Adverse reactions occurring more often than in single cases are listed according to the following gradation: very often (≥10%); often (≥1%, <10%); infrequently (≥0.1%, <1%); rarely (≥0.01%, <0.1%); very rarely (<0.01%). Disturbances from the blood system and lymphatic system:
very often - anemia, leukopenia and thrombocytopenia; often - febrile neutropenia; very rarely - thrombocytosis.
Immune system disorders:
very rarely - anaphylactic reaction.
Disorders from the metabolism and nutrition:
often - anorexia.
Impaired nervous system:
often - headache, insomnia, drowsiness; infrequently - impaired cerebral circulation; very rarely - a syndrome of reversible posterior encephalopathy.
Heart Disease:
infrequently - heart failure; arrhythmia, predominantly supraventricular; rarely - myocardial infarction.
Vascular disorders:
very often - swelling, peripheral edema; rarely - lowering blood pressure, peripheral vasculitis, gangrene; very rarely - the syndrome of increased permeability of capillaries.
Disturbances from the respiratory system:
very often - shortness of breath; often - cough, rhinitis; infrequently - bronchospasm, interstitial pneumonitis; rarely - pulmonary edema, adult respiratory distress syndrome.
Disorders from the gastrointestinal tract system: very often - nausea, vomiting, increased activity of "hepatic" enzymes aspartate aminotransferase (ACT), alanine aminotransferase (ALT) and alkaline phosphatase; often - diarrhea, stomatitis, ulcerative lesions of the oral mucosa, constipation, increased bilirubin concentration; infrequently -hepatotoxicity of severe degree, including hepatic insufficiency,in some cases fatal; rarely - increase in the concentration of gamma-glutamyl transferase (GGT); very rarely is ischemic colitis.
Disturbances from the skin and subcutaneous tissues:
very often - allergic skin rashes of mild degree, accompanied by itching; alopecia (usually minimal hair loss); often-itching, sweating; rarely - ulcers, vesicle formation, peeling, severe skin reactions, including desquamation and bullous skin damage; very rarely-toxic epidermal necrolysis, Stevens-Johnson syndrome.
Disorders from the kidneys and urinary tract:
very often - mild proteinuria and hematuria; infrequent - renal insufficiency; rarely - an increase in the concentration of creatinine, urea and lactate dehydrogenase (LDH) in hemolytic-uremic syndrome.
Disturbances from the musculoskeletal and connective tissue:
often - back pain, myalgia.
Other:
very often - flu-like syndrome. Also, cases of malaise, sweating were reported; often-elevation of body temperature, asthenia, chills; rarely - reactions at the injection site of a predominantly mild degree.
Hypersensitivity: anaphylactoid reactions were recorded very rarely. Radiation toxicity was rarely reported (see Interaction with other therapies).
The use of gemcitabine in combination with paclitaxel in breast cancer
Undesirable phenomena of the third degree of severity
Hematologic Toxicity:
anemia - 5,7%, thrombocytopenia - 5,3%, neutropenia - 31,3%.
Non-hematological toxicity:
febrile neutropenia - 4.6%, fatigue - 5.7%, diarrhea - 3.1%, motor neuropathy - 2.3%, sensory neuropathy - 5.3%.
Undesirable phenomena of the IV degree of severity
Hematologic Toxicity:
anemia 1.1%, thrombocytopenia 0.4%, neutropenia 17.2% (grade IV neutropenia lasting more than 7 days was recorded in 12.6% of patients).
Non-hematological toxicity:
febrile neutropenia - 0,4%, fatigue - 0,8%, motor neuropathy - 0,4%, sensory neuropathy -0,4%.
The use of gemcitabine in combination with cisplatin in bladder cancer
Undesirable phenomena of the third degree of severity
Hematologic Toxicity:
Anemia - 24%, thrombocytopenia - 29%.
Non-hematological toxicity:
nausea and vomiting - 22%, diarrhea - 3%, infection - 2%, stomatitis - 1%.
Undesirable phenomena of the IV degree of severity
Hematologic Toxicity:
Anemia - 4%, thrombocytopenia - 29%.
Non-hematological toxicity:
infection - 1%.
The use of gemcitabine in combination with carboplatin in ovarian cancer
Undesirable phenomena of the third degree of severity
Hematologic Toxicity:
anemia 22.3%, neutropenia 41.7%, thrombocytopenia 30.3%, and leukopenia 48.0%.
Non-hematological toxicity:
bleeding - 1.8%, febrile neutropenia - 1.1%.
Undesirable phenomena of the IV degree of severity
Hematologic Toxicity:
anemia -5,1%, neutropenia -28,6%, thrombocytopenia - 4,6%, leukopenia - 5,1%.
Non-hematological toxicity:
infection without neutropenia - 0,6%.