Drug Notebook

FDA Alerts

    Toxicity
  • Highly toxic drug with a low therapeutic index.
  • Possible severe, sometimes life-threatening or fatal, adverse effects.
    Limit to Qualified Personnel
  • Administer only under supervision of qualified clinicians experienced in use of cytotoxic therapy. (See Adequate Patient Evaluation and Monitoring under Cautions.)
    Carcinogenicity
  • Hydroxyurea is genotoxic and is a presumed human carcinogen; also, mutagenic and clastogenic in vitro.
  • Secondary leukemias have been reported in patients receiving long-term therapy for myeloproliferative disorders (e.g., polycythemia vera, thrombocythemia).
  • Carefully consider risks of developing secondary malignancies against the benefits of therapy. (See Carcinogenicity under Cautions.)

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hydroxyurea
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(hy drox ee yoo REE uh)

What are the possible side effects of hydroxyurea?

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. Call your doctor at once if you have any of these serious side effects:
  • pinpoint red spots on your skin;

  • red patches, skin ulcers, or darkened skin (especially on your legs or feet);

  • fever, chills, body aches, flu symptoms;

  • nausea or vomiting;

  • loss of appetite;

  • diarrhea;

  • white patches or sores inside your mouth or on your lips; or

  • easy bruising or bleeding, unusual weakness.

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 hydroxyurea?

There may be other drugs that can affect hydroxyurea. 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 can provide more information about hydroxyurea.

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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