Drug profile

The FDA adverse-event record for Sertraline

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

36
adverse-event reports
0.0%
death-coded share
Dog
most-reported species
8
Accidental exposure - 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.
36
Total Reports
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

Sertraline

Administration Routes

UnknownOral

Species Affected

Dog 19
Human 15
Unknown 1
Cat 1

Most Affected Breeds

Unknown 16
Retriever - Labrador 3
Terrier - Boston 2
Dog (unknown) 2
Crossbred Canine/dog 2
Chihuahua 2
Pit Bull 1
Patterdale Terrier 1
Shih Tzu 1
Retriever - Nova Scotia Duck Tolling 1

Most Reported Reactions

Accidental exposure 8
Lack of efficacy - NOS 6
Skin disorders NOS 2
Itching 2
Shaking 2
Dizziness 2
Aggression 2
Seizure NOS 2
Skin swelling 2
Warm feeling to the touch 2
Fever 2
Welt 2

Outcome Breakdown

Outcome Unknown
16 (45.7%)
Ongoing
10 (28.6%)
Recovered/Normal
8 (22.9%)
Recovered with Sequela
1 (2.9%)

Sertraline Adverse Event Insights

36 reports name Sertraline; 0 recorded a death outcome (0.0% of reported events, not a population-level mortality rate). Active ingredient: Sertraline. Administration routes: Unknown, Oral.

By species: Dog (19 reports), Human (15 reports), Unknown (1 reports). By breed: Unknown (16), Retriever - Labrador (3), Terrier - Boston (2).

Leading clinical signs: Accidental exposure (8), Lack of efficacy - NOS (6), Skin disorders NOS (2), Itching (2). Outcome, 35 coded reports: Outcome Unknown leads at 45.7%.

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.