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Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Gastroenterology | Family Medicine | Hepatology (Liver, Pancreatic, Gall Bladder)

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Prilosec (omeprazole)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Astra Merck
Approval Status: Approved March 1996
Treatment Area: gastric ulcers

General Information

Prilosec has been approved as a short-term treatment for active benign gastric ulcers.

The first of a class of medications called proton pump inhibitors, Prilosec targets acid production at its source, slowing production of acid from the cells of the stomach lining.

Clinical Results

In clinical trials of subject’s with endoscopically diagnosed gastric ulcer, 85% of subjects with ulcers healed at week eight with Prilosec.

Side Effects

Prilosec is generally well tolerated; side effects, which are usually mild and transient, include headache, diarrhea, abdominal pain, and nausea.

Additional Information

An ulcer is a lesion that forms in the lining of the stomach or the duodenum (the upper part of the small intestine). Recent research shows that most gastric ulcers develop as a result of infection with bacteria called Helicobacter pylori (H. pylori). The bacteria produces substances that weaken the stomach's protective mucus and make the stomach more susceptible to damaging effects of acid and pepsin.

Gastric ulcers are found throughout the stomach, but most commonly along the lesser curvature of the stomach. They tend to be larger in size and carry a higher mortality rate than duodenal ulcers.

About 20 million Americans develop at least one peptic ulcer during their lifetime. Each year, ulcers affect about five million people, with more than one million hospitalized for the condition.

In addition to the indication for gastric ulcers, Prilosec is also used as short-term treatment of duodenal ulcers, erosive esophagitis, and poorly responsive symptomatic gastroesophageal reflux disease. It is also indicated to maintain healing of erosive esophagitis, and for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.