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Hydrea Side Effects

Generic Name: hydroxyurea

Note: This document contains side effect information about hydroxyurea. Some of the dosage forms listed on this page may not apply to the brand name Hydrea.

For the Consumer

Applies to hydroxyurea: oral capsule, oral tablet

Along with its needed effects, hydroxyurea (the active ingredient contained in Hydrea) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking hydroxyurea:

More Common

  • Chills
  • cough
  • fever
  • hoarseness
  • lower back or side pain
  • painful or difficult urination

Less Common

  • Black, tarry stools
  • blackening of the fingernails and toenails
  • blood in the urine or stools
  • pinpoint red spots on the skin
  • sores in the mouth and on the lips
  • unusual bleeding or bruising

Rare

  • Confusion
  • dizziness
  • headache
  • joint pain
  • seeing, hearing, or feeling things that are not there
  • seizures
  • swelling of the feet or lower legs

Incidence Not Known

  • Bleeding under the skin
  • blisters on the skin
  • bluish or pale color on the skin of the fingers or toes
  • coldness of the fingers or toes
  • crater-like lesions on the skin
  • fast heartbeat
  • hives, itching, skin rash
  • irritation
  • joint pain, stiffness, or swelling
  • numbness or tingling of the fingers or toes
  • pain in the fingers or toes
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • troubled breathing or swallowing
  • unusual tiredness or weakness
  • weight loss

Some side effects of hydroxyurea may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

Less Common

  • Constipation
  • redness of skin at the place of radiation
  • skin rash and itching

Incidence Not Known

  • Bluish-brownish bands on the nails

For Healthcare Professionals

Applies to hydroxyurea: compounding powder, oral capsule, oral tablet

Hematologic

Very common (10% or more): Bone marrow failure, CD4 lymphocytes decreased, leukopenia, thrombocytopenia, platelet count decreased, anemia

Common (1% to 10%): Neutropenia[Ref]

Gastrointestinal

Very common (10% or more): Pancreatitis, nausea, vomiting, diarrhea, stomatitis, constipation, mucositis, stomach discomfort, dyspepsia, abdominal pain, melena[Ref]

Other

Very common (10% or more): Pyrexia, asthenia, chills, malaise, fever, edema[Ref]

Dermatologic

Very common (10% or more): Cutaneous vasculitis, dermatomyositis, alopecia, maculopapular rash, papular rash, skin exfoliation, skin atrophy, skin ulcer, erythema, skin hyperpigmentation, nail disorder

Very rare (less than 0.01%): Transverse melanonychia

Frequency not reported: Squamous dysplasia, facial erythema[Ref]

Oncologic

Common (1% to 10%): Skin cancers, neoplasms benign and malignant [including cysts and polyps])

Frequency not reported: This drug has been shown to be mutagenic, clastogenic, and cause cellular transformation to a tumorigenic phenotype. This drug has been reported to be unequivocally genotoxic and a presumed transspecies carcinogen, which implies a carcinogenic risk to humans.[Ref]

Genitourinary

Very common (10% or more): Azoospermia, oligospermia

Very rare (less than 0.01%): Dysuria[Ref]

Nervous system

Common (1% to 10%): Convulsion, dizziness, peripheral neuropathy, drowsiness

Frequency not reported: Severe peripheral neuropathy has been reported in HIV-infected patients who received this drug in combination with antiretroviral drugs[Ref]

Hepatic

Common (1% to 10%): Hepatotoxicity, hepatic enzyme increased, cholestasis, hepatitis

Frequency not reported: Both fatal and nonfatal hepatotoxicity have been reported in HIV-infected patients who received this drug in combination with antiretroviral agents[Ref]

Respiratory

Common (1% to 10%): Pulmonary fibrosis, pulmonary edema, lung infiltration, dyspnea[Ref]

Metabolic

Very rare (less than 0.01%): Tumor lysis syndrome[Ref]

Psychiatric

Common (1% to 10%): Hallucination, disorientation[Ref]

Renal

Very common (10% or more): Dysuria, blood creatinine increased, blood urea increased, blood uric acid increased[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Hydroxyurea (hydroxyurea (hydroxyUREA))." Par Pharmaceutical Inc, Chestnut Ridge, NY.

3. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

4. "Product Information. Droxia (hydroxyurea)." Bristol-Myers Squibb, Princeton, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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