Gracevit Adverse Reactions

The following adverse reactions may appear, so observe thoroughly and if abnormalities are observed, appropriate measures such as discontinuing administration should be taken.
Clinically significant adverse reactions: Shock (frequency unknown), anaphylaxis (frequency unknown).
If any abnormality is observed, such as blood pressure reductions, dyspnea, rash, or angioedema, administration should be discontinued and appropriate measures should be taken.
Toxic epidermal necrolysis (TEN) (frequency unknown), mucocutaneous ocular syndrome (Stevens-Johnson syndrome) (frequency unknown), erythema multiforme (frequency unknown).
Acute renal failure (frequency unknown).
Hepatic function disorders (frequency unknown), jaundice (frequency unknown).
Disorders, such as increased AST and increased ALT, may occur.
Pancytopenia (frequency unknown), agranulocytosis (frequency unknown), hemolytic anemia (frequency unknown), thrombocytopenia (frequency unknown).
Pseudomembranous colitis (frequency unknown).
If such symptoms as abdominal pain and frequent diarrhea are noted, administration should be discontinued and appropriate measures should be taken.
Hypoglycemia (frequency unknown).
Some cases of hypoglycemic coma have been reported. Hypoglycemia is more likely to occur in patients with diabetes mellitus, patients with impaired renal function and the elderly.
Psychiatric symptoms such as confusion (frequency unknown), delirium (frequency unknown) and hallucination (frequency unknown).
Aortic aneurysm, aortic dissection (frequency unknown) (see Important Precautions under Precautions).
Tendon disorders such as Achilles tendonitis and tendon rupture (frequency unknown).
If symptoms such as pain, edema, and redness around the tendon are observed, administration should be discontinued and appropriate measures should be taken.
Convulsion (frequency unknown).
QT prolongation (frequency unknown), ventricular tachycardia (including Torsade de pointes) (frequency unknown).
Interstitial pneumonia (frequency unknown).
Rhabdomyolysis (frequency unknown).
Other Adverse Reactions: See Table 11.

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Clinically significant adverse reactions reported in association with the use of other quinolones: The following clinically significant adverse reactions have been reported in association with the use of the other quinolones. Therefore, careful monitoring of patients being treated with Gracevit Tab 50 is recommended. The drug should be discontinued if any abnormal symptoms related to the events occur, and appropriate therapies should be initiated immediately.
Toxic epidermal necrolysis (TEN); Convulsions; QT prolongation, ventricular tachycardia (including Torsade de pointes); Jaundice; Interstitial pneumonia; Rhabdomyolysis; Tendon disorders; Agranulocytosis; Pancytopenia; Hemolytic anemia; Exacerbation of myasthenia gravis.