Pet Recall Facts

Ingredients / Ketoconazole

Ketoconazole: FDA adverse event reports for pets

Reports received through June 26, 2026. Data and limitations.

1,675Total reports
1,627Dog reports
27Cat reports

FDA-approved products with this ingredient (Green Book)

No matching Green Book entry is supplied in this dataset. This alone does not establish regulatory status.

No Green Book record matches this ingredient name. It may be a human medicine used by veterinarians, a compounded product, a supplement or a product regulated by another agency; this alone does not establish regulatory status.

Brand names come only from the Green Book. Brand names in FDA's public report data are masked, so counts cannot be attributed to any brand. Ingredient names in the reports are written many ways; we group them under one ingredient name and count each report once per ingredient (method).

Reports by year received

19981
19991
20011
20031
20051
20061
20072
20091
20102
201110
2012167
2013216
201477
201578
2016157
2017118
201881
201991
202095
202154
202233
202371
2024120
2025215
202681

Species named in reports

Dog1,627
Cat27
Human19
Not given2

Signs reported after Ketoconazole

Vomiting206
Lethargy (see also Central nervous system depression in Neurological)199
Lack of efficacy - NOS172
Other abnormal test result NOS157
Diarrhoea151
Emesis127
Weight loss81
INEFFECTIVE, ATOPY CONTROL74
Anorexia72
Decreased appetite61
Pruritus60
Ataxia58
Gingival hyperplasia56
Not eating56
Elevated alanine aminotransferase (ALT)54
Death by euthanasia53
Emesis (multiple)49
Neutropenia49
Seizure NOS48
Behavioural disorder NOS48
Elevated serum alkaline phosphatase (SAP)46
Death43
Skin lesion NOS42
Anaemia NOS42
Underdose42

Breeds named in reports

Retriever - Labrador208
Dog (unknown)148
Shepherd Dog - German105
Crossbred Canine/dog84
Retriever - Golden80
Shih Tzu77
Pit Bull69
Terrier - West Highland White60
Boxer (German Boxer)49
Bulldog48
Terrier - Bull - American Pit42
Beagle41
Poodle (unspecified)39
Spaniel - Cocker American37
Bulldog - French36

Reported outcomes

Ongoing654
Recovered/Normal499
Outcome Unknown357
Died52
Euthanized51
Recovered with Sequela48

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