Hydrea Side Effects Center

Last updated on RxList: 3/23/2021
Hydrea Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Hydrea?

Hydrea (hydroxyurea) is an antineoplastic (anti-cancer) 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 in generic form.

What Are Side Effects of Hydrea?

Common side effects of Hydrea include:

  • nausea,
  • vomiting,
  • upset stomach,
  • diarrhea,
  • constipation,
  • skin changes such as peeling or discoloration,
  • flu-like symptoms,
  • hair loss,
  • rash,
  • headache,
  • dizziness,
  • drowsiness, or
  • weight gain.

Serious side effects of Hydrea include:

Dosage for Hydrea

Hydrea (hydroxyurea) is available in 500 mg tablets. Dosage depends on the problem being treated; the prescribing doctor will determine dosage.

What Drugs, Substances, or Supplements Interact with Hydrea?

Hydrea may interact with didanosine, stavudine, or an interferon. Tell your doctor all medications and supplements you use.

Hydrea During Pregnancy and Breastfeeding

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 breastfeeding women. The safety and effectiveness of Hydrea in pediatric patients has not been established.

Additional Information

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.

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Hydrea Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • numbness, tingling, or burning pain in your hands or feet;
  • skin numbness or purple discoloration;
  • skin ulcers or open sores;
  • sudden chest pain, wheezing, dry cough, feeling short of breath;
  • low blood cell counts--fever, chills, tiredness, mouth sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed; or
  • signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • loss of appetite, nausea;
  • constipation, diarrhea;
  • low blood cell counts;
  • bleeding; or
  • mouth sores.

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)

Hydrea Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described in detail in other labeling sections:

  • Myelosuppression [see WARNINGS AND PRECAUTIONS]
  • Malignancies [see WARNINGS AND PRECAUTIONS]
  • Vasculitic toxicities [see WARNINGS AND PRECAUTIONS]
  • Risks with concomitant use of antiretroviral drugs [see WARNINGS AND PRECAUTIONS]
  • Radiation recall [see WARNINGS AND PRECAUTIONS]
  • Macrocytosis [see WARNINGS AND PRECAUTIONS]
  • Pulmonary Toxicity [see WARNINGS AND PRECAUTIONS]

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of HYDREA. Because these reactions are reported voluntarily froma population of uncertain size, it is not always possible to reliably estimate their frequency.

  • Reproductive Systemand Breast disorders: azoospermia, and oligospermia
  • Gastrointestinal disorders: stomatitis, nausea, vomiting, diarrhea, and constipation
  • Metabolismand Nutrition disorders: anorexia, tumor lysis syndrome
  • Skin and subcutaneous tissue disorders: maculopapular rash, skin ulceration, cutaneous lupus erythematosus, dermatomyositis-like skin changes, peripheral and facial erythema, hyperpigmentation, nail hyperpigmentation, atrophy of skin and nails, scaling, violet papules, and alopecia
  • Renal and urinary disorders: dysuria, elevations in serumuric acid, blood urea nitrogen (BUN), and creatinine levels
  • Nervous systemdisorders: headache, dizziness, drowsiness, disorientation, hallucinations, and convulsions
  • General Disorders: fever, chills, malaise, edema, and asthenia
  • Hepatobiliary disorders: elevation of hepatic enzymes, cholestasis, and hepatitis
  • Respiratory disorders: diffuse pulmonary infiltrates, dyspnea, and pulmonary fibrosis, interstitial lung disease, pneumonitis, alveolitis, allergic alveolitis and cough
  • Immune disorders: systemic lupus erythematosus
  • Hypersensitivity: Drug-induced fever (pyrexia) (>39°C, >102°F) requiring hospitalization has been reported concurrently with gastrointestinal, pulmonary, musculoskeletal, hepatobiliary, dermatological or cardiovascular manifestations. Onset typically occurred within 6 weeks of initiation and resolved upon discontinuation of hydroxyurea. Upon re-administration fever re-occurred typically within 24 hours.

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 may potentiate some adverse reactions usually seen with irradiation alone, such as gastric distress and mucositis.

Read the entire FDA prescribing information for Hydrea (Hydroxyurea)

© Hydrea Patient Information is supplied by Cerner Multum, Inc. and Hydrea Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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