Pet Recall Facts

Ingredients / Omeprazole

Omeprazole: FDA adverse event reports for pets

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

3,820Total reports
934Dog reports
36Cat reports

FDA-approved products with this ingredient (Green Book)

All approved products with this ingredient, for any species.

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

20001
20012
20026
20035
200426
200539
200654
200745
200878
200960
201039
201131
201298
2013110
201495
201580
2016148
2017173
2018145
2019170
2020210
2021223
2022225
2023321
2024515
2025550
2026371

Species named in reports

Horse1,932
Dog934
Not given862
Human45
Cat36
Pig5
Mule3
Alpaca1

Signs reported after Omeprazole

Lack of efficacy - NOS945
INEFFECTIVE, GASTRIC ULCER(S)811
Vomiting297
Lethargy (see also Central nervous system depression in Neurological)288
Diarrhoea225
Partial lack of efficacy223
Locking Mechanism Abnormal188
Death by euthanasia167
Anorexia165
Other abnormal test result NOS149
Decreased appetite128
Not eating116
Weight loss112
Elevated alanine aminotransferase (ALT)110
Gastric ulcer105
Underfilling, Package99
Overdose99
Uncoded sign96
Elevated serum alkaline phosphatase (SAP)87
Containers, Damaged84
Neutrophilia83
Fever82
Behavioural disorder NOS82
Tubes, Leaking80
Anaemia NOS78

Breeds named in reports

Quarter Horse415
Thoroughbred350
Horse (unknown)346
Warmblood (unspecified)210
Retriever - Labrador149
Dog (unknown)115
Arab71
Retriever - Golden64
Paint51
Poodle (unspecified)48
Hanovarian47
Crossbred Canine/dog45
Warmblood - Dutch44
Shepherd Dog - German42
Horse (other)32

Reported outcomes

Outcome Unknown1,009
Ongoing974
Recovered/Normal560
Euthanized167
Died80
Recovered with Sequela15

Report a problem to FDA