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Roxee Medication Guide

Omeprazole

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Reference complete FDA data linked Rx required Paste Multiple FDA labelers Official label facts Owner quick guide first
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Showing simplified owner view. Switch to Vet View for full technical detail.

Data freshness

Reference facts
Reference refreshed
Jun 22, 2026, 10:41 a.m.

These are the reference facts Roxee uses on browse cards and quick facts.

FDA applications
FDA application data refreshed
Jun 22, 2026, 10:41 a.m.

Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports
Safety data refreshed
Jun 21, 2026, 5:14 a.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Apr 7, 2026, 10:01 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
Image coming soon
Omeprazole

Omeprazole

Drug type: Generic ingredient • Branded profile • FDA branded products available

Both Paste Rx required 100% reference complete

Species: Both

Manufacturer: Multiple FDA labelers

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Omeprazole

Proton pump inhibitor used to reduce stomach acid (ulcers, reflux). Species commonly shown: Both, Horse, Not For Meat Production, Horse, Foals 4 Weeks And Older, Not For Food.

Generic name
Omeprazole
Brand names
GastroGard®, UlcerGard®, Gastrobim™, Omeprazole Sodium
Manufacturer
Multiple FDA labelers
Species
Both, Horse, Foals 4 weeks of age and older
Dosage forms
Paste, Oral paste
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
GastroGard® UlcerGard® Gastrobim™ Omeprazole Sodium Omeprazole Gastrobim AX Pharmaceutical Corp PrimeGuard ULCERGARD GASTROGARD
Dosage forms
Paste Oral paste

Indications / Uses

Proton pump inhibitor used to reduce stomach acid (ulcers, reflux).

Administration / How To Give

Oral

Storage

Store at room temperature.

Warnings / Contraindications

Use caution with liver disease; check interactions with other medications.

  • Use caution with liver disease; check interactions with other medications.

Side Effects

Generally well tolerated; occasional GI upset.

FAQ

Both, Horse, Not For Meat Production, Horse, Foals 4 Weeks And Older, Not For Food, Horse, Foals 4 weeks of age and older

Yes. Roxee shows this as prescription-only.

Paste, Oral paste

Store at room temperature.

Related Medications

Bedinvetmab Same category: Pain & Arthritis Carprofen Same category: Pain & Arthritis Deracoxib Same category: Pain & Arthritis Gabapentin Same category: Pain & Arthritis Grapiprant Same category: Pain & Arthritis Meloxicam Same category: Pain & Arthritis

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

For treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older.

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

  • Use caution with liver disease
  • check interactions with other medications
  • wobbly/unsteady walking (1 reports)
  • Loss of appetite (1 reports)
  • Decreased haematocrit (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

What to tell or ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence
Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Omeprazole; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-047564
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 32 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-047564
Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case USA-USFDACVM-2025-US-047564
Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Unsteady walking (ataxia) (1 reports), Loss of appetite (1 reports), Decreased haematocrit (1 reports), Decreased appetite (1 reports), Death by euthanasia (1 reports)

Body systems represented Signal grouping

Digestive (3), Neurologic (1), Behavior (2), Other (26)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (22 reports), Cat (10 reports)

Breed metadata in reports Metadata only

Chihuahua (1), ['Retriever - Golden', 'Beagle', 'Chow Chow'] (1), Domestic Shorthair (1), Siberian Husky (1). These are report metadata, not proof that a breed is at higher risk.

What your vet may verify

Fit for this patient Vet check

Verify whether Omeprazole fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

Use caution with liver disease, check interactions with other medications, wobbly/unsteady walking, Loss of appetite, Decreased haematocrit

Call sooner if Escalation

Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.

Bottom line: Use this Omeprazole brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA case USA-USFDACVM-2025-US-047564 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. FDA application profile · official_label · quick facts
  5. Medication usage source · fda_animal_drugs · quick facts
  6. FOI · document · documents
  7. SPL · document · documents
  8. FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: February 12, 2026, 7:40 PM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Use caution with liver disease
  • check interactions with other medications
  • wobbly/unsteady walking
  • Loss of appetite
  • Decreased haematocrit

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Loss of appetite (1 reports)
  • Decreased haematocrit (1 reports)
Explore reported case details

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Foals 4 weeks of age and older, Horse
Indication / use
For treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older.
Form / route / dose
Form: Oral paste, Paste
Route: Oral
Confirm product label and patient-specific plan.
Warnings
  • High: Use caution with liver disease; check interactions with other medications.
Adverse-event caveat
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Source docs

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Multiple FDA labelers
Form: Oral paste, Paste
Identifiers:
ANADA: 200842 NADA: 141123 NADA: 141227 NDC Package: 0010-3704-01 NDC Package: 0010-3704-02 NDC Package: 0010-9719-01 NDC Package: 0010-9719-02 NDC Package: 58597-7030-8 NDC Package: 58597-7030-9 NDC Package: 61133-4018-1 NDC Package: 62157-643-01 NDC Package: 62157-807-01 NDC Package: 73309-128-01 NDC Package: 86065-002-01 NDC Package: 86213-221-01 NDC Package: 86213-221-02 NDC Package: 86213-222-01 NDC Package: 86213-222-02 NDC Package: 86213-223-01 NDC Package: 86213-223-02
Source metadata:

Warnings / Contraindications

Use caution with liver disease; check interactions with other medications.

  • High: Use caution with liver disease; check interactions with other medications.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Reported case explorer

Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.

Clear filters
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Stored reports
14
Matching reports
4
Active filters
2
Selected filters
Reaction: Vomiting Clear Body system: Other Clear
Reset
Drill into common report signals
Vomiting (4) Death by euthanasia (3) Lack of efficacy - NOS (3) Dehydration (2) Other (13) Digestive (6) Effectiveness (5) Neurologic (4)
Showing up to 50 matching reports.

USA-USFDACVM-2025-US-072107

Received 2025-12-01 · MSK · MSK

Serious
Species
Dog
Breed
Shepherd Dog - German
Size / weight
50-99 lb (40.1 Kilogram)
Age
8+ years (10.5 Year)
Sex
Male Neutered
Region
USA
Reactions
VocalisationAbnormal tail posturePain NOSWeight lossDecreased appetiteVomitingChewing disorderPantingTremblingLying downAnxietyExcessive chewing, licking and/or groomingMuscle atrophy (see also Muscle wasting)Musculoskeletal disorder NOSAbnormal radiograph findingSpondylosisJoint effusionElevated gamma-glutamyl transferase (GGT)LymphopeniaLethargy (see also Central nervous system depression in Neurological)Thoracic painDeath by euthanasiaMedication error NOS
Body systems
OtherDigestiveBehaviorNeurologic
Outcomes
Euthanized

USA-USFDACVM-2025-US-075298

Received 2025-11-28 · MSK · MSK

Non-serious
Species
Dog
Breed
Dachshund - Miniature
Size / weight
10-24 lb (6.07 Kilogram)
Age
4-7 years (5.25 Year)
Sex
Male Neutered
Region
USA
Reactions
Haemorrhagic gastroenteritisLack of efficacy (endoparasite) - roundworm NOSDiarrhoeaEar infection NOSHypochloraemiaSneezingVomiting
Body systems
OtherEffectivenessDigestive
Outcomes
Ongoing

USA-USFDACVM-2025-US-069774

Received 2025-11-25 · MSK · MSK

Non-serious
Species
Dog
Breed
Dachshund - Miniature
Size / weight
10-24 lb (6.07 Kilogram)
Age
4-7 years (5.25 Year)
Sex
Male Neutered
Region
USA
Reactions
Haemorrhagic gastroenteritisLack of efficacy (endoparasite) - roundworm NOSDiarrhoeaEar infection NOSHypochloraemiaSneezingVomiting
Body systems
OtherEffectivenessDigestive
Outcomes
Ongoing

USA-USFDACVM-2025-US-069596

Received 2025-11-24 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6.2 Kilogram)
Age
8+ years (13 Year)
Sex
Male Neutered
Region
USA
Reactions
Not eatingVomitingCardiac enlargementSplenomegalyAbnormal ultrasound findingHaematuriaPyuriaNon-regenerative anaemiaDecreased haematocritHypokalaemiaBladder distensionDehydrationElevated creatinineNot urinatingIntentional misuseUrinary tract disorder NOS
Body systems
OtherDigestive
Outcomes
Ongoing

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
32
Serious reports
32
Species represented
2
Grouped by Body System
Digestive (3) · Loss of appetite, Decreased appetite, Blood in vomit Neurologic (1) · Unsteady walking (ataxia) Behavior (2) · Behavioral disorder (unspecified), Anxiety Other (26) · Decreased haematocrit, Death by euthanasia, Death
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Dog 1
Digestive 1 Cat 1
Other 1 Cat 1
Digestive 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (22) Cat (10)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Neurologic Dog Serious - 1
Digestive Cat Serious - 1
Other Cat Serious - 1
Digestive Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Digestive Cat Serious - 1
Other Cat Serious - 1
Behavior Dog Serious - 1
Other Dog Serious - 1
Behavior Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Source metadata:

Storage & Handling

Store at room temperature.

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

Gastrobim™ SPL · SPL GastroGard® SPL · SPL UlcerGard® SPL · SPL

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

12

FOI

3

Gastrobim™

SPL · SPL

Open original
FDA Structured Product Label

Gastrobim™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Bimeda Animal Health Ltd.
ANADA
200-842
Status
RX
Form
Oral paste
Route
Oral
Species
Foals 4 weeks of age and older
Composition / specifications
37% w/w omeprazole (370 mg/g)

Horses and foals 4 weeks of age and older

Indication

For treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older.

Dosage

For treatment of gastric ulcers, Gastrobim™ Paste should be administered orally once-a-day for 4 weeks at the recommended dosage of 1.8 mg omeprazole/lb body weight (4 mg/kg). For the prevention of recurrence of gastric ulcers, continue treatment for at least an additional 4 weeks by administering Gastrobim™ Paste at the recommended daily maintenance dose of 0.9 mg/lb (2 mg/kg).

GastroGard®

SPL · SPL

Open original
FDA Structured Product Label

GastroGard®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Boehringer Ingelheim Animal Health USA, Inc.
NADA
141-123
Status
RX
Form
Paste
Route
Oral
Species
Horse
Composition / specifications
Each syringe contains 2.28 g of omeprazole

Horses and Foals (4 Weeks of Age and Older)

Indication
For treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older.
Dosage
For treatment of gastric ulcers, GastroGard Paste should be administered orally once-a-day for 4 weeks at the recommended dosage of 1.8 mg omeprazole/lb body weight (4 mg/kg). For the prevention of recurrence of gastric ulcers, continue treatment for at least an additional 4 weeks by administering GastroGard Paste at the recommended daily maintenance dose of 0.9 mg/lb (2 mg/kg).
Limitations
Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption. The safety of GastroGard Paste has not been determined in pregnant or lactating mares.

UlcerGard®

SPL · SPL

Open original
FDA Structured Product Label

UlcerGard®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Boehringer Ingelheim Animal Health USA, Inc.
NADA
141-227
Status
OTC
Form
Paste
Route
Oral
Species
Horse
Composition / specifications
Each syringe contains 2.28 g of omeprazole

Horses

Indication
For the prevention of gastric ulcers in horses.
Dosage
The minimum recommended dosage is 1 mg/kg per day (0.45 mg/lb) or 1/4 syringe. Horses over 1,200 lb body weight should receive two doses per day.

Gastrobim SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Gastrobim. Use the source link for the full official labeling record.

GASTROGARD SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for GASTROGARD. Use the source link for the full official labeling record.

PrimeGuard SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for PrimeGuard. Use the source link for the full official labeling record.

ULCERGARD SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for ULCERGARD. Use the source link for the full official labeling record.

AX Pharmaceutical Corp SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for AX Pharmaceutical Corp. Use the source link for the full official labeling record.

Omeprazole SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Omeprazole. Use the source link for the full official labeling record.

OMEPRAZOLE SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for OMEPRAZOLE. Use the source link for the full official labeling record.

Omeprazole SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Omeprazole. Use the source link for the full official labeling record.

Omeprazole Sodium SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Omeprazole Sodium. Use the source link for the full official labeling record.

FOI Summary oA 200-842 Approved April 6, 2026.pdf

FOI · FOI

Open original

ucm117173.pdf

FOI · FOI

Open original

ucm118038.pdf

FOI · FOI

Open original
Source metadata:
Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Apr 7, 2026, 10:01 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: AX Pharmaceutical Corp GASTROGARD Gastrobim OMEPRAZOLE Omeprazole Omeprazole Sodium PrimeGuard ULCERGARD
Manufacturer mapping: Multiple FDA labelers
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Foals 4 weeks of age and older, Horse
Rx/OTC: OTC, RX
Form/route: Oral paste, Paste • Oral
Applications: ANADA 200-842 • NADA 141-123 • NADA 141-227
NDC: Packages 0010-3704-01 0010-3704-02 0010-9719-01 0010-9719-02 58597-7030-8 58597-7030-9 • Products 0010 58597 61133 62157 73309 86065
Documents: 3 (FOI: 3) • SPL: 3 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 84 • Cat 29 • View
Case summaries: 14 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • Use caution with liver disease; check interactions with other medications. (Contraindication, High)
Top reaction signals
Unsteady walking (ataxia) (1) Loss of appetite (1) Decreased haematocrit (1) Decreased appetite (1) Death by euthanasia (1) Death (1) Cyanosis (1) Crackles on auscultation (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
ANADA: 200842 NADA: 141123 NADA: 141227 NDC Package: 0010-3704-01 NDC Package: 0010-3704-02 NDC Package: 0010-9719-01 NDC Package: 0010-9719-02 NDC Package: 58597-7030-8 NDC Package: 58597-7030-9 NDC Package: 61133-4018-1 NDC Package: 62157-643-01 NDC Package: 62157-807-01 NDC Package: 73309-128-01 NDC Package: 86065-002-01 NDC Package: 86213-221-01 NDC Package: 86213-221-02 NDC Package: 86213-222-01 NDC Package: 86213-222-02 NDC Package: 86213-223-01 NDC Package: 86213-223-02 NDC Product: 0010 NDC Product: 58597 NDC Product: 61133 NDC Product: 62157
Package NDC Product NDC Form / Route Status
0010-3704-01 0010 -
0010-3704-02 0010 -
0010-9719-01 0010 -
0010-9719-02 0010 -
58597-7030-8 58597 -
58597-7030-9 58597 -
61133-4018-1 61133 -
62157-643-01 62157 -
62157-807-01 62157 -
73309-128-01 73309 -
86065-002-01 86065 -
86213-221-01 86213 -
86213-221-02 86213 -
86213-222-01 86213 -
86213-222-02 86213 -
86213-223-01 86213 -
86213-223-02 86213 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

  • Gastrobim SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • GASTROGARD SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • PrimeGuard SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • ULCERGARD SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • AX Pharmaceutical Corp SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Omeprazole SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • OMEPRAZOLE SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Omeprazole SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Omeprazole Sodium SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • FOI Summary oA 200-842 Approved April 6, 2026.pdf • FOI summary • Official • April 30, 2026
    FDA FOI summary for application 200842
  • ucm118038.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 141227
  • ucm117173.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 141123

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 128 Clinical 4 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Generally well tolerated; occasional GI upset. (Clinical, 2026-04-11)
  • storage_handling: Store at room temperature. (Clinical, 2026-04-12)
  • storage_handling: Store at room temperature. (Clinical, 2026-04-11)
  • storage_handling: Store at room temperature. (Clinical, 2026-02-12)
  • contraindications: Use caution with liver disease; check interactions with other medications. (Official, 2026-04-12)
  • contraindications: Use caution with liver disease; check interactions with other medications. (Official, 2026-04-11)
  • contraindications: Use caution with liver disease; check interactions with other medications. (Official, 2026-02-12)
  • indications: For the prevention of gastric ulcers. For the treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older. (Official, 2026-06-22)
  • indications: For the prevention of gastric ulcers. For the treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older. (Official, 2026-06-22)
  • indications: For the prevention of gastric ulcers. For the treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older. (Official, 2026-06-21)
  • indications: For the prevention of gastric ulcers. For the treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older. (Official, 2026-06-20)
  • indications: For the prevention of gastric ulcers. For the treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older. (Official, 2026-06-13)
  • indications: For the prevention of gastric ulcers. For the treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older. (Official, 2026-06-12)
  • indications: For the prevention of gastric ulcers. For the treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older. (Official, 2026-06-12)
  • indications: For the prevention of gastric ulcers. For the treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older. (Official, 2026-06-11)
  • indications: For the prevention of gastric ulcers. For the treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older. (Official, 2026-06-11)
  • indications: For the prevention of gastric ulcers. For the treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older. (Official, 2026-06-10)
  • indications: For the prevention of gastric ulcers. For the treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older. (Official, 2026-06-09)
  • indications: For the prevention of gastric ulcers. For the treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older. (Official, 2026-06-08)
  • indications: For the prevention of gastric ulcers. For the treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older. (Official, 2026-06-07)
Recent Revisions
  • side_effects updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
Gastrobim™
RX
Omeprazole
Oral paste • Oral
Label highlights
Official documents
Bimeda Animal Health Ltd. ANADA 200-842 Approved Apr 30, 2026
GastroGard®
RX
Omeprazole
Paste • Oral
Label highlights
Official documents
Boehringer Ingelheim Animal Health USA, Inc. NADA 141-123 Approved Jun 1, 2016
UlcerGard®
OTC
Omeprazole
Paste • Oral
Label highlights
Official documents
Boehringer Ingelheim Animal Health USA, Inc. NADA 141-227 Approved Jun 1, 2016

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Foals 4 weeks of age and older
Composition / specifications
37% w/w omeprazole (370 mg/g)
Horses and foals 4 weeks of age and older
Indication

For treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older.

Dosage

For treatment of gastric ulcers, Gastrobim™ Paste should be administered orally once-a-day for 4 weeks at the recommended dosage of 1.8 mg omeprazole/lb body weight (4 mg/kg). For the prevention of recurrence of gastric ulcers, continue treatment for at least an additional 4 weeks by administering Gastrobim™ Paste at the recommended daily maintenance dose of 0.9 mg/lb (2 mg/kg).

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Horse
Composition / specifications
Each syringe contains 2.28 g of omeprazole
Horses and Foals (4 Weeks of Age and Older)
Indication
For treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older.
Dosage
For treatment of gastric ulcers, GastroGard Paste should be administered orally once-a-day for 4 weeks at the recommended dosage of 1.8 mg omeprazole/lb body weight (4 mg/kg). For the prevention of recurrence of gastric ulcers, continue treatment for at least an additional 4 weeks by administering GastroGard Paste at the recommended daily maintenance dose of 0.9 mg/lb (2 mg/kg).
Limitations
Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption. The safety of GastroGard Paste has not been determined in pregnant or lactating mares.

FDA page: Open in Animal Drugs @ FDA

Species: Horse
Composition / specifications
Each syringe contains 2.28 g of omeprazole
Horses
Indication
For the prevention of gastric ulcers in horses.
Dosage
The minimum recommended dosage is 1 mg/kg per day (0.45 mg/lb) or 1/4 syringe. Horses over 1,200 lb body weight should receive two doses per day.
Limitations

FDA page: Open in Animal Drugs @ FDA

Usage

Proton pump inhibitor used to reduce stomach acid (ulcers, reflux).

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Use caution with liver disease; check interactions with other medications.

Side Effects

Generally well tolerated; occasional GI upset.

Source: FDA openFDA • Reference

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Loss of appetite (1) • Cat Decreased appetite (1) • Dog Blood in vomit (1) • Cat

Showing top 5 for Digestive.

Neurologic
Unsteady walking (1) • Dog

Showing top 5 for Neurologic.

Behavior
Behavioral disorder (1) • Dog Anxiety (1) • Dog

Showing top 5 for Behavior.

Other
Decreased haematocrit (1) • Cat Death by euthanasia (1) • Cat Death (1) • Dog Cyanosis (1) • Dog Crackles on auscultation (1) • Dog
Show more (21)
Conjunctivitis (1) • Dog Cognitive disorder NOS (1) • Dog Chewing disorder (1) • Dog Chemosis (1) • Dog Cardiac enlargement (1) • Cat Cardiac arrest (1) • Dog Bumps on skin (1) • Dog Bulging eye (1) • Dog Bladder distension (1) • Cat Apnoea (1) • Dog Angioedema (1) • Dog Anaemia NOS (1) • Cat Allergic reaction (1) • Dog Adipsia (1) • Cat Acute renal failure (1) • Dog Accidental exposure (1) • Dog Abnormal ultrasound finding (1) • Cat Abnormal tail posture (1) • Dog Abnormal radiograph finding (1) • Dog Abnormal histology NOS (1) • Dog Abdominal pain (1) • Cat

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Dog, Chihuahua, Female, 1.5 year, 3.583 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Leucocytosis NOS, Elevated bile acids, Overdose • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075415
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 1.50 Year
  • Weight: 3.583 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Leucocytosis NOS Elevated bile acids Overdose
Outcomes: Ongoing

Dog, ['Retriever - Golden', 'Beagle', 'Chow Chow'], Male, 11 year, 19.504 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Unsteady walking (ataxia), Vestibular disorder NOS, Weight loss, Head tilt - neurological disorder, Low vision… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075189
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 11.00 Year
  • Weight: 19.504 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Unassigned
Reactions Reported:
Unsteady walking (ataxia) Vestibular disorder NOS Weight loss Head tilt - neurological disorder Low vision Urinary incontinence Unable to rise Urinary tract infection Polydipsia Horizontal nystagmus Generalised weakness Depression
Outcomes: Ongoing

Cat, Domestic Shorthair, Male, 13 year, 4.12 kilogram • Drug: MSK, Unknown • Reactions: Vomiting bile, Dehydration, Elevated serum alkaline phosphatase, Elevated blood urea nitrogen, Neutrophilia… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074998
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 13.00 Year
  • Weight: 4.120 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Vomiting bile Dehydration Elevated serum alkaline phosphatase Elevated blood urea nitrogen Neutrophilia Hyperglycaemia Elevated alanine aminotransferase Elevated total bilirubin Hypokalaemia Monocytosis Elevated gamma-glutamyl transferase Eosinophilia Urinary tract infection Unwell Glucosuria
Outcomes: Outcome Unknown

Dog, Siberian Husky, Male, 7 year, 23.587 kilogram • Drug: MSK, Oral, Dose: 1 tablet per dose, Frequency: 12 per hour • Reactions: Bulging eye, Tiredness (lethargy), Tachycardia, Sternoabdominal recumbency, Depression… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075029
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 7.00 Year
  • Weight: 23.587 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Dose: 1 tablet per dose
  • Frequency: 12 per hour
Reactions Reported:
Bulging eye Tiredness (lethargy) Tachycardia Sternoabdominal recumbency Depression Chemosis Allergic reaction Tachypnoea Weakness Pale mucous membrane Overdose
Outcomes: Ongoing

Dog, Poodle - Standard, Female, 2 year, 20.412 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Death by euthanasia, Conjunctivitis, Ulceration NOS, Ear canal erythema, Welt… • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2025-US-072787
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 2.00 Year
  • Weight: 20.412 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Unassigned
Reactions Reported:
Death by euthanasia Conjunctivitis Ulceration NOS Ear canal erythema Welt Bumps on skin Skin inflammation NOS Loss of appetite Pain NOS Difficulty to rise Pyoderma Abnormal histology NOS Seizure NOS Neutropenia Monocytosis Elevated creatinine Thrombocytopenia Hyperkeratosis Itching
Outcomes: Euthanized

Dog, Bulldog - French, Female, 8 year, 12.927 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Tachycardia, Apnoea, Cyanosis, Cardiac arrest, Death… • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-073109
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 8.00 Year
  • Weight: 12.927 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Unassigned
Reactions Reported:
Tachycardia Apnoea Cyanosis Cardiac arrest Death Angioedema
Outcomes: Died

Dog, Terrier - Yorkshire, Female, 13.5 year, 2.8 kilogram • Drug: MSK, Unknown • Reactions: Pale mucous membrane, Laboured breathing, Increased respiratory rate, Crackles on auscultation, Prolonged capillary refill time… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-072177
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 13.50 Year
  • Weight: 2.800 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Pale mucous membrane Laboured breathing Increased respiratory rate Crackles on auscultation Prolonged capillary refill time Other abnormal test result NOS
Outcomes: Ongoing

Dog, Shepherd Dog - German, Male, 10.5 year, 40.1 kilogram • Drug: MSK, Unknown • Reactions: Vocalisation, Abnormal tail posture, Pain NOS, Weight loss, Decreased appetite… • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2025-US-072107
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 10.50 Year
  • Weight: 40.100 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Vocalisation Abnormal tail posture Pain NOS Weight loss Decreased appetite Vomiting Chewing disorder Panting Trembling Lying down Anxiety Excessive chewing, licking and/or grooming Muscle atrophy Musculoskeletal disorder NOS Abnormal radiograph finding Spondylosis Joint effusion Elevated gamma-glutamyl transferase Lymphopenia Tiredness (lethargy) Thoracic pain Death by euthanasia Medication error NOS
Outcomes: Euthanized

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

Store at room temperature.

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