Does NIVOLUMAB Cause Myositis? 682 Reports in FDA Database

Q: Does NIVOLUMAB cause Myositis?

682 reports of Myositis have been filed with the FDA for NIVOLUMAB, representing 0.8% of all NIVOLUMAB adverse event reports.

Q: How dangerous is Myositis from NIVOLUMAB?

Of 682 reports, 238 (34.9%) resulted in death and 455 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 682 reports of Myositis have been filed in association with NIVOLUMAB (OPDIVO). This represents 0.8% of all adverse event reports for NIVOLUMAB.

682

Reports of Myositis with NIVOLUMAB

0.8%

of all NIVOLUMAB reports

238

Deaths

455

Hospitalizations

How Dangerous Is Myositis From NIVOLUMAB?

Of the 682 reports, 238 (34.9%) resulted in death, 455 (66.7%) required hospitalization, and 184 (27.0%) were considered life-threatening.