Hydroxyurea (Hydroxyurea) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

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 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. Hydroxyurea capsules, USP may cause temporary impairment of renal tubular function accompanied by elevations in serum uric acid, blood urea nitrogen (BUN), and creatinine levels. Abnormal 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 rarely and only in the presence of marked leukopenia. 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 rarely 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.)

REPORTS OF SUSPECTED HYDROXYUREA SIDE EFFECTS / ADVERSE REACTIONS

Possible Hydroxyurea side effects / adverse reactions in 78 year old male

Reported by a consumer/non-health professional from Brazil on 2011-10-02

Patient: 78 year old male weighing 44.0 kg (96.8 pounds)

Reactions: Cyanosis, Tongue Oedema, LIP Oedema

Suspect drug(s):
Hydroxyurea
    Start date: 2011-01-13

Sprycel
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2011-02-10
    End date: 2011-02-17

Possible Hydroxyurea side effects / adverse reactions in 55 year old male

Reported by a consumer/non-health professional from United Kingdom on 2011-10-13

Patient: 55 year old male

Reactions: Drug Interaction, Application Site Erythema, Application Site Vesicles, Application Site Pruritus

Suspect drug(s):
Hydroxyurea

Other drugs received by patient possibly interacting with the suspect drug:
Neupro
    Dosage: patch
    Indication: Parkinson's Disease
    Start date: 2010-10-25
    End date: 2011-06-20

Other drugs received by patient: Sinemet

Possible Hydroxyurea side effects / adverse reactions in 80 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-19

Patient: 80 year old female

Reactions: Actinic Keratosis, Bowen's Disease

Suspect drug(s):
Hydroxyurea