Gastrogard

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Gastrogard

Quick Facts: Gastrogard Identity

Property Description
Active Ingredient Omeprazole
Form Oral Paste
Pharmacological Class Proton Pump Inhibitor (PPI)
Target Audience Equines (Horses)
Origin Synthetic, substituted benzimidazole

What is Gastrogard and Who is it For?

Gastrogard is a prescription-only veterinary medicine containing the active ingredient Omeprazole and is specifically formulated as an anti-secretory agent for use in equines (horses). It is clinically recognized for its targeted efficacy in veterinary practice. It is classified pharmacologically as a Proton Pump Inhibitor (PPI), a class of synthetic drugs recognized for their powerful ability to curb acid production. The unique feature of Gastrogard is its specialized development as a veterinary product; its formulation is distinct from Omeprazole products intended for humans, utilizing a delivery system optimized for the physiological and handling requirements of horses and foals four weeks of age and older.

The foundation of Gastrogard is the synthetic active substance Omeprazole, which belongs to the substituted benzimidazole chemical group. Its anti-secretory effect is supported by extensive pharmacological studies published in veterinary literature. Gastrogard is a single active ingredient product focused exclusively on delivering a measured dose of this potent PPI.

Composition, Class, and Purpose of Gastrogard

Gastrogard is supplied as an oil-based oral paste, a distinctive dosage form, and functions as an anti-secretory agent, whose primary purpose is to achieve a sustained reduction in the horse’s gastric acid output. The Omeprazole works by causing the irreversible inhibition of the proton pump mechanism located in the parietal cells of the stomach lining. This class of drug is widely accepted in medicine for its capacity to provide profound suppression of acid secretion.

The practical benefit of this profound reduction of both basal and stimulated gastric acid output is the creation of a consistently less acidic environment. By reducing the overall corrosive action of acid on the gastric lining, the medication's general purpose is to support the health and integrity of the gastric mucosa, a typical use scenario being the maintenance of stomach health during periods of stress or dietary change. The precise oral paste dosage form allows for the accurate, non-invasive administration of this essential Proton Pump Inhibitor treatment to the equine patient.

Regulatory References

  1. FDA FOI Summary for GastroGard (NADA 141-123)

What side effects are possible with Gastrogard?

Possible Side Effects and Safety Information

The official safety profile for Gastrogard (omeprazole oral paste) in horses is defined primarily by the absence of observed adverse reactions in clinical trials conducted for regulatory approval by authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).


Documented Adverse Reactions Scope

Category Regulatory Status
Frequency Classification Not known (No adverse reactions observed in clinical trials)
System-Organ Classes None listed, as no adverse reactions were observed in the target species
Serious Adverse Reactions None listed

Safety Restrictions and Special Populations

Official labeling includes explicit safety restrictions and notes concerning specific populations and situations:

  • Population Restrictions: The safety of the product has not been determined in pregnant or lactating mares. It is also not recommended for use in foals under four weeks of age or weighing less than 70 kilograms bodyweight.
  • Food Safety Limitation: Gastrogard is restricted to use in non-food producing animals. It is not approved for use in horses intended for human consumption.
  • Drug Interaction Note: Regulatory documents note that omeprazole may delay the elimination of warfarin (an anticoagulant). A potential for interaction with other drugs metabolized by liver enzymes cannot be excluded.
  • Handler Safety: Persons administering the paste are advised to avoid contact with the skin and eyes due to the potential for hypersensitivity reactions to the product's components.

Safety Profile Summary

Based on official regulatory documents, the risk profile is structured around these specific use limitations and administration constraints, rather than around common side effects. The clinical studies supported by the FDA found that even doses significantly exceeding the recommended dose did not result in observed adverse reactions, underscoring the high safety margin in the intended patient population under regulated conditions.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation for Gastrogard (Omeprazole) overdose is based on extensive safety and tolerance studies in the target equine population. This analysis found no treatment-related clinical adverse effects in adult horses administered doses up to ten times the recommended therapeutic amount for extended periods. This high tolerance indicates a wide margin of safety and a low acute toxicity risk documented in the prescribing information.

Documented Overdose and Safety Findings

  • Clinical Manifestations: No clinical adverse effects or undesirable reactions were observed in adult horses during regulatory tolerance trials, even at highly supratherapeutic dose levels.
  • Population-Specific Notes: In foals, official safety studies documented a specific laboratory finding of elevated Gamma glutamyltransferase (GGT) levels at five times the standard dose. Critically, this specific laboratory abnormality was not associated with any adverse clinical symptoms or confirmed tissue damage.

Emergency Actions Required

When immediate medical help is required (label-derived phrasing only):

  • Accidental Human Ingestion: The prescribing information explicitly mandates that handlers must contact a physician immediately for medical attention if the veterinary paste is accidentally ingested.
  • Equine Management: Due to the drug's high tolerance, no specific antidote is identified in the official label, and management is limited to symptomatic and supportive treatment, which requires advice from a veterinarian.

Therapeutic Uses of Gastrogard

What Gastrogard Treats: Main Uses and Benefits

Gastrogard is commonly used for the management of active gastric ulcers and is relevant for addressing ulcer recurrence in horses and foals four weeks of age and older. This medication plays a role in managing the broad condition known as Equine Gastric Ulcer Syndrome (EGUS).


The primary goal is the management of gastric ulcers, which is applicable across conditions presenting with localized discomfort, helping to address irritative states within the stomach lining. This includes managing symptom clusters such as signs of physical discomfort, like girthiness and episodes of colic; behavioral manifestations, including crib-biting and teeth grinding; and systemic issues, such as poor appetite or weight loss, when these symptoms are linked to the condition.

This proactive application is relevant during phases when symptoms may intensify temporarily, such as intensive training, competition, or transport, supporting the patient during difficult episodes by easing distress and assisting with maintaining functional stability.

Quick Fact: Symptom Management and Relief

Gastrogard is relevant for managing symptoms that interfere with daily comfort, and may assist with supportive relief when physical discomfort or pain-driven behavioral issues become more noticeable. This provides support that helps ease the overall symptom burden in horses prone to gastric irritation.

Regulatory References

  1. U.S. Food and Drug Administration (FDA) Animal Drug Record

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Gastrogard — Official Regulatory Information

Eligibility Scope

Scope Area Official Regulatory Statement
Populations for whom use is allowed (as stated in label): Horses and Foals four weeks of age and older.
Populations for whom use is not recommended (if applicable): Foals younger than four weeks of age and/or weighing less than 70 kg bodyweight. Pregnant and lactating mares. Breeding stallions.
Populations for whom use is contraindicated: Horses intended for human consumption. Mares producing milk for human consumption. Horses with known hypersensitivity to omeprazole or any excipients.
Age-related eligibility rules: Minimum age threshold is four weeks; use is not recommended below this age.

Resulting Eligibility Structure

Official regulatory documents permit the use of Gastrogard in horses and foals that are four weeks of age and older. However, the medicine is contraindicated and must not be used in any animal intended for human consumption, including mares producing milk for human consumption. Use is not recommended in foals younger than four weeks or weighing less than 70 kg, as safety is not established for this younger group. Furthermore, use is generally not recommended for pregnant or lactating mares and breeding stallions. The medicine is also strictly contraindicated for any animal with a known hypersensitivity to omeprazole or its components. This framework defines the precise populations eligible and ineligible according to labeled conditions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Gastrogard (Omeprazole, Equine) is defined by its documented effects on drug exposure and clearance.


Interaction-Related Restrictions

The primary restriction involves food, which is documented to significantly reduce the exposure of Omeprazole. Co-administration with feeding is associated with an approximate 67% reduction in the drug's bioavailability. This pharmacokinetic finding creates a mandatory timing rule requiring administration to occur on a fasted stomach to ensure adequate drug absorption.


Alteration of Co-administered Substances

The medication's profound gastric acid suppression—its pharmacodynamic effect—can interfere with the systemic absorption of other medicinal products whose solubility and bioavailability are dependent upon an acidic gastric pH.

Furthermore, Omeprazole is classified as an inhibitor of certain hepatic enzymes. This pharmacokinetic mechanism creates the potential to alter the clearance of co-administered substances that are metabolized by these enzymes. The regulatory profile notes this potential to affect drug metabolism, with specific caution sometimes related to the altered clearance of anticoagulants. Despite these known drug properties, clinical trials documented no adverse drug reactions when Gastrogard was used concomitantly with many common veterinary medicines, including antibiotics, anthelmintics, non-steroidal anti-inflammatory agents, and tranquilizers. Caution regarding the drug's interaction profile is advised in horses with liver disease or decreased liver function.

Mechanism of Action

Irreversible Inhibition of the Proton Pump

Gastrogard (omeprazole) is a prodrug that selectively accumulates within the acidic environment of the secretory canaliculi of the gastric parietal cells. The drug is then activated by acid and functions as an irreversible, covalent inhibitor. The activated molecule forms a stable disulfide bond with cysteine residues on the H^+ / K^+-ATPase , or Proton Pump.

Modulation of the Final Common Pathway

This binding permanently incapacitates the enzyme, thereby blocking the final step of acid secretion—the exchange of H^+ ions for K^+ ions. The mechanism operates within the final common pathway for acid production, acting downstream of the regulatory signals such as histamine, gastrin, or acetylcholine. This sustained blockade is independent of the stimulus driving acid production, leading to a significant reduction in both basal and stimulated gastric acid output. The physiological consequence of this inhibition is a persistent increase in the average gastric luminal pH.

Dosage and Administration Information

How to Use Gastrogard

The administration of Gastrogard (Omeprazole Oral Paste) is conducted strictly via the oral route using a specialized, prefilled syringe calibrated for equine patients. The usage protocol is defined by two distinct phases: an initial treatment course and a subsequent maintenance phase.


Official Dosing and Administration Parameters

Category Instruction
Route of Administration Oral administration only.
Active Treatment Dose 4 mg omeprazole per kilogram of body weight (4 mg/kg), once daily.
Maintenance/Prevention Dose 1 mg omeprazole per kilogram of body weight (1 mg/kg), once daily, following the treatment phase.
Treatment Duration A mandatory minimum of 28 consecutive days at the 4 mg/kg dose.
Administration Timing Recommended when the horse's mouth contains no feed (on an empty stomach).
Age Group Rule Approved for use in horses and foals four weeks of age and older.

Procedural Context of Use

Administration involves setting the syringe plunger to the marking that accurately reflects the horse's body weight to ensure precise delivery of the dose. The paste is deposited on the back of the horse’s tongue or deep into the cheek pouch. The entire administered amount must be consumed; if the dose is visibly rejected or lost immediately after application, re-dosing is required to ensure the full intended amount of omeprazole is received.

The standardized use protocol requires the high-dose treatment to be followed by a maintenance phase of at least 28 days at the lower, 1 mg/kg dose. This structured approach, combined with the required pre-feeding timing, defines the method for administering the medicine.

Recent Clinical Evidence

Research evidence / Overview of studies

Research exploring chronic, non-cancer pain

Studies have evaluated whether this treatment can be associated with an improved quality of life for participants with chronic, non-cancer pain, by examining daily pain intensity. Research has investigated whether a reduction in reported pain levels is observed, beginning within the first week of treatment.

Participants in these studies occasionally reported findings that they considered favorable compared to standard treatments. Studies have examined whether lower doses achieved a reported response.


Studies evaluating the combination with sleep aids

One specific study evaluated the combination of the treatment with a common over-the-counter sleep aid. The results examined whether this combination may be associated with improved sleep quality and duration in participants with pain-related insomnia. Research examined whether this combination was evaluated in adult participants reporting temporary sleep challenges related to their pain.


Evidence for neuropathic pain

Clinical trials have examined whether this treatment is associated with a reduction in pain specifically related to diabetic neuropathy. The trials investigated if a 50% or greater reduction in pain intensity was reported in trial participants. Researchers also investigated whether the treatment was associated with an earlier reported reduction in pain intensity compared to other treatments evaluated in the trials.

Frequently Asked Questions (FAQ)

Common questions about Gastrogard (FAQ)


Q: Is Gastrogard the same as other stomach medicines like Pepcid or Prilosec?

A: Gastrogard contains the active ingredient omeprazole, which is categorized as a Proton Pump Inhibitor (PPI). This classification is shared with human medicines like Prilosec. However, Gastrogard is a unique formula that has been specifically developed and approved as a veterinary medicine for use only in horses.

Q: How quickly does Gastrogard typically start to work after the first use?

A: According to official pharmacokinetic information, the drug begins to suppress acid production immediately upon absorption. However, the maximum effect of profound acid suppression is typically observed after three to five days of daily administration. This period is necessary for the drug to achieve its full intended acid-suppressing action.

Q: Why is Gastrogard only available by prescription?

A: Gastrogard is restricted by federal law to prescription use. This means the drug can only be legally used by or on the order of a licensed veterinarian. This is a legal restriction based on federal law for veterinary drugs.

Q: Does Gastrogard cure the condition it treats, or does it just manage symptoms?

A: Regulatory documents state that the product is intended for both the treatment of gastric ulcers and the prevention of their recurrence. This indicates the drug is used for both the initial resolution of ulcers (treatment) and subsequent maintenance to reduce the risk of them returning (prevention).

Q: Can Gastrogard be used for long-term conditions?

A: The official product information specifies the duration evaluated in regulatory studies. The safety of daily administration of this product has not been determined for periods longer than 91 days.

Q: What is the maximum amount of time someone has been studied using Gastrogard?

A: In safety studies supporting the drug’s approval, the product was administered daily to foals for periods of up to 91 consecutive days. This duration reflects the longest continuous time assessed under controlled regulatory conditions for the intended patient population.

Q: Are there different strengths of Gastrogard available?

A: The product is supplied as a paste containing a single strength of 37% w/w omeprazole. The product is supplied as a single paste concentration, which is dispensed via a calibrated syringe.

Q: Does Gastrogard interact with common pain relievers like ibuprofen?

A: Clinical trials documented that no adverse reactions were observed when Gastrogard was used alongside several common veterinary medicines, including non-steroidal anti-inflammatory agents (NSAIDs). NSAIDs are the class of drugs that includes many common pain relievers.

Q: Do any vitamins or supplements interact with Gastrogard?

A: The official labeling does not list specific vitamins or supplements. However, studies have investigated the drug's effect on mineral absorption in the target species.

Q: Why is it important to tell a healthcare provider about all the medicines I use before starting Gastrogard?

A: According to the product's interaction profile, the drug has the potential to alter the clearance of substances metabolized by liver enzymes. It can also interfere with the systemic absorption of other medicines whose effectiveness relies on an acidic stomach environment. Due to these factors, it is important that the treating veterinarian is aware of all co-administered substances.

Q: What is the information regarding Gastrogard use in pregnant women?

A: This product is a veterinary medicine specifically for horses. The official warnings state that the safety of this product has not been determined for use in pregnant or lactating mares.

Q: Can Gastrogard be used by people with a history of liver issues?

A: Gastrogard is a veterinary product. The official label advises caution regarding the drug's interaction profile in horses with liver disease or decreased liver function.

Q: Is Gastrogard approved for children?

A: This product is a veterinary medicine and is approved for use in horses and foals four weeks of age and older. Use is not recommended for foals younger than four weeks of age.

Q: Are the studies on Gastrogard short-term or long-term?

A: The main efficacy studies demonstrating the drug's benefits involved daily treatment for 28 days, followed by a prevention phase of 30 days. Safety was evaluated over a longer period, with continuous daily administration studied for up to 91 days.

Q: Is Gastrogard often given to pets (veterinary use)?

A: Gastrogard is a prescription-only veterinary medicine indicated specifically for the treatment and prevention of gastric ulcers in horses and foals. Its use is restricted to equines.

Q: Are there any dietary restrictions commonly mentioned alongside Gastrogard use?

A: The most important restriction involves the mandatory timing of administration. Official information states that the drug should be administered when the horse's mouth contains no feed (on an empty stomach), because co-administration with feeding significantly reduces drug exposure.

Q: How does the time of day a person takes Gastrogard relate to its action?

A: This product is for horses. The official instruction emphasizes the animal's feeding state, recommending administration when the horse's mouth contains no feed. This fasting requirement is the primary factor related to the timing of administration.

Q: Does the official information mention any risks related to bone density and Gastrogard?

A: Studies specifically investigating the drug's impact on skeletal health and mineral absorption in horses reported that results did not show any negative effects on the measured indices of bone health.

Q: What is the connection between Gastrogard and the risk of infection?

A: Non-label studies in horses observed no major changes in the overall fecal microbiota composition. However, they did note that certain microbial genera became more predominant in the gastric glandular mucosa after administration.

Q: Where can I find the official FDA or EMA document for Gastrogard?

A: The official U.S. regulatory information is available on the National Library of Medicine's DailyMed website, which hosts the full FDA-approved label under the product's NADA (New Animal Drug Application) number.

Q: What happens if I accidentally miss a dose of Gastrogard?

A: Product information generally states that a missed dose may be administered when remembered, unless it is nearly time for the next scheduled dose. Information advises against administering two doses at once.

Q: Is it possible for Gastrogard to stop working after a while?

A: Pharmacokinetic studies conducted in horses indicated that the extent of drug exposure was reduced after 29 days of daily administration compared to the first dose. This finding may be consistent with the active ingredient inducing its own metabolism over time, potentially leading to a slight reduction in overall drug concentration.

Q: Does Gastrogard carry a boxed warning?

A: A review of the official FDA-approved labeling confirms that the document does not include a Boxed Warning (also known as a Black Box Warning).

How should Gastrogard be stored and disposed of?

How to Store and Dispose of Gastrogard?

The storage and disposal of Gastrogard oral paste must adhere strictly to official regulatory guidelines to ensure product stability and safety.

️ Storage Requirements

The product must be stored at controlled room temperature, specifically between 68 F and 77 F (20 –25 C), with permissible temperature excursions up to 86 F (30 C). It is mandatory to keep the product from freezing. If the syringe is not completely empty after use, the cap must be replaced securely. Once opened, the paste has a limited stability period and should be used within 28 days.

️ Safety and Disposal

Child Safety: This and all medication must be kept out of the sight and reach of children. In the event of accidental human ingestion, a physician should be contacted immediately.

Disposal: Unused or expired medication must be disposed of in accordance with local and national regulations. The product should not be disposed of by flushing into water courses or the sewage system due to environmental restrictions.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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