Vioxx

(Generic versions may still be available.)

DRUG DESCRIPTION

VIOXX* (rofecoxib) is described chemically as 4-[4-(methylsulfonyl)phenyl]-3-phenyl-2(5H)-furanone. It has the following chemical structure:

Rofecoxib is a white to off-white to light yellow powder. It is sparingly soluble in acetone, slightly soluble in methanol and isopropyl acetate, very slightly soluble in ethanol, practically insoluble in octanol, and insoluble in water. The empirical formula for rofecoxib is C17H14O4S, and the molecular weight is 314.36.

Each tablet of VIOXX (rofecoxib) for oral administration contains either 12.5 mg, 25 mg, or 50 mg of rofecoxib and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, and yellow ferric oxide. The 50 mg tablets also contain red ferric oxide.

Each 5 mL of the oral suspension contains either 12.5 or 25 mg of rofecoxib and the following inactive ingredients: citric acid (monohydrate), sodium citrate (dihydrate), sorbitol solution, strawberry flavor, xanthan gum, and purified water. Added as preservatives are sodium methylparaben 0.13% and sodium propylparaben 0.02%.

*Registered trademark of MERCK & CO., Inc., Whitehouse Station, New Jersey, USA COPYRIGHT ? MERCK & CO., Inc., 1998, 2002 All rights reserved

What are the possible side effects of rofecoxib (Vioxx)?

Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; blood in your vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of your 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 rofecoxib and seek medical treatment or contact your doctor immediately:

    ...

Read All Potential Side Effects and See Pictures of Vioxx »


Vioxx Patient Information Including Side Effects

Brand Names: Vioxx

Generic Name: rofecoxib (oral) (Pronunciation: row feh COCK sib)

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

What is rofecoxib (Vioxx)?

Rofecoxib (Vioxx) was withdrawn from the U.S. market in 2004.

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

Rofecoxib is used to reduce pain, inflammation, and stiffness caused by osteoarthritis, rheumatoid arthritis and certain forms of juvenile rheumatoid arthritis; to manage acute pain in adults; to treat migraines; and to treat menstrual pain.

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

What are the possible side effects of rofecoxib (Vioxx)?

Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; blood in your vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of your 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 rofecoxib and seek medical treatment or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • abdominal pain, tenderness, or discomfort;
  • bloody, black, or tarry stools;
  • nausea or heartburn;
  • blood in your vomit;
  • unexplained weight gain;
  • swelling or water retention;
  • unusual fatigue or lethargy;
  • a skin rash or itching;
  • yellowing of your skin or eyes;
  • "flu-like" symptoms; or
  • unusual bruising or bleeding.

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

  • dizziness;
  • mild fatigue or weakness; or
  • diarrhea.

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 rofecoxib (Vioxx)?

Rofecoxib (Vioxx) was withdrawn from the U.S. market in 2004.

The manufacturer of rofecoxib (Vioxx) has announced a voluntary withdrawal of the drug from the U.S. and worldwide market. This withdrawal is due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking rofecoxib.

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

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