Drug Notebook

FDA Alerts

    CHF
  • Thiazolidinediones, including rosiglitazone, cause or exacerbate CHF in some patients. Monitor patients for signs and symptoms of CHF (e.g., dyspnea, rapid weight gain, edema) after initiation of therapy and dosage titration. If signs and symptoms of CHF develop, manage disorder according to current standards of care; in addition, consider discontinuance or reduction in dosage of rosiglitazone.
  • Not recommended in patients with symptomatic CHF (NYHA class I or II).
  • Initiation of rosiglitazone in patients with NYHA class III or IV CHF contraindicated. (See Heart Failure and Other Cardiac Effects under Cautions.)

    Myocardial Ischemia
  • Potential risk for myocardial ischemia (e.g., angina, MI); available data on such risk inconclusive. Findings from a meta-analysis of short-term clinical trials (6 months; 42 clinical trials, majority placebo-controlled) indicate the risk of myocardial ischemia is increased in patients receiving rosiglitazone. Data from 3 large long-term clinical trials that compared rosiglitazone with placebo or active comparators did not confirm or exclude this risk.

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rosiglitazone
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What are the possible side effects of rosiglitazone?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using rosiglitazone and call your doctor at once if you have any of these serious side effects:

Less serious side effects may include:

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect rosiglitazone?

You may be more likely to have hyperglycemia (high blood sugar) if you are taking rosiglitazone with other drugs that raise blood sugar. Drugs that can raise blood sugar include:

You may be more likely to have hypoglycemia (low blood sugar) if you are taking rosiglitazone with other drugs that lower blood sugar. Drugs that can lower blood sugar include:

Some medications may interact with rosiglitazone. Tell your doctor if you are using any of the following drugs:

This list is not a complete and there may be other drugs that can interact with rosiglitazone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has additional information about rosiglitazone written for health professionals that you may read.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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