Note: This document contains side effect information about hydroxyurea. Some dosage forms listed on this page may not apply to the brand name Mylocel.
Applies to hydroxyurea: oral capsules.
Warning
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Toxicity
- Highly toxic drug with a low therapeutic index.c
- Possible severe, sometimes life-threatening or fatal, adverse effects.177 178
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Limit to Qualified Personnel
- Administer only under supervision of qualified clinicians experienced in use of cytotoxic therapy.177 178 (See Adequate Patient Evaluation and Monitoring under Cautions.)
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Carcinogenicity
- Hydroxyurea is genotoxic and is a presumed human carcinogen;177 178 also, mutagenic and clastogenic in vitro.177 178
- Secondary leukemias have been reported in patients receiving long-term therapy for myeloproliferative disorders (e.g., polycythemia vera, thrombocythemia).177 178
- Carefully consider risks of developing secondary malignancies against the benefits of therapy.a (See Carcinogenicity under Cautions.)
Side effects include:
Bone marrow suppression.
For Healthcare Professionals
Applies to hydroxyurea: compounding powder, oral capsule, oral tablet.
General
The more commonly reported adverse reactions among children have been infections and neutropenia. Among adults, hematologic, gastrointestinal symptoms, infections, headache, anorexia, and dry skin have been commonly reported.
Hematologic
Very common (10% or more): Neutropenia (13%)
Common (1% to 10%): Thrombocytopenia, anemia
Postmarketing reports: Hemolytic anemia, macrocytosis[Ref]
Gastrointestinal
Common (1% to 10%): Nausea, upper abdominal pain, diarrhea, constipation
Postmarketing reports: Stomatitis, vomiting, gastrointestinal ulcer, oral mucositis, pancreatitis[Ref]
Pancreatitis has occurred when hydroxyurea was administered concomitantly with antiretroviral drugs, including didanosine and stavudine.[Ref]
Other
Common (1% to 10%): Fever, asthenia, pyrexia, fatigue, peripheral edema
Postmarketing reports: Chills, malaise[Ref]
Dermatologic
Very common (10% or more): Dry skin (12%)
Common (1% to 10%): Skin ulcer, alopecia
Postmarketing reports: Skin ulceration, cutaneous lupus erythematosus, dermatomyositis-like skin changes, peripheral and facial erythema, nail hyperpigmentation, atrophy of skin and nails, scaling, violet papules, skin reactions (oral, ungula and cutaneous pigmentation), rash, melanonychia[Ref]
Oncologic
Leukemia secondary to long-term hydroxyurea (the active ingredient contained in Mylocel) has also been reported in patients with sickle cell disease. Leukemia has also been reported in patients with sickle cell disease and no prior history of treatment with hydroxyurea. Skin cancer has also been reported in patients receiving long-term hydroxyurea.[Ref]
Frequency not reported: Leukemia, skin cancers[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection
Postmarketing reports: Azoospermia, oligospermia, amenorrhea, dysuria[Ref]
Nervous system
Peripheral neuropathy has occurred when hydroxyurea (the active ingredient contained in Mylocel) was administered concomitantly with antiretroviral drugs, including didanosine and stavudine.[Ref]
Very common (10% or more): Headache (20%)
Common (1% to 10%): Dizziness
Frequency not reported: Peripheral neuropathy
Postmarketing reports: Drowsiness, convulsions[Ref]
Hepatic
Uncommon (0.1% to 1%): 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%): Cough, lung disorder, dyspnea, nasopharyngitis
Postmarketing reports: Diffuse pulmonary infiltrates, dyspnea, pulmonary fibrosis, interstitial lung disease, pneumonitis, alveolitis, allergic alveolitis[Ref]
Metabolic
Common (1% to 10%): Vitamin D deficiency, other metabolic and nutrition disorders, weight gain, increased weight
Very rare (less than 0.01%): Tumor lysis syndrome
Postmarketing reports: Anorexia, severe hypomagnesemia[Ref]
Psychiatric
Postmarketing reports: Hallucinations, disorientation[Ref]
Renal
Postmarketing reports: Elevations in serum uric acid, blood urea nitrogen (BUN), and creatinine levels[Ref]
Hypersensitivity
Drug-induced fever requiring hospitalization has been reported in the postmarketing period. It 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 (the active ingredient contained in Mylocel) Upon re-administration fever reoccurred typically within 24 hours.
Postmarketing reports: Drug-induced fever
Immunologic
Common (1% to 10%): Viral infections, bacterial infections, influenza
Postmarketing reports: Systemic lupus erythematosus
Musculoskeletal
Common (1% to 10%): Arthralgia, back pain, extremity pain
