Droxia Side Effects

Generic Name: hydroxyurea

Please note - some side effects for Droxia may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Droxia - for the Consumer

Droxia

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Droxia:

Constipation; drowsiness; hair loss; inflammation of the mouth; loss of appetite; nausea; redness of the face.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood disorders, including low numbers of red or white blood cells; blood in the urine; chills; diarrhea; fever; inflammation of the pancreas; liver toxicity; lower back or abdominal pain; painful urination; persistent cough; secondary leukemia; shortness of breath; skin cancer; skin sore or lesions; sore throat; sores on the mouth or lips; unusual bruising or bleeding; vomiting.

Droxia Side Effects - for the Professional

Droxia

Sickle Cell Anemia

In patients treated for sickle cell anemia in the Multicenter Study of Hydroxyurea in Sickle Cell Anemia,1 the most common adverse reactions were hematologic, with neutropenia, and low reticulocyte and platelet levels necessitating temporary cessation in almost all patients. Hematologic recovery usually occurred in two weeks.

Non-hematologic events that possibly were associated with treatment include hair loss, skin rash, fever, gastrointestinal disturbances, weight gain, bleeding, and parvovirus B-19 infection; however, these non-hematologic events occurred with similar frequencies in the hydroxyurea and placebo treatment groups. Melanonychia has also been reported in patients receiving Droxia (hydroxyurea capsules, USP) for SCA.

Other

Adverse events associated with the use of hydroxyurea in the treatment of neoplastic diseases, in addition to hematologic effects include: gastrointestinal symptoms (stomatitis, anorexia, nausea, vomiting, diarrhea, and constipation), and dermatological reactions such as maculopapular rash, skin ulceration, dermatomyositis-like skin changes, peripheral erythema, 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. 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 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.

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.

Side Effects by Body System

Hematologic

Hematologic side effects have been the most common reported and have included neutropenia, and very low reticulocyte and platelet levels, which required discontinuation of therapy. Elevated mean corpuscular volume of red cells have also been reported.

Hematologic recovery usually occurred within two weeks.

Gastrointestinal

Gastrointestinal side effects have included stomatitis, anorexia, nausea, vomiting, diarrhea, and constipation. Both fatal and nonfatal pancreatitis have been reported in HIV-infected patients who received hydroxyurea in combination with antiretroviral agents.

Other

Vasculitic toxicities were reported most often in patients with a history of, or currently receiving, interferon therapy.

Other side effects have included cutaneous vasculitic toxicities such as vasculitic ulcerations and gangrene, which have occurred in patients with myeloproliferative disorders during therapy with hydroxyurea.

Dermatologic

Dermatologic side effects including maculopapular rash, skin ulceration, dermatomyositis-like skin changes, peripheral erythema, squamous dysplasia, nail pigmentation, and facial erythema have been reported. In patients who have received several years of long-term daily maintenance therapy, hyperpigmentation, atrophy of skin and nails, scaling and violet papules have been reported. Alopecia has been reported very rarely. A case of transverse melanonychia has also been reported.

Oncologic

Oncologic side effects have included skin cancer. Use of hydroxyurea has been mutagenic, clastogenic, and cause cellular transformation to a tumorigenic phenotype. The drug has been reported to be unequivocally genotoxic and a presumed transspecies carcinogen, which implies a carcinogenic risk to humans.

Genitourinary

Genitourinary side effects have been reported to occasionally include a temporary impairment of renal tubular function accompanied by elevations in serum uric acid, BUN, and creatinine levels. Dysuria has been reported very rarely.

General

General side effects have included fever, chills, malaise, edema, asthenia, and moderate drowsiness following large doses.

Nervous system

Nervous system side effects including headache, dizziness, disorientation, hallucinations, and convulsions have been reported very rarely. Severe peripheral neuropathy has been reported in HIV-infected patients who received hydroxyurea in combination with antiretroviral agents.

Hepatic

Hepatic side effects have included elevation of hepatic enzymes. Both fatal and nonfatal hepatotoxicity have been reported in HIV-infected patients who received hydroxyurea in combination with antiretroviral agents.

Respiratory

Respiratory side effects have rarely included the development of acute pulmonary infiltrates, fever, dyspnea, and pulmonary fibrosis.

Metabolic

Metabolic side effects including two cases of tumor lysis syndrome have been reported.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.