ATC codes: A02BC01
Gastro-oesophageal reflux disease ICD11 code: DA22.Z
Medicine type
Chemical agent
List type
Oral > Liquid: 20 mg powder for oral liquid ; 40 mg powder for oral liquid
Oral > Solid: 10 mg ; 20 mg ; 40 mg
EML status history
First added in 2009 (TRS 958)
Also recommended for children
Therapeutic alternatives
Medicines within the same pharmacological class can be used
Patent information
Patents have expired in most jurisdictions
Summary of evidence and Expert Committee recommendations
An application proposed the addition of omeprazole as a representative of proton pump inhibitors (PPIs) in the core Model List. Comments in support were received from MSF, which also requested the retention of antacids int he core Model List. The Committee noted the public health need for PPIs in the effective treatment of Helicobacter pylori, prevention of gastric cancer and various other conditions, and that PPIs are recommended by the American College of Gastroenterology Practice Guidelines for Dyspepsia, and the British National Health Service (NHS) guidelines. the Committee noted the evidence provided in the application (based on the National Institute for Clinical and Public Health Excellence Guidelines) and the additional Cochrane systematic reviews identified by the Secretariat, of greater efficacy of PPIs than other therapies for gastro-oesophageal reflux, dyspepsia, and upper gastrointestinal tract bleeding in control of symptoms and inflammation. The same reviews established the comparability of the efficacy of other PPIs with that of omeprazole. The Committee noted that the safety profile of omeprazole is acceptable for short-term use and that there have been case reports of rare toxic hepatitis and acute intestinal nephritis. In the long term, PPIs interfere with calcium absorption resulting in increased prevalence of hip fractures (1), and also increase susceptibility to gastrointestinal and respiratory infections. The minimum effective dose is recommended for long-term use. The committee accepted that the cost per dose of omeprazole is similar to that of histamine-2 receptor antagonists, making PPIs more cost-effective. The Committee recommended the inclusion of omeprazole as a representative PPI in the core Model List. It recommended a review of antacids and histamine-2 receptor antagonists to assess their continued usefulness relative to PPIs in the Model List and a review of treatment regimens for H. pylori infections. Reference: 1. Cote GA, Howden CW. Potential adverse effects of proton pump inhibitors. Current Gastroenterology Reports, 2008, 10:208–214.