Omeprazole

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Omeprazole delayed-release capsules should be taken before eating.
• In the clinical trials, antacids were used concomitantly with omeprazole.
• Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.
• For patients unable to swallow an intact capsule, alternative administration options are available [ See Dosage and Administration (2.8) ].
• Indication Omeprazole Dose Frequency Treatment of Active Duodenal Ulcer ( 2.1 ) 20 mg Once daily for 4 weeks.
• Some patients may require an additional 4 weeks H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence ( 2.2 ) Triple Therapy:
• Omeprazole 20 mg Each drug twice daily for 10 days Amoxicillin 1000 mg Clarithromycin 500 mg Dual Therapy:
• Omeprazole 40 mg Once daily for 14 days Clarithromycin 500 mg Three times daily for 14 days Gastric Ulcer ( 2.3 ) 40 mg Once daily for 4 to 8 weeks GERD ( 2.4 ) 20 mg Once daily for 4 to 8 weeks Maintenance of Healing of Erosive Esophagitis ( 2.5 ) 20 mg Once daily Pathological Hypersecretory Conditions ( 2.6 ) 60 mg (varies with individual patient) Once daily Pediatric Patients (2 to 16 years of age) ( 2.7 ) Weight Dose GERD And Maintenance of Healing of Erosive Esophagitis 10 < 20 kg 10 mg Once daily ≥ 20 kg 20 kg
• 2.1 Short-Term Treatment of Active Duodenal Ulcer The recommended adult oral dose of omeprazole delayed-release capsules are 20 mg once daily.
• Most patients heal within four weeks.
• Some patients may require an additional four weeks of therapy.
• 2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence Triple Therapy (omeprazole/clarithromycin/amoxicillin) The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days.
• In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.
• Dual Therapy (omeprazole/clarithromycin) The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days.
• In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.
• 2.3 Gastric Ulcer The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.
• 2.4 Gastroesophageal Reflux Disease (GERD) The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks.
• The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.
• 2.5 Maintenance of Healing of Erosive Esophagitis The recommended adult oral dose is 20 mg daily. [ See Clinical Studies (14.4) ]
• 2.6 Pathological Hypersecretory Conditions The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient.
• The recommended adult oral starting dose is 60 mg once daily.
• Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated.
• Doses up to 120 mg three times daily have been administered.
• Daily dosages of greater than 80 mg should be administered in divided doses.
• Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.
• 2.7 Pediatric Patients For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:
• Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mg On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for
• adults.
• Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [ See Dosage and Administration (2.8) ].
• 2.8 Alternative Administration Options Omeprazole is available as a delayed-release capsule.
• For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce.
• One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened.
• All of the pellets inside the capsule should be carefully emptied on the applesauce.
• The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets.
• The applesauce used should not be hot and should be soft enough to be swallowed without chewing.
• The pellets should not be chewed or crushed.
• The pellets/applesauce mixture should not be stored for future use.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

Side effects

• Adults: Most common adverse reactions in adults (incidence ≥ 2%) are
• Headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence ( 6 ) Pediatric patients (2 to 16 years of age):
• Safety profile similar to that in
• adults, except that respiratory system events and fever were the most frequently reported reactions in pediatric studies ( 8.4 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex at 1-800-667-4708 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience with Omeprazole Monotherapy Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflects exposure to omeprazole delayed-release capsules in 3096 patients from worldwide clinical trials (465 patients from US studies and 2,631 patients from international studies). Indications clinically studied in US trials included duodenal ulcer, resistant ulcer, and Zollinger-Ellison syndrome. The international clinical trials were double blind and open-label in design. The most common adverse reactions reported (i.e., with an incidence rate ≥ 2%) from omeprazole-treated patients enrolled in these studies included headache (6.9%), abdominal pain (5.2%), nausea (4.0%), diarrhea (3.7%), vomiting (3.2%), and flatulence (2.7%). Additional adverse reactions that were reported with an incidence ≥1% included acid regurgitation (1.9%), upper respiratory infection (1.9%), constipation (1.5%), dizziness (1.5%), rash (1.5%), asthenia (1.3%), back pain (1.1%), and cough (1.1%). The clinical trial safety profile in patients greater than 65 years of age was similar to that in patients 65 years of age or less. The clinical trial safety profile in pediatric patients who received omeprazole delayed-release capsules was similar to that in adult patients. Unique to the pediatric population, however, adverse reactions of the respiratory system were most frequently reported in the 2 to 16 year age group (18.5%). Similarly, accidental injuries were reported frequently in the 2 to 16 year age group (3.8%). [ See Use in Specific Populations (8.4) ] 6.2 Clinical Trials Experience with Omeprazole in Combination Therapy for H. pylori Eradication In clinical trials using either dual therapy with omeprazole and clarithromycin, or triple therapy with omeprazole, clarithromycin, and amoxicillin, no adverse reactions unique to these drug combinations were observed. Adverse reactions observed were limited to those previously reported with omeprazole, clarithromycin, or amoxicillin alone. Dual Therapy (omeprazole/clarithromycin) Adverse reactions observed in controlled clinical trials using combination therapy with omeprazole and clarithromycin (n = 346) that differed from those previously described for omeprazole alone were taste perversion (15%), tongue discoloration (2%), rhinitis (2%), pharyngitis (1%) and flu-syndrome (1%). (For more information on clarithromycin, refer to the clarithromycin prescribing information, Adverse Reactions section). Triple Therapy (omeprazole/clarithromycin/amoxicillin) The most frequent adverse reactions observed in clinical trials using combination therapy with omeprazole, clarithromycin, and amoxicillin (n = 274) were diarrhea (14%), taste perversion (10%), and headache (7%). None of these occurred at a higher frequency than that reported by patients taking antimicrobial agents alone. (For more information on clarithromycin or amoxicillin, refer to the respective prescribing information, Adverse Reactions sections). 6.3 Post-marketing Experience The following adverse reactions have been identified during post-approval use of omeprazole delayed-release capsules. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their actual frequency or establish a causal relationship to drug exposure. Body As a Whole:
• Hypersensitivity reactions including anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, urticaria, (see also Skin below); fever; pain; fatigue; malaise; Cardiovascular:
• Chest pain or angina, tachycardia, bradycardia, palpitations, elevated blood pressure, peripheral edema Endocrine:
• Gynecomastia Gastrointestinal:
• Pancreatitis (some fatal), anorexia, irritable colon, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, stomatitis, abdominal swelling, dry mouth, microscopic colitis. During treatment with omeprazole, gastric fundic gland polyps have been noted rarely. These polyps are benign and appear to be reversible when treatment is discontinued. Gastroduodenal carcinoids have been reported in patients with ZE syndrome on long-term treatment with omeprazole. This finding is believed to be a manifestation of the underlying condition, which is known to be associated with such tumors. Hepatic:
• Liver disease including hepatic failure (some fatal), liver necrosis (some fatal), hepatic encephalopathy hepatocellular disease, cholestatic disease, mixed hepatitis, jaundice, and elevations of liver function tests [ALT, AST, GGT, alkaline phosphatase, and bilirubin] Infections and Infestations:
• Clostridium difficile associated diarrhea Metabolism and Nutritional disorders:
• Hypoglycemia, hypomagnesemia, hyponatremia, weight gain Musculoskeletal:
• Muscle weakness, myalgia, muscle cramps, joint pain, leg pain, bone fracture Nervous System/Psychiatric:
• Psychiatric and sleep disturbances including depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, apathy, somnolence, anxiety, and dream abnormalities; tremors, paresthesia; vertigo Respiratory:
• Epistaxis, pharyngeal pain Skin:
• Severe generalized skin reactions including toxic epidermal necrolysis (some fatal), Stevens-Johnson syndrome, and erythema multiforme; photosensitivity; urticaria; rash; skin inflammation; pruritus; petechiae; purpura; alopecia; dry skin; hyperhidrosis Special Senses:
• Tinnitus, taste perversion Ocular:
• Optic atrophy, anterior ischemic optic neuropathy, optic neuritis, dry eye syndrome, ocular irritation, blurred vision, double vision Urogenital:
• Interstitial nephritis, hematuria, proteinuria, elevated serum creatinine, microscopic pyuria, urinary tract infection, glycosuria, urinary frequency, testicular pain Hematologic:
• Agranulocytosis (some fatal), hemolytic anemia, pancytopenia, neutropenia, anemia, thrombocytopenia, leukopenia, leucocytosis

Quoted from the official label, section “Adverse Reactions”.

Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

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Same active substance

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