Fludarabine Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 21, 2025.

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

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

While you are being treated with fludarabine injection, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Fludarabine injection may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have recently taken oral polio vaccine. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Fludarabine injection can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection (e.g. pneumonia). It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you have fever or chills, cough or hoarseness, lower back or side pain, painful or difficult urination; shortness of breath; or unusual bleeding or bruising.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

You should not use this medicine if you are also taking pentostatin (Nipent®). Taking it together with this medicine may increase the chance of serious side effect.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are taking this medicine and for 6 months after stopping it. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause unusual weakness, trouble in thinking, or trouble in seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

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:

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:

For healthcare professionals

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

Hematologic adverse events

• 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]

See also:

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.

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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