Tofacitinib vs Upadacitinib: side effects in FDA adverse event reports
At a glance
| Tofacitinib | Upadacitinib | |
|---|---|---|
| Drug class | – | Janus Kinase Inhibitor |
| Brand names | – | Rinvoq |
| FAERS reports | 183,399 | 81,026 |
| Serious | 48% | 68% |
| Death outcome | 9,244 | 3,016 |
| 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, and THROMBOSIS SERIOUS INFECTIONS Patients treated with RINVOQ /RINVOQ LQ are at |
Signals both drugs share
| Reaction | Tofacitinib | Upadacitinib | Label screen (A / B) |
|---|---|---|---|
| Subcutaneous drug absorption impaired | 217 · PRR 75.6 | 105 · PRR 61.7 | Not in label — unassessed / Not in label — unassessed |
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 Upadacitinib
- Ileostomy — n=288, PRR 33.2 Labeled adverse reaction
- Eczema herpeticum — n=83, PRR 57.7 Labeled adverse reaction
- Small intestinal resection — n=66, PRR 15.6 Labeled (related wording)
- Disease risk factor — n=31, PRR 22.1 Labeled (related wording)
Common questions
Which has more reported side effects, Tofacitinib or Upadacitinib?
Tofacitinib has 183,399 FAERS reports and Upadacitinib 81,026. 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 68%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Tofacitinib and Upadacitinib share?
Both drugs carry disproportionality signals for subcutaneous drug absorption impaired. Shared signals often reflect a shared drug class or the condition both are used for.
Is Tofacitinib or Upadacitinib 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.