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Brand Name: Vioxx®
Active Ingredient:   rofecoxib
Strength(s): 12.5mg & 25mg tablets or 12.5mg/5ml & 25mg/5ml
Dosage Form(s):   Tablets and oral suspension
Company Name:    Merck & Co., Inc.
Prescription only
*Date Approved by the FDA:   May 21, 2022
*Approval by FDA does not mean that the
drug is available to consumers at this time.

What is Vioxx used for?

Vioxx is used to relieve:

  • Signs and symptoms of osteoarthritis
  • Acute pain in adults
  • Painful menstrual cycles.

Who should not take Vioxx?

You should not take Vioxx if you have experienced asthma, hives, or
allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs
(NSAIDs). A few examples of other NSAIDs are ibuprofen, naproxen, diclofenac, nabumetone,
and ketoprofen.

Special Warnings with Vioxx:

Serious problems from stomach ulcers, such as bleeding, are well-known
complications in people treated with NSAIDs. Similar problems have occurred in people
treated with Vioxx, although very rarely. The likelihood of stomach problems increases the
longer you take drugs like Vioxx. However, even short-term treatment is not without risk.
These problems can happen without any warning, but in some people may cause symptoms such
as gnawing or burning stomach pain, black or tarry stools, or vomiting. If this happens,
stop taking Vioxx and call your health care provider right away.

Check with your health care provider. Vioxx may not be right for you, if you:

  • have had ulcers or stomach bleeding
  • have had asthma, hives, or allergic-type reactions after taking aspirin or other
  • have severe kidney problems
  • have severe liver problems
  • are pregnant

General Precautions with Vioxx:

Do not stop taking any medications that you have been prescribed without first
talking to your doctor.

Serious problems such as liver damage have occurred in people treated with
NSAIDs. Some of the warning signs of liver damage can be nausea, vomiting, fatigue, loss
of appetite, itching, yellow coloring of skin or eyes, "flu-like" symptoms and
dark urine. If you experience any of these symptoms, call your health care provider right

Vioxx can cause your body to retain fluid and swell. Your health care provider
will decide if Vioxx is right for you, if you:

If you have asthma, you may have aspirin-sensitive asthma. If an
aspirin-sensitive asthmatic takes aspirin it can cause severe narrowing of the airway
(bronchospasm), and even death. Since this type of reaction to aspirin and other NSAIDs
have occurred in aspirin-sensitive patients, Vioxx should not be given to
aspirin-sensitive patients.

The safety and effectiveness of Vioxx in patients below the age of 18 years has
not been determined.

What should I tell my doctor or health care provider?

Tell your health care provider if you are trying to become pregnant, are already
pregnant, or are breast-feeding.

Because certain other medications can interact with Vioxx, review all
medications that you are taking with your health care provider, including those that you
take without a prescription.

Your health care provider may have to adjust your dose or monitor you more
closely if you take:

  • certain blood pressure medications called ACE-inhibitors
  • furosemide
  • lithium
  • methotrexate
  • rifampin
  • warfarin
  • aspirin

Avoid taking Vioxx with antacids that contain calcium carbonate and
magnesium/aluminum combination products, because they may reduce the amount of Vioxx your
body absorbs.

What are some possible side effects of Vioxx? (This is NOT
a complete list of side effects reported with Vioxx. Your health care provider can discuss
with you a more complete list of side effects.

Side effects can include:

  • Upper respiratory tract infection
  • Diarrhea
  • Nausea
  • Heartburn
  • Swelling of the lower legs or feet
  • high blood pressure

Rarely, serious ulcers have occurred in patients taking Vioxx.

For more detailed information about Vioxx, ask your health care provider.    Link to
Vioxx’s Labeling 

Updated 10/8/99

Revised 7/11/01

Revised 11/27/02


Back to Drug Side Effects

source: FDA

last update: December 2004

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