Tofacitinib vs Tocilizumab: side effects in FDA adverse event reports
At a glance
| Tofacitinib | Tocilizumab | |
|---|---|---|
| Drug class | – | Interleukin-6 Receptor Antagonist |
| Brand names | – | Actemra, Actemra Actpen |
| FAERS reports | 183,399 | 113,340 |
| Serious | 48% | 77% |
| Death outcome | 9,244 | 12,342 |
| Boxed warning | Yes SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with tofacitinib tablets are | Yes RISK OF SERIOUS INFECTIONS Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death [see |
Signals both drugs share
| Reaction | Tofacitinib | Tocilizumab | Label screen (A / B) |
|---|---|---|---|
| Duodenal ulcer perforation | 4,332 · PRR 166.2 | 5,011 · PRR 406.8 | Labeled (related wording) / Labeled — boxed warning |
| Sleep disorder due to general medical condition, insomnia type | 2,554 · PRR 75.1 | 3,133 · PRR 176.4 | Not in label — unassessed / Labeled (related wording) |
| Hepatic enzyme | 81 · PRR 158.9 | 85 · PRR 291.0 | Labeled (related wording) / Labeled (related wording) |
| Synovitis | 9,435 · PRR 125.9 | 10,546 · PRR 263.3 | Not in label — unassessed / Not in label — unassessed |
| Pemphigus | 6,427 · PRR 123.0 | 9,201 · PRR 543.9 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 7,050 · PRR 134.5 | 7,961 · PRR 291.7 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 4,568 · PRR 93.0 | 5,103 · PRR 186.7 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 3,673 · PRR 63.0 | 4,662 · PRR 152.9 | Not in label — unassessed / Not in label — unassessed |
| Muscle injury | 3,301 · PRR 76.9 | 4,172 · PRR 192.6 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 2,897 · PRR 228.9 | 3,320 · PRR 607.2 | Likely indication confounding / Likely indication confounding |
| Facet joint syndrome | 1,570 · PRR 113.9 | 1,954 · PRR 306.1 | Not in label — unassessed / Not in label — unassessed |
| Bone erosion | 1,294 · PRR 65.7 | 1,573 · PRR 148.3 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,125 · PRR 155.1 | 1,381 · PRR 451.4 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 941 · PRR 83.8 | 1,043 · PRR 164.1 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 879 · PRR 88.5 | 1,018 · PRR 190.0 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 731 · PRR 184.1 | 807 · PRR 397.8 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 604 · PRR 64.7 | 672 · PRR 124.9 | Not in label — unassessed / Not in label — unassessed |
| Granuloma skin | 445 · PRR 133.4 | 525 · PRR 325.1 | Not in label — unassessed / Not in label — unassessed |
| Subcutaneous drug absorption impaired | 217 · PRR 75.6 | 218 · PRR 123.6 | Not in label — unassessed / Not in label — unassessed |
| Swollen joint count | 128 · PRR 124.5 | 150 · PRR 292.6 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Tofacitinib
- Peripheral venous disease — n=1,297, PRR 54.8 Labeled (related wording)
Labeled signals distinctive to Tocilizumab
- None stood out among the strongest labeled signals.
Common questions
Which has more reported side effects, Tofacitinib or Tocilizumab?
Tofacitinib has 183,399 FAERS reports and Tocilizumab 113,340. 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 77%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Tofacitinib and Tocilizumab share?
Both drugs carry disproportionality signals for duodenal ulcer perforation, sleep disorder due to general medical condition, insomnia type, hepatic enzyme, synovitis, pemphigus. Shared signals often reflect a shared drug class or the condition both are used for.
Is Tofacitinib or Tocilizumab 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.