Lomustine

Verify with FDA CVM →

30 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.
30
Total Reports
10
Deaths Reported
3330.0%
Death Rate

Active Ingredients

Lomustine

Administration Routes

UnknownOralIntravenous

Species Affected

Dog 21
Cat 9

Most Affected Breeds

Domestic Shorthair 9
Retriever - Labrador 3
Mountain Dog - Bernese 2
Crossbred Canine/dog 2
Dog (unknown) 2
Chihuahua 2
Terrier - Fox (unspecified) 1
Bulldog - French 1
Pug 1
Portuguese Water Dog 1

Most Reported Reactions

Decreased appetite 7
Death by euthanasia 7
Lack of efficacy - NOS 6
Diarrhoea 6
Lethargy (see also Central nervous system depression in 'Neurological') 6
Behavioural disorder NOS 5
Anorexia 4
Weight loss 4
Elevated serum alkaline phosphatase (SAP) 4
Elevated blood urea nitrogen (BUN) 4
Elevated creatinine 4
Vomiting 3

Outcome Breakdown

Ongoing
10 (33.3%)
Euthanized
7 (23.3%)
Outcome Unknown
6 (20.0%)
Recovered/Normal
4 (13.3%)
Died
3 (10.0%)

Data Summary

Metric Value
Total adverse event reports 30
Reports involving death 10
Case-fatality rate (reported events) 3330.0%
Distinct species in reports 2
Distinct breeds in reports 16
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.

Lomustine Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 30 adverse event reports referencing Lomustine, including 10 reports in which the animal died — a 3330.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Lomustine. Reported administration routes include Unknown, Oral, Intravenous. 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 Lomustine reports are Dog (21 reports), Cat (9 reports), with Dog accounting for the largest share. Within those species, Domestic Shorthair (9), Retriever - Labrador (3), Mountain Dog - Bernese (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 Lomustine are Decreased appetite (7), Death by euthanasia (7), Lack of efficacy - NOS (6), Diarrhoea (6). Of the 30 reports with a coded outcome, Ongoing is the leading category at 33.3%. 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 Lomustine.

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