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The U.S. Food and Drug Administration (FDA) notified healthcare professionals and patients on July 25, 2010, that the labels of both prescription and over-the-counter Prilosec® and other proton pump inhibitors were being revised to include new safety information. Proton pump inhibitors are medications to treat heartburn by reducing the amount of acid produced in the stomach.

The new labels will include a warning that using the drug may increase the risk of fractures of the hip, wrist or spine. The FDA based its new information on a review of several studies that showed that persons who were at greatest risk for these fractures took high doses of the medication for more than a year.

The results of a number of clinical trials involving 3,096 patients world wide, indicated the following Prilosec® side effects occurred in patients:

• Vomiting
• Diarrhea
• Gas
• Headache
• Nausea
• Stomach pain

Prilosec® is sometimes given in combination with antibiotics clarithromycin and amoxicillin. In these situations additional side effects can include:

• Inflammation of the nose
• Sore throat
• A discolored tongue
• A change in taste perception

Long-term use of Prilosec® can lead to severe inflammation of the stomach.

Prilosec® when taken in combination with other drugs can alter the effects of Prilosec®, the effects of the other drugs, or both. You should tell your doctor before  you take Prilosec® if you’re taking:

• Any drugs containing ampicillin
• Cyclosporine
• Diazepam
• Disulfiram
• Iron
• Ketoconazole
• Phenytoin
• Warfarin

Prilosec® Side Effects in Infants

The most common side effects of Prilosec® in infants and toddlers are:

• Colds
• Ear aches
• Diarrhea

Rare side effects in pediatric patients are:

• Liver problems such as jaundice, pale stools and dark urine
• Blood disorders that can result in a serious infection. Parents should watch for high fevers or signs the infant is not well
• Severe skin rashes or mouth ulcers

Long-Term Prilosec® Side Effects

As previously mentioned, Prilosec® may increase the risk of fractures of the hip, wrist and spine. Depending upon the severity of the fracture and how well it heals, Prilosec® might have long-lasting side effects.

If you or someone you love has suffered what you believe is a side effects of Prilosec®, contact our Prilosec® lawyers for information about seeking compensation for your injuries and loss.