Capromorelin

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897 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.
897
Total Reports
174
Deaths Reported
1940.0%
Death Rate

Active Ingredients

Capromorelin

Administration Routes

OralUnknownOtherOphthalmicTopical

Species Affected

Dog 533
Cat 237
Unknown 120
Human 6
Rabbit 1

Most Affected Breeds

Unknown 126
Domestic Shorthair 117
Dog (unknown) 57
Cat (unknown) 45
Retriever - Labrador 40
Crossbred Canine/dog 33
Chihuahua 25
Shih Tzu 25
Shepherd Dog - German 18
Domestic Mediumhair 18

Most Reported Reactions

Vomiting 135
Lethargy (see also Central nervous system depression in 'Neurological') 122
Death by euthanasia 112
Not eating 94
Lack of efficacy - NOS 90
Hypersalivation 83
Lethargy (see also Central nervous system depression in Neurological) 75
Diarrhoea 74
UNPALATABLE 73
Behavioural disorder NOS 60
Death 59
Bradycardia 58

Outcome Breakdown

Recovered/Normal
270 (34.6%)
Outcome Unknown
221 (28.3%)
Ongoing
112 (14.4%)
Euthanized
111 (14.2%)
Died
64 (8.2%)
Recovered with Sequela
2 (0.3%)

Data Summary

Metric Value
Total adverse event reports 897
Reports involving death 174
Case-fatality rate (reported events) 1940.0%
Distinct species in reports 5
Distinct breeds in reports 20
Distinct reactions reported 20
Active ingredients on file 1

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

Capromorelin Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 897 adverse event reports referencing Capromorelin, including 174 reports in which the animal died — a 1940.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Capromorelin. Reported administration routes include Oral, Unknown, Other, Ophthalmic. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.

The species most frequently named in Capromorelin reports are Dog (533 reports), Cat (237 reports), Unknown (120 reports), with Dog accounting for the largest share. Within those species, Unknown (126), Domestic Shorthair (117), Dog (unknown) (57) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.

The most commonly reported clinical signs associated with Capromorelin are Vomiting (135), Lethargy (see also Central nervous system depression in 'Neurological') (122), Death by euthanasia (112), Not eating (94). Of the 780 reports with a coded outcome, Recovered/Normal is the leading category at 34.6%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Capromorelin.

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

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial