Label Changes for:
Demadex (Torsemide) Tablets
August 2012
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 2010 and August 2012
August 2012
ADVERSE REACTIONS
Postmarketing Experience
- Pancreatitis has been reported in association with torsemide use…
January 2010
ADVERSE REACTIONS
Post-Marketing
- 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.
