Tocilizumab vs Sarilumab: side effects in FDA adverse event reports
At a glance
| Tocilizumab | Sarilumab | |
|---|---|---|
| Drug class | Interleukin-6 Receptor Antagonist | Interleukin-6 Receptor Antagonist |
| Brand names | Actemra, Actemra Actpen | Kevzara |
| FAERS reports | 113,340 | 26,254 |
| Serious | 77% | 42% |
| Death outcome | 12,342 | 2,540 |
| Boxed warning | 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 | Yes RISK OF SERIOUS INFECTIONS Patients treated with KEVZARA are at increased risk for developing serious infections that may lead to hospitalization or death [see |
Signals both drugs share
| Reaction | Tocilizumab | Sarilumab | Label screen (A / B) |
|---|---|---|---|
| Duodenal ulcer perforation | 5,011 · PRR 406.8 | 2,153 · PRR 332.7 | Labeled — boxed warning / Labeled — boxed warning |
| Sleep disorder due to general medical condition, insomnia type | 3,133 · PRR 176.4 | 859 · PRR 123.0 | Labeled (related wording) / Not in label — unassessed |
| Hepatic enzyme | 85 · PRR 291.0 | 35 · PRR 267.4 | Labeled (related wording) / Labeled (related wording) |
| Synovitis | 10,546 · PRR 263.3 | 2,674 · PRR 139.0 | Not in label — unassessed / Not in label — unassessed |
| Pemphigus | 9,201 · PRR 543.9 | 2,812 · PRR 234.0 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 7,961 · PRR 291.7 | 2,745 · PRR 212.5 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 5,103 · PRR 186.7 | 2,051 · PRR 201.5 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 4,662 · PRR 152.9 | 1,448 · PRR 130.3 | Not in label — unassessed / Not in label — unassessed |
| Muscle injury | 4,172 · PRR 192.6 | 1,327 · PRR 154.2 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 3,320 · PRR 607.2 | 1,503 · PRR 421.1 | Likely indication confounding / Likely indication confounding |
| Facet joint syndrome | 1,954 · PRR 306.1 | 867 · PRR 303.9 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,381 · PRR 451.4 | 662 · PRR 408.9 | Not in label — unassessed / Not in label — unassessed |
| Bone erosion | 1,573 · PRR 148.3 | 400 · PRR 101.6 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,043 · PRR 164.1 | 556 · PRR 266.8 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 1,018 · PRR 190.0 | 541 · PRR 293.8 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 807 · PRR 397.8 | 454 · PRR 495.6 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 672 · PRR 124.9 | 356 · PRR 216.8 | Not in label — unassessed / Not in label — unassessed |
| Subcutaneous drug absorption impaired | 218 · PRR 123.6 | 187 · PRR 419.3 | Not in label — unassessed / Not in label — unassessed |
| Swollen joint count | 150 · PRR 292.6 | 81 · PRR 393.5 | Not in label — unassessed / Not in label — unassessed |
| Grip strength | 137 · PRR 270.2 | 76 · PRR 390.9 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Tocilizumab
- None stood out among the strongest labeled signals.
Labeled signals distinctive to Sarilumab
- None stood out among the strongest labeled signals.
Common questions
Which has more reported side effects, Tocilizumab or Sarilumab?
Tocilizumab has 113,340 FAERS reports and Sarilumab 26,254. 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 (77% vs 42%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Tocilizumab and Sarilumab 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 Tocilizumab or Sarilumab 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.