Fluoxetine Hydrochloride

496 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.
496
Total Reports
15
Deaths Reported
300.0%
Death Rate

Active Ingredients

Fluoxetine Hydrochloride

Administration Routes

OralUnknownIntraocular

Species Affected

Dog 421
Unknown 40
Cat 35

Most Affected Breeds

Unknown 40
Retriever - Labrador 28
Crossbred Canine/dog 23
Shepherd Dog - German 20
Domestic Shorthair 18
Shih Tzu 18
Dog (unknown) 17
Dog (other) 16
Terrier - Yorkshire 16
Chihuahua 15

Most Reported Reactions

Lack of efficacy - NOS 114
Vomiting 55
Behavioural disorder NOS 48
Decreased appetite 47
Lethargy (see also Central nervous system depression in Neurological) 40
Tablets, Abnormal 37
Anxiety 37
Seizure NOS 30
Anorexia 30
Diarrhoea 28
Emesis 24
Panting 24

Outcome Breakdown

Outcome Unknown
149 (32.7%)
Recovered/Normal
147 (32.2%)
Recovered with Sequela
84 (18.4%)
Ongoing
61 (13.4%)
Euthanized
9 (2.0%)
Died
6 (1.3%)

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