Drug profile

The FDA adverse-event record for Dirlotapide

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

685
adverse-event reports
2.9%
death-coded share
Dog
most-reported species
173
Vomiting - 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.
685
Total Reports
20
Deaths Reported
2.9%
Death Rate

Active Ingredients

Dirlotapide

Administration Routes

OralUnknownTopicalOphthalmic

Species Affected

Dog 602
Unknown 76
Human 7

Most Affected Breeds

Unknown 83
Crossbred Canine/dog 76
Retriever - Labrador 73
Dachshund (unspecified) 43
Retriever - Golden 37
Chihuahua 32
Beagle 31
Dog (unknown) 23
Pug 19
Sheepdog - Shetland 17

Most Reported Reactions

Vomiting 173
Hyperextension 123
INEFFECTIVE, WEIGHT LOSS 123
Anorexia 105
Depression 81
INEFFECTIVE, APPETITE SUPPRESSION 76
Diarrhoea 60
Weight gain 50
Vials, Leaking 49
Elevated alanine aminotransferase (ALT) 37
Elevated serum alkaline phosphatase (SAP) 37
Uncoded sign 28

Outcome Breakdown

Ongoing
66 (55.9%)
Recovered/Normal
20 (16.9%)
Died
19 (16.1%)
Outcome Unknown
12 (10.2%)
Euthanized
1 (0.8%)

Dirlotapide Adverse Event Insights

685 reports name Dirlotapide; 20 recorded a death outcome (2.9% of reported events, not a population-level mortality rate). Active ingredient: Dirlotapide. Administration routes: Oral, Unknown, Topical, Ophthalmic.

By species: Dog (602 reports), Unknown (76 reports), Human (7 reports). By breed: Unknown (83), Crossbred Canine/dog (76), Retriever - Labrador (73).

Leading clinical signs: Vomiting (173), Hyperextension (123), INEFFECTIVE, WEIGHT LOSS (123), Anorexia (105). Outcome, 118 coded reports: Ongoing leads at 55.9%.

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.