Abatacept vs Tocilizumab: side effects in FDA adverse event reports
At a glance
| Abatacept | Tocilizumab | |
|---|---|---|
| Drug class | Selective T Cell Costimulation Modulator | Interleukin-6 Receptor Antagonist |
| Brand names | Orencia | Actemra, Actemra Actpen |
| FAERS reports | 137,367 | 113,340 |
| Serious | 60% | 77% |
| Death outcome | 9,239 | 12,342 |
| Boxed warning | No | 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 | Abatacept | Tocilizumab | Label screen (A / B) |
|---|---|---|---|
| Duodenal ulcer perforation | 4,534 · PRR 249.6 | 5,011 · PRR 406.8 | Not in label — unassessed / Labeled — boxed warning |
| Sleep disorder due to general medical condition, insomnia type | 2,944 · PRR 128.9 | 3,133 · PRR 176.4 | Not in label — unassessed / Labeled (related wording) |
| Hepatic enzyme | 83 · PRR 225.3 | 85 · PRR 291.0 | Not in label — unassessed / Labeled (related wording) |
| Synovitis | 10,370 · PRR 208.0 | 10,546 · PRR 263.3 | Not in label — unassessed / Not in label — unassessed |
| Pemphigus | 8,847 · PRR 385.9 | 9,201 · PRR 543.9 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 7,748 · PRR 224.0 | 7,961 · PRR 291.7 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 4,729 · PRR 132.4 | 5,103 · PRR 186.7 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 4,372 · PRR 112.1 | 4,662 · PRR 152.9 | Not in label — unassessed / Not in label — unassessed |
| Muscle injury | 3,966 · PRR 143.2 | 4,172 · PRR 192.6 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 2,990 · PRR 337.7 | 3,320 · PRR 607.2 | Likely indication confounding / Likely indication confounding |
| Facet joint syndrome | 1,671 · PRR 173.1 | 1,954 · PRR 306.1 | Not in label — unassessed / Not in label — unassessed |
| Bone erosion | 1,361 · PRR 95.1 | 1,573 · PRR 148.3 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,171 · PRR 228.5 | 1,381 · PRR 451.4 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,010 · PRR 127.1 | 1,043 · PRR 164.1 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 935 · PRR 132.3 | 1,018 · PRR 190.0 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 763 · PRR 276.5 | 807 · PRR 397.8 | Not in label — unassessed / Not in label — unassessed |
| Granuloma skin | 504 · PRR 239.6 | 525 · PRR 325.1 | Not in label — unassessed / Not in label — unassessed |
| Presbyacusis | 147 · PRR 137.2 | 147 · PRR 166.7 | Not in label — unassessed / Not in label — unassessed |
| Swollen joint count | 122 · PRR 150.5 | 150 · PRR 292.6 | Not in label — unassessed / Not in label — unassessed |
| Grip strength | 134 · PRR 210.6 | 137 · PRR 270.2 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Abatacept
- None stood out among the strongest labeled signals.
Labeled signals distinctive to Tocilizumab
- None stood out among the strongest labeled signals.
Common questions
Which has more reported side effects, Abatacept or Tocilizumab?
Abatacept has 137,367 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 (60% vs 77%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Abatacept 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 Abatacept 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.