Xeljanz

256,614 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

drug ineffective

44,338

pain

26,183

arthralgia

19,939

condition aggravated

19,809

Timeline

Filter by authority:

Status changed: Authorised → Refused

23 Jul 2018

status_changedregulatory

Xeljanz authorised

22 Mar 2017

authorisedregulatory

🇺🇸 Also approved in the US (FDA)

TOFACITINIB — SOMERSET THERAPS LLC, approved 2026-06-03 (ANDA220137).

Most reported adverse events (US / FAERS)

256,614 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

drug ineffective

44,338

pain

26,183

arthralgia

19,939

condition aggravated

19,809

rheumatoid arthritis

19,342

fatigue

17,016

off label use

15,385

joint swelling

14,723

headache

13,651

rash

12,318

drug intolerance

12,134

malaise

10,710

abdominal discomfort

10,526

pain in extremity

10,420

nausea

10,120