The incidence of adverse events described below was determined according to the classification of the World Health Organization: very often (> 1/10); often (> 1/100 - <1/10); infrequently (> 1/1000 - <1/100); rarely (> 1/10000 - <1000); very rarely (<1/10000), the frequency is unknown (according to available data, it is impossible to estimate the frequency of development).
The undesirable phenomena associated with the use of linezolid are usually of mild or moderate severity.
More often than others the diarrhea, a headache, a nausea, vomiting are marked.
Adult patients
Infectious and parasitic diseases: often - candidiasis (including candidiasis of the oral cavity, vaginal candidiasis), fungal infections; infrequently - vaginitis; rarely - colitis, caused by the use of antibiotics (including pseudomembranous colitis).
Violations of the blood and lymphatic system: often - anemia; infrequently - leukopenia, neutropenia, thrombocytopenia, eosinophilia; rarely - pancytopenia; frequency unknown - myelosuppression, sideroblastic anemia.
Immune system disorders: the frequency of anaphylaxis is unknown.
Disorders from the metabolism and nutrition: infrequently - hyponatremia; frequency is unknown - lactic acidosis.
Disorders of the psyche: often - insomnia.
Disturbances from the nervous system: often - headache, perversion of taste (metallic taste in the mouth), dizziness, infrequent - convulsions, hypesthesia, paresthesia, frequency unknown - serotonin syndrome, peripheral neuropathy.
Disturbances on the part of the organ of sight: infrequently - blurred vision; rarely - the appearance of visual field defects; frequency unknown - neuropathy of the optic nerve, optic neuritis, loss of vision, changes in visual acuity, change in color vision.
Hearing disorders and labyrinthine disorders: infrequent - ringing in the ears.
Disorders from the cardiovascular system: often - increased blood pressure; infrequently - arrhythmia (tachycardia), transient ischemic attack, phlebitis, thrombophlebitis.
Disorders from the gastrointestinal tract: often - diarrhea, nausea, vomiting, localized or diffuse pain in the abdomen, constipation, indigestion; infrequently - pancreatitis, gastritis, bloating, dry mouth, glossitis, loose stools,stomatitis, discoloration of the mucous membrane of the tongue and other disorders of the language, rarely - a superficial change in the color of the enamel of the teeth.
Disturbances from the liver and bile ducts: often changes in the results of functional liver tests, increased activity of hepatic enzymes (including alanine aminotransferase (ALT), aspartate aminotransferase (ACT), alkaline phosphatase (alkaline phosphatase)); infrequently, an increase in the concentration of total bilirubin.
Disturbances from the skin and subcutaneous tissues: often - itching, rash; infrequently - hives, dermatitis, excessive sweating; frequency unknown - bullous skin lesions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis), angioedema, alopecia. Disorders from the nights and urinary tract: often - increased blood urea concentration; infrequent renal failure, increased creatinine concentration in the blood plasma, polyuria.
Violations of the genitals and mammary gland: infrequently - violations of the vagina and vulva.
General disorders and disorders at the site of administration: often - fever, localized pain; infrequently - chills, weakness, thirst.
Laboratory indicators: increasing the number of neutrophils, eosinophils, reducing hemoglobin, hematocrit or red blood cell number, increasing or decreasing the number of platelets or leukocytes, increasing the activity of lactate dehydrogenase, creatine kinase, lipase, amylase, increasing fasting glucose, reducing the total protein, albumin, sodium or calcium, increase or decrease of potassium or hydrocarbonates; infrequent - an increase in the content of sodium or calcium in the blood plasma, a decrease in glucose concentration not fasting, an increase or decrease in blood chlorides, an increase in the number of reticulocytes, a decrease in the number of neutrophils.
The following side effects with linezolid in rare cases were classified as serious: localized abdominal pain, transient ischemic attack, arterial hypertension.
In controlled clinical trials in which linezolid was used for a maximum of 28 days, only 2% of the patients developed anemia. In another study among patients with life-threatening infections, 2.5% (33/1326) of patients who received linezolid less than 28 days, anemia developed, while with linezolid more than 28 days, anemia developed in 12.3% (53/430) patients. The ratio of cases of development of anemia, requiring blood transfusion, was 9% among patients receiving linezolid less than 28 days (3/33), and 15% (8/53) in those cases where linezolid used more than 28 days.
Side effects in children do not differ from those in adult patients.