Mycophenolate Mofetil

Verify with FDA CVM →

19 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.
19
Total Reports
7
Deaths Reported
3680.0%
Death Rate

Active Ingredients

Mycophenolate Mofetil

Administration Routes

UnknownOral

Species Affected

Dog 17
Human 2

Most Affected Breeds

Retriever - Labrador 5
Unknown 2
Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog) 2
Boxer (German Boxer) 1
Dog (unknown) 1
Corgi (unspecified) 1
Pug 1
Dachshund - Standard Smooth-haired 1
Terrier (unspecified) 1
Crossbred Canine/dog 1

Most Reported Reactions

Leucocytosis NOS 6
Vomiting 6
Immune mediated haemolytic anaemia 6
Lethargy (see also Central nervous system depression in 'Neurological') 5
Diarrhoea 5
Thrombocytopenia 4
Neutrophilia 4
Death by euthanasia 4
Not eating 4
Anorexia 4
Lethargy (see also Central nervous system depression in Neurological) 4
Death 3

Outcome Breakdown

Ongoing
8 (42.1%)
Euthanized
4 (21.1%)
Died
3 (15.8%)
Recovered/Normal
2 (10.5%)
Outcome Unknown
2 (10.5%)

Data Summary

Metric Value
Total adverse event reports 19
Reports involving death 7
Case-fatality rate (reported events) 3680.0%
Distinct species in reports 2
Distinct breeds in reports 13
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.

Mycophenolate Mofetil Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 19 adverse event reports referencing Mycophenolate Mofetil, including 7 reports in which the animal died — a 3680.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Mycophenolate Mofetil. Reported administration routes include Unknown, Oral. 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 Mycophenolate Mofetil reports are Dog (17 reports), Human (2 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (5), Unknown (2), Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog) (2) 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 Mycophenolate Mofetil are Leucocytosis NOS (6), Vomiting (6), Immune mediated haemolytic anaemia (6), Lethargy (see also Central nervous system depression in 'Neurological') (5). Of the 19 reports with a coded outcome, Ongoing is the leading category at 42.1%. 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 Mycophenolate Mofetil.

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