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

Recent information suggests a possible increased risk for heart attack and stroke in patients taking Celebrex. The relevance of this information is still not known. Ask your doctor if Celebrex is right for you.

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

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

What is Celebrex?

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

Celebrex is used to reduce pain, inflammation, and stiffness caused by osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Celebrex is also used to reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP), to treat acute pain, and to treat pain associated with menstruation.

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

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

Recent information suggests a possible increased risk for heart attack and stroke in patients taking Celebrex. The relevance of this information is still not known. Ask your doctor if Celebrex is right for you.

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

Before taking Celebrex, tell your doctor if you

smoke;

drink alcohol;

have an ulcer or bleeding in the stomach;

have liver disease;

have kidney disease;

have coronary artery disease (CAD);

have arteriosclerotic disease (hardening of the arteries, clogged or blocked arteries);

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 Celebrex, 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.

Celebrex is in the FDA pregnancy category C. This means that it is not known whether it will harm an unborn baby. Celebrex should not be taken late in pregnancy (the third trimester) because it may affect the formation of the baby's heart. Do not take Celebrex without talking to your doctor first if you are pregnant.

It is not known whether Celebrex passes into breast milk. Do not take Celebrex without talking to your doctor first if you are breast-feeding.

If you are over the age of 65 years, you may be more likely to experience side effects from Celebrex. You may require a lower dosage or special monitoring during your therapy.

How should I take Celebrex?

Take Celebrex exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Celebrex can be taken with or without food or milk. Follow your doctor's instructions.

Your doctor may request you to have blood tests or other medical evaluations during treatment with Celebrex to monitor progress and side effects.

Store Celebrex at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose as directed. Do not take a double dose of this medication unless your doctor directs otherwise.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a Celebrex overdose include drowsiness, vomiting, nausea, stomach pain, dizziness, headache, blurred vision, ringing in the ears, little or no urine production, slow breathing, and coma.

What should I avoid while taking Celebrex?

There are no restrictions on food, beverages, or activity while taking Celebrex unless otherwise directed by your doctor.

What are the possible side effects of Celebrex?

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

If you experience any of the following serious side effects, stop taking Celebrex.