Hydrea

DRUG DESCRIPTION

HYDREAź (hydroxyurea capsules, USP) is an antineoplastic agent available for oral use as capsules providing 500 mg hydroxyurea. Inactive ingredients: citric acid, colorants (D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red 40, and D&C Red 28), gelatin, lactose, magnesium stearate, sodium phosphate, and titanium dioxide.

Hydroxyurea is an essentially tasteless, white crystalline powder. Its structural formula is:

HYDREAź
(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 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...

Read All Potential Side Effects and See Pictures of Hydrea »

What are the precautions when taking hydroxyurea (Hydrea)?

Before taking hydroxyurea, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, blood/bone marrow disorders (such as bone marrow suppression, neutropenia, thrombocytopenia, anemia), HIV infection, high uric acid level in the blood.

Hydroxyurea can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such...

Read All Potential Precautions of Hydrea »


Hydrea Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, loss of appetite, mouth sores, diarrhea, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause you to bruise or bleed more easily. Tell your doctor immediately if you develop any of the following symptoms: signs of an infection (such as fever, chills, persistent sore throat), easy bruising/bleeding, pale skin, unusual tiredness.

Tell your doctor immediately if any of these unlikely but serious side effects occur: skin problems (such as ulcers, darkened/blackened/reddened skin, unusual growths/moles).

Tell your doctor immediately if any of these rare but serious side effects occur: mental/mood changes (such as confusion, hallucinations), seizures, shortness of breath, chest pain, persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing skin/eyes, numbness/tingling of arms/legs, change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking hydroxyurea, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, blood/bone marrow disorders (such as bone marrow suppression, neutropenia, thrombocytopenia, anemia), HIV infection, high uric acid level in the blood.

Hydroxyurea can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug.

It is unknown if this medication affects the sperm. If you plan to father a child, discuss the risks and benefits of this medication with your doctor.

Hydroxyurea is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately.

Hydroxyurea passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Hydrea Patient Information Including Side Effects

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.

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.

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