Drugs A - Z

Omeprazole Gastro-resistant tablet

It prevents the production of acid in the stomach

Generic Name: omeprazole  |  Brand Name: Prilosec

Brand Names: Prilosec OTC, Prilosec

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 03/02/2011] ISSUE: FDA notified healthcare professionals and the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements. In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.

BACKGROUND: PPIs work by reducing the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.

RECOMMENDATION: Healthcare professionals should consider obtaining serum magnesium levels prior to initiation of prescription PPI treatment in patients expected to be on these drugs for long periods of time, as well as patients who take PPIs with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia. For patients taking digoxin, a heart medicine, this is especially important because low magnesium can increase the likelihood of serious side effects. Healthcare professionals should consider obtaining magnesium levels periodically in these patients. For additional information, refer to the Data Summary section of the FDA Drug Safety Communication. For more information visit the FDA website at: [Web] and [Web].

[Posted 05/25/2010] FDA notified healthcare professionals and patients of revisions to the prescription and over-the-counter [OTC] labels for proton pump inhibitors, which work by reducing the amount of acid in the stomach, to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.

The new safety information is based on FDA's review of several epidemiological studies that found those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. While the greatest increased risk for fractures in these studies involved people who had been taking prescription proton pump inhibitors for at least one year or who had been taking high doses of the prescription medications (not available over-the-counter), as a precaution, the “Drug Facts” label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk. FDA recommends healthcare professionals, when prescribing proton pump inhibitors, should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.

The safety communication includes a data summary with a table and references which support the epidemiological studies reviewed for this communication. For more information visit the FDA website at: [Web] and [Web].

What is this medicine?

OMEPRAZOLE (oh ME pray zol) prevents the production of acid in the stomach. It is used to treat the symptoms of heartburn. You can buy this medicine without a prescription. This product is not for long-term use, unless otherwise directed by your doctor or health care professional.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • black or bloody stools
  • chest pain
  • difficulty swallowing
  • have had heartburn for over 3 months
  • have heartburn with dizziness, lightheadedness or sweating
  • liver disease
  • stomach pain
  • unexplained weight loss
  • vomiting with blood
  • wheezing
  • an unusual or allergic reaction to omeprazole, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the product label. If you are taking this medicine without a prescription, take one tablet every day. Do not use for longer than 14 days or repeat a course of treatment more often than every 4 months unless directed by a doctor or healthcare professional. Take your dose at regular intervals every 24 hours. Swallow the tablet whole with a drink of water. Do not crush, break or chew. This medicine works best if taken on an empty stomach 30 minutes before breakfast. If you are using this medicine with the prescription of your doctor or healthcare professional, follow the directions you were given. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • atazanavir
  • clopidogrel
  • nelfinavir

This medicine may also interact with the following medications:

  • ampicillin
  • certain medicines for anxiety or sleep
  • certain medicines that treat or prevent blood clots like warfarin
  • cyclosporine
  • diazepam
  • digoxin
  • disulfiram
  • iron salts
  • phenytoin
  • prescription medicine for fungal or yeast infection like itraconazole, ketoconazole, voriconazole
  • saquinavir
  • tacrolimus

What should I watch for while using this medicine?

It can take several days before your heartburn gets better. Check with your doctor or health care professional if your condition does not start to get better, or if it gets worse.

Do not treat diarrhea with over the counter products. Contact your doctor if you have diarrhea that lasts more than 2 days or if it is severe and watery.

Do not treat yourself for heartburn with this medicine for more than 14 days in a row. You should only use this medicine for a 2-week treatment period once every 4 months. If your symptoms return shortly after your therapy is complete, or within the 4 month time frame, call your doctor or health care professional.


Last Updated: September 17, 2012
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