Fludarabine Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 21, 2024.

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

Important warnings This medicine can cause some serious health issues

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 fludarabine

Along with its needed effects, fludarabine 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

• arm, back, or jaw pain
• black, tarry stools
• blood in the urine or stools
• chest pain or discomfort
• chest tightness or heaviness
• constipation
• cough or hoarseness
• coughing or spitting up blood
• fast or irregular heartbeat
• fever or chills
• general feeling of discomfort or illness
• lower back or side pain
• nausea
• pain
• painful, burning, or difficult urination
• pale skin
• pinpoint red spots on the skin
• shortness of breath
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain, severe
• sweating
• swelling
• tender, swollen glands in the neck
• thickening of bronchial secretions
• troubled breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• wheezing

Less common

• agitation
• aneurysm
• bleeding gums
• blurred vision
• confusion
• decreased urine output
• difficulty in breathing or swallowing
• dilated neck veins
• dizziness
• extreme fatigue
• fainting
• fast, pounding, or irregular heartbeat or pulse
• headache
• increased menstrual flow or vaginal bleeding
• irregular breathing
• loss of hearing
• nosebleeds
• numbness or tingling in the fingers, toes, or face
• pain, redness, or swelling in the arm or leg
• paralysis
• prolonged bleeding from cuts
• seizures
• slurred speech
• sudden and severe inability to speak
• temporary blindness
• weakness in the arm or leg on one side of the body, sudden and severe
• weight gain

Rare

• blindness
• continuing vomiting
• dark-colored urine
• drowsiness
• frequent urination
• hives
• itching
• light-colored stools
• loss of appetite
• loss of consciousness
• lower abdominal cramping
• muscle tremors
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid, deep breathing
• restlessness
• skin rash
• stomach pain
• trouble speaking, thinking, or walking
• yellow eyes or skin

Other side effects of fludarabine

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

• abdominal pain
• bladder pain
• body aches or pain
• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• cloudy urine
• congestion
• diarrhea
• difficulty in moving
• dry mouth or throat
• flushed, dry skin
• frequent urge to urinate
• fruit-like breath odor
• increased hunger
• increased thirst
• increased urination
• joint pain
• muscle aching or cramping
• muscle pains or stiffness
• runny nose
• swollen joints
• trouble in swallowing
• voice changes
• weight loss

Less common

• abdominal fullness
• bluish color of skin
• changes in skin color
• cracked lips
• dandruff
• decrease in height
• decreased urination
• difficulty in sleeping
• discouragement
• feeling sad or empty
• gaseous abdominal pain
• heartburn
• irritability
• loss of interest or pleasure
• lightheadedness
• oily skin
• pain or tenderness around the eyes and cheekbones
• rapid breathing
• recurrent fever
• stuffy nose
• sunken eye
• trouble concentrating
• wrinkled skin

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]

Further information

Fludarabine 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.

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

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