Drug Notebook

FDA Alerts

Special Alerts:

[UPDATE 12/11/2007] FDA informed healthcare professionals of the issuance of the Agency’s follow-up communication regarding its review of safety data for the drugs omeprazole (Prilosec) and esomeprazole (Nexium) that raised concerns about a potential increased risk of heart problems for patients treated with these drugs. The Agency conducted a comprehensive review of the data from two studies that were submitted to FDA. FDA continues to believe that long-term use of omeprazole or esomeprazole is not likely to be associated with an increased risk of heart problems and recommends that healthcare providers continue to prescribe and patients continue to use these products in the manner described in the labeling for the two products. See the “Update of Safety Review” for information regarding the two studies that were reviewed. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Omeprazole and http://www.fda.gov/cder/drug/early_comm/omeprazole_esomepazole_update.htm.

[Posted August 09, 2007] FDA issued an early communication about the ongoing review of new safety data for the proton pump inhibitors, omeprazole (Prilosec) and esomeprazole (Nexium). The new safety data was from two small long-term clinical studies in patients with severe gastroesophageal reflux disease (GERD). In both studies, patients were randomly assigned to receive treatment with a drug (either omeprazole or esomeprazole) or to have surgery to control their GERD.

The results from the study of omeprazole and analyses from an ongoing study of esomeprazole raised concerns that long-term use of omeprazole or esomeprazole may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery. After reviewing these and other data submitted by the company, FDA’s preliminary conclusion at this time, is that collectively, these data do not suggest an increased risk of heart problems for patients treated with omeprazole or esomeprazole. Healthcare providers should not change their prescribing practices and patients should not change their use of these products at this time.

Both drugs are used for the treatment of GERD, esophageal erosions and for maintenance of healing erosions of the esophagus. They are also used for the treatment of ulcers. Omeprazole is also sold over the counter for frequent heartburn. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Omeprazole and http://www.fda.gov/cder/drug/early_comm/omeprazole_esomeprazole.htm.

Media Gallery
Drug Info Tools
Pill Finder
Search by color, shape and markings. click here
Drug Interaction Checker
Check any 2 drugs for interactions. click here
Drug Compare
Compare any two drugs side by side. click here
Healthline Part D Plan Selector Medicare Part D
Medicare's drug plans are subsidized by the US federal government and offered through insurers.
Advertisement
Marketplace
Licensed from
omeprazole
(oh MEP ra zol)

What is omeprazole?
Omeprazole decreases the amount of acid produced in the stomach. Omeprazole is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions caused by excess stomach acid. Omeprazole is also used to promote healing of erosive esophagitis (damage to your esophagus caused by stomach acid). Omeprazole may also be given together with antibiotics to treat gastric ulcer caused by infection with helicobacter pylori (H. pylori). Omeprazole may also be used for other purposes not listed in this medication guide.

Back to Top

What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Omeprazole 10MG CPDR KREMERS URBAN30/$32.99 or 90/$76.98
Omeprazole 20MG CPDR MYLAN90/$63.97 or 180/$119.93
Prilosec 20MG CPDR ASTRAZENECA LP30/$142.98 or 90/$405.95
Prilosec 40MG CPDR ASTRAZENECA LP30/$216.3 or 90/$591.64
Prilosec OTC 20MG Enteric-coated Tablets P & G HEALTH14/$19.99 or 42/$39.97
Prilosec OTC 20MG Enteric-coated Tablets P & G HEALTH28/$21.34 or 84/$64.02
Zegerid 40-1100MG Capsules SANTARUS30/$150.84 or 90/$419.52

Back to Top

What are the possible side effects of omeprazole?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Other less serious side effects are more likely to occur, such as:

  • stomach pain, gas;

  • nausea, vomiting, diarrhea; or

  • headache.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

Back to Top

How should I take omeprazole?
Omeprazole is not for immediate relief of heartburn symptoms. Take this medication exactly as directed on the label, or as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on the medicine label or on your prescription label. Take each dose of omeprazole with a full glass (8 ounces) of water. Omeprazole is usually taken before eating. Follow your doctor's instructions. Do not crush, break, or open a delayed-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

Back to Top

What is the most important information I should know about omeprazole?
Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, dizziness, pain spreading to the arm or shoulder, sweating, nausea or vomiting, and a general ill feeling. Before using this medication, tell your doctor if you are allergic to any drugs, or if you have heart disease or liver disease. You may need a dose adjustment or special tests to safely take this medication. Omeprazole is not for immediate relief of heartburn symptoms.

Back to Top

What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Back to Top

What other drugs will affect omeprazole?
Before taking omeprazole, tell your doctor if you are taking any of the following drugs: a blood thinner such as warfarin (Coumadin); atazanavir (Reyataz); disulfiram (Antabuse); cyclosporine (Gengraf, Neoral, Sandimmune); digoxin (digitalis, Lanoxin); tacrolimus (Prograf); phenytoin (Dilantin); theophylline (TheoBid, Theo-Dur, Theochron, Theolair, Elixophyllin, Slo-Phyllin); fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Nizoral); ampicillin (Omnipen, Principen); iron (Feosol, Mol-Iron, Fergon, Femiron, others); or

Back to Top

Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Omeprazole has been assigned to pregnancy category C by the FDA. Some animal studies have revealed evidence of embryolethality and fetotoxicity. There are no controlled data in human pregnancy. Omeprazole has been used during labor and delivery to prevent Mendelson's syndrome. Omeprazole should only be given during pregnancy when benefit outweighs risk.

Data pertaining to the use of omeprazole during pregnancy are limited. In one study, omeprazole 80 mg was administered orally one time to prevent Mendelson's syndrome in 20 women with uncomplicated pregnancies of at least 36 weeks duration (mean, 38.3 weeks) requiring scheduled Cesarean section. Cesarean section was done approximately 13 to 16 hours after the dose. Omeprazole was undetectable (<20 nmol/l) in umbilical vein samples from 16/20 infants. Omeprazole was undetectable in umbilical artery samples from 10/17 infants. There were no apparent adverse effects in the neonates.

There are no data on the excretion of omeprazole into human milk. Sporadic reports have been received of congenital abnormalities occurring in infants born to women who have received omeprazole during pregnancy. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account he importance of the drug to the mother.

Back to Top

Who should NOT use this medication?

  • Known hypersensitivity to omeprazole, any ingredient in the formulation, or esomeprazole or other substituted benzimidazoles (e.g., lansoprazole, pantoprazole, rabeprazole).

Back to Top

What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include drowsiness, blurred vision, fast heartbeat, nausea, vomiting, sweating, headache, or dry mouth.

Back to Top

What should I discuss with my healthcare provider before taking omeprazole?
Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, dizziness, pain spreading to the arm or shoulder, sweating, nausea or vomiting, and a general ill feeling. Do not use this medication if you are allergic to omeprazole. Before using this medication, tell your doctor if you are allergic to any drugs, or if you have heart disease or liver disease. You may need a dose adjustment or special tests to safely take this medication.

Back to Top

Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

Back to Top

I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

Back to Top

Where can I get more information?
More Information

Back to Top

Back to Top