The following Council of International Organizations of Medical Sciences (CIOMS) frequency rating is used: Very common: 10%≤ incidence; common: 1%≤ incidence <10%; uncommon: 0.1%≤ incidence <1%; rare: 0.01%≤ incidence <0.1%; very rare: Incidence <0.01%.
Blood and Lymphatic System Disorders: Uncommon: Anemia. Very Rare: Thrombocytopenia*. Incidence Unknown: Pancytopenia*, agranulocytosis*, hemolytic anemia with hemoglobinuria*.
Immune System Disorder: Incidence Unknown: Anaphylactoid reaction*.
Metabolism and Nutrition Disorder: Uncommon: Anorexia. Incidence Unknown: Hypoglycemia (hypoglycemic coma may occur)*, hyperglycemia*.
Psychiatric Disorders: Common: Sleep loss. Incidence Unknown: Psychiatric symptoms eg, confusion*, delirium*, depression*, hallucination.
Nervous System Disorders: Common: Dizziness, headache. Uncommon: Somnolence, numbness, tremor, mental dullness, dysgeusia. Rare: Disturbed consciousness. Very Rare: Convulsion*, ageusia. Incidence Unknown: Peripheral nerve disorder, extrapyramidal disorder, anosmia, parosmia.
Eye Disorders: Rare: Abnormal vision.
Ear and Labyrinth Disorders: Uncommon: Tinnitus. Incidence Unknown: Hearing losses.
Cardiac Disorders: Uncommon: Palpitations. Incidence Unknown: Ventricular tachycardia (including Torsades de pointes)*, prolonged QT*, tachycardia.
Vascular Disorders: Very Rare: Shock*. Incidence Unknown: Hypotension.
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Dry throat. Incidence Unknown: Interstitial and eosinophilic pneumonia*.
Gastrointestinal Disorders: Common: Nausea, vomiting, diarrhea, abdominal discomfort. Uncommon: Abdominal pain and distension, dyspepsia, constipation. Rare: Stomatitis. Very Rare: Glossitis. Incidence Unknown: Colitis with bloody stool eg, pseudomembranous colitis*.
Hepatobiliary Disorders: Uncommon: Abnormal hepatic function. Incidence Unknown: Fulminant hepatitis*, jaundice*.
Skin and Subcutaneous Tissue Disorders: Uncommon: Pruritus, rash. Rare: Hyperhidrosis, urticaria. Very Rare: Photosensitivity. Incidence Unknown: Toxic epidermal necrolysis (TEN)*, oculomucocutaneous syndrome (Stevens-Johnson syndrome)*, hypersensitivity vasculitis*.
Musculoskeletal and Connective Tissue Disorders: Uncommon: Arthralgia, pain in extremity, back pain, weakness. Rare: Arthropathy, myalgia. Incidence Unknown: Rhabdomyolysis*, tendon disorders eg, Achilles tendonitis or tendon rupture*, myasthenia gravis exacerbation*, muscle rupture.
Renal and Urinary Disorders: Uncommon: Hematuria. Rare: Pollakiuria, oliguria, acute renal failure*. Incidence Unknown: Interstitial nephritis*, anuria, dysuria, urinary retention.
General Disorders and Administration Site Conditions: Uncommon: Thirst, chest discomfort, malaise, feeling hot, edema. Very Rare: Pyrexia. Incidence Unknown: Chest pain.
Investigations: Common: Increased AST, ALT, LDH and eosinophil count, decreased white blood cell count. Uncommon: Increased creatinine, alkaline phosphatase, γ-GTP, blood bilirubin and CPK, positive urinary protein, decreased lymphocyte, neutrophil and platelet count, and blood glucose, present glucose urine. Rare: Increased BUN, decreased urine output. Very Rare: Increased blood glucose.
*See Warnings.
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