Monitoring the safety of medicines used off-label

Clin Pharmacol Ther. 2012 May;91(5):787-95. doi: 10.1038/clpt.2012.24.


Off-label use of medicines is common. Because many off-label uses have not been carefully studied, it is important that postmarketing drug safety systems be able to identify, assess, and monitor adverse events that occur in the off-label setting. The full range of postmarketing surveillance and analysis tools can be utilized to study the adverse effects of medicines used off-label.

Publication types

  • Review

MeSH terms

  • Adverse Drug Reaction Reporting Systems
  • Drug-Related Side Effects and Adverse Reactions*
  • Humans
  • Off-Label Use*