ORTHO EVRA Side Effects Information







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	Full US Prescribing Info

Common side effects may occur when you start using ORTHO EVRA, but they tend to decrease over time and may gradually disappear. In clinical trials, the most common side effects women experienced were breast symptoms, a reaction of the site of application, headache, nausea, upper respiratory infection, and menstrual cramps.

The most frequent adverse events leading to discontinuation in 1.0% to 2.4% of women included nausea and/or vomiting, application site reaction, breast symptoms,* headache, and emotional changes.

In addition to these common side effects, serious side effects have been reported. These risks include blood clots, stroke and heart attacks. Please click here for more information.

*Breast symptoms include pain, tenderness, and engorgement.

Important Safety Information
Serious as well as minor side effects have been reported with the use of the Patch. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks and are increased if you smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use the Patch are strongly advised not to smoke. Some women should not use the Patch, including women who have blood clots, certain cancers, a history of heart attack, blood clots, or stroke, as well as those who are or may be pregnant.

Hormones from ORTHO EVRA^® get into the blood stream and are processed by the body differently than hormones from birth control pills. You will be exposed to about 60% more estrogen if you use ORTHO EVRA^® than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen may increase the risk of side effects. The risk of venous thromboembolic events (blood clots in the legs and/or the lungs) may be increased with ORTHO EVRA^® use compared with use of birth control pills. Studies examined the risk of these serious blood clots in women who used either ORTHO EVRA^® or birth control pills containing one of two progestins (levonorgestrel or norgestimate) and 30-35 micrograms of estrogen. Results of these studies ranged from an approximate doubling of risk of serious blood clots to no increase in risk in women using ORTHO EVRA^® compared to women using birth control pills.

You should discuss with your healthcare professional whether ORTHO EVRA^® is a good method of contraception for you. The Patch does not protect against HIV or sexually transmitted diseases.

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This information is intended for use by our customers, patients and healthcare professionals in the United States only. Ortho Women's Health & Urology™, Division of Ortho-McNeil-Janssen Pharmaceuticals recognizes that the Internet is a global communications medium; however, laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The prescribing information included here may not be appropriate for use outside the United States.

Last Modified Mar 14 2008 at 14:47:28 EDT

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