Does PEMBROLIZUMAB Cause Hepatitis? 935 Reports in FDA Database

Q: Does PEMBROLIZUMAB cause Hepatitis?

935 reports of Hepatitis have been filed with the FDA for PEMBROLIZUMAB, representing 1.1% of all PEMBROLIZUMAB adverse event reports.

Q: How dangerous is Hepatitis from PEMBROLIZUMAB?

Of 935 reports, 167 (17.9%) resulted in death and 431 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 935 reports of Hepatitis have been filed in association with PEMBROLIZUMAB (KEYTRUDA). This represents 1.1% of all adverse event reports for PEMBROLIZUMAB.

935

Reports of Hepatitis with PEMBROLIZUMAB

1.1%

of all PEMBROLIZUMAB reports

167

Deaths

431

Hospitalizations

How Dangerous Is Hepatitis From PEMBROLIZUMAB?

Of the 935 reports, 167 (17.9%) resulted in death, 431 (46.1%) required hospitalization, and 79 (8.4%) were considered life-threatening.

Is Hepatitis Listed in the Official Label?

Yes, Hepatitis is listed as a known adverse reaction in the official FDA drug label for PEMBROLIZUMAB.

What Other Side Effects Does PEMBROLIZUMAB Cause?

Malignant neoplasm progression (10,111) Death (4,744) Diarrhoea (4,251) Fatigue (3,833) Off label use (3,416) Product use in unapproved indication (3,191) Pyrexia (3,155) Rash (2,900) Nausea (2,670) Decreased appetite (2,486)

What Other Drugs Cause Hepatitis?

METHOTREXATE (1,835) ACETAMINOPHEN (1,450) TOCILIZUMAB (1,184) HYDROXYCHLOROQUINE (1,133) ADALIMUMAB (1,096) RITUXIMAB (1,017) ETANERCEPT (1,013) LEFLUNOMIDE (997) NIVOLUMAB (930) ABATACEPT (902)

Which PEMBROLIZUMAB Alternatives Have Lower Hepatitis Risk?

PEMBROLIZUMAB vs PEMETREXED PEMBROLIZUMAB vs PEMIGATINIB PEMBROLIZUMAB vs PENICILLAMINE PEMBROLIZUMAB vs PENICILLIN PEMBROLIZUMAB vs PENICILLIN G

PEMBROLIZUMAB Full Profile All Hepatitis Reports All Drugs Causing Hepatitis PEMBROLIZUMAB Demographics