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Hydrea

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Hydrea

Hydrea Side Effects Center

Pharmacy Editor: Charles Patrick Davis, MD, PhD

Hydrea (hydroxyurea) is an antineoplastic agent used to treat melanoma, resistant chronic myelocytic leukemia, and recurrent, metastatic, or inoperable carcinoma of the ovary and primary squamous cell (epidermoid) carcinomas of the head and neck. Hydrea is available as a generic named hydroxyurea. Common side effects include nausea, vomiying, diarrhea, skin changes and flu-like symptoms.

Hydrea (hydroxyurea) is available in 500 mg tablets. Dosage depends on the problem being treated; the prescribing doctor will determine dosage. Serious side effects include anemia, myelosuppression and leukemia. Because of the drug's effects on cells, Hydrea should not be used in pregnant women; breast milk may contain the drug so the benefits should be weighed against the possible harm to the infant if the drug is administered to lactating women. The safety and effectiveness of Hydrea in pediatric patients has not been established.

Our Hydrea 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.

Hydrea 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;
  • 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.

Read the entire detailed patient monograph for Hydrea (Hydroxyurea) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Hydrea Overview - Patient Information: Side Effects

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.

Read the entire patient information overview for Hydrea (Hydroxyurea)»

What is Prescribing information?

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

Hydrea FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Reported adverse reactions are bone marrow depression (leukopenia, anemia, and thrombocytopenia), gastrointestinal symptoms (stomatitis, anorexia, nausea, vomiting, diarrhea, and constipation), and dermatological reactions such as maculopapular rash, skin ulceration, dermatomyositis-like skin changes, peripheral and facial erythema. Hyperpigmentation, atrophy of skin and nails, scaling, and violet papules have been observed in some patients after several years of long-term daily maintenance therapy with HYDREA (hydroxyurea) . Skin cancer has been reported. Cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, have occurred in patients with myeloproliferative disorders during therapy with hydroxyurea. These vasculitic toxicities were reported most often in patients with a history of, or currently receiving, interferon therapy (see WARNINGS). Dysuria and alopecia have been reported. Large doses may produce moderate drowsiness. Neurological disturbances have occurred and were limited to headache, dizziness, disorientation, hallucinations, and convulsions. HYDREA (hydroxyurea) may cause temporary impairment of renal tubular function accompanied by elevations in serum uric acid, blood urea nitrogen (BUN), and creatinine levels. Abnormal bromsulphalein (BSP) retention has been reported. Fever, chills, malaise, edema, asthenia, and elevation of hepatic enzymes have also been reported.

Adverse reactions observed with combined hydroxyurea and irradiation therapy are similar to those reported with the use of hydroxyurea or radiation treatment alone. These effects primarily include bone marrow depression (anemia and leukopenia), gastric irritation, and mucositis. Almost all patients receiving an adequate course of combined hydroxyurea and irradiation therapy will demonstrate concurrent leukopenia. Platelet depression ( < 100,000 cells/mm³) has occurred in the presence of marked leukopenia. HYDREA (hydroxyurea) may potentiate some adverse reactions usually seen with irradiation alone, such as gastric distress and mucositis.

The association of hydroxyurea with the development of acute pulmonary reactions consisting of diffuse pulmonary infiltrates, fever, and dyspnea has been reported. Pulmonary fibrosis also has been reported.

In HIV-infected patients who received hydroxyurea in combination with antiretroviral agents, in particular, didanosine plus stavudine, fatal and nonfatal pancreatitis and hepatotoxicity, and severe peripheral neuropathy have been reported. Patients treated with hydroxyurea in combination with didanosine, stavudine, and indinavir in Study ACTG 5025 showed a median decline in CD4 cells of approximately 100/mm³. (See WARNINGS and PRECAUTIONS.)

Read the entire FDA prescribing information for Hydrea (Hydroxyurea) »

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Hydrea - User Reviews

Hydrea User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Hydrea sorted by most helpful. Patient Discussions FAQs

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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