What is the most important information I should know about hydroxyurea? Back to top

Do not use hydroxyurea if you are pregnant. It could harm the unborn baby.

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.

What is hydroxyurea? Back to top

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.

What should I discuss with my healthcare provider before taking hydroxyurea? Back to top

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.

To make sure you can safely take hydroxyurea, tell your doctor if you have any of these other conditions:

• bone marrow suppression;
• HIV or AIDS;
• liver disease;
• kidney disease; or
• if you are receiving chemotherapy or radiation.

FDA pregnancy category D. Do not use hydroxyurea if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

This medication may affect fertility (your ability to have children), whether you are a man or a woman.

Hydroxyurea can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking hydroxyurea.

Older adults may be more likely to have side effects from this medicine.

How should I take hydroxyurea? Back to top

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

Drink 8 to 10 glasses of liquid per day while you are taking hydroxyurea. You may take the medicine with or without food.

Hydroxyurea is either taken once per day or once every third day, depending on the condition being treated. On each of your dosing days, take the medicine at the same time of day. Your doctor may also want you to take a folic acid supplement. Follow your doctor's instructions very carefully.

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.

To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor.

Use hydroxyurea regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose? Back to top

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Back to top

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include drowsiness, mouth sores, and swelling with pain and purple discoloration in your hands and feet.

What should I avoid while taking hydroxyurea? Back to top

Do not handle hydroxyurea pills or the medicine bottle without skin protection (disposable gloves).

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

What are the possible side effects of hydroxyurea? Back to top

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 other drugs will affect hydroxyurea? Back to top

Some medicines can increase your risk of certain side effects while taking hydroxyurea. Tell your doctor if you are also using:

• didanosine (Videx);
• stavudine (Zerit); or
• an interferon such as Actimmune, Alferon, Avonex, Betaseron, Extavia, Infergen, Intron, Rebetron, Rebif, or Roferon.

This list is not complete and other drugs may interact with hydroxyurea. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information? Back to top

Your pharmacist can provide more information about hydroxyurea.