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Gastroprotective Pregnancy: Omeprazole can be used during pregnancy — results from three prospective epidemiological studies (more than 1000 exposed outcomes) indicate no adverse effects on pregnancy or on the health of the foetus/newborn. Omeprazole is excreted in breast milk but is not likely to influence the child at therapeutic doses.

Omeprazole

Brand names: Losec, Prilosec

Omeprazole is a proton pump inhibitor used for gastro-oesophageal reflux disease, peptic ulcer disease, eradication regimens for Helicobacter pylori and the prevention of NSAID-associated ulcers.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 20 mg once daily
Route: Oral (gastro-resistant formulation)
Frequency: Once daily
Dose by indication (all adults): Active duodenal ulcer — 20 mg once daily; healing usually within two weeks, with a further two weeks if not fully healed; poorly responsive duodenal ulcer — 40 mg once daily, healing usually within four weeks. Prevention of relapse of duodenal ulcer (H. pylori negative or where eradication is not possible) — 20 mg once daily; 10 mg daily may suffice in some patients; on therapy failure increase to 40 mg. Gastric ulcer — 20 mg once daily, healing usually within four weeks (further four weeks if needed); poorly responsive gastric ulcer — 40 mg once daily, healing usually within eight weeks. Prevention of relapse of poorly responsive gastric ulcer — 20 mg once daily, increased to 40 mg once daily if needed. H. pylori eradication in peptic ulcer disease (antibiotic choice per national/regional/local resistance patterns and guidelines): omeprazole 20 mg + clarithromycin 500 mg + amoxicillin 1,000 mg, each twice daily for one week; OR omeprazole 20 mg + clarithromycin 250 mg (alternatively 500 mg) + metronidazole 400 mg (or 500 mg, or tinidazole 500 mg), each twice daily for one week; OR omeprazole 40 mg once daily with amoxicillin 500 mg and metronidazole 400 mg (or 500 mg, or tinidazole 500 mg), both three times a day for one week; therapy may be repeated if the patient remains H. pylori positive. Treatment of NSAID-associated gastric and duodenal ulcers — 20 mg once daily for four weeks (further four weeks if needed). Prevention of NSAID-associated ulcers in patients at risk (age over 60, previous ulcer or upper GI bleeding history) — 20 mg once daily. Reflux oesophagitis — 20 mg once daily for four weeks (further four weeks if needed); severe oesophagitis — 40 mg once daily, healing usually within eight weeks. Long-term management of healed reflux oesophagitis — 10 mg once daily, increased to 20-40 mg once daily if needed. Symptomatic GORD — 20 mg daily; some patients respond to 10 mg daily, so individual dose adjustment should be considered; if symptoms are not controlled after four weeks on 20 mg daily, further investigation is recommended. Zollinger-Ellison syndrome — individually adjusted; recommended initial dose 60 mg daily; over 90% of patients maintained on 20-120 mg daily; when the dose exceeds 80 mg daily it should be divided and given twice daily. Hepatic impairment: the SPC text is truncated in the source bundle at 'In patients with impaired hepatic function a daily dose of 10-20 ...' — verify the full statement against the SPC. Paediatric population (children over 1 year of age and at least 10 kg) — reflux oesophagitis and symptomatic heartburn/acid regurgitation in GORD: age 1 year and over weighing 10-20 kg, 10 mg once daily, increased to 20 mg once daily if needed; age 2 years and over weighing over 20 kg, 20 mg once daily, increased to 40 mg once daily if needed. Treatment time 4-8 weeks for reflux oesophagitis and 2-4 weeks for symptomatic heartburn/acid regurgitation (investigate further if not controlled). Children and adolescents over 4 years of age — duodenal ulcer caused by H. pylori, treatment supervised by a specialist: 15-30 kg, omeprazole 10 mg with amoxicillin 25 mg/kg and clarithromycin 7.5 mg/kg, all twice daily for one week; 31-40 kg, omeprazole 20 mg with amoxicillin 750 mg and clarithromycin 7.5 mg/kg, all twice daily for one week; over 40 kg, omeprazole 20 mg with amoxicillin 1 g and clarithromycin 500 mg, all twice daily for one week. Verify all paediatric dosing against a children's formulary.

Dose adjustments

Renal

Dose adjustment is not needed in patients with impaired renal function.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance, to substituted benzimidazoles, or to any of the excipients
  • Must not be used concomitantly with nelfinavir

Side effects

  • Common (1-10%): headache
  • Common: abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, benign fundic gland polyps
  • Uncommon: dizziness, paraesthesia, somnolence, insomnia, vertigo; increased liver enzymes
  • Uncommon: dermatitis, pruritus, rash, urticaria; fracture of the hip, wrist or spine
  • Not known: hypomagnesaemia (may result in hypocalcaemia and be associated with hypokalaemia); microscopic colitis
  • Rare/very rare: severe cutaneous adverse reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, AGEP), hypersensitivity reactions including anaphylaxis, tubulointerstitial nephritis, hepatitis, agranulocytosis/pancytopenia

Interactions

  • Nelfinavir — concomitant use is contraindicated (§4.3)
  • Atazanavir — co-administration with proton pump inhibitors is not recommended; if judged unavoidable, close clinical monitoring with atazanavir increased to 400 mg plus ritonavir 100 mg, and omeprazole 20 mg should not be exceeded (§4.4)
  • Clopidogrel — an interaction is observed with omeprazole; clinical relevance uncertain, but as a precaution concomitant use should be discouraged (§4.4)
  • Omeprazole is a CYP2C19 inhibitor — consider the potential for interactions with drugs metabolised through CYP2C19 when starting or stopping omeprazole (§4.4)
  • Digoxin and drugs that may cause hypomagnesaemia (e.g. diuretics) — consider measuring magnesium levels before and periodically during prolonged PPI treatment (§4.4)
  • May reduce absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria on long-term therapy (§4.4)

Clinical monograph

How it works

It irreversibly inhibits the H+/K+-ATPase (proton pump) on the luminal surface of gastric parietal cells, markedly reducing both basal and stimulated gastric acid secretion.

Prescribing in practice

  • Long-term or high-dose use is associated with hypomagnesaemia, an increased risk of fractures and a small increased risk of Clostridioides difficile and other enteric infections; review the indication periodically and use the lowest effective dose.
  • It is a CYP2C19 inhibitor and can raise levels of interacting drugs; co-prescription with clopidogrel may reduce clopidogrel's antiplatelet effect.
  • Acid suppression can mask the symptoms of gastric malignancy, so investigate alarm features before and during treatment.

Monitoring

Check serum magnesium before and periodically during prolonged therapy, and review the ongoing need for treatment at regular intervals.

Counselling the patient

  • Take before food, typically in the morning, and swallow capsules whole.
  • Report new diarrhoea, muscle cramps or unexplained tiredness, which may indicate infection or low magnesium.
  • Do not stop abruptly after long-term use without discussing a step-down with your prescriber.

Evidence & guidelines

Proton pump inhibitor efficacy in acid-related disease is well established and reflected in NICE dyspepsia and GORD guidance.

Reference: NICE CG184 GORD; NICE NG12 H. pylori; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.