Celebrex: Warnings

• Serious gastrointestinal toxicity such as bleeding, ulceration, and perforation can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Although celecoxib minimizes the gastrointestinal side effects by selectively inhibiting cyclooxygenase-2; the risk is still present.
• Patients should promptly report skin rash, unexplained weight gain, edema, or the symptoms of gastrointestinal ulceration or bleeding such as stomach pain and black or tarry stools to their physicians.
• Patients who experience nausea, fatigue, lethargy, itching, jaundice (yellow skin or yellow eyes), right-upper-abdominal tenderness, and flu-like symptoms should stop therapy and seek immediate medical attention.

Infants and Children
Safety and efficacy have not been established in children less than 18 years of age.

Adults Over 60
Dosage adjustment is usually not necessary. Nevertheless, use caution in this age group, as older patients are more likely to experience the drug's adverse reactions.

Drug Dependency
This drug is not expected to cause physical or psychological dependence.

Pregnancy Risk Category: C

Pregnancy Warnings
There are no studies with the use of celecoxib in pregnant women. This drug should be used during the first and second trimesters only if the benefits to the mother clearly outweigh the potential risks to the fetus. This drug may cause fetal harm if used in the third trimester or near delivery. Avoid using at those times.

Nursing Mothers
It is not known whether celecoxib is distributed into breast milk. However, celecoxib is excreted in the milk of lactating rats. Because of the risk of potential harm to the nursing infant, avoid using this drug while breastfeeding. If therapy is necessary, avoid breastfeeding while on this drug.

Operating a Vehicle or Heavy Machinery
This drug may produce side effects that impair your mental alertness, such as dizziness or faintness. Avoid driving or operating machinery if you experience such symptoms. In addition, avoid consuming alcohol or other central nervous system depressants while taking this drug, because they may intensify these side effects.

Sun Exposure
This drug may cause a photosensitivity reaction upon overexposure to the sun. Avoid prolonged exposure to the sun, or wear sunblock or protective clothing. If a rash or a bad case of sunburn occurs, call your physician.