Esomeprazole
Proton Pump Inhibitors
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- Drug class
- Proton Pump Inhibitors
- Availability
- Prescription and OTC
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 168
- FDA reports (12 mo)
- 5,805
Overview
Plain-language summary, compiled from the cited regulatory records
Esomeprazole is a medication belonging to the drug class of proton pump inhibitors [1]. It is approved for specific uses in both adults and pediatric patients aged 12 to 17 years [1].
In adults and pediatric patients aged 12 to 17, esomeprazole is indicated for the short-term treatment to heal erosive esophagitis [1]. It is also used for the maintenance of healing of erosive esophagitis in adults [1]. Additionally, esomeprazole is approved for the short-term treatment of heartburn and other symptoms associated with GERD in adults and pediatric patients aged 12 to 17 [1].
There were 5,805 adverse event reports for esomeprazole in the last 12 months [2]. The most frequently reported adverse events include "Drug Ineffective," "Nausea," "Off Label Use," "Diarrhoea," and "Headache" [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 109 | May 29, 2026 |
| CA Canada | Health Canada | 36 | May 28, 2026 |
| US United States | FDA | 22 | February 12, 2026 |
| EU European Union | EMA | 1 | March 2, 2026 |
GBUnited Kingdom· MHRA
109 products
Uses
Esomeprazole gastro-resistant tablets are indicated in adults for: • Gastroesophageal Reflux Disease (GERD) o treatment of erosive reflux esophagitis. v. induced prevention of rebleeding of peptic ulcers. • Treatment of Zollinger Ellison Syndrome Esomeprazole gastro-resistant tablets are indicated in adolescents from the age of 12 years for: Gastroesophageal Reflux Disease (GERD) • treatment of erosive reflux esophagitis
How to take
CACanada· Health Canada
36 products
Uses
e. heartburn and regurgitation) • healing of NSAID*-associated gastric ulcers • reduction of risk of NSAID-associated gastric ulcers • treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome • Helicobacter pylori (H.
pylori) eradication PRO-ESOMEPRAZOLE, in combination with clarithromycin and amoxicillin, is indicated for the treatment of patients with duodenal ulcer disease associated with Helicobacter pylori infection to eradicate the H. pylori and heal ulcers.
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. *Note: Superiority of esomeprazole delayed release tablets over ranitidine 150 mg BID with the use of non-selective NSAIDs was demonstrated. Superiority was not established with the use of COX-2 selective NSAIDs alone due to the small number of patients analyzed in this subgroup (see Table 15).
1 Pediatrics Pediatrics (12 to 17 years of age) PRO-ESOMEPRAZOLE IS NOT RECOMMENDED FOR USE IN CHILDREN UNDER 12 YEARS OF AGE. Based on the data submitted and reviewed by Health Canada, the safety and efficacy of esomeprazole delayed release tablets in pediatric patients has been established.
USUnited States· FDA
22 products
Uses
Uses treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
How to take
EUEuropean Union· EMA
1 product
Uses
g. heartburn and acid regurgitation) in adults.
How to take
Drug interactions
Known interactions involving Esomeprazole. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL002400664 · revised May 29, 2026
- [2]Health Canada (DPD) · 02568314 · revised May 19, 2026
- [3]FDA DailyMed · 034bcbad-f57f-43… · revised February 12, 2026 [PDF]
- [4]European Medicines Agency · EMEA/H/C/002618 · revised March 2, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.