Mylocel Side Effects

Generic name: hydroxyurea

Medically reviewed by Drugs.com. Last updated on Jul 22, 2024.

Note: This document provides detailed information about Mylocel Side Effects associated with hydroxyurea. Some dosage forms listed on this page may not apply specifically to the brand name Mylocel.

Applies to hydroxyurea: oral capsule, oral tablet.

Serious side effects of Mylocel

Along with its needed effects, hydroxyurea (the active ingredient contained in Mylocel) 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:

Other side effects of Mylocel

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:

For healthcare professionals

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

General adverse events

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.

Hematologic

• Very common (10% or more): Neutropenia (13%)
• Common (1% to 10%): Thrombocytopenia, anemia
• Postmarketing reports: Hemolytic anemia, macrocytosis^[Ref]

Gastrointestinal

• 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]

Other

• Common (1% to 10%): Fever, asthenia, pyrexia, fatigue, peripheral edema
• Postmarketing reports: Chills, malaise^[Ref]

Dermatologic

• 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]

Oncologic

• Frequency not reported: Leukemia, skin cancers^[Ref]

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

Genitourinary

• 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]

Hepatic

• 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]

Respiratory

• 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]

Metabolic

• 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]

Psychiatric

• Postmarketing reports: Hallucinations, disorientation^[Ref]

Renal

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

Hypersensitivity

• 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.

Immunologic

• Common (1% to 10%): Viral infections, bacterial infections, influenza
• Postmarketing reports: Systemic lupus erythematosus

Musculoskeletal

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

Further information

Mylocel side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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