文档介绍：DetailedView:SafetyLabelingChangesApprovedByFDACenterforDrugEvaluationandResearch(CDER)   January2011SummaryView1 CONTRAINDICATIONSZithromaxiscontraindicatedinpatientswithahistoryofcholestaticjaundice/,hepatitis,cholestaticjaundice,ecrosis,andhepaticfailurehavebeenreported,-MarketingExperience/BiliaryAdversereactionsrelatedtohepaticdysfunctionhavebeenreportedinpostmarketingexperiencewithazithromycin.(SeeWARNINGS,Hepatotoxicity.)  August2010 SummaryView2 ADVERSEREACTIONSPostmarketingExperienceGastrointestinal:Anorexia,constipation,dyspepsia,flatulence,vomiting/diarrheararelyresultingindehydration,pseudomembranouscolitis,pancreatitis,oralcandidiasis,pyloricstenosis,andrarereportsoftonguediscoloration.