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What is the most important information I should know about rofecoxib?

Rofecoxib (Vioxx) was withdrawn from the U.S. market in 2004.

The manufacturer of rofecoxib (Vioxx) has announced a voluntary withdrawal of the drug from the U.S. and worldwide market. This withdrawal is due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking rofecoxib.

Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; blood in your vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of your skin or eyes;"flu-like" symptoms; or unusual bruising or bleeding. These symptoms could be early signs of dangerous side effects.

What is rofecoxib?

Rofecoxib (Vioxx) was withdrawn from the U.S. market in 2004.

Rofecoxib is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Rofecoxib works by reducing substances that cause inflammation, pain, and fever in the body.

Rofecoxib is used to reduce pain, inflammation, and stiffness caused by osteoarthritis, rheumatoid arthritis and certain forms of juvenile rheumatoid arthritis; to manage acute pain in adults; to treat migraines; and to treat menstrual pain.

Rofecoxib may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking rofecoxib?

The manufacturer of rofecoxib (Vioxx) has announced a voluntary withdrawal of the drug from the U.S. and worldwide market. This withdrawal is due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking rofecoxib.

Do not take rofecoxib without first talking to your doctor if you have experienced asthma, hives, or an allergic reaction after taking aspirin or another NSAID such as ibuprofen (Motrin, Advil, Nuprin), naproxen (Aleve, Naprosyn, Anaprox), ketoprofen (Orudis KT, Orudis, Oruvail), diclofenac (Voltaren, Cataflam), diflunisal (Dolobid), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), tolmetin (Tolectin), celecoxib (Celebrex), valdecoxib (Bextra), or meloxicam (Mobic). You may experience a similar reaction to rofecoxib.

Before taking rofecoxib, tell your doctor if you

• smoke;

• drink alcohol;

• have ever had an ulcer or bleeding in your stomach;

• have liver disease;
• have kidney disease;

• have asthma;

• have congestive heart failure;

• have fluid retention;

• have heart disease;

• have high blood pressure;

• have a coagulation (bleeding) disorder or are taking an anticoagulant (blood thinner) such as warfarin (Coumadin); or

• are taking a steroid medicine such as prednisone (Deltasone and others), methylprednisolone (Medrol and others), prednisolone (Prelone, Pediapred, and others), and others.

You may not be able to take rofecoxib, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions, or are taking any of the medicines, listed above.

Rofecoxib is in the FDA pregnancy category C. This means that it is not known whether it will harm an unborn baby. Rofecoxib should not be taken late in pregnancy (the third trimester) because it may affect the formation of the baby's heart. Do not take rofecoxib without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether rofecoxib passes into breast milk. Do not take rofecoxib without first talking to your doctor if you are breast-feeding. If you are over the age of 65 years, you may be more likely to experience side effects from rofecoxib. You may require a lower dosage or special monitoring during treatment.

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