Adalimumab vs Tofacitinib: side effects in FDA adverse event reports
At a glance
| Adalimumab | Tofacitinib | |
|---|---|---|
| Drug class | – | – |
| Brand names | Humira | – |
| FAERS reports | 703,389 | 183,399 |
| Serious | 51% | 48% |
| Death outcome | 30,045 | 9,244 |
| Boxed warning | Yes WARNING: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with HUMIRA are at increased risk for developing serious infections that may lead | Yes SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with tofacitinib tablets are |
Signals both drugs share
| Reaction | Adalimumab | Tofacitinib | Label screen (A / B) |
|---|---|---|---|
| Synovitis | 11,430 · PRR 50.9 | 9,435 · PRR 125.9 | Labeled adverse reaction / Not in label — unassessed |
| Duodenal ulcer perforation | 4,928 · PRR 60.4 | 4,332 · PRR 166.2 | Labeled (related wording) / Labeled (related wording) |
| Muscle injury | 3,785 · PRR 24.9 | 3,301 · PRR 76.9 | Labeled (related wording) / Not in label — unassessed |
| Granuloma skin | 539 · PRR 54.9 | 445 · PRR 133.4 | Labeled (related wording) / Not in label — unassessed |
| Pemphigus | 9,240 · PRR 86.7 | 6,427 · PRR 123.0 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 8,490 · PRR 54.5 | 7,050 · PRR 134.5 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 5,291 · PRR 31.5 | 4,568 · PRR 93.0 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 4,615 · PRR 23.5 | 3,673 · PRR 63.0 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 3,220 · PRR 83.8 | 2,897 · PRR 228.9 | Likely indication confounding / Likely indication confounding |
| Facet joint syndrome | 1,918 · PRR 45.6 | 1,570 · PRR 113.9 | Not in label — unassessed / Not in label — unassessed |
| Bone erosion | 2,023 · PRR 39.0 | 1,294 · PRR 65.7 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,428 · PRR 79.9 | 1,125 · PRR 155.1 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,248 · PRR 37.4 | 941 · PRR 83.8 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 1,172 · PRR 40.7 | 879 · PRR 88.5 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 888 · PRR 87.9 | 731 · PRR 184.1 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 809 · PRR 27.4 | 604 · PRR 64.7 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Adalimumab
- Injection site papule — n=3,181, PRR 70.5 Labeled (related wording)
- Rheumatoid nodule — n=1,249, PRR 23.7 Labeled (related wording)
- Injection site burning — n=562, PRR 73.3 Labeled (related wording)
Labeled signals distinctive to Tofacitinib
- Peripheral venous disease — n=1,297, PRR 54.8 Labeled (related wording)
- Hepatic enzyme — n=81, PRR 158.9 Labeled (related wording)
Common questions
Which has more reported side effects, Adalimumab or Tofacitinib?
Adalimumab has 703,389 FAERS reports and Tofacitinib 183,399. 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 (51% vs 48%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Adalimumab and Tofacitinib share?
Both drugs carry disproportionality signals for synovitis, duodenal ulcer perforation, muscle injury, granuloma skin, pemphigus. Shared signals often reflect a shared drug class or the condition both are used for.
Is Adalimumab or Tofacitinib 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.