Adalimumab vs Sarilumab: side effects in FDA adverse event reports
At a glance
| Adalimumab | Sarilumab | |
|---|---|---|
| Drug class | – | Interleukin-6 Receptor Antagonist |
| Brand names | Humira | Kevzara |
| FAERS reports | 703,389 | 26,254 |
| Serious | 51% | 42% |
| Death outcome | 30,045 | 2,540 |
| 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 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 | Adalimumab | Sarilumab | Label screen (A / B) |
|---|---|---|---|
| Synovitis | 11,430 · PRR 50.9 | 2,674 · PRR 139.0 | Labeled adverse reaction / Not in label — unassessed |
| Duodenal ulcer perforation | 4,928 · PRR 60.4 | 2,153 · PRR 332.7 | Labeled (related wording) / Labeled — boxed warning |
| Muscle injury | 3,785 · PRR 24.9 | 1,327 · PRR 154.2 | Labeled (related wording) / Not in label — unassessed |
| Pemphigus | 9,240 · PRR 86.7 | 2,812 · PRR 234.0 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 8,490 · PRR 54.5 | 2,745 · PRR 212.5 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 5,291 · PRR 31.5 | 2,051 · PRR 201.5 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 4,615 · PRR 23.5 | 1,448 · PRR 130.3 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 3,220 · PRR 83.8 | 1,503 · PRR 421.1 | Likely indication confounding / Likely indication confounding |
| Facet joint syndrome | 1,918 · PRR 45.6 | 867 · PRR 303.9 | Not in label — unassessed / Not in label — unassessed |
| Bone erosion | 2,023 · PRR 39.0 | 400 · PRR 101.6 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,428 · PRR 79.9 | 662 · PRR 408.9 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,248 · PRR 37.4 | 556 · PRR 266.8 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 1,172 · PRR 40.7 | 541 · PRR 293.8 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 888 · PRR 87.9 | 454 · PRR 495.6 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 809 · PRR 27.4 | 356 · PRR 216.8 | 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)
- Granuloma skin — n=539, PRR 54.9 Labeled (related wording)
Labeled signals distinctive to Sarilumab
- Hepatic enzyme — n=35, PRR 267.4 Labeled (related wording)
Common questions
Which has more reported side effects, Adalimumab or Sarilumab?
Adalimumab has 703,389 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 (51% vs 42%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Adalimumab and Sarilumab share?
Both drugs carry disproportionality signals for synovitis, duodenal ulcer perforation, muscle injury, pemphigus, hand deformity. Shared signals often reflect a shared drug class or the condition both are used for.
Is Adalimumab 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.