Prednisone vs Sarilumab: side effects in FDA adverse event reports
At a glance
| Prednisone | Sarilumab | |
|---|---|---|
| Drug class | Corticosteroid | Interleukin-6 Receptor Antagonist |
| Brand names | – | Kevzara |
| FAERS reports | 499,794 | 26,254 |
| Serious | 79% | 42% |
| Death outcome | 52,153 | 2,540 |
| Boxed warning | No | 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 | Prednisone | Sarilumab | Label screen (A / B) |
|---|---|---|---|
| Duodenal ulcer perforation | 4,860 · PRR 82.3 | 2,153 · PRR 332.7 | Labeled (related wording) / Labeled — boxed warning |
| Pemphigus | 9,174 · PRR 119.7 | 2,812 · PRR 234.0 | Likely indication confounding / Not in label — unassessed |
| Synovitis | 8,900 · PRR 40.3 | 2,674 · PRR 139.0 | Likely indication confounding / Not in label — unassessed |
| Glossodynia | 8,626 · PRR 25.9 | 2,711 · PRR 110.2 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 7,949 · PRR 64.7 | 2,745 · PRR 212.5 | Not in label — unassessed / Not in label — unassessed |
| Pericarditis | 6,736 · PRR 28.0 | 2,683 · PRR 153.4 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 5,030 · PRR 40.4 | 2,051 · PRR 201.5 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 4,563 · PRR 32.7 | 1,448 · PRR 130.3 | Not in label — unassessed / Not in label — unassessed |
| Muscle injury | 4,043 · PRR 40.2 | 1,327 · PRR 154.2 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 3,108 · PRR 104.3 | 1,503 · PRR 421.1 | Likely indication confounding / Likely indication confounding |
| Sleep disorder due to general medical condition, insomnia type | 3,038 · PRR 37.0 | 859 · PRR 123.0 | Not in label — unassessed / Not in label — unassessed |
| Facet joint syndrome | 1,801 · PRR 55.5 | 867 · PRR 303.9 | Not in label — unassessed / Not in label — unassessed |
| Peripheral venous disease | 1,457 · PRR 23.7 | 693 · PRR 167.9 | Not in label — unassessed / Likely indication confounding |
| Deep vein thrombosis postoperative | 1,287 · PRR 80.1 | 662 · PRR 408.9 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,083 · PRR 39.3 | 556 · PRR 266.8 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 1,072 · PRR 47.2 | 541 · PRR 293.8 | Not in label — unassessed / Not in label — unassessed |
| Bone erosion | 1,189 · PRR 20.8 | 400 · PRR 101.6 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 814 · PRR 91.1 | 454 · PRR 495.6 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 721 · PRR 31.4 | 356 · PRR 216.8 | Likely indication confounding / Not in label — unassessed |
Labeled signals distinctive to Prednisone
- Nocardiosis — n=888, PRR 21.9 Labeled (related wording)
- Steroid diabetes — n=492, PRR 21.0 Labeled (related wording)
- Secondary immunodeficiency — n=420, PRR 22.4 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, Prednisone or Sarilumab?
Prednisone has 499,794 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 (79% vs 42%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Prednisone and Sarilumab share?
Both drugs carry disproportionality signals for duodenal ulcer perforation, pemphigus, synovitis, glossodynia, hand deformity. Shared signals often reflect a shared drug class or the condition both are used for.
Is Prednisone 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.