An antimetabolite - treats Chronic Myelogenous Leukemia, Solid Tumors, and Sickle Cell Anemia
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.)
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.
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:
constipation;
skin rash;
itching;
leg sores;
redness of the face;
hair loss;
drowsiness;
headache; or
dizziness.
This is not a complete list of side effects and others may occur. Tell
your doctor about any unusual or bothersome side effect.
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