Mitotane

41 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.
41
Total Reports
4
Deaths Reported
980.0%
Death Rate

Active Ingredients

Mitotane

Administration Routes

OralUnknown

Species Affected

Dog 41

Most Affected Breeds

Schnauzer (unspecified) 3
Lhasa Apso 3
Terrier - Yorkshire 3
Crossbred Canine/dog 3
Dog (unknown) 2
Shepherd Dog - German 2
Dachshund (unspecified) 2
Boxer (German Boxer) 2
Poodle - Miniature 2
Mastiff 2

Most Reported Reactions

Lethargy (see also Central nervous system depression in 'Neurological') 8
Elevated serum alkaline phosphatase (SAP) 7
Weight loss 6
Diarrhoea 6
Hypoadrenocorticism 6
Elevated alanine aminotransferase (ALT) 6
Seizure NOS 5
Underdose 4
Abnormal adrenocorticotropic hormone (ACTH) stimulation test 4
Pancreatitis 4
Decreased appetite 4
INEFFECTIVE, CUSHINGS 3

Outcome Breakdown

Outcome Unknown
15 (36.6%)
Ongoing
13 (31.7%)
Recovered/Normal
7 (17.1%)
Euthanized
3 (7.3%)
Recovered with Sequela
2 (4.9%)
Died
1 (2.4%)

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