Rarely: <0.1%, infrequently: 0.1-<5%, no specific designation: ≥5% or frequency unknown.
Patients should be carefully observed for the following adverse reactions. In the event of abnormalities, therapy should be discontinued and appropriate measures should be taken.
Clinically Significant Adverse Reactions: The following clinically significant adverse reactions may occur rarely: Shock, anaphylactoid symptoms (precursory symptoms eg, erythema, chills and dyspnea). Toxic epidermal necrolysis (Lyell's syndrome). Mucocutaneous ocular syndrome (Stevens-Johnson syndrome). Convulsion. Acute renal failure. Jaundice (precursory symptoms, eg nausea and/or vomiting, anorexia, malaise and pruritus). Agranulocytosis (precursory symptoms eg, fever, pharyngeal pain and malaise). Interstitial pneumonia (symptoms eg, fever, cough, dyspnea, abnormality on chest x-ray films and eosinophilia; treatment eg, corticosteroids).
Severe colitis with blood in stool, eg pseudomembranous colitis (symptoms, eg abdominal pain and frequent diarrhea). Rhabdomyolysis (may be accompanied by acute exacerbation of renal functions; symptoms eg, myalgia, muscle weakness, increase in CPK and increase in myoglobin in serum or urine).
Hypoglycemia (patients with diabetes mellitus or renal disorders are susceptible).
Tendon disorders eg, Achilles tendinitis or tendon rupture.
Psychiatric symptoms eg, confusion.
Clinically Significant Adverse Reactions in Foreign Countries: Hemolytic anemia. Hypersensitivity vasculitis. Depression.
Other Adverse Reactions: Hypersensitivity: The following symptoms may also be observed eg, edema, urticaria, feeling of warmth or photosensitivity may occur rarely. Rash or pruritus may occur infrequently. In the event of such symptoms, treatment should be discontinued.
Psychoneurologic: Tremor, numbness, abnormal vision, tinnitus, hallucination or sleepiness may occur rarely. Symptoms eg, insomnia, dizziness or headache may occur infrequently.
Renal: Increased BUN or creatinine may occur infrequently.
Hepatic: Increased GOT, GPT, Al-P or γ-GTP may occur infrequently.
Hematologic: Anemia, leukopenia, thrombocytopenia or eosinophilia may occur infrequently. In the event of such symptoms, treatment should be discontinued.
Gastrointestinal: Nausea, vomiting, abdominal discomfort, diarrhea, anorexia, abdominal pain or dyspepsia may occur infrequently. Stomatitis, glossitis, thirst, enlarged feeling of abdomen or constipation may occur rarely.
Others: Malaise, fever, arthralgia, palpitation or taste abnormality may occur rarely.