Formulary
Esomeprazole: Indications, Dosing, Side Effects and Interactions
For all proton pump inhibitors Proton pump inhibitors inhibit gastric acid secretion by blocking the hydrogen-potassium adenosine triphosphatase enzyme system...
MedNext Academy | 6 min read
Esomeprazole: Indications, Dosing, Side Effects and Interactions
For all proton pump inhibitors Proton pump inhibitors inhibit gastric acid secretion by blocking the hydrogen-potassium adenosine triphosphatase enzyme system...
Drug action
For all proton pump inhibitors Proton pump inhibitors inhibit gastric acid secretion by blocking the hydrogen-potassium adenosine triphosphatase enzyme system (the 'proton pump') of the gastric parietal cell.
Indications and dose
**Peptic ulcer disease**
- **Adult** (By Mouth): 20 mg once daily for 4-8 weeks.
**NSAID-associated gastric ulcer**
- **Adult** (By Mouth): 20 mg once daily for 4-8 weeks.
- **Adult** (By Intravenous Injection, Or By Intravenous Infusion): 20 mg once daily until oral administration possible.
**Prophylaxis of NSAID-associated gastric ulcer in patients with an increased risk of gastroduodenal complications who require continued NSAID treatment**
- **Adult** (By Mouth): 20 mg once daily.
**Prophylaxis of NSAID-associated gastric or duodenal ulcer**
- **Adult** (By Intravenous Injection, Or By Intravenous Infusion): 20 mg once daily until oral administration possible.
**Gastro-oesophageal reflux disease (in the presence of erosive reflux oesophagitis)**
- **Child** (By Mouth): 12-17 years 40 mg once daily for 4 weeks, continued for further 4 weeks if not fully healed or symptoms persist; maintenance 20 mg once daily.
- **Adult** (By Intravenous Injection, Or By Intravenous Infusion): 40 mg once daily until oral administration possible.
**Severe oesophagitis**
- **Adult** (By Mouth): 40 mg once daily for 8 weeks, continue as maintenance treatment if appropriate.
**Severe oesophagitis, refractory to initial treatment**
- **Adult** (By Mouth): 40 mg twice daily.
**Gastro-oesophageal reflux disease (in the absence of oesophagitis)**
- **Child** (By Mouth): 12-17 years 20 mg once daily for up to 4 weeks.
- **Adult** (By Mouth): 20 mg once daily for 4 or 8 weeks, then 20 mg once daily as required.
- **Adult** (By Intravenous Injection, Or By Intravenous Infusion): 20 mg once daily until oral administration possible.
**Uninvestigated dyspepsia**
- **Adult** (By Mouth): 20 mg once daily for 4 weeks.
**Zollinger-Ellison syndrome**
- **Adult** (By Mouth): Initially 40 mg twice daily, to be adjusted according to response; usual dose 80-160 mg per day, doses above 80 mg per day should be given in 2 divided doses.
**Helicobacter pylorieradication [in combination with other drugs]**
- **Adult** (By Mouth): Helicobacter pylori eradication [in combination with other drugs] 20 mg twice daily for 7 days for first- and second-line eradication therapy; 10 days for third-line eradication therapy.
**Gastro-oesophageal reflux disease (in the presence of erosive reflux oesophagitis) for esomeprazole**
- **Child 1-11 years (body-weight 10-19 kg)** (By mouth): 10 mg once daily for 8 weeks.
- **Child 1-11 years (body-weight 20 kg and above)** (By mouth): 10-20 mg once daily for 8 weeks.
- **Child 12-17 years** (By mouth): 40 mg once daily for 4 weeks, continued for further 4 weeks if not fully healed or symptoms persist; maintenance 20 mg once daily.
- **Child 1-11 years (body-weight up to 20 kg)** (By intravenous injection, or by intravenous infusion): 10 mg once daily until oral administration possible.
- **Child 1-11 years (body-weight 20 kg and above)** (By intravenous injection, or by intravenous infusion): 10-20 mg once daily until oral administration possible.
- **Child 12-17 years** (By intravenous injection, or by intravenous infusion): 40 mg once daily until oral administration possible.
**Gastro-oesophageal reflux disease (in the absence of oesophagitis) for esomeprazole**
- **Child 1-11 years (body-weight 10 kg and above)** (By mouth): 10 mg once daily for up to 8 weeks.
- **Child 12-17 years** (By mouth): 20 mg once daily for up to 4 weeks.
- **Child 1-11 years** (By intravenous injection, or by intravenous infusion): 10 mg once daily until oral administration possible.
- **Child 12-17 years** (By intravenous injection, or by intravenous infusion): 20 mg once daily until oral administration possible.
Cautions
For all proton pump inhibitors Can increase the risk of fractures (particularly when used at high doses for over a year in the elderly) (in adults); may increase the risk of gastro-intestinal infections (including Clostridioides difficile infection); may mask the symptoms of gastric cancer (in adults); may reduce absorption of vitamin B 12 with long-term treatment; patients at risk of osteoporosis Cautions, further information Risk of osteoporosis Patients at risk of osteoporosis should maintain an adequate intake of calcium and vitamin D, and if necessary, receive other preventative therapy. Gastric cancer In adults: Particular care is required in those presenting with 'alarm features', in such cases gastric malignancy should be ruled out before treatment. Elderly In adults: Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) criteria to aid medication reviews (see Prescribing in the elderly for information): potentially inappropriate for uncomplicated peptic ulcer disease or erosive peptic oesophagitis at full therapeutic dosage for longer than 8 weeks (dose reduction or earlier discontinuation indicated).
Side effects
For all proton pump inhibitors Common or very common Abdominal pain; constipation; diarrhoea; dizziness; dry mouth; gastrointestinal disorders; headache; insomnia; nausea; skin reactions; vomiting Uncommon Arthralgia; bone fractures; confusion; depression; drowsiness; leucopenia; malaise; myalgia; paraesthesia; peripheral oedema; thrombocytopenia; vertigo; vision disorders Rare or very rare Agranulocytosis; alopecia; gynaecomastia; hallucination; hepatic disorders; hyperhidrosis; hyponatraemia; nephritis tubulointerstitial; pancytopenia; photosensitivity reaction; severe cutaneous adverse reactions (SCARs); stomatitis; taste altered Frequency not known Gastrointestinal infection; hypomagnesaemia (more common after 1 year of treatment, but sometimes after 3 months of treatment); subacute cutaneous lupus erythematosus Side-effects For esomeprazole General side-effects: Rare or very rare Aggression; agitation; bronchospasm; gastrointestinal candidiasis; muscle weakness; renal failure Specific side-effects: Rare or very rare With parenteral use Encephalopathy
Interactions
**Severe interactions:**
- Probenecid Probenecid given concurrently increases naproxen anion plasma levels and extends its plasma half-life significantly.
- In healthy volunteers, concomitant administration of 40 mg esomeprazole resulted in a 32% increase in area under the plasma concentration-time curve (AUC) and a 31% prolongation of elimination...
**Other interactions (57):**
- Contraindications of concomitant use (see section 4.3) Antiretroviral agents Omeprazole, the racemate of D+S omeprazole (esomeprazole), has been reported to interact with some antiretroviral drugs.
- Increased gastric pH during omeprazole treatment may change the absorption of the antiretroviral drug.
- For some antiretroviral drugs, such as atazanavir and nelfinavir, decreased serum levels have been reported when given together with omeprazole.
- Co-administration of omeprazole (40 mg once daily) with atazanavir 300 mg/ritonavir 100 mg to healthy volunteers resulted in a substantial reduction in atazanavir exposure (approximately 75%...
- Increasing the atazanavir dose to 400 mg did not compensate for the impact of omeprazole on atazanavir exposure.
- Co-administration of omeprazole (40 mg qd) reduced mean nelfinavir AUC, C max and C min by 36-39% and mean AUC, C max and C min for the pharmacologically active metabolite M8 was reduced by 75-92%.
Pregnancy
Manufacturer advises caution-no information available.
Breast feeding
Specialist sources indicate use with caution-limited human data available. Likely to be present in milk, but amount probably too small to be harmful.
Hepatic impairment
Manufacturer advises caution in severe impairment. Dose adjustments With oral use in adults: Manufacturer advises max. 20 mg daily in severe impairment. With intravenous use in adults: Manufacturer advises for gastro-oesophageal reflux disease, max. 20 mg daily in severe impairment. With intravenous use in adults: Manufacturer advises for bleeding ulcers, by intravenous infusion, initially 80 mg, then 4 mg/hour for 72 hours in severe impairment. In children: Manufacturer advises in children 1-11 years, max. 10 mg daily in severe impairment. Manufacturer advises in children 12-17 years, max. 20 mg daily in severe impairment.
Renal impairment
Manufacturer advises caution in severe renal insufficiency.
Medicinal forms
Suspension,Tablet,Capsule,Granules,Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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