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Roxee Medication Guide
Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
Veterinary professional?
These are the reference facts Roxee uses on browse cards and quick facts.
Sponsor, product, and application records imported from Animal Drugs @ FDA.
openFDA reaction terms and case summaries are supporting evidence, not proof of causality.
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: Multiple FDA labelers
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
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.
Proton pump inhibitor used to reduce stomach acid (ulcers, reflux).
Oral
Store at room temperature.
Use caution with liver disease; check interactions with other medications.
Generally well tolerated; occasional GI upset.
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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:
When to call the vet:
What to tell or ask your vet today:
A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.
Roxee has limited cited overview evidence for Omeprazole; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 28 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.
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.
Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.
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.
Unsteady walking (ataxia) (1 reports), Loss of appetite (1 reports), Conjunctivitis (1 reports), Collapse NOS (1 reports), Cognitive disorder NOS (1 reports)
Digestive (4), Neurologic (1), Behavior (2), Other (25)
Dog (27 reports), Cat (5 reports)
Retriever - Labrador (2), Rottweiler (1), Siberian Husky (1), Shar Pei (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Omeprazole fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.
Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.
Use caution with liver disease, check interactions with other medications, wobbly/unsteady walking, Loss of appetite, Conjunctivitis
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Review status / Updated / Sources
Review status: Clinical reviewer not listed
Updated: February 12, 2026, 7:40 PM UTC
Side effects to monitor:
Most reported reactions:
Emergency warning signs:
Source-backed clinical checkpoints for quick review.
Official label facts first, then secondary summaries. Marketing content is separated below.
Use caution with liver disease; check interactions with other medications.
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.
Received 2026-03-25 · MSK · MSK
Received 2026-03-20 · MSK · MSK
Received 2026-03-19 · MSK · MSK
Received 2026-03-16 · MSK · MSK
Received 2026-03-16 · MSK · MSK
Received 2026-02-24 · MSK · MSK
Received 2025-12-22 · MSK · MSK
Received 2025-12-15 · MSK · MSK
Received 2025-12-15 · MSK · MSK
Received 2025-12-01 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Neurologic | 1 | Dog | 1 | |
| Digestive | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 |
Species coverage: Dog (27) Cat (5)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Neurologic | Dog | Serious | - | 1 | |
| Digestive | 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 | Dog | Serious | - | 1 | |
| Digestive | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Behavior | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Behavior | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | 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 | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 |
Store at room temperature.
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.
Full source previews and metadata remain in the veterinary/professional layer.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
For treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older.
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).
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
FOI · FOI
FOI · FOI
FOI · FOI
Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.
Quick facts and links to official labeling and safety signals.
Diagnosis-code mappings are not available for this medication yet.
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| 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 | - |
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
Every non-trivial field is expected to include provenance and update timestamps.
Official sponsor/proprietary-name/application-status records linked by active ingredient.
| Product | Sponsor | Application | Status | Published |
|---|---|---|---|---|
|
Gastrobim™
RX
Omeprazole
Oral paste
• Oral
|
Bimeda Animal Health Ltd. | ANADA 200-842 | Approved | Apr 30, 2026 |
|
GastroGard®
RX
Omeprazole
Paste
• Oral
|
Boehringer Ingelheim Animal Health USA, Inc. | NADA 141-123 | Approved | Jun 1, 2016 |
|
UlcerGard®
OTC
Omeprazole
Paste
• Oral
|
Boehringer Ingelheim Animal Health USA, Inc. | NADA 141-227 | Approved | Jun 1, 2016 |
Data source: FDA Animal Drugs @ FDA (public search export).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
For treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older.
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).
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
Proton pump inhibitor used to reduce stomach acid (ulcers, reflux).
Source: FDA Animal Drugs @ FDA • Reference
Use caution with liver disease; check interactions with other medications.
Generally well tolerated; occasional GI upset.
Source: FDA openFDA • Reference
De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).
Showing top 5 for Digestive.
Showing top 5 for Neurologic.
Showing top 5 for Behavior.
Showing top 5 for Other.
Data source: FDA openFDA Animal & Veterinary adverse event reports.
These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.
Dog, Retriever - Labrador, Female, 6.75 year, 22.044 kilogram • Drug: MSK, Unknown • Reactions: Not himself/herself, Loss of appetite, Tiredness (lethargy), Anaemia NOS, Thrombocytopenia… • Outcome: Recovered/Normal
Dog, Retriever - Labrador, Male, 10 year, 28.576 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Limping, Limb weakness, Cough, Neurological signs NOS, Wobbliness… • Outcome: Ongoing
Dog, Rottweiler, Male, 10 year, 43.001 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Musculoskeletal disorder NOS, Collapse NOS, Tiredness (lethargy), Unable to walk, Not eating… • Outcome: Died
Dog, Siberian Husky, Male, 15 year, 25.855 kilogram • Drug: MSK, Unknown, Dose: 20 Milligram per animal, Frequency: 12 per hour • Reactions: Neurological signs NOS, Unsteady walking (ataxia), Disorientation, Knuckling, Neutrophilia… • Outcome: Ongoing
Dog, Shar Pei, Female, 11 year, 32.7 kilogram • Drug: MSK, Unknown • Reactions: Arthritis, Decreased appetite, High sodium-potassium ratio, Vomiting, Diarrhea… • Outcome: Recovered/Normal
Cat, Domestic Shorthair, Female, 17 year, 3.5 kilogram • Drug: MSK, Unknown • Reactions: Decreased mean corpuscular volume, Decreased haematocrit, Decreased mean corpuscular haemoglobin concentration, Lack of efficacy - NOS, Iron deficiency anaemia • Outcome: Ongoing
Dog, Portuguese Water Dog, Female, 13.58 year, 18.23 kilogram • Drug: MSK, Unknown • Reactions: Polydipsia, Pacing, Tiredness (lethargy), Disorientation, Gagging… • Outcome: Recovered/Normal
Dog, ['Spaniel - King Charles Cavalier', 'Poodle (unspecified)'], Female, 4 year, 5.4 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Vomiting, Not eating, Dehydration, Quiet, Leukocytosis NOS… • Outcome: Ongoing
Data source: FDA openFDA Animal & Veterinary adverse event reports.
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
Store at room temperature.
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.