Capromorelin Tartrate

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1,542 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.
1,542
Total Reports
223
Deaths Reported
1450.0%
Death Rate

Active Ingredients

Capromorelin Tartrate

Administration Routes

OralUnknownIntravenousTransdermalCutaneousIntraocularTopicalOphthalmicOther

Species Affected

Dog 769
Cat 476
Unknown 277
Human 17
Ferret 1
Primate 1
Mouse 1

Most Affected Breeds

Unknown 295
Domestic Shorthair 189
Dog (unknown) 146
Cat (unknown) 137
Retriever - Labrador 46
Chihuahua 37
Domestic Longhair 36
Shih Tzu 34
Domestic Mediumhair 33
Crossbred Canine/dog 28

Most Reported Reactions

Lack of efficacy - NOS 258
Vomiting 181
Death by euthanasia 124
Lethargy (see also Central nervous system depression in 'Neurological') 117
UNPALATABLE 117
Hypersalivation 105
Behavioural disorder NOS 99
Death 96
Lethargy (see also Central nervous system depression in Neurological) 94
Diarrhoea 83
Not eating 83
Drooling 68

Outcome Breakdown

Outcome Unknown
509 (40.1%)
Recovered/Normal
269 (21.2%)
Ongoing
267 (21.1%)
Euthanized
123 (9.7%)
Died
100 (7.9%)

Data Summary

Metric Value
Total adverse event reports 1,542
Reports involving death 223
Case-fatality rate (reported events) 1450.0%
Distinct species in reports 7
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 Tartrate Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 1,542 adverse event reports referencing Capromorelin Tartrate, including 223 reports in which the animal died — a 1450.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Capromorelin Tartrate. Reported administration routes include Oral, Unknown, Intravenous, Transdermal. 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 Tartrate reports are Dog (769 reports), Cat (476 reports), Unknown (277 reports), with Dog accounting for the largest share. Within those species, Unknown (295), Domestic Shorthair (189), Dog (unknown) (146) 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 Tartrate are Lack of efficacy - NOS (258), Vomiting (181), Death by euthanasia (124), Lethargy (see also Central nervous system depression in 'Neurological') (117). Of the 1,268 reports with a coded outcome, Outcome Unknown is the leading category at 40.1%. 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 Tartrate.

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