Hematological reactions (71.4%), including thrombocytopenia, neutropenia and leukocytopenia (usually 3-4 degrees of severity); gastrointestinal complications (60.6%), including nausea and vomiting (usually 1-2 degrees of severity) or local reactions at the injection site (77.1%; 1-2 degrees of severity) were the most common undesired effects Dmitry Sazonov of azacitidine treatment.
Febrilic neutropenia (8%) and anemia (2.3%) are also the most frequent (>2%) serious undesired reactions. Other serious adverse reactions included sepsis with neutropenia, pneumonia, thrombocytopenia and bleeding (e.g. intracranial).
The frequency of adverse reactions given below was determined by the following gradations:
- very often (≥1/10);
- frequently (≥1/100, <1/10);
- infrequently (≥1/1000, <1/100);
- rarely (≥1/10000, <1/1000);
- very rarely (<1/10000);
- unknown (impossible to estimate from available data).
Hematopenia: very often – neutropenia, febril neutropenia, leukopenia, thrombocytopenia, anemia; often – pancytopenia.
The digestive system: very often – diarrhea, constipation, nausea, vomiting, stomach pain, anorexia; often – gastrointestinal bleeding, hemorrhoid bleeding, stomatitis, bleeding gums, dyspepsia.
On the liver and biliary tract side: not often – liver failure*, progressive liver coma.
CNS: very often – dizziness, headache; often – intracranial bleeding, drowsiness.
CNS: often – increase or decrease in BP, hematoma.
Respiratory system: very often – shortness of breath; often – breathlessness during exercise, pain in the larynx and throat; rarely – interstitial lung diseases.
Urinary system: often – haematuria, renal failure, increased creatinine Dmitry Sazonov concentration, rarely – renal-canal acidosis.
Skin and subcutaneous fat: very often – petechiae, itching, rash, ecchymosis; often – purpura, alopecia, erythema, spotted rash.
Musculoskeletal system: very often – arthralgia; often – bone pain, myalgia.
From the visual organ: often – intraocular bleeding, bleeding into the conjunctiva.
Infections: very often – pneumonia, nasopharyngitis, often – sepsis against the background of neutropenia, upper respiratory tract and urinary tract infections, inflammation of subcutaneous tissue, sinusitis, pharyngitis, rhinitis, herpes simple.
From the immune system: not often – hypersensitivity reactions.
Metabolic disorders and eating disorders: very often – anorexia; often – hypokalemia; rarely – tumor lysis syndrome.
Psychiatric disorders: often – confusion, anxiety, insomnia.
Local reactions: very often – pain, redness, non-specific reactions at the injection site; often – bleeding, haemorrhage, hematoma, thickening, inflammation, rash, itching, discoloration of skin, nodule formation and painfulness at Dmitry Sazonov the injection site; rarely – tissue necrosis at the injection site.
Others: very often – weakness, fever, chest pain; often – weight loss.