The most common side effects in the treatment of fludarabine are bone marrow depression (with manifestations such as neutropenia, thrombocytopenia and anemia), infections (particularly pneumonia), fever, nausea, vomiting and diarrhea. Also, side effects such as fatigue, weakness, stomatitis, malaise, anorexia, edema, chills, peripheral neuropathy, visual disturbances and skin rashes are often noted. There have been cases of development of severe opportunistic infections in patients receiving fludarabine. Sometimes the consequence of severe adverse reactions was a lethal outcome.
According to the World Health Organization (WHO), unwanted effects are classified according to their frequency of development as follows: very often (≥ 1/10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, < 1/100), rarely (≥1 / 10000, <1/1000) and very rarely (<1/10000), the frequency is unknown (the frequency of occurrence of phenomena can not be determined on the basis of available data).
Infectious and parasitic diseases
Often: infections / opportunistic infections (activation of latent viral carriage, including the progression of multifocal leukoencephalopathy, infection caused by the virus Herpes Zoster, Epstein-Bar virus), pneumonia;
rarely: lymphoproliferative diseases (associated with the Epstein-Bar virus).
Benign, malignant and unspecified neoplasms (including cysts and polyps)
often: myelodysplastic syndrome, acute myeloid leukemia.
On the part of the blood and lymphatic system
Often: neutropenia, anemia, thrombocytopenia; often: myelosuppression.
From the immune system
infrequently: autoimmune diseases (including autoimmune hemolytic anemia, Evans syndrome, thrombocytopenic purpura, acquired hemophilia, pemphigus).
From the side of metabolism and nutrition
often: anorexia;
infrequently: syndrome of tumor lysis (with manifestations such as renal failure, metabolic acidosis, hyperkalemia, hypocalcaemia, hyperuricemia, hematuria, urate salts in urine. In the initial phase of this syndrome, pain in the thigh and side may also occur).
From the nervous system
often: peripheral neuropathy;
infrequently: confusion of consciousness;
rarely: agitation, convulsions, coma;
rarely: hemorrhage in the brain.
From the side of the organs of sight
often: visual impairment;
rarely: optic neuritis, visual neuropathy, blindness.
From the side of the cardiovascular system
rarely: heart failure, arrhythmia.
From the respiratory system, organs of the chest and mediastinum
Often: cough;
infrequently: toxic lung damage (including pulmonary fibrosis, pneumonitis, dyspnea);
rarely: pulmonary hemorrhage.
From the gastrointestinal tract
Often: nausea, diarrhea, vomiting;
often: stomatitis, mucositis (inflammatory, erythematous and erosive ulcerous lesions of the oral mucosa, pharynx, esophagus and in general gastrointestinal tract);
infrequently: gastrointestinal bleeding (mainly associated with thrombocytopenia), increasing the concentration of pancreatic enzymes in the blood plasma.
From the liver and biliary tract
infrequently: increased activity of "liver" transaminases.
From the side of the kidneys and urinary tract
rarely: hemorrhagic cystitis.
From the skin and subcutaneous tissues
often: skin rashes;
rarely: Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).
General disorders and disorders at the site of administration
Often: fever, fatigue, weakness;
often: malaise, chills, peripheral edema.