Infections and infestations: Candida infection, fungal infection, pathogen resistance, pseudomembranous/Clostridium difficile colitis.
Blood and lymphatic system disorders: Agranulocytosis, anemia (aplastic and hemolytic), epistaxis, eosinophilia, granulocytopenia, leukopenia, neutropenia, pancytopenia, prolongation of prothrombin time, thrombocytopenia including thrombotic thrombocytopenic purpura.
Immune system disorders: Hypersensitivity reactions, sometimes fatal including anaphylactic/anaphylactoid reaction/shock, angioedema, bronchospasm, exacerbation of myasthenia gravis, laryngeal edema, serum sickness.
Metabolism and nutrition disorders: Anorexia, hyperglycemia, hypoglycemia, hypoglycemic coma, hypokalemia, moniliasis.
Psychiatric disorders: Agitation, anxiety, confusional states, depression, dysphonia, hallucinations, nervousness, paranoia, sleep disorder, suicidal ideation or suicidal attempt.
Nervous system disorders: Abnormal dreams, abnormal gait, ageusia, amnesia, convulsion, dysgeusia, dyskinesia, encephalopathy (isolated reports), extrapyramidal disorder, hyperkinesias, nightmares, paresthesia, peripheral sensory motor neuropathy, peripheral sensory neuropathy, pseudotumor cerebri, somnolence, tremor.
Eye disorders: Blurred vision, diplopia, scotoma, transient visual loss, uveitis, vision disturbances.
Ear and labyrinth disorders: Hypoacusis, tinnitus, vertigo.
Cardiac disorders: Cardiac arrest, chest pain, palpitation, tachycardia, torsades de pointes, ventricular arrhythmia, ventricular tachycardia.
Vascular disorders: Aortic aneurysm, aortic dissection, benign intracranial hypertension, hypotension, phlebitis, syncope, vasculitis, vasodilatation.
Respiratory, thoracic and mediastinal disorders: Allergic pneumonitis, anosmia, bronchospasm, dyspnea, interstitial pneumonia, parosmia.
Gastrointestinal disorders: Abdominal pain, dyspepsia, esophagitis, flatulence, gastritis, gastroenteritis, glossitis, pancreatitis, stomatitis, vomiting.
Hepatobiliary disorders: Abnormal hepatic function, acute liver failure, hepatic failure (including fatal cases), hepatic necrosis, hepatitis, jaundice, severe liver injury.
Skin and subcutaneous tissue disorders: Bullous eruptions including acute generalized exanthematous pustulosis (AGEP), erythema multiforme, fixed drug eruption, Stevens-Johnson syndrome and toxic epidermal necrolysis; hyperhidrosis, leukocytoclastic vasculitis, photosensitivity/phototoxicity reaction, pruritus, rash, tendon rupture, urticaria.
Musculoskeletal and connective tissue disorders: Achilles tendon, arthralgia, arthritis, hypertonia, ligament rupture, muscle rupture myalgia, myositis, rhabdomyolysis, skeletal pain, tendinitis.
Renal and urinary disorders: Abnormal renal function, acute renal failure, glomerulonephritis, interstitial nephritis, nephrosis.
Reproductive system and breast disorders: Vaginitis.
General disorders and administration site conditions: Asthenia, edema, injection site reaction, malaise, multiple organ failure, pain (including pain in back, chest and extremities), pyrexia.
Investigations: Abnormal electroencephalogram (EEG), increased blood bilirubin, blood creatinine, hepatic enzymes [alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT)], muscle enzymes, prolonged Electrocardiogram QT.
View ADR Monitoring Form