Brand Names: Droxia, Hydrea

Generic Name: hydroxyurea (Pronunciation: hy drox ee yoo REE uh)

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

What is hydroxyurea (Hydrea)?

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

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. Hydroxyurea is also used to treat sickle cell anemia.

Hydroxyurea may also be used for other 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 (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 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. You may report side effects to FDA at 1-800-FDA-1088.

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

Hydroxyurea can lower the 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. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. It is important that you not miss any scheduled visits to your doctor.

Do not use this medication if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Talk with your doctor if you have trouble swallowing the capsule. Your doctor may instruct you to open the capsule, pour the medicine powder into a glass of water, and drink this mixture. If you open a capsule, do not inhale the powder or let it come in contact with your skin. Wash your hands before and after handling the pills, and wear disposable gloves when opening the capsule. If any of the medicine is spilled, wipe up the spill with a damp cloth and throw the cloth away in a sealed plastic bag. Keep all medicine and empty capsule shells out of the reach of children and pets.

Handle the tablets and capsules with extreme care. The medicine from a crushed or broken tablet or capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. Wash your hands before and after handling the pills or the medicine bottle. For best protection, wear disposable gloves whenever handling the bottle or the pills. Ask your doctor or pharmacist how to safely dispose of any unused tablets or capsules.

Call your doctor promptly if you have any skin changes such as pinpoint red spots, red patches, skin ulcers, or darkened skin (especially on your legs or feet). These may be early signs of a serious side effect.