Does NIVOLUMAB Cause Myocarditis? 959 Reports in FDA Database

Q: Does NIVOLUMAB cause Myocarditis?

959 reports of Myocarditis have been filed with the FDA for NIVOLUMAB, representing 1.1% of all NIVOLUMAB adverse event reports.

Q: How dangerous is Myocarditis from NIVOLUMAB?

Of 959 reports, 369 (38.5%) resulted in death and 614 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 959 reports of Myocarditis have been filed in association with NIVOLUMAB (OPDIVO). This represents 1.1% of all adverse event reports for NIVOLUMAB.

959

Reports of Myocarditis with NIVOLUMAB

1.1%

of all NIVOLUMAB reports

369

Deaths

614

Hospitalizations

How Dangerous Is Myocarditis From NIVOLUMAB?

Of the 959 reports, 369 (38.5%) resulted in death, 614 (64.0%) required hospitalization, and 307 (32.0%) were considered life-threatening.