Ursodiol

691 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.
691
Total Reports
107
Deaths Reported
1550.0%
Death Rate

Active Ingredients

Ursodiol

Administration Routes

OralUnknownOther

Species Affected

Dog 653
Cat 38

Most Affected Breeds

Retriever - Labrador 75
Crossbred Canine/dog 41
Chihuahua 37
Shih Tzu 26
Domestic Shorthair 26
Beagle 25
Schnauzer - Miniature 22
Sheepdog - Shetland 20
Spitz - German Pomeranian 19
Dog (unknown) 19

Most Reported Reactions

Vomiting 138
Elevated alanine aminotransferase (ALT) 116
Diarrhoea 101
Lethargy (see also Central nervous system depression in 'Neurological') 99
Elevated serum alkaline phosphatase (SAP) 88
Decreased appetite 80
Death by euthanasia 77
Weight loss 65
Elevated total bilirubin 63
Anorexia 61
Abnormal ultrasound finding 58
Other abnormal test result NOS 54

Outcome Breakdown

Ongoing
225 (32.6%)
Outcome Unknown
214 (31.0%)
Recovered/Normal
132 (19.1%)
Euthanized
77 (11.2%)
Died
30 (4.3%)
Recovered with Sequela
12 (1.7%)

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