The incidence of adverse events is indicated on the basis of clinical trial data, regardless of the cause-and-effect relationship with fludarabine, according to the following gradation: very often (≥10%), often (<10% -≥1%), infrequently (<1% - ≥0,1%), rarely (<0,1% - ≥0,01%), the frequency is unknown.
Infectious and parasitic diseases
Very often - joining of secondary infections / opportunistic infections (for example, reactivation of latent viruses, including herpes and Epstein-Barr viruses, progressive multifocal leukoencephalopathy), pneumonia;
rarely - lymphoproliferative disorders (associated with the Epstein-Barr virus).
Violations of the blood and lymphatic system
Very often - neutropenia, thrombocytopenia and anemia;
often - myelosuppression.
Immune system disorders
Infrequently, autoimmune disorders (including autoimmune hemolytic anemia, thrombocytopenic purpura, pemphigus, Evans syndrome, acquired hemophilia).
Disorders from the gastrointestinal tract
Very often - nausea, vomiting, diarrhea; often - anorexia, stomatitis, mucositis;
infrequently - gastrointestinal bleeding, changes in the activity of liver and pancreatic enzymes.
Disorders from the metabolism and nutrition
Infrequently - as a result of tumor lysis, hyperuricemia, hyperphosphataemia, hypocalcemia, metabolic acidosis, hyperkalemia, hematuria, urate crystalluria and renal insufficiency may develop.
Disturbances from the nervous system
Often - peripheral neuropathy;
infrequently - confusion of consciousness; rarely excitation, convulsions, coma.
Disturbances on the part of the organ of sight
The privateo - impaired vision;
rarely - optic neuritis, optic nerve neuropathy and blindness.
Disturbances from the respiratory system, chest and mediastinal organs
Very often - cough;
infrequently - shortness of breath, pulmonary fibrosis, pneumonitis.
Heart Disease
Rarely - heart failure, arrhythmias.
Disorders from the kidneys and urinary tract
Rarely, hemorrhagic cystitis.
Disturbances from the skin and subcutaneous tissues
Often - skin rash;
Rarely, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome). There have been reports of rare cases of increased growth of skin cancer, as well as the development of skin cancer during or after treatment with fludarabine.
General disorders and disorders at the site of administration
Very often - fever temperature increase, fatigue, weakness;
Often - chills, malaise, swelling.
Benign, malignant and unspecified neoplasms (including cysts and polyps)
In patients who received fludarabine before, after or simultaneously with alkylating antistatic agents, topoisomerase inhibitors or radiotherapy, in rare cases, myelodysplastic syndrome (MDS) / acute myeloid leukemia (AML) was observed.
Post-registration data
Disturbances from the nervous system
The frequency is unknown - leukoencephalopathy, acute toxic leukoencephalopathy, reversible leukoencephalopathy syndrome (COPD).
Vascular disorders
The frequency is unknown - bleeding (including cerebral bleeding, pulmonary hemorrhage).