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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

Warning

Oral route (Tablet)

Myelosuppression and MalignanciesMyelosuppression: Hydroxyurea oral tablets may cause severe myelosuppression. Monitor blood counts at baseline and throughout treatment. Interrupt treatment and reduce dose as necessary.Malignancies: Hydroxyurea is carcinogenic. Advise sun protection and monitor patients for malignancies.

Oral route (Capsule)

Hydroxyurea may cause severe myelosuppression. Monitor blood counts at baseline and throughout treatment. Interrupt treatment and reduce dose as necessary. Hydroxyurea is carcinogenic. Advise sun protection and monitor patients for malignancy.

Side effects requiring immediate medical attention

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

  • Black, tarry stools
  • blood in the urine or stools
  • chills
  • cough
  • fever
  • hoarseness
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • sore throat
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Less common

  • Blackening of the fingernails and toenails
  • troubled breathing with exertion

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
  • drowsiness
  • fast heartbeat
  • hives, itching, skin rash
  • irritation
  • itching, pain, redness, or swelling on the leg
  • joint stiffness or swelling
  • loss of appetite
  • muscle spasms (tetany) or twitching seizures
  • nausea
  • numbness or tingling of the fingers or toes
  • pain in the fingers or toes
  • sore on the leg
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • trembling
  • troubled breathing or swallowing
  • vomiting
  • weight loss

Side effects not requiring immediate medical attention

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
  • weight gain

Incidence not known

  • Absent, missed, or irregular menstrual periods
  • bluish-brownish bands on the nails
  • hair loss or thinning of hair
  • indigestion
  • passing of gas
  • stomach pain, fullness, or discomfort
  • stopping of menstrual bleeding

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

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

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

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

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.