Drug profile

The FDA adverse-event record for Gentamicin Sulfate

165 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Gentamicin Sulfate. See the species affected, top reactions, and outcomes below.

165
adverse-event reports
13.9%
death-coded share
Dog
most-reported species
19
Vomiting - top reaction
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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
165
Total Reports
23
Deaths Reported
13.9%
Death Rate

Active Ingredients

Gentamicin Sulfate

Administration Routes

UnknownTopicalIntravenousAuricular (Otic)OphthalmicSubcutaneousIntraocularParenteralNasalOral

Species Affected

Dog 76
Unknown 40
Horse 34
Cat 11
Rat 2
Human 1
Pig 1

Most Affected Breeds

Unknown 51
Retriever - Labrador 11
Domestic Shorthair 9
Dog (unknown) 6
Terrier - Yorkshire 6
Maltese 6
Quarter Horse 6
Horse (unknown) 6
Warmblood (unspecified) 6
Retriever - Golden 4

Most Reported Reactions

Vomiting 19
Death 15
Lethargy (see also Central nervous system depression in 'Neurological') 14
Other abnormal test result NOS 14
Administration device NOS, malfunction 12
Anorexia 11
Diarrhoea 11
Lack of efficacy - NOS 11
Weight loss 10
Colic 10
Behavioural disorder NOS 9
Decreased appetite 9

Outcome Breakdown

Recovered/Normal
44 (34.6%)
Ongoing
31 (24.4%)
Outcome Unknown
26 (20.5%)
Died
16 (12.6%)
Euthanized
7 (5.5%)
Recovered with Sequela
3 (2.4%)

Gentamicin Sulfate Adverse Event Insights

165 reports name Gentamicin Sulfate; 23 recorded a death outcome (13.9% of reported events, not a population-level mortality rate). Active ingredient: Gentamicin Sulfate. Administration routes: Unknown, Topical, Intravenous, Auricular (Otic).

By species: Dog (76 reports), Unknown (40 reports), Horse (34 reports). By breed: Unknown (51), Retriever - Labrador (11), Domestic Shorthair (9).

Leading clinical signs: Vomiting (19), Death (15), Lethargy (see also Central nervous system depression in 'Neurological') (14), Other abnormal test result NOS (14). Outcome, 127 coded reports: Recovered/Normal leads at 34.6%.

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.