Pacferatam Adverse Reactions

Shock: Shock, anaphylactoid symptom (dyspnea) may rarely occur; cautious observation is required. If symptoms eg, discomfort, abnormal sense of oral cavity, stridor, incontinence, tinnitus and sweating occur, administration should be discontinued.
Hypersensitivity: Hypersensitive reaction eg, rash, urticaria, erythema, pruritus, fever may occur. In these cases, administration should be discontinued and appropriate measures are taken. Since Stevens-Johnson syndrome may occur, cautious observation is required. In the event of abnormal reaction, therapy is discontinued and appropriate measures are taken.
Kidney: Rarely, acute renal failure; occasionally, renal dysfunction including increase of blood, urea, nitrogen (BUN) and creatinine, oliguria and proteinuria might occur. Therefore, careful observation and regular examination are instituted. In the event of the symptom, administration are discontinued and appropriate measures are taken.
Blood: Occasionally, severe blood disease including hemolytic anemia, panhematopenia, granulocytopenia (including agranulocytosis), erythropenia, eosinophilia, thrombocytopenia may occur. Therefore, careful observation and regular examination are instituted. In the event of the symptom, administration are discontinued and appropriate measures are taken. In other cephem class administration (cephalothin sodium, cephaloridine), hemolytic anemia was reported.
Liver: Occasionally, elevation of AST, ALT, ALP and bilirubin may occur. There is the risk of occurrence of fulminant hepatitis. Therefore, tests including periodic hepatic function test are instituted enough. In the event of abnormal reaction, therapy is discontinued and appropriate measures are taken.
Gastrointestinal Tract System: Rarely, fever, abnormal pain, leukocytosis, pseudomembranous colitis including a formation of pseudomembranous stigma in endoscopy (severe colitis including primary symptom of severe diarrhea with mucus and hemafecia) might occur. When abdominal pain and frequent diarrhea occur, appropriate measures, including drug therapy, are taken. Occasionally, diarrhea, loose stools, vomiting and nausea might occur.
Respiratory System: Rarely, fever, cough, dyspnea, abnormality in thoracic X-ray, interstitial pneumonia with increase of eosinophil and pulmonary infiltration with eosinophilia (PIE) syndrome might occur. In these cases, therapy is discontinued and appropriate measures including corticosteroidal therapy are taken.
Superinfection: Rarely, stomatitis and candidiasis might occur.
Vitamin Deficiency: Rarely, vitamin K deficiency symptoms (hypoprothrombinemia and bleeding tendency) and vitamin B deficiency symptoms (stomatitis, glossitis, anorexia, neuritis) might occur.
Central Nervous System: Convulsion may occur.
Others: Rarely, hypotension, vasculitis, headache, pain at injection site, phlebitis and chill might occur.