Fluoxetine

1,238 adverse event reports submitted to the FDA

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
1,238
Total Reports
62
Deaths Reported
500.0%
Death Rate

Active Ingredients

Fluoxetine

Administration Routes

OralUnknownTransdermalAuricular (Otic)Topical

Species Affected

Dog 1,006
Cat 133
Unknown 83
Human 15
Other 1

Most Affected Breeds

Crossbred Canine/dog 120
Unknown 101
Retriever - Labrador 98
Domestic Shorthair 84
Shepherd Dog - German 48
Dog (unknown) 46
Retriever - Golden 30
Shih Tzu 29
Beagle 27
Terrier (unspecified) 24

Most Reported Reactions

Vomiting 159
Lack of efficacy - NOS 141
Anorexia 105
Diarrhoea 86
Seizure NOS 74
Lethargy (see also Central nervous system depression in Neurological) 64
Behavioural disorder NOS 62
Lethargy (see also Central nervous system depression in 'Neurological') 58
Decreased appetite 55
Depression 51
Accidental exposure 47
Shaking 47

Outcome Breakdown

Outcome Unknown
318 (36.4%)
Recovered/Normal
247 (28.3%)
Ongoing
229 (26.2%)
Died
31 (3.5%)
Euthanized
31 (3.5%)
Recovered with Sequela
18 (2.1%)

Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Data reflects voluntary submissions and may not represent actual incidence rates.