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U.S. Department of Health and Human Services


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Demadex (torsemide) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2010 and August 2012


August 2012

Summary View



Postmarketing Experience
  • Pancreatitis has been reported in association with torsemide use…


January 2010 

Summary View




  • The following adverse reactions have been identified during the post approval use of the Demadex. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions reported include the following: leukopenia, thrombocytopenia.
  • Serious skin reactions (i.e., Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported in association with torsemide use.