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Prilosec OTC Warnings and Drug Interactions

Warnings

Allergy alert:

Do not use if you are allergic to omeprazole

Do not use if you have:

  • trouble or pain swallowing food, vomiting with blood, or bloody or black stools

  • heartburn with lightheadedness, sweating or dizziness

  • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

  • frequent chest pain

These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have:

  • had heartburn over 3 months. This may be a sign of a more serious condition.

  • frequent wheezing, particularly with heartburn

  • unexplained weight loss

  • nausea or vomiting

  • stomach pain

Ask a doctor or pharmacist before use if you are taking:

  • warfarin, clopidogrel, or cilostazol (blood-thinning medicines)

  • prescription antifungal or anti-yeast medicines

  • diazepam (anxiety medicine)

  • digoxin (heart medicine)

  • tacrolimus or mycophenolate mofetil (immune system medicine)

  • prescription antiretrovirals (medicines for HIV infection)

  • methotrexate (arthritis medicine)

Stop use and ask a doctor if:

  • Your heartburn continues or worsens

  • You need to take this product for more than 14 days

  • You need to take more than 1 course of treatment every 4 months

  • You get diarrhea

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Other Information about Prilosec OTC:

  • Read the directions and warnings before use.

  • Keep the carton. It contains important information.

  • Store at 20-25°C (68-77°F) and protect from moisture.

Prilosec OTC Inactive ingredients:

Glyceryl monostearate, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, paraffin, polyethylene glycol 6000, polysorbate 80, polyvinylpyrrolidone, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate

Prilosec OTC Wildberry Flavor Inactive ingredients:

FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, flavor, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, mica, microcrystalline cellulose, polyethylene glycol 6000, polysorbate 80, polyvinylpyrrolidone, saccharin sodium, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate

Prilosec OTC® in Combination with Other Drugs

Prilosec OTC®, Plavix®†, and Pletal®‡ (clopidogrel and cilostazol): FDA Health Advisory Issued


A public health advisory was issued by the FDA on November 17, 2009 regarding clopidogrel, (marketed as PlavixR) recommending patients avoid the combination of omeprazole with this drug. Subsequently in March, 2010, a potential for interaction was found with cilostazol (marketed as PletalR). Therefore, P&G added this warning to Prilosec OTC’s label as well.


The FDA recommends patients avoid the combination of these drugs because, according to data provided by the makers of Plavix® and Pletal®, omeprazole may reduce the anti-clotting effect of Plavix® and Pletal®. However, the FDA recognizes that when used individually, these products provide significant health benefits.


In 2012, FDA issued a Drug Safety Communication regarding an increased incidence of Clostridium difficile-associated diarrhea with use of proton pump inhibitors (PPI’s). Based on this information, P&G added a diarrhea warning to Prilosec OTC’s labeling indicating that consumers should stop taking the drug and contact their physician.


In 2014, FDA recommended all proton pump inhibitors labeling contain wording to warn consumers that they should seek the advice of a doctor or pharmacist if they are considering taking an OTC PPI while also taking methotrexate or mycophenolate mofetil due to potential drug-drug interactions. Co-administration can lead to methotrexate toxicity or a decrease in effectiveness of mycophenolate mofetil.


When used as directed, Prilosec OTC has a strong safety profile—millions of consumers have tried it since it became available over-the-counter in 2003. However, consistent with the FDA, we encourage our consumers to avoid the combination of omeprazole with the drugs mentioned above unless under the care of their physician.


Individuals should talk to a medical professional before they stop or start taking any medication or if they have additional questions.

Please refer to the FDA drug safety site for more information:

Plavix (Clopidogrel)

Pletal (Cilostazol)

Clostridium difficile-associated diarrhea

Methotrexate

†Plavix is a registered trademark of Sanofi.
‡Pletal is a registered trademark of Otsuka Pharmaceutical Co.

Prilosec OTC tablets are indicated for the treatment of frequent heartburn, which is heartburn that occurs two or more days a week. The label for Prilosec OTC gives specific information for appropriate use to treat frequent heartburn.

Questions? Call 1-800-289-9181.

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