Does PEMBROLIZUMAB Cause Myositis? 596 Reports in FDA Database

Q: Does PEMBROLIZUMAB cause Myositis?

596 reports of Myositis have been filed with the FDA for PEMBROLIZUMAB, representing 0.7% of all PEMBROLIZUMAB adverse event reports.

Q: How dangerous is Myositis from PEMBROLIZUMAB?

Of 596 reports, 172 (28.9%) resulted in death and 362 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 596 reports of Myositis have been filed in association with PEMBROLIZUMAB (KEYTRUDA). This represents 0.7% of all adverse event reports for PEMBROLIZUMAB.

596

Reports of Myositis with PEMBROLIZUMAB

0.7%

of all PEMBROLIZUMAB reports

172

Deaths

362

Hospitalizations

How Dangerous Is Myositis From PEMBROLIZUMAB?

Of the 596 reports, 172 (28.9%) resulted in death, 362 (60.7%) required hospitalization, and 108 (18.1%) were considered life-threatening.