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U.S. Department of Health and Human Services

Safety

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Gris-PEG (griseofulvin ultramicrosized) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2010

Summary View

 

WARNINGS

Serious Skin Reactions
  • Severe skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis) and erythema multiforme have been reported with griseofulvin use. These reactions may be serious and may result in hospitalization or death. If severe skin reactions occur, griseofulvin should be discontinued
Hepatotoxicity
  • Elevations in AST, ALT, bilirubin, and jaundice have been reported with griseofulvin use. These reactions may be serious and may result in hospitalization or death. Patients should be monitored for hepatic adverse events and discontinuation of griseofulvin considered if warranted

ADVERSE REACTIONS

  • There have been post-marketing reports of severe skin and hepatic adverse events associated with griseofulvin use