Pet Recall Facts

Ingredients / Fluoxetine

Fluoxetine: FDA adverse event reports for pets

Reports received through June 26, 2026. Data and limitations.

2,984Total reports
2,564Dog reports
232Cat reports

FDA-approved products with this ingredient (Green Book)

All approved products with this ingredient, for any species.

Brand names come only from the Green Book. Brand names in FDA's public report data are masked, so counts cannot be attributed to any brand. Ingredient names in the reports are written many ways; we group them under one ingredient name and count each report once per ingredient (method).

Reports by year received

20041
2007224
2008228
2009211
2010195
2011205
2012198
2013147
201462
201561
201674
201775
201871
201979
202087
2021106
202298
2023133
2024261
2025318
2026150

Species named in reports

Dog2,564
Cat232
Not given161
Human25
Other2

Signs reported after Fluoxetine

Lack of efficacy - NOS382
Vomiting360
Anorexia330
Lethargy (see also Central nervous system depression in Neurological)244
Depression226
Diarrhoea193
Behavioural disorder NOS151
Seizure NOS143
Accidental exposure140
Decreased appetite128
Weight loss121
Aggression111
Shaking106
Trembling101
Emesis101
Panting97
Anxiety93
Not eating91
Elevated alanine aminotransferase (ALT)88
Ataxia85
Vocalisation82
Death by euthanasia77
Tablets, Abnormal75
Apprehension73
INEFFECTIVE, LOSS OF EFFECT71

Breeds named in reports

Crossbred Canine/dog336
Dog (unknown)316
Retriever - Labrador235
Shepherd Dog - German132
Domestic Shorthair129
Poodle (unspecified)93
Beagle79
Shih Tzu78
Retriever - Golden70
Chihuahua66
Pit Bull62
Boxer (German Boxer)59
Terrier (unspecified)55
Dog (other)52
Terrier - Yorkshire51

Reported outcomes

Outcome Unknown602
Recovered/Normal574
Ongoing504
Recovered with Sequela108
Euthanized64
Died61

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