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Droxia Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Droxia (hydroxyurea) is used to treat melanoma (a type of skin cancer), chronic myelocytic leukemia, cancer of the ovary, and primary squamous cell (skin) cancer of the head and neck. It is also used to treat sickle cell anemia. Droxia affects certain cells in the body, such as cancer cells or sickled red blood cells. Common side effects include nausea, vomiting, loss of appetite, mouth sores, diarrhea, or constipation.

Dosage of Droxia is based on weight, medical condition, laboratory test results, and response to treatment. The initial dose of Droxia is 15 mg/kg/day as a single dose. Treatment may be stopped for a short time if blood counts are too low. Other drugs may interact with Droxia. Tell your doctor all medications and supplements you use. Droxia is not recommended for use during pregnancy. It may harm a fetus. Discuss birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor. This drug passes into breast milk and may have undesirable effects on a nursing infant. Breastfeeding while using this drug is not recommended.

Our Droxia (hydroxyurea) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Droxia in Detail - Patient Information: Side Effects

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 sores;
  • painful or difficult urination;
  • confusion, hallucinations, seizure; or
  • nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes).

Less serious side effects may include:

  • hair loss;
  • skin peeling or discoloration, mild rash;
  • upset stomach, constipation, diarrhea, vomiting;
  • headache, dizziness, drowsiness; or
  • weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Droxia (Hydroxyurea Capsules)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Droxia FDA Prescribing Information: Side Effects
(Adverse Reactions)


The following adverse reactions are described in detail in other labeling sections:

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trial Experience

In 299 patients treated for sickle cell anemia in the Multicenter Study of Hydroxyurea in Sickle Cell Anemia, the most common adverse reactions were hematologic, with neutropenia, and low reticulocyte and platelet levels necessitating temporary cessation in almost all patients. Hematologic recovery usually occurred in two weeks.

Other adverse reactions include hair loss, macrocytosis, bleeding, and melanonychia.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of hydroxyurea in the treatment of neoplastic diseases. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

Read the entire FDA prescribing information for Droxia (Hydroxyurea Capsules)

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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