Adverse reactions have been primarily bone marrow depression (leukopenia, anemia, and occasionally thrombocytopenia), and less frequently 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 occur very rarely. Large doses may produce moderate drowsiness. Neurological disturbances have occurred extremely rarely and were limited to headache, dizziness, disorientation, hallucinations, and convulsions. Hydroxyurea capsules, USP occasionally may cause temporary impairment of renal tubular function accompanied by elevations in serum uric acid, 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 rarely.
Fatal and nonfatal pancreatitis and hepatotoxicity, and severe peripheral neuropathy have been reported in HIV-infected patients who received hydroxyurea in combination with antiretroviral agents, in particular, didanosine plus stavudine. 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
Below is a sample of reports where side effects / adverse reactions may be related to Hydroxyurea. The information is not vetted and should not be considered as verified clinical evidence.
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
Start date: 2011-01-13
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
Other drugs received by patient possibly interacting with the suspect drug:
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