IMPORTANT SAFETY INFORMATION AND INDICATIONS

All prescription NSAIDs, like CELEBREX, ibuprofen, naproxen, and meloxicam, increase the risk of heart attack or stroke that can lead to death. This may happen early in treatment and may increase with increasing doses of NSAIDs and with longer use of NSAIDs.

CELEBREX should never be used right before or after a heart surgery called “coronary artery bypass graft” (CABG).

Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to do so. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

NSAID medications, like CELEBREX, cause an increased risk of bleeding, ulcers, and tears (perforation) of the esophagus, stomach, and intestines, at any time during treatment, which can occur without warning and may cause death.

Prescription CELEBREX should be used exactly as prescribed at the lowest dose possible and for the shortest time needed.

Do not take CELEBREX if you have had an asthma attack, hives, or other allergic reactions to aspirin, any other NSAID medicine, or certain drugs called sulfonamides.

Before you take CELEBREX, inform your healthcare provider of any medical conditions you may have and of all of the medications you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements, as they may increase the risk for serious side effects. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

Tell your doctor about all of your medical conditions, including if you:

  • have liver or kidney problems
  • have a history of ulcers or bleeding in the stomach or intestines
  • have high blood pressure or heart failure
  • have asthma
  • are pregnant or plan to become pregnant. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 weeks of pregnancy
  • are breastfeeding or plan to breast feed

CELEBREX can cause serious side effects, including:

  • new or worse high blood pressure
  • heart failure
  • liver problems including liver failure
  • kidney problems including kidney failure
  • low red blood cells (anemia)
  • life-threatening allergic reactions
  • life-threatening skin reactions

Other side effects of NSAIDs, including CELEBREX, are stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you have any of the following symptoms: shortness of breath or trouble breathing, chest pain, weakness in one part or side of your body, slurred speech, or swelling of the face or throat. Discontinue CELEBREX at first sign of skin rash, or blisters with fever.

INDICATIONS

CELEBREX is used to treat pain and redness, swelling, and heat (inflammation) from osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis in patients 2 years and older, and ankylosing spondylitis; for the management of acute pain in adults, and for the management of menstrual cramps.

Please see Full Prescribing Information, including Boxed WARNING, and Medication Guide.