Valerate, Gentamicin SulfateMed-Pharmex, Inc.DogsANADA 200-188
Gentoralapproval voluntarily withdrawnGentamicin SulfateMed-Pharmex, Inc.SwineANADA 200-190
Gentasolapproval voluntarily withdrawnGentamicin SulfateMed-Pharmex, Inc.TurkeysANADA 200-191
Tri-Otic Ointmentapproval voluntarily withdrawnBetamethasone Valerate, Clotrimazole, Gentamicin SulfateMed-Pharmex, Inc.DogsANADA 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.