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Droxia Side Effects

Generic name: hydroxyurea

Medically reviewed by Last updated on Jul 20, 2023.

Note: This document contains side effect information about hydroxyurea. Some dosage forms listed on this page may not apply to the brand name Droxia.

Applies to hydroxyurea: oral capsule, oral tablet.


Oral route (Tablet; Capsule)

Myelosuppression and MalignanciesMyelosuppression: Hydroxyurea oral tablets may cause severe myelosuppression.Do not give if bone marrow function is markedly depressed.Monitor blood counts at baseline and throughout treatment. Interrupt treatment and reduce dose as necessary.Malignancies: Hydroxyurea is carcinogenic. Advise sun protection and monitor patients for malignancies.

Serious side effects of Droxia

Along with its needed effects, hydroxyurea (the active ingredient contained in Droxia) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking hydroxyurea:

More common

Less common


Incidence not known

Other side effects of Droxia

Some side effects of hydroxyurea may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

Incidence not known

For Healthcare Professionals

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


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.


Very common (10% or more): Neutropenia (13%)

Common (1% to 10%): Thrombocytopenia, anemia

Postmarketing reports: Hemolytic anemia, macrocytosis[Ref]


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]


Common (1% to 10%): Fever, asthenia, pyrexia, fatigue, peripheral edema

Postmarketing reports: Chills, malaise[Ref]


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]


Leukemia secondary to long-term hydroxyurea (the active ingredient contained in Droxia) 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]


Common (1% to 10%): Urinary tract infection

Postmarketing reports: Azoospermia, oligospermia, amenorrhea, dysuria[Ref]

Nervous system

Very common (10% or more): Headache (20%)

Common (1% to 10%): Dizziness

Frequency not reported: Peripheral neuropathy

Postmarketing reports: Drowsiness, convulsions[Ref]

Peripheral neuropathy has occurred when hydroxyurea was administered concomitantly with antiretroviral drugs, including didanosine and stavudine.[Ref]


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]


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]


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]


Postmarketing reports: Hallucinations, disorientation[Ref]


Postmarketing reports: Elevations in serum uric acid, blood urea nitrogen (BUN), and creatinine levels[Ref]


Postmarketing reports: Drug-induced fever

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. Upon re-administration fever reoccurred typically within 24 hours.


Common (1% to 10%): Viral infections, bacterial infections, influenza

Postmarketing reports: Systemic lupus erythematosus


Common (1% to 10%): Arthralgia, back pain, extremity pain


1. (2001) "Product Information. Droxia (hydroxyurea)." Bristol-Myers Squibb

2. Cerner Multum, Inc. "UK Summary of Product Characteristics."

3. Pharmaceutical Society of Australia (2006) APPGuide online. Australian prescription products guide online.

4. (2022) "Product Information. Hydroxyurea (hydroxyurea)." Par Pharmaceutical Inc

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.