The following undesirable effects have been observed and reported during treatment with linezolid with the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); Not known (cannot be estimated from the available data).
Infections and infestations:
Common: Candidiasis, oral candidiasis, vaginal candidiasis, fungal infections. Uncommon: Vaginitis. Rare: Antibiotic-associated colitis, including pseudomembranous colitis*.
Blood and the lymphatic system disorders:
Common: Anaemia*†. Uncommon: Leucopenia*, neutropenia, thrombocytopenia*, eosinophilia. Rare: Pancytopenia*. Frequency not known: Myelosuppression*, sideroblastic anaemia*.
Immune system disorders:
Frequency not known: Anaphylaxis.
Metabolism and nutrition disorders:
Uncommon: Hyponatraemia. Frequency not known: Lactic acidosis*.
Nervous system disorders:
Common: Headache, taste perversion (metallic taste), dizziness. Uncommon: Convulsions*, hypoaesthesia, paraesthesia. Frequency not known: Serotonin syndrome**, peripheral neuropathy*.
Uncommon: Blurred vision*. Rare: Changes in visual field defect*. Frequency not known: Optic neuropathy*, optic neuritis*, loss of vision*, changes in visual acuity*, changes in colour vision*.
Ear and labyrinth disorders:
Uncommon: Arrhythmia (tachycardia).
Common: Hypertension. Uncommon: Transient ischaemic attacks, phlebitis, thrombophlebitis.
Common: Diarrhoea, nausea, vomiting, localised or general abdominal pain, constipation, dry mouth, dyspepsia. Uncommon: Pancreatitis, gastritis, abdominal distention, dry mouth, glossitis, loose stools, stomatitis, tongue discolouration or disorder. Rare: Superficial tooth discolouration.
Common: Abnormal liver function test; increased AST, ALT or alkaline phosphatase. Uncommon: Increased total bilirubin.
Skin and subcutaneous tissue disorders:
Common: Pruritus, rash. Uncommon: Urticaria, dermatitis, diaphoresis. Frequency not known: Bullous disorders such as those described as Stevens-Johnson syndrome and toxic epidermal necrolysis, angioedema, alopecia.
Renal and urinary disorders:
Common: Increased BUN. Uncommon: Renal failure, increased creatinine, polyuria.
Reproductive system and breast disorders:
Uncommon: Vulvovaginal disorder.
General disorders and administration site conditions:
Common: Fever, localised pain. Uncommon: Chills, fatigue, injection site pain, increased thirst.
Common: Chemistry: Increased LDH, creatine kinase, lipase, amylase or non-fasting glucose. Decreased total protein, albumin, sodium or calcium. Increased or decreased potassium or bicarbonate.
Haematology: Increased neutrophils or eosinophils. Decreased haemoglobin, haematocrit or red blood cell count. Increased or decreased platelet or white blood cell counts. Uncommon: Chemistry:
Increased sodium or calcium. Decreased non fasting glucose. Increased or decreased chloride.
Haematology: Increased reticulocyte count. Decreased neutrophils.
* See Precautions.
** See Contraindications and Interactions.
† See below.
The following adverse reactions to linezolid were considered to be serious in rare cases: localised abdominal pain, transient ischaemic attacks and hypertension.
†In controlled clinical trials where linezolid was administered for up to 28 days, 2.0% of the patients reported anaemia. In a compassionate use program of patients with life-threatening infections and underlying co-morbidities, the percentage of patients who developed anaemia when receiving linezolid for ≤ 28 days was 2.5% (33/1326) as compared with 12.3% (53/430) when treated for >28 days. The proportion of cases reporting drug-related serious anaemia and requiring blood transfusion was 9% (3/33) in patients treated for ≤ 28 days and 15% (8/53) in those treated for >28 days.
Inform doctors about unexpected reactions after using drugs.