Tofacitinib vs Baricitinib: side effects in FDA adverse event reports
At a glance
| Tofacitinib | Baricitinib | |
|---|---|---|
| Drug class | – | Janus Kinase Inhibitor |
| Brand names | – | Olumiant |
| FAERS reports | 183,399 | 9,584 |
| Serious | 48% | 69% |
| Death outcome | 9,244 | 877 |
| Boxed warning | Yes SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with tofacitinib tablets are | Yes SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR |
Signals both drugs share
No strong shared signal after removing coding and lab terms.
Labeled signals distinctive to Tofacitinib
- Duodenal ulcer perforation — n=4,332, PRR 166.2 Labeled (related wording)
- Peripheral venous disease — n=1,297, PRR 54.8 Labeled (related wording)
- Hepatic enzyme — n=81, PRR 158.9 Labeled (related wording)
Labeled signals distinctive to Baricitinib
- Covid-19 pneumonia — n=96, PRR 17.8 Labeled adverse reaction
- Thrombocytosis — n=43, PRR 26.1 Labeled adverse reaction
- Diverticulitis intestinal perforated — n=23, PRR 165.4 Labeled (related wording)
- Ophthalmic herpes zoster — n=19, PRR 23.5 Labeled (related wording)
- Eczema herpeticum — n=13, PRR 64.3 Labeled adverse reaction
- Smoke sensitivity — n=10, PRR 73.9 Labeled (related wording)
Common questions
Which has more reported side effects, Tofacitinib or Baricitinib?
Tofacitinib has 183,399 FAERS reports and Baricitinib 9,584. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (48% vs 69%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Tofacitinib and Baricitinib share?
They share no strong flagged signal after artifacts and lab terms are removed.
Is Tofacitinib or Baricitinib safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.