KEYTRUDA (pembrolizumab) - Risk of Severe Skin Reactions: Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis

Cases of SJS and TEN have been reported internationally in the clinical trials and post-marketing setting. There were 8 cases of SJS (1 of them with a fatal outcome) and 2 cases of TEN (1 of them with a fatal outcome). Of these reports, one case of SJS was reported in Canada.