Droxia 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 Droxia.

Some side effects of Droxia may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to hydroxyurea: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking hydroxyurea (the active ingredient contained in Droxia) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• skin redness, skin ulcers, or open sores;

• painful or difficult urination;

• confusion, hallucinations, seizure; or

• nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes).

Less serious side effects of hydroxyurea may include:

• hair loss;

• skin peeling or discoloration, mild rash;

• upset stomach, constipation, diarrhea, vomiting;

• headache, dizziness, drowsiness; or

• weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to hydroxyurea: compounding powder, oral capsule, oral tablet

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 (the active ingredient contained in Droxia) 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 (the active ingredient contained in Droxia) 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 (the active ingredient contained in Droxia) 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 (the active ingredient contained in Droxia) in combination with antiretroviral agents. Fatal hepatic events were reported most often in patients treated with the combination of hydroxyurea, didanosine, and stavudine. This combination should be avoided.

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.

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