Drug profile

The FDA adverse-event record for Omeprazole 37% Oral Paste

412 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Omeprazole 37% Oral Paste. See the species affected, top reactions, and outcomes below.

412
adverse-event reports
2.4%
death-coded share
Horse
most-reported species
171
INEFFECTIVE, GASTRIC ULCER(S) - top reaction
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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
412
Total Reports
10
Deaths Reported
2.4%
Death Rate

Active Ingredients

Omeprazole 37% Oral Paste

Administration Routes

OralUnknownOtherTopical

Species Affected

Horse 226
Unknown 179
Human 4
Dog 1
Cat 1
Pig 1

Most Affected Breeds

Unknown 184
Horse (unknown) 58
Thoroughbred 42
Quarter Horse 31
Warmblood - Dutch 15
Hanovarian 12
Paint 7
Standardbred (unspecified) 6
Warmblood (unspecified) 6
Arab 6

Most Reported Reactions

INEFFECTIVE, GASTRIC ULCER(S) 171
Uncoded sign 96
Gastric ulcer 90
Locking Mechanism Abnormal 80
Overdose 48
Gastric ulceration NOS 47
Lack of efficacy - NOS 30
Colic 29
Behavioural disorder NOS 19
Containers, Damaged 18
Other abnormal test result NOS 16
Digestive tract disorder NOS 12

Outcome Breakdown

Outcome Unknown
152 (65.0%)
Recovered/Normal
39 (16.7%)
Ongoing
31 (13.2%)
Euthanized
9 (3.8%)
Recovered with Sequela
2 (0.9%)
Died
1 (0.4%)

Omeprazole 37% Oral Paste Adverse Event Insights

412 reports name Omeprazole 37% Oral Paste; 10 recorded a death outcome (2.4% of reported events, not a population-level mortality rate). Active ingredient: Omeprazole 37% Oral Paste. Administration routes: Oral, Unknown, Other, Topical.

By species: Horse (226 reports), Unknown (179 reports), Human (4 reports). By breed: Unknown (184), Horse (unknown) (58), Thoroughbred (42).

Leading clinical signs: INEFFECTIVE, GASTRIC ULCER(S) (171), Uncoded sign (96), Gastric ulcer (90), Locking Mechanism Abnormal (80). Outcome, 234 coded reports: Outcome Unknown leads at 65.0%.

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.