Xromi Side Effects
Generic name: hydroxyurea
Note: This document contains side effect information about hydroxyurea. Some dosage forms listed on this page may not apply to the brand name Xromi.
Applies to hydroxyurea: oral capsule, oral tablet.
Warning
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 Xromi
Along with its needed effects, hydroxyurea (the active ingredient contained in Xromi) 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
- Black, tarry stools
- blood in the urine or stools
- chills
- cough
- fever
- hoarseness
- lower back or side pain
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- sore throat
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
Less common
- Blackening of the fingernails and toenails
- trouble breathing
Rare
- Confusion
- dizziness
- headache
- joint pain
- seeing, hearing, or feeling things that are not there
- seizures
- swelling of the feet or lower legs
Incidence not known
- Back, leg, or stomach pains
- bleeding gums
- bleeding under the skin
- blisters on the skin
- bluish or pale color on the skin of the fingers or toes
- chest tightness
- coldness of the fingers or toes
- crater-like lesions on the skin
- dark urine
- drowsiness
- fast heartbeat
- general body swelling
- hives, itching, skin rash
- irritation
- itching, pain, redness, or swelling on the leg
- joint stiffness or swelling
- loss of appetite
- muscle spasms (tetany) or twitching seizures
- nausea
- nosebleeds
- numbness or tingling of the fingers or toes
- pain in the fingers or toes
- sore on the leg
- swelling of the eyelids, face, lips, hands, or feet
- trembling
- trouble swallowing
- vomiting
- weight loss
- yellowing of the eyes or skin
Other side effects of Xromi
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
- Diarrhea
- dry skin
Less common
- Constipation
- redness of skin at the place of radiation
- weight gain
Incidence not known
- Absent, missed, or irregular menstrual periods
- bluish-brownish bands on the nails
- indigestion
- passing of gas
- stomach pain, fullness, or discomfort
- stopping of menstrual bleeding
- thinning or loss of hair
For Healthcare Professionals
Applies to hydroxyurea: compounding powder, oral capsule, oral tablet.
General
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
Leukemia secondary to long-term hydroxyurea (the active ingredient contained in Xromi) 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]
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
More about Xromi (hydroxyurea)
- Check interactions
- Compare alternatives
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: antimetabolites
- Breastfeeding
Patient resources
Other brands
Hydrea, Droxia, Siklos, Mylocel
Professional resources
Other brands
Related treatment guides
References
1. Product Information. Droxia (hydroxyurea). Bristol-Myers Squibb. 2001;PROD.
2. Cerner Multum, Inc. UK Summary of Product Characteristics.
3. Pharmaceutical Society of Australia. APPGuide online. Australian prescription products guide online. http://www.appco.com.au/appguide/default.asp 2006.
4. Product Information. Hydroxyurea (hydroxyurea). Par Pharmaceutical Inc. 2022.
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.