Drug · FAERS side-effect profile with label screen
Sarilumab side effects: what 26,254 FDA adverse event reports show
Drug class
Interleukin-6 Receptor Antagonist
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Kevzara
openFDA label
Who reports
26,254 reports · 42% serious · 2,540 with death outcome · 83% female
openFDA FAERS counts, all years, deduplication not applied
Used for
KEVZARA ® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).
FDA label, Indications and Usage
What it is
Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture.
FDA label, Description section
Boxed warning
RISK OF SERIOUS INFECTIONS Patients treated with KEVZARA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ]. Opportunistic infections have also been reported in patients receiving KEVZARA.
FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled — boxed warning 1Labeled (related wording) 1Likely indication confounding 4Lab value / disease marker 7Not in label — unassessed 27
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 985 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Swollen joint count increased | 1,220 | 516.5 481.0–554.6ROR 541.6 · calibrated p 3e-14 ✓ | 310.7 EB05 296.3 · IC025 +8.0 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Lab value / disease marker | serious n=1,134 · 91% clinician | not reported in cached trials |
| Lupus vulgaris | 454 | 495.6 440.9–557.0ROR 504.3 · calibrated p 6e-14 ✓ | 300.6 EB05 278.1 · IC025 +7.7 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.2) | Not in label — unassessed | serious n=454 · 94% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 2,582 | 458.4 437.3–480.4ROR 508.3 · calibrated p 5e-14 ✓ | 289.4 EB05 280.2 · IC025 +8.0 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Lab value / disease marker | serious PRR 400.5 · 91% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 232 | 427.6 364.6–501.5ROR 431.4 · calibrated p 4e-13 ✓ | 271.2 EB05 243.2 · IC025 +7.2 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Lab value / disease marker | serious n=232 · 92% clinician | not reported in cached trials |
| Rheumatic fever | 1,503 | 421.1 396.0–447.8ROR 446.6 · calibrated p 2e-13 ✓ | 273.7 EB05 262.3 · IC025 +7.9 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Likely indication confounding shares a disease stem with the indications wording | serious n=1,502 · 93% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 187 | 419.3 351.3–500.5ROR 422.3 · calibrated p 5e-13 ✓ | 266.4 EB05 235.9 · IC025 +7.1 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.2 (0.2–0.3) | Not in label — unassessed | serious n=187 · 98% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 662 | 408.9 372.6–448.9ROR 419.5 · calibrated p 4e-13 ✓ | 267.4 EB05 250.7 · IC025 +7.7 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | serious n=662 · 90% clinician | not reported in cached trials |
| Rheumatoid factor positive | 1,944 | 407.9 386.7–430.2ROR 440.4 · calibrated p 2e-13 ✓ | 268.3 EB05 258.4 · IC025 +7.9 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Lab value / disease marker | serious n=1,942 · 91% clinician | not reported in cached trials |
| C-reactive protein | 299 | 394.2 343.2–452.6ROR 398.7 · calibrated p 7e-13 ✓ | 258.6 EB05 234.9 · IC025 +7.3 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Lab value / disease marker | serious n=299 · 94% clinician | not reported in cached trials |
| Swollen joint count | 81 | 393.5 301.5–513.6ROR 394.7 · calibrated p 2e-12 ✓ | 247.4 EB05 205.4 · IC025 +6.3 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.2) | Not in label — unassessed | serious n=81 · 94% clinician | not reported in cached trials |
| Grip strength | 76 | 390.9 297.0–514.6ROR 392.1 · calibrated p 2e-12 ✓ | 245.4 EB05 202.5 · IC025 +6.2 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.2) | Not in label — unassessed | serious n=76 · 93% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 2,153 | 332.7 316.8–349.4ROR 362.3 · calibrated p 2e-12 ✓ | 233.7 EB05 225.5 · IC025 +7.7 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Labeled — boxed warning synonym match | serious PRR 321.9 · 92% clinician | not reported in cached trials |
| Facet joint syndrome | 867 | 303.9 281.3–328.4ROR 314.3 · calibrated p 6e-12 ✓ | 218.5 EB05 206.5 · IC025 +7.5 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | serious n=867 · 95% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 541 | 293.8 266.4–324.1ROR 300.0 · calibrated p 1e-11 ✓ | 212.6 EB05 198.0 · IC025 +7.3 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.2) | Not in label — unassessed | serious n=540 · 95% clinician | not reported in cached trials |
| Hepatic enzyme | 35 | 267.4 182.3–392.3ROR 267.8 · calibrated p 1e-10 ✓ | 180.3 EB05 135.5 · IC025 +5.2 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.2) | Labeled (related wording) related wording | serious n=35 · 100% clinician | NCT04315298: 1/92 (1.1%) on Sarilumab (serious AE) |
| Dislocation of vertebra | 556 | 266.8 242.5–293.5ROR 272.6 · calibrated p 3e-11 ✓ | 198.2 EB05 184.7 · IC025 +7.3 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.2) | Not in label — unassessed | serious n=556 · 94% clinician | not reported in cached trials |
| X-ray abnormal | 431 | 254.8 228.8–283.9ROR 259.1 · calibrated p 4e-11 ✓ | 191.1 EB05 176.5 · IC025 +7.1 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Lab value / disease marker | serious n=431 · 97% clinician | not reported in cached trials |
| Pemphigus | 2,812 | 234.0 224.7–243.6ROR 261.9 · calibrated p 3e-11 ✓ | 180.4 EB05 174.8 · IC025 +7.4 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | serious PRR 249.3 · 91% clinician | not reported in cached trials |
| Retinitis | 356 | 216.8 193.0–243.7ROR 219.8 · calibrated p 2e-10 ✓ | 168.7 EB05 154.5 · IC025 +6.9 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.2) | Not in label — unassessed | serious n=356 · 94% clinician | not reported in cached trials |
| Hand deformity | 2,745 | 212.5 204.1–221.2ROR 237.1 · calibrated p 9e-11 ✓ | 167.3 EB05 162.1 · IC025 +7.3 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | serious PRR 249.8 · 90% clinician | not reported in cached trials |
| Helicobacter infection | 2,051 | 201.5 192.2–211.2ROR 218.5 · calibrated p 2e-10 ✓ | 160.4 EB05 154.6 · IC025 +7.2 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | serious PRR 233.3 · 92% clinician | not reported in cached trials |
| Peripheral venous disease | 693 | 167.9 154.8–182.0ROR 172.4 · calibrated p 1e-9 ✓ | 138.0 EB05 129.6 · IC025 +6.9 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Likely indication confounding shares a disease stem with the indications wording | serious n=693 · 95% clinician | not reported in cached trials |
| Hypocholesterolaemia | 53 | 166.2 123.6–223.4ROR 166.5 · calibrated p 4e-9 ✓ | 131.0 EB05 104.0 · IC025 +5.5 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.2 (0.1–0.3) | Not in label — unassessed | serious n=53 · 96% clinician | not reported in cached trials |
| Muscle injury | 1,327 | 154.2 145.5–163.3ROR 162.3 · calibrated p 2e-9 ✓ | 128.8 EB05 123.1 · IC025 +6.9 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | serious PRR 192.4 · 94% clinician | not reported in cached trials |
| Pericarditis | 2,683 | 153.4 147.5–159.6ROR 170.8 · calibrated p 2e-9 ✓ | 128.4 EB05 124.4 · IC025 +6.9 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | serious PRR 178.4 · 92% clinician | not reported in cached trials |
| Tender joint count | 13 | 144.1 79.8–260.3ROR 144.2 · calibrated p 8e-8 ✓ | 103.8 EB05 64.6 · IC025 +3.5 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: only this drug | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Synovitis | 2,674 | 139.0 133.7–144.6ROR 154.7 · calibrated p 4e-9 ✓ | 118.2 EB05 114.5 · IC025 +6.8 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | serious PRR 170.3 | not reported in cached trials |
| Overlap syndrome | 102 | 138.6 112.4–171.1ROR 139.2 · calibrated p 1e-8 ✓ | 115.5 EB05 97.9 · IC025 +5.9 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.2 (0.2–0.3) | Not in label — unassessed | serious n=102 · 91% clinician | not reported in cached trials |
| Folliculitis | 1,448 | 130.3 123.4–137.5ROR 137.8 · calibrated p 9e-9 ✓ | 111.8 EB05 107.0 · IC025 +6.7 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | serious PRR 180.9 · 93% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 859 | 123.0 114.6–132.0ROR 127.1 · calibrated p 2e-8 ✓ | 106.3 EB05 100.4 · IC025 +6.5 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | serious n=857 · 92% clinician | not reported in cached trials |
| Nonalcoholic fatty liver disease | 26 | 120.4 79.7–181.8ROR 120.5 · calibrated p 9e-8 ✓ | 97.3 EB05 69.7 · IC025 +4.5 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=26 · 100% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, hypersomnia type | 13 | 119.0 66.4–213.1ROR 119.0 · calibrated p 3e-7 ✓ | 90.2 EB05 56.1 · IC025 +3.5 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: only this drug | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Seronegative arthritis | 139 | 112.9 94.5–134.8ROR 113.5 · calibrated p 5e-8 ✓ | 97.6 EB05 84.7 · IC025 +5.9 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Likely indication confounding shares a disease stem with the indications wording | serious n=139 · 92% clinician | not reported in cached trials |
| Glossodynia (burning tongue/mouth pain) | 2,711 | 110.2 106.1–114.6ROR 122.8 · calibrated p 2e-8 ✓ | 96.8 EB05 93.7 · IC025 +6.5 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | serious PRR 192.2 · 91% clinician | not reported in cached trials |
| C-reactive protein abnormal | 751 | 106.1 98.4–114.3ROR 109.1 · calibrated p 6e-8 ✓ | 93.4 EB05 87.9 · IC025 +6.3 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.0–0.1) | Lab value / disease marker | serious n=750 · 94% clinician | not reported in cached trials |
| Breast cancer stage iii | 751 | 105.5 97.9–113.8ROR 108.6 · calibrated p 6e-8 ✓ | 93.0 EB05 87.5 · IC025 +6.3 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | serious n=751 · 95% clinician | not reported in cached trials |
| Bone erosion | 400 | 101.6 91.7–112.7ROR 103.2 · calibrated p 9e-8 ✓ | 89.8 EB05 82.6 · IC025 +6.2 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | serious n=399 · 96% clinician | not reported in cached trials |
| Activities of daily living decreased | 52 | 92.0 69.0–122.5ROR 92.1 · calibrated p 4e-7 ✓ | 80.1 EB05 63.4 · IC025 +5.1 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: only this drug | Not in label — unassessed | serious n=8 | not reported in cached trials |
| Onychomadesis | 393 | 83.4 75.2–92.5ROR 84.7 · calibrated p 4e-7 ✓ | 75.2 EB05 69.2 · IC025 +5.9 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | serious n=393 · 94% clinician | not reported in cached trials |
| Wound | 2,619 | 83.0 79.9–86.3ROR 92.1 · calibrated p 2e-7 ✓ | 75.2 EB05 72.8 · IC025 +6.1 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | age-adj. PRR 65.6 · serious PRR 122.3 · 90% clinician | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Liver injury | 3,652 | 9.89.5–10.1 | signal |
| Interstitial lung disease | 814 | 6.86.4–7.3 | signal |
| Hyperglycaemia / diabetes | 1,804 | 4.24.0–4.4 | signal |
| Serious infection | 3,030 | 3.13.0–3.2 | signal |
| Depression | 1,048 | 3.02.8–3.2 | signal |
| Rhabdomyolysis / myopathy | 212 | 2.11.8–2.4 | raised |
| Pancreatitis | 156 | 1.51.3–1.8 | raised |
| Opportunistic infection | 229 | 1.31.2–1.5 | raised |
| Fall / fracture | 531 | 1.11.0–1.2 | raised |
| Tendon disorder | 44 | 0.90.7–1.2 | no difference |
| Neutropenia / agranulocytosis | 251 | 0.80.7–0.9 | lower than other drugs |
| Gi bleeding | 172 | 0.80.6–0.9 | lower than other drugs |
| Thrombocytopenia | 205 | 0.70.6–0.9 | lower than other drugs |
| Anaphylaxis / angioedema | 93 | 0.60.5–0.7 | lower than other drugs |
| Venous thromboembolism | 119 | 0.40.4–0.5 | lower than other drugs |
| Malignancy | 205 | 0.40.4–0.5 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Sarilumab as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (1 of 40 signal terms matched).
- NCT04315298 — Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19 (N=1912, PHASE2, PHASE3; 303 AE terms posted; arms: Phase 2: Placebo; Phase 2: Sarilumab 200mg IV; Phase 2: Sarilumab 400mg IV; Phase 3 Cohort 1: Placebo - Critical)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 6,058 | 3.7 3.6–3.8ROR 4.5 · calibrated p 0.297 | 3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.0 (0.0–0.0) | Reporting / coding artifact | age-adj. PRR 4.1 · serious PRR 8.1 | not reported in cached trials |
| Pain | 5,975 | 7.8 7.6–8.0ROR 9.8 · calibrated p 0.034 ✓ | 7.8 EB05 7.6 · IC025 +2.9 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | age-adj. PRR 7.5 · serious PRR 10.3 | NCT04315298: 1/137 (0.7%) on Sarilumab (serious AE) |
| Arthralgia (joint pain) | 5,168 | 10.1 9.8–10.3ROR 12.3 · calibrated p 0.015 ✓ | 10.0 EB05 9.7 · IC025 +3.3 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | age-adj. PRR 9.1 · serious PRR 14.4 | not reported in cached trials |
| Rheumatoid arthritis | 4,646 | 34.2 33.3–35.1ROR 41.3 · calibrated p 4e-5 ✓ | 32.8 EB05 32.0 · IC025 +5.0 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 29.8 · serious PRR 54.9 | not reported in cached trials |
| Joint swelling | 4,578 | 31.5 30.7–32.4ROR 38.0 · calibrated p 7e-5 ✓ | 30.3 EB05 29.6 · IC025 +4.9 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | age-adj. PRR 25.9 · serious PRR 50.9 | not reported in cached trials |
| Condition aggravated | 3,764 | 10.1 9.8–10.4ROR 11.6 · calibrated p 0.019 ✓ | 9.9 EB05 9.7 · IC025 +3.3 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Reporting / coding artifact | age-adj. PRR 8.7 · serious PRR 14.9 | not reported in cached trials |
| Fatigue (tiredness) | 3,555 | 3.7 3.6–3.8ROR 4.1 · calibrated p 0.362 | 3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Labeled adverse reaction exact term | age-adj. PRR 3.0 · serious PRR 8.0 | not reported in cached trials |
| Rash | 3,349 | 6.2 6.0–6.4ROR 7.0 · calibrated p 0.100 | 6.2 EB05 6.0 · IC025 +2.6 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Labeled adverse reaction exact term | age-adj. PRR 5.3 · serious PRR 15.9 | not reported in cached trials |
| Alopecia (hair loss) | 3,073 | 12.7 12.2–13.1ROR 14.2 · calibrated p 0.009 ✓ | 12.5 EB05 12.1 · IC025 +3.6 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | age-adj. PRR 10.6 · serious PRR 34.7 | not reported in cached trials |
| Abdominal discomfort | 3,007 | 14.6 14.1–15.1ROR 16.4 · calibrated p 0.005 ✓ | 14.4 EB05 13.9 · IC025 +3.8 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | age-adj. PRR 12.6 · serious PRR 43.0 | not reported in cached trials |
| Hepatic enzyme increased | 2,940 | 36.1 34.8–37.4ROR 40.5 · calibrated p 5e-5 ✓ | 34.5 EB05 33.5 · IC025 +5.0 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Labeled — boxed warning synonym match | age-adj. PRR 27.6 · serious PRR 66.0 | NCT04315298: 1/92 (1.1%) on Sarilumab (serious AE) |
| Systemic lupus erythematosus | 2,875 | 70.6 68.1–73.2ROR 79.2 · calibrated p 6e-7 ✓ | 64.9 EB05 62.9 · IC025 +5.9 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | age-adj. PRR 65.1 · serious PRR 91.6 · 90% clinician | not reported in cached trials |
| Pemphigus | 2,812 | 234.0 224.7–243.6ROR 261.9 · calibrated p 3e-11 ✓ | 180.4 EB05 174.8 · IC025 +7.4 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | serious PRR 249.3 · 91% clinician | not reported in cached trials |
| Hand deformity | 2,745 | 212.5 204.1–221.2ROR 237.1 · calibrated p 9e-11 ✓ | 167.3 EB05 162.1 · IC025 +7.3 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | serious PRR 249.8 · 90% clinician | not reported in cached trials |
| Swelling | 2,718 | 23.9 23.1–24.8ROR 26.6 · calibrated p 5e-4 ✓ | 23.2 EB05 22.5 · IC025 +4.5 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 0.1 (0.1–0.1) | Not in label — unassessed | age-adj. PRR 19.4 · serious PRR 49.0 | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Lupus vulgaris — n=454, PRR 495.6
- Subcutaneous drug absorption impaired — n=187, PRR 419.3
- Deep vein thrombosis postoperative — n=662, PRR 408.9
- Swollen joint count — n=81, PRR 393.5
- Grip strength — n=76, PRR 390.9
- Facet joint syndrome — n=867, PRR 303.9
- Adjustment disorder with depressed mood — n=541, PRR 293.8
- Dislocation of vertebra — n=556, PRR 266.8
- Pemphigus — n=2,812, PRR 234.0
- Retinitis — n=356, PRR 216.8
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Sarilumab?
In FDA FAERS, the most frequently co-reported reaction terms for Sarilumab are pain, arthralgia, rheumatoid arthritis, joint swelling, fatigue, rash. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Sarilumab have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: RISK OF SERIOUS INFECTIONS Patients treated with KEVZARA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ]. Opportunistic infections have also been reported in patients receiving KEVZARA.
Do FAERS signals prove that Sarilumab causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 827bc01c-d379-4266-a18c-c7f904b76af3, effective 20260227; matched on
openfda.generic_name.exact:"SARILUMAB") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,025 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
SARILUMAB, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.