Does LEFLUNOMIDE Cause Hepatitis? 997 Reports in FDA Database

Q: Does LEFLUNOMIDE cause Hepatitis?

997 reports of Hepatitis have been filed with the FDA for LEFLUNOMIDE, representing 1.8% of all LEFLUNOMIDE adverse event reports.

Q: How dangerous is Hepatitis from LEFLUNOMIDE?

Of 997 reports, 418 (41.9%) resulted in death and 587 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 997 reports of Hepatitis have been filed in association with LEFLUNOMIDE (Leflunomide). This represents 1.8% of all adverse event reports for LEFLUNOMIDE.

997

Reports of Hepatitis with LEFLUNOMIDE

1.8%

of all LEFLUNOMIDE reports

418

Deaths

587

Hospitalizations

How Dangerous Is Hepatitis From LEFLUNOMIDE?

Of the 997 reports, 418 (41.9%) resulted in death, 587 (58.9%) required hospitalization, and 429 (43.0%) were considered life-threatening.