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Brand Names: Droxia, Hydrea

Generic Name: hydroxyurea (Pronunciation: hye DROX ee yoo REE a)

• What is hydroxyurea (Droxia, Hydrea)?
• What are the possible side effects of hydroxyurea (Droxia, Hydrea)?
• What is the most important information I should know about hydroxyurea (Droxia, Hydrea)?
• What should I discuss with my healthcare provider before taking hydroxyurea (Droxia, Hydrea)?
• How should I take hydroxyurea (Droxia, Hydrea)?
• What happens if I miss a dose (Droxia, Hydrea)?
• What happens if I overdose (Droxia, Hydrea)?
• What should I avoid while taking hydroxyurea (Droxia, Hydrea)?
• What other drugs will affect hydroxyurea (Droxia, Hydrea)?
• Where can I get more information?

What is hydroxyurea (Droxia, Hydrea)?

Hydroxyurea affects certain cells in the body, such as cancer cells or sickled red blood cells.

Hydroxyurea is used to treat chronic myelocytic leukemia, ovarian cancer, and certain types of skin cancer (melanoma and primary squamous cell cancer of the head and neck).

Hydroxyurea is also used to reduce pain episodes and the need for blood transfusions in people with sickle cell anemia. Hydroxyurea will not cure sickle cell anemia.

Hydroxyurea may also be used for purposes not listed in this medication guide.

Droxia 200 mg

turquoise, imprinted with DROXIA 6335

Droxia 300 mg

purple, imprinted with DROXIA 6336

Hydrea 500 mg

pink/turquoise, imprinted with HYDREA 830

Hydroxyurea 500 mg-BAR

pink/purple, imprinted with barr, 882

Hydroxyurea 500 mg-ROX

green/peach, imprinted with 54 072

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 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;
• headache, dizziness; 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.

What is the most important information I should know about hydroxyurea (Droxia, Hydrea)?

You should not use hydroxyurea if you are allergic to it, or if you have severe bone marrow suppression, severe anemia, or low levels of platelets in your blood.

Before using hydroxyurea, tell your doctor if you have bone marrow suppression, HIV or AIDS, liver or kidney disease, or if you are receiving chemotherapy or radiation.

Wash your hands before and after you handle a hydroxyurea capsule or the bottle that contains the pills. For best protection, wear disposable gloves when handling the pills.

Do not open the hydroxyurea capsule. Do not use a pill that has been accidentally opened or broken. The medicine from an open capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water.

If any powder from an open capsule is spilled, wipe it up at once with a damp paper towel and throw the towel away in a sealed plastic bag where children and pets cannot get to it.

Hydroxyurea can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

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