Drug profile

The FDA adverse-event record for Nystatin

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

20
adverse-event reports
5.0%
death-coded share
Dog
most-reported species
8
Potency, Low - 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.
20
Total Reports
1
Deaths Reported
5.0%
Death Rate

Active Ingredients

Nystatin

Administration Routes

UnknownTopicalOral

Species Affected

Dog 11
Unknown 9

Most Affected Breeds

Unknown 14
Bulldog - American 1
Pug 1
Shepherd Dog - Australian 1
American Pit Bull Terrier 1
Pit Bull 1
Poodle - Toy 1

Most Reported Reactions

Potency, Low 8
Product Defect, General 7
Temporary deafness 4
Diarrhoea 2
Ataxia 2
Horner's syndrome 1
Palpebral disorder NOS 1
Circling - neurological disorder (see also 'Behavioural disorders') 1
Death 1
Loss of hearing 1
Vomiting 1
Unsteady gait 1

Outcome Breakdown

Recovered/Normal
5 (45.5%)
Ongoing
4 (36.4%)
Died
1 (9.1%)
Outcome Unknown
1 (9.1%)

Nystatin Adverse Event Insights

20 reports name Nystatin; 1 recorded a death outcome (5.0% of reported events, not a population-level mortality rate). Active ingredient: Nystatin. Administration routes: Unknown, Topical, Oral.

By species: Dog (11 reports), Unknown (9 reports). By breed: Unknown (14), Bulldog - American (1), Pug (1).

Leading clinical signs: Potency, Low (8), Product Defect, General (7), Temporary deafness (4), Diarrhoea (2). Outcome, 11 coded reports: Recovered/Normal leads at 45.5%.

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.