Celebrex is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.

Celebrex is used to treat pain or inflammation caused by many conditions such as arthritis, ankylosing spondylitis, and menstrual pain.

Celebrex is used to treat juvenile rheumatoid arthritis in children who are at least 2 years old. It is also used in the treatment of hereditary polyps in the colon.

Celebrex may cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults. You should not take this medicine if you already have bleeding in your stomach or intestines.

Celecoxib can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use Celebrex just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Before taking this medicine

You should not use Celebrex if you are allergic to celecoxib, or if you have:

• an allergy to sulfa drugs; or

• a history of asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• a stomach ulcer, bleeding in your stomach or intestines;

• heart disease, high blood pressure;

• asthma;

• bleeding problems;

• liver or kidney disease; or

• if you smoke or drink alcohol.

If you are pregnant, you should not take Celebrex unless your doctor tells you to. Taking a NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Do not give this medicine to a child without medical advice.

Take Celebrex exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides. Use the lowest dose that is effective in treating your condition.

You may take Celebrex with or without food.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture with water. You may save this applesauce mixture for later use in a refrigerator for up to 6 hours.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Pain:

Acute pain: 400 mg initially, followed by 200 mg if needed on the first day. Then, 200 mg twice daily as needed.

Usual Adult Dose for Dysmenorrhea:

400 mg initially, followed by 200 mg if needed on the first day. Then, 200 mg twice daily as needed.

Usual Adult Dose for Osteoarthritis:

200 mg orally once daily or 100 mg orally twice daily.

Usual Adult Dose for Rheumatoid Arthritis:

100 to 200 mg orally twice daily.

Usual Adult Dose for Familial Adenomatous Polyposis:

400 mg orally twice daily with food.

Usual Adult Dose for Ankylosing Spondylitis:

200 mg orally once daily or 100 mg orally twice daily. If after 6 weeks of therapy no results are observed, a trial dose of 400 mg orally daily may be worthwhile. If no response is seen after 6 weeks, consideration should be given to alternate treatment options.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis:

2 years or older:

10 to less than or equal to 25 kg: 50 mg orally twice daily

Greater than 25 kg: 100 mg orally twice daily

You should not use Celebrex if you are allergic to celecoxib, or if you have:

• an allergy to sulfa drugs; or

• a history of asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• a stomach ulcer, bleeding in your stomach or intestines;

• heart disease, high blood pressure;

• asthma;

• bleeding problems;

• liver or kidney disease; or

• if you smoke or drink alcohol.

If you are pregnant, you should not take Celebrex unless your doctor tells you to. Taking a NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Do not give this medicine to a child without medical advice.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid taking aspirin or other NSAIDs while you are taking Celebrex, unless your doctor tells you to.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to celecoxib (such as aspirin, ibuprofen, ketoprofen, or naproxen).

Get emergency medical help if you have signs of an allergic reaction to Celebrex (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using Celebrex and seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Stop using Celebrex and call your doctor at once if you have:

• the first sign of any skin rash, no matter how mild;

• heart problems - swelling, rapid weight gain, feeling short of breath;

• signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• liver problems - nausea, stomach pain (upper right side), itching, tiredness, dark urine, jaundice (yellowing of the skin or eyes);

• kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common Celebrex side effects may include:

• stomach pain, heartburn, gas, diarrhea, constipation, nausea, vomiting;

• swelling in your hands or feet;

• dizziness; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ask your doctor before using Celebrex if you take an antidepressant, steroid medicine, or medicine to treat or prevent blood clots. Taking certain medicines with an NSAID may increase your risk of a stomach ulcer or bleeding.

Many drugs can interact with celecoxib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

After you take it, Celebrex takes about three hours to reach its peak concentrations. The pain-relieving effects of this medicine should last about 12 hours.

Let your doctor know if you experience any unusual side effects while using Celebrex.

Dosages depend on your medical condition, age, and other factors.

Your healthcare provider will probably put you on the lowest effective dose of Celebrex for the shortest time possible.

Be sure to take this medicine exactly as your doctor prescribes.

Celebrex is sometimes used “off-label” to treat other conditions, including gout (a type of arthritis caused by a buildup of uric acid in the joints), colon polyps (abnormal growths), and fibromatosis (soft tissue tumors).