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Oforta Side Effects

Generic name: fludarabine

Medically reviewed by Drugs.com. Last updated on Jul 7, 2024.

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

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 Oforta

Along with its needed effects, fludarabine (the active ingredient contained in Oforta) 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 side effects

  • 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 side effects

  • 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

Other side effects of Oforta

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 side effects

  • 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 side effects

  • 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 adverse events

Immunologic

Gastrointestinal

Nervous system

Respiratory

Cardiovascular

Genitourinary

Renal

Hypersensitivity

Metabolic

Very common (10% or more):

Dermatologic

Oncologic

Hepatic

Musculoskeletal

Ocular

Psychiatric

Other

References

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

2. Cerner Multum, Inc. "Australian Product Information."

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

Further information

Oforta 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.