The following adverse reactions have been reported in clinical studies and post-marketing experience. The incidence identified as follows reflects exposure to levofloxacin 500 mg in total of 1,930 patients in pooled phase 3 and 4 clinical trials [eg, 1,582 patients from phase 3 clinical trials conducted in Japan (337 patients) and China (1,245 patients) and 348 patients from phase 4 clinical trials] or 29,880 patients in a post-marketing studies conducted in Japan. If the incidence category of an adverse reaction is different between each source (ie, the incidence from the pooled clinical trials and the incidence from the post-marketing study), the higher frequency is represented.
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.