Methotrexate vs Sarilumab: side effects in FDA adverse event reports
At a glance
| Methotrexate | Sarilumab | |
|---|---|---|
| Drug class | – | Interleukin-6 Receptor Antagonist |
| Brand names | – | Kevzara |
| FAERS reports | 483,097 | 26,254 |
| Serious | 73% | 42% |
| Death outcome | 37,640 | 2,540 |
| Boxed warning | Yes WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, BENZYL ALCOHOL TOXICITY, and OTHER SERIOUS ADVERSE REACTIONS • Methotrexate Injection can cause embr | 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 | Methotrexate | Sarilumab | Label screen (A / B) |
|---|---|---|---|
| Pericarditis | 6,863 · PRR 30.0 | 2,683 · PRR 153.4 | Labeled adverse reaction / Not in label — unassessed |
| Duodenal ulcer perforation | 5,067 · PRR 97.3 | 2,153 · PRR 332.7 | Labeled (related wording) / Labeled — boxed warning |
| Bone erosion | 2,084 · PRR 61.7 | 400 · PRR 101.6 | Labeled (related wording) / Not in label — unassessed |
| Synovitis | 13,569 · PRR 133.8 | 2,674 · PRR 139.0 | Not in label — unassessed / Not in label — unassessed |
| Pemphigus | 9,382 · PRR 135.9 | 2,812 · PRR 234.0 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 8,885 · PRR 92.3 | 2,745 · PRR 212.5 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 5,277 · PRR 46.1 | 2,051 · PRR 201.5 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 5,035 · PRR 40.8 | 1,448 · PRR 130.3 | Not in label — unassessed / Not in label — unassessed |
| Muscle injury | 4,306 · PRR 47.5 | 1,327 · PRR 154.2 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 3,282 · PRR 133.3 | 1,503 · PRR 421.1 | Likely indication confounding / Likely indication confounding |
| Sleep disorder due to general medical condition, insomnia type | 3,191 · PRR 42.2 | 859 · PRR 123.0 | Not in label — unassessed / Not in label — unassessed |
| Facet joint syndrome | 1,964 · PRR 71.6 | 867 · PRR 303.9 | Not in label — unassessed / Not in label — unassessed |
| Peripheral venous disease | 1,635 · PRR 29.6 | 693 · PRR 167.9 | Not in label — unassessed / Likely indication confounding |
| Deep vein thrombosis postoperative | 1,372 · PRR 101.8 | 662 · PRR 408.9 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,211 · PRR 51.4 | 556 · PRR 266.8 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 1,109 · PRR 52.7 | 541 · PRR 293.8 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 867 · PRR 117.7 | 454 · PRR 495.6 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 790 · PRR 38.5 | 356 · PRR 216.8 | Not in label — unassessed / Not in label — unassessed |
| Seronegative arthritis | 555 · PRR 42.0 | 139 · PRR 112.9 | Likely indication confounding / Likely indication confounding |
Labeled signals distinctive to Methotrexate
- Lymphoproliferative disorder — n=1,503, PRR 44.9 Labeled (related wording)
- Rheumatoid lung — n=451, PRR 37.7 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, Methotrexate or Sarilumab?
Methotrexate has 483,097 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 (73% vs 42%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Methotrexate and Sarilumab share?
Both drugs carry disproportionality signals for pericarditis, duodenal ulcer perforation, bone erosion, synovitis, pemphigus. Shared signals often reflect a shared drug class or the condition both are used for.
Is Methotrexate 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.