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Fludara Side Effects

Generic name: fludarabine

Medically reviewed by Drugs.com. Last updated on Feb 26, 2024.

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

Applies to fludarabine: intravenous powder for solution, intravenous solution.

Warning

Intravenous route (Powder for Solution; Solution)

Fludarabine can severely suppress bone marrow function when used at high doses. In dose-ranging studies in patients with acute leukemia, fludarabine was associated with severe neurologic effects, including blindness, coma, and death. Life-threatening and sometimes fatal autoimmune hemolytic anemia, autoimmune thrombocytopenia/thrombocytopenic purpura (ITP), Evan's syndrome, and acquired hemophilia has been reported to occur after one or more cycles of treatment. Closely monitor patients for hemolysis. In a clinical investigation using fludarabine for injection in combination with pentostatin (deoxycoformycin) for the treatment of refractory CLL, there was an unacceptably high incidence of fatal pulmonary toxicity. Therefore, the use of fludarabine for injection in combination with pentostatin is not recommended.

Serious side effects of Fludara

Along with its needed effects, fludarabine (the active ingredient contained in Fludara) 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 or nurse immediately if any of the following side effects occur while taking fludarabine:

More common

Less common

Rare

Other side effects of Fludara

Some side effects of fludarabine 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

For Healthcare Professionals

Applies to fludarabine: intravenous powder for injection, intravenous solution, oral tablet.

Hematologic

Very common (10% or more): Neutropenia, anemia, thrombocytopenia

Common (1% to 10%): Hemorrhage, myelosuppression[Ref]

Immunologic

Very common (10% or more): Opportunistic infection (e.g., latent viral reactivation, progressive multifocal leukoencephalopathy, Herpes zoster virus, Epstein-Barr-virus) (44%)

Uncommon (0.1% to 1%): Autoimmune disorder (e.g., autoimmune hemolytic anemia, Evans syndrome, thrombocytopenic purpura, acquired hemophilia, pemphigus)

Rare (less than 0.1%): Lymphoproliferative disorder (EBV-associated)[Ref]

Gastrointestinal

Very common (10% or more): Nausea/vomiting (36%), anorexia (34%), diarrhea (15%)

Common (1% to 10%): Dehydration, stomatitis, GI hemorrhage, esophagitis, mucositis, constipation, dysphagia[Ref]

Nervous system

Very common (10% or more): Weakness (69%), paresthesia (12%)

Common (1% to 10%): Headache, cerebellar syndrome, impaired mentation, peripheral neuropathy

Rare (less than 0.1%): Coma, seizures

Frequency not reported: Cerebral hemorrhage[Ref]

Respiratory

Very common (10% or more): Cough (69%), pneumonia (22%), dyspnea (22%), upper respiratory tract infection (16%)

Common (1% to 10%): Sinusitis, pharyngitis, allergic pneumonitis, epistaxis, hemoptysis, bronchitis, hypoxia

Uncommon (0.1% to 1%): Pulmonary toxicity (e.g., pulmonary fibrosis, pneumonitis, dyspnea)

Frequency not reported: Pulmonary hemorrhage[Ref]

Cardiovascular

Very common (10% or more): Edema (19%)

Common (1% to 10%): Angina, congestive heart failure arrhythmia, supraventricular tachycardia, myocardial infarction, deep venous thrombosis, phlebitis, transient ischemic attack, aneurysm, cerebrovascular accident[Ref]

Genitourinary

Common (1% to 10%): Dysuria, urinary tract infection, hematuria, proteinuria, urinary hesitancy[Ref]

Renal

Common (1% to 10%): Renal failure, abnormal renal function tests

Frequency not reported: Hemorrhagic cystitis[Ref]

Hypersensitivity

Common (1% to 10%): Anaphylaxis[Ref]

Metabolic

Very common (10% or more):

Common (1% to 10%): Hyperglycemia, tumor lysis syndrome (TLS), anorexia

Uncommon (0.1% to 1%): Tumor lysis syndrome (including renal failure, metabolic acidosis, hyperkalemia, hypocalcemia, hyperuricemia, hematuria, urate crystalluria, hyperphosphatemia)[Ref]

Dermatologic

Very common (10% or more): Rash (15%), diaphoresis (13%)

Common (1% to 10%): Alopecia, pruritus, seborrhea

Rare (less than 0.1%): Skin cancer, necrolysis epidermal toxic (Lyell type) , Stevens-Johnson syndrome[Ref]

Oncologic

Common (1% to 10%): Myelodysplastic syndrome, acute myeloid leukemia (mainly associated with prior, concomitant or subsequent treatment with alkylating agents, topoisomerase inhibitors, or irradiation)[Ref]

Hepatic

Common (1% to 10%): Hepatic failure, abnormal liver function tests, cholelithiasis[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (16%)

Common (1% to 10%): Osteoporosis, arthralgia[Ref]

Ocular

Common (1% to 10%): Visual disturbance

Rare (less than 0.1%): Blindness, optic neuritis, optic neuropathy[Ref]

Psychiatric

Common (1% to 10%): Sleep disorder, depression

Uncommon (0.1% to 1%): Confusion

Rare (less than 0.1%): Agitation[Ref]

Other

Very common (10% or more): Fever (69%), chills (19%), fatigue (38%), pain (22%)

Common (1% to 10%): Malaise, hearing loss, chills, mucositis, edema[Ref]

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Fludarabine Phosphate (fludarabine). Hospira Inc. 2019.

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.