The below mentioned provides a listing of adverse drug reactions that occurred at frequencies ≥ 0.1% or considered to be serious in clinical studies that enrolled more than 2,000 adult patients who received the recommended linezolid doses for up to 28 days.
Those most commonly reported were diarrhoea (8.4%), headache (6.5%), nausea (6.3%) and vomiting (4.0%).
The most commonly reported drug-related adverse events which led to discontinuation of treatment were headache, diarrhoea, nausea and vomiting. About 3% of patients discontinued treatment because they experienced a drug-related adverse event.
Additional adverse reactions reported from post-marketing experience are included in the table with frequency category 'Not known', since the actual frequency cannot be estimated from the available data.
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.
Frequency not known: Antibiotic-associated colitis, including pseudomembranous colitis*.
Blood and the lymphatic system disorders:
Uncommon: Leucopenia*, neutropenia, thrombocytopenia*, eosinophilia.
Frequency not known: Myelosuppression*, sideroblastic anaemia*.
Immune system disorders:
Frequency not known: Anaphylaxis.
Metabolism and nutrition disorders:
Frequency not known: Lactic acidosis*.
Nervous system disorders:
Common: Headache, taste perversion (metallic taste), dizziness.
Uncommon: Convulsions, hypoaesthesia, paraesthesia.
Frequency not known: Serotonin syndrome**, convulsions*, 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*, changes in visual field defect*.
Ear and labyrinth disorders:
Uncommon: Arrhythmia (tachycardia).
Uncommon: phlebitis, thrombophlebitis. Transient ischaemic attacks.
Common: Diarrhoea, nausea, vomiting, localized or general abdominal pain, constipation, dyspepsia.
Uncommon: Pancreatitis, gastritis, abdominal distention, dry mouth, glossitis, loose stools, stomatitis, tongue discolouration or disorder.
Frequency not known: 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: Polyuria, increased creatinine, Renal failure.
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 Contraindications and Interactions.
See as follows.
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.
Paediatric population: Safety data from clinical studies based on more than 500 paediatric patients (from birth to 17 years) do not indicate that the safety profile of linezolid for paediatric patients differs from that for adult patients.
Adverse Drug Reactions:
Inform doctors about unexpected reactions after using drugs.