Does TOFACITINIB Cause Hepatitis? 505 Reports in FDA Database

Q: Does TOFACITINIB cause Hepatitis?

505 reports of Hepatitis have been filed with the FDA for TOFACITINIB, representing 0.3% of all TOFACITINIB adverse event reports.

Q: How dangerous is Hepatitis from TOFACITINIB?

Of 505 reports, 251 (49.7%) resulted in death and 362 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 505 reports of Hepatitis have been filed in association with TOFACITINIB (XELJANZ XR). This represents 0.3% of all adverse event reports for TOFACITINIB.

505

Reports of Hepatitis with TOFACITINIB

0.3%

of all TOFACITINIB reports

251

Deaths

362

Hospitalizations

How Dangerous Is Hepatitis From TOFACITINIB?

Of the 505 reports, 251 (49.7%) resulted in death, 362 (71.7%) required hospitalization, and 265 (52.5%) were considered life-threatening.

Is Hepatitis Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for TOFACITINIB. However, 505 reports have been filed with the FAERS database.

What Other Side Effects Does TOFACITINIB Cause?

Drug ineffective (30,382) Pain (21,659) Condition aggravated (16,925) Arthralgia (15,640) Fatigue (13,551) Rheumatoid arthritis (12,277) Off label use (11,736) Headache (11,061) Joint swelling (10,686) Malaise (9,040)

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) PEMBROLIZUMAB (935) NIVOLUMAB (930)

Which TOFACITINIB Alternatives Have Lower Hepatitis Risk?

TOFACITINIB vs TOFERSEN TOFACITINIB vs TOLNAFTATE TOFACITINIB vs TOLODODEKIN ALFA TOFACITINIB vs TOLTERODINE TOFACITINIB vs TOLVAPTAN

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