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Label Changes for:

Zithromax (azithromycin) tablet, single-dose packet, IV for injection, and oral suspension

August 2010

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

 

January 2011

 

CONTRAINDICATIONS

  • Zithromax is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.

WARNINGS

Hepatotoxicity
  • Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur.

ADVERSE REACTIONS

Post-Marketing Experience/Biliary
  • Adverse reactions related to hepatic dysfunction have been reported in postmarketing experience with azithromycin. (See WARNINGS, Hepatotoxicity.)
     

 

August 2010 

 

ADVERSE REACTIONS

Postmarketing Experience
  • Gastrointestinal: Anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhea rarely resulting in dehydration, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis, and rare reports of tongue discoloration.
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