GastrobimTM — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

GastrobimTM

Active ingredient

Omeprazole

Application type

ANADA

Sponsor

Bimeda Animal Health Ltd.

Applications on record

1

First published

April 30, 2026

Adverse event reports

Source: openFDA VeDDRA

3,213

Reports mentioning this ingredient

November 9, 2000 – March 25, 2026

671

Classified serious

per reporter assessment

1,467

Lack of expected efficacy

resistance signal

42

Human operator exposure

needle-stick or splash

Not a risk measure. Veterinary adverse event reports are influenced by how many animals are treated, reporting practice and product age. Reports do not establish that the product caused the event, and a single report can cover an entire herd or flock. Attribution here is by active ingredient because the source dataset redacts brand names.

Attributed by active ingredient “OMEPRAZOLE”. Green Book ingredient names and VeDDRA ingredient names do not always agree exactly, so attribution is approximate and labelled as such.

Reported reactions

Source: openFDA VeDDRA

Clinical signs coded in the VICH VeDDRA four-level hierarchy, most frequent first.

Reaction terms reported for this ingredient, by report count.
Reaction (VeDDRA term)	Reports	Relative frequency
Lack of efficacy - NOS	721
INEFFECTIVE, GASTRIC ULCER(S)	640
Partial lack of efficacy	204
Locking Mechanism Abnormal	110
Underfilling, Package	93
Tubes, Leaking	68
Containers, Damaged	66
Tubes, Damaged	48
Difficulty of Use	45
Product syringe issue	44
Suspect counterfeit product	37
Anorexia	28
Appearance, Abnormal	28
Syringe, Abnormal	28
Overdose	27
Product syringe improperly calibrated	25
Product label issues	24
Caps, Abnormal	23
Fever	22
Containers, Abnormal	21

Species affected

Source: openFDA VeDDRA

Horse 1,595 Dog 906 Human 41 Cat 33 Pig 4 Mule 2 Alpaca 1 Llama 1 Cattle 1

Regulatory context

Abbreviated New Animal Drug Application (ANADA). A generic animal drug demonstrating bioequivalence, pharmaceutical equivalence and identical manufacturing criteria to the pioneer application. Veterinary generics have no formal therapeutic-equivalence coding system; they match the pioneer NADA specification instead.

Extra-label use in food-producing animals is governed by the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) and 21 CFR Part 530. It requires a valid veterinarian-client-patient relationship and is prohibited outright for certain drug classes. Withdrawal times are determined by FARAD, not by this index.

Sources for this page

Animal Drugs @ FDA	FDA CVM	Applications, sponsor, status, withdrawal
Animal & Veterinary Events	FDA CVM	VeDDRA adverse event aggregates by active ingredient