November 24, 2015
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(hydroxyurea) Capsules, USP



Myelosuppression: DROXIA may cause severe myelosuppression. Monitor blood counts at baseline and throughout treatment. Interrupt treatment and reduce dose as necessary [see WARNINGS AND PRECAUTIONS].

Malignancies: Hydroxyurea is carcinogenic. Advise sun protection and monitor patients for malignancies [see WARNINGS AND PRECAUTIONS].


DROXIA® (hydroxyurea capsules, USP) is available for oral use as capsules containing 200 mg, 300 mg, and 400 mg hydroxyurea. Inactive ingredients include citric acid, gelatin, lactose, magnesium stearate, sodium phosphate, titanium dioxide, and capsule colorants: FD&C Blue No. 1 and FD&C Green No. 3 (200 mg capsules); D&C Red No. 28, D&C Red No. 33, and FD&C Blue No. 1 (300 mg capsules); D&C Red No. 28, D&C Red No. 33, and D&C Yellow No. 10 (400 mg capsules).

Hydroxyurea is a white crystalline powder. It has a molecular weight of 76.05. Its structural formula is:

DROXIA (hydroxyurea) Structural Formula Illustration

What are the possible side effects of hydroxyurea (Droxia, Hydrea)?

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 a serious side effect such as:

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • skin redness, skin ulcers, or open...

Read All Potential Side Effects and See Pictures of Droxia »

Last reviewed on RxList: 8/6/2015
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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