Bextra

(Generic versions may still be available.)

DRUG DESCRIPTION

Valdecoxib is chemically designated as 4-(5-methyl-3-phenyl-4-isoxazolyl) benzenesulfonamide and is a diaryl substituted isoxazole.

The empirical formula for valdecoxib is C16H14N2O3S, and the molecular weight is 314.36. Valdecoxib is a white crystalline powder that is relatively insoluble in water (10 g/mL) at 25 C and pH 7.0, soluble in methanol and ethanol, and freely soluble in organic solvents and alkaline (pH=12) aqueous solutions.

BEXTRA (valdecoxib) Tablets for oral administration contain either 10 mg or 20 mg of valdecoxib. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol, polysorbate 80, and titanium dioxide.

What are the possible side effects of valdecoxib (Bextra)?

Serious skin reactions have occurred in patients taking valdecoxib. These reactions tend to occur within the first two weeks of treatment, but may occur at any time during treatment. Stop taking valdecoxib and contact your doctor immediately if you develop a skin rash; hives; itching; difficulty breathing; swelling of the lips, tongue or face; or other symptoms of an allergic reaction.

Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; bloody vomit; bloody, black, or tarry stools; unexplained weight...

Read All Potential Side Effects and See Pictures of Bextra


Bextra Patient Information Including Side Effects

Brand Names: Bextra

Generic Name: valdecoxib (Pronunciation: val deh COCK sib)

  • What is valdecoxib (Bextra)?
  • What are the possible side effects of valdecoxib (Bextra)?
  • What is the most important information I should know about valdecoxib (Bextra)?
  • What should I discuss with my healthcare provider before taking valdecoxib (Bextra)?
  • How should I take valdecoxib (Bextra)?
  • What happens if I miss a dose (Bextra)?
  • What happens if I overdose (Bextra)?
  • What should I avoid while taking valdecoxib (Bextra)?
  • What other drugs will affect valdecoxib (Bextra)?
  • Where can I get more information?

What is valdecoxib (Bextra)?

Valdecoxib (Bextra) was withdrawn from the U.S. market in 2005.

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

Valdecoxib is used to reduce pain, inflammation, and stiffness caused by osteoarthritis and adult rheumatoid arthritis. Valdecoxib is also used to treat painful menstruation.

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

What are the possible side effects of valdecoxib (Bextra)?

Serious skin reactions have occurred in patients taking valdecoxib. These reactions tend to occur within the first two weeks of treatment, but may occur at any time during treatment. Stop taking valdecoxib and contact your doctor immediately if you develop a skin rash; hives; itching; difficulty breathing; swelling of the lips, tongue or face; or other symptoms of an allergic reaction.

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.

Other, less serious side effects may be more likely to occur. Continue to take valdecoxib and talk to your doctor if you experience

  • diarrhea;
  • nausea or upset stomach; or
  • headache.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What is the most important information I should know about valdecoxib (Bextra)?

Valdecoxib (Bextra) was withdrawn from the U.S. market in 2005.

The manufacturer of valdecoxib (Bextra) has announced the voluntary withdrawal of the drug from the U.S. market. This withdrawal is due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking non-steroidal anti-inflammatory drugs (valdecoxib is a "COX-2" selective non-steroidal anti-inflammatory drug) and safety concerns of an increased risk of rare but serious skin reactions in patients taking valdecoxib.

Do not take valdecoxib 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 celecoxib (Celebrex), 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 valdecoxib.

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.

Serious skin reactions have occurred in patients taking valdecoxib. These reactions tend to occur within the first two weeks of treatment, but may occur at any time during treatment. Stop taking valdecoxib and contact your doctor immediately if you develop a skin rash; hives; itching; difficulty breathing; swelling of the lips, tongue or face; or other symptoms of an allergic reaction.

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