Drug profile

The FDA adverse-event record for Dirlotapide

685 FDA reports name Dirlotapide, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#240 of 2,679
by report volume (all drugs)
685
adverse-event reports
2.9%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Dirlotapide ranks #240 of 2679 by total reports (685) and #925 of 1130 by death-coded share (2.9%). National dual: Milbemycin Oxime + Spinosad is #1 of 2679 drugs by total adverse-event reports (149,624) at death-coded-share rank 965 of 1130 drugs with at least 50 reports (2.3%); separately, Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) is #1 highest death-coded share at 97.8% (report rank #821).

149,624
Milbemycin Oxime + Spinosad reports (#1)
97.8%
Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) death share (#1)
#240
This drug, reports of 2679
#925
This drug, death share of 1130

Report volume reflects how common a breed or drug is and how often owners and vets file — not actual risk. Death-coded share ranks are limited to entries with enough reports to be meaningful. The two maps do not agree at #1.

Release-over-release change

What changed in the latest FDA data snapshot

PlainBreed reconstructed the prior snapshot from dated openFDA partitions through 2025 Q4, then compared it with the 2026-07-27 openFDA export. Dirlotapide has 685 reports now versus 685 in that prior snapshot: 0 the same number of (0.0%).

Report change
+0
Death-coded reports
+0
Death-coded share
+0.0 pts

This compares reported-event counts in two source snapshots. It does not establish a change in real-world risk, product safety, or disease incidence.

Subscribe to Dirlotapide changes

Signature read: 685 reports place Dirlotapide in the upper third of FDA AER volume (#240 of 2,679).

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-coded share of reports

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 serum alkaline phosphatase (SAP) 37
Elevated alanine aminotransferase (ALT) 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: low death-coded share in the FDA AER row

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.

High-volume nationwide drug peers

Two openFDA-derived peer sets for Dirlotapide, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other drugs by FDA report count (685 here).

What to do with this drug

A report does not prove a drug caused the reaction; consult a veterinarian before acting on this data.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

openFDA Animal & Veterinary Adverse Events (FDA CVM) for Dirlotapide (#240 of 2,679 by report volume); death-coded 2.9%. PlainBreed drug row · report volume stamp 685 · vintage 2025.

Informational only. FDA adverse-event reports are voluntary and do not prove causation; consult a veterinarian before acting on them. Verify with FDA CVM →