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Proton Pump Inhibitor (PPI) Pregnancy: A moderate amount of data in pregnant women (300-1000 outcomes) indicates no malformative or foeto/neonatal toxicity and animal studies show no reproductive toxicity, but caution should be exercised when prescribing to pregnant women. Breast-feeding: it is not known whether esomeprazole is excreted in human breast milk and there is insufficient information on effects in newborns/infants - esomeprazole should not be used during breast-feeding.

Esomeprazole

Brand names: Nexium

Esomeprazole is a proton pump inhibitor, the S-enantiomer of omeprazole, used for gastro-oesophageal reflux disease, peptic ulcer disease, Helicobacter pylori eradication and the prevention and treatment 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: 40 mg
Route: Oral
Frequency: Once daily for 4 weeks (treatment of erosive reflux oesophagitis)
Max: Zollinger-Ellison syndrome: doses individually adjusted, majority controlled on 80-160 mg daily; doses above 80 mg daily should be divided and given twice daily
SPC §4.2 gives 40 mg once daily for 4 weeks for erosive reflux oesophagitis, with an additional 4 weeks if oesophagitis has not healed or symptoms persist. Other adult regimens: long-term maintenance of healed oesophagitis 20 mg once daily; symptomatic GORD without oesophagitis 20 mg once daily (on-demand 20 mg once daily when needed - not recommended for symptom control in NSAID-treated patients at risk of ulcers); H. pylori eradication 20 mg with amoxicillin 1 g and clarithromycin 500 mg, all twice daily for 7 days; healing of NSAID-associated gastric ulcers 20 mg once daily for 4-8 weeks; prevention of NSAID-associated gastric/duodenal ulcers in at-risk patients 20 mg once daily; continued treatment after i.v.-induced prevention of peptic ulcer rebleeding 40 mg once daily for 4 weeks; Zollinger-Ellison syndrome initially 40 mg twice daily, then individually adjusted (most patients controlled on 80-160 mg daily; divide doses above 80 mg daily into twice-daily administration). Adolescents from 12 years use the same GORD regimens as adults; for H. pylori duodenal ulcer in this group the SPC gives weight-band combination therapy (30-40 kg: esomeprazole 20 mg + amoxicillin 750 mg + clarithromycin 7.5 mg/kg twice daily for one week; >40 kg: esomeprazole 20 mg + amoxicillin 1 g + clarithromycin 500 mg twice daily for one week) - the per-kg component is clarithromycin, not esomeprazole. Esomeprazole should not be used in children under 12 years (no data). Swallow capsules whole with liquid; do not chew or crush - for swallowing difficulty the capsule may be opened and the pellets dispersed in half a glass of non-carbonated water and taken within 5 minutes. Hepatic impairment: no adjustment in mild-moderate; do not exceed 20 mg in severe. Elderly: no adjustment.

Dose adjustments

Renal

Dose adjustment is not required in impaired renal function; treat patients with severe renal insufficiency with caution owing to limited experience.

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 esomeprazole, to substituted benzimidazoles, or to any of the excipients
  • Concomitant use with nelfinavir

Side effects

  • Headache (common)
  • Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, benign fundic gland polyps (common)
  • Dizziness, paraesthesia, somnolence, insomnia, peripheral oedema (uncommon)
  • Dermatitis, pruritus, rash, urticaria (uncommon); increased liver enzymes (uncommon)
  • Hypomagnesaemia with prolonged use (not known); fracture of hip, wrist or spine (uncommon)
  • Rare/very rare: hypersensitivity reactions including anaphylaxis, hyponatraemia, hepatitis, agranulocytosis, Stevens-Johnson syndrome/TEN/DRESS, interstitial nephritis

Interactions

  • Nelfinavir: must not be used concomitantly (SPC §4.3)
  • Clarithromycin (used in triple therapy) is a potent CYP3A4 inhibitor - consider its contraindications and interactions in patients taking other CYP3A4-metabolised drugs such as cisapride
  • Digoxin and drugs that may cause hypomagnesaemia (e.g. diuretics): consider measuring magnesium before and periodically during prolonged PPI treatment
  • (§4.5 was not included in the fetched bundle - the above are taken from SPC §4.3/§4.4; verify against the full SPC)

Clinical monograph

How it works

It irreversibly inhibits the gastric H+/K+-ATPase (proton pump) in parietal cells, profoundly reducing both basal and stimulated gastric acid secretion.

Prescribing in practice

  • Treatment may mask the symptoms of gastric cancer, so investigate alarm features such as unintended weight loss, dysphagia, vomiting or gastrointestinal bleeding before and during therapy.
  • It inhibits CYP2C19 and can reduce the activation of clopidogrel; long-term use is associated with hypomagnesaemia, increased fracture risk, rebound acid hypersecretion on withdrawal and Clostridioides difficile infection.
  • Use the lowest effective course; consider the risk of subacute cutaneous lupus erythematosus and assess the need for continued long-term therapy periodically.

Monitoring

Consider checking serum magnesium before and during prolonged therapy or with interacting drugs, and reassess the ongoing need for treatment at review.

Counselling the patient

  • Take the dose before food, swallowing the capsule or tablet whole.
  • Report persistent or new symptoms such as difficulty swallowing or unexplained weight loss.
  • Do not stop long-term treatment abruptly without advice as symptoms may rebound.

Evidence & guidelines

Proton pump inhibitor efficacy in acid-related disease is supported by extensive randomised trial evidence and reflected in NICE guidance.

Reference: NICE CG141 Peptic Ulcer; HEAT Study (Lancet 2016); 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.