Belimumab side effects: what 31,397 FDA adverse event reports show
Drug class
B Lymphocyte Stimulator-specific Inhibitor
Brand names
Benlysta
Who reports
31,397 reports · 43% serious · 893 with death outcome · 93% female
Used for
BENLYSTA is indicated for the treatment of patients 5 years of age and older with: • Active systemic lupus erythematosus (SLE) who are receiving standard therapy, and • Active lupus nephritis who are receiving standard therapy. Limitations of Use The efficacy of BENLYSTA has not been evaluated in patients with severe active central nervous system (CNS) lupus. Use of BENLYSTA is not recommended in this situation.
What it is
Belimumab is a human IgG1λ monoclonal antibody specific for soluble human B lymphocyte stimulator protein (BLyS, also referred to as BAFF and TNFSF13B). Belimumab has a molecular weight of approximately 147 kDa. Belimumab is produced by recombinant DNA technology in a murine cell (NS0) expression system.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- 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.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,089 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Antinuclear antibody negative | 17 | 620.0 319.6–1,202.9ROR 620.3 · χ² 5,089 / p <1e-300 | 235.2 EB05 155.5 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=17 | not reported in cached trials |
| Lupus enteritis | 19 | 311.8 180.6–538.3ROR 312.0 · χ² 3,783 / p <1e-300 | 174.8 EB05 118.3 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious n=19 | NCT01705977: 1/2,002 (0.0%) on Belimumab (serious AE) |
| Sle arthritis | 85 | 283.2 219.7–365.2ROR 284.0 · χ² 16,504 / p <1e-300 | 189.8 EB05 158.3 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=85 | NCT01705977: 4/2,001 (0.2%) control (serious AE) |
| Pericarditis lupus | 10 | 243.1 117.7–502.2ROR 243.2 · χ² 1,587 / p <1e-300 | 133.2 EB05 77.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=9 | NCT00424476: 1/290 (0.3%) on Belimumab; 1/287 (0.3%) control (serious AE) |
| Lupus pneumonitis | 25 | 195.4 125.0–305.3ROR 195.5 · χ² 3,577 / p <1e-300 | 135.4 EB05 96.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=25 · 100% clinician | NCT01705977: 1/2,002 (0.0%) on Belimumab; 1/2,001 (0.0%) control (serious AE) |
| Lupus nephritis | 409 | 191.1 171.3–213.2ROR 193.6 · χ² 59,762 / p <1e-300 | 147.2 EB05 135.6 · IC025 +6.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=408 | NCT01705977: 6/2,002 (0.3%) on Belimumab; 11/2,001 (0.5%) control (serious AE) |
| Personality change due to a general medical condition | 25 | 165.8 106.9–257.0ROR 165.9 · χ² 3,139 / p <1e-300 | 120.6 EB05 85.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=25 · 100% consumer | not reported in cached trials |
| Central nervous system lupus | 43 | 165.1 118.2–230.6ROR 165.3 · χ² 5,473 / p <1e-300 | 124.9 EB05 96.6 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications | serious n=43 | NCT01705977: 1/2,002 (0.0%) on Belimumab (serious AE) |
| Lupus endocarditis | 11 | 150.4 78.1–289.6ROR 150.5 · χ² 1,209 / p 3e-265 | 101.5 EB05 60.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Complement factor increased | 14 | 135.2 76.0–240.2ROR 135.2 · χ² 1,437 / p <1e-300 | 97.7 EB05 61.8 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=14 | not reported in cached trials |
| Lupus vasculitis | 12 | 83.8 46.0–152.8ROR 83.8 · χ² 799 / p 5e-176 | 66.9 EB05 40.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | NCT01705977: 1/2,002 (0.0%) on Belimumab; 1/2,001 (0.0%) control (serious AE) |
| Systemic lupus erythematosus | 3,924 | 83.1 80.6–85.8ROR 94.8 · χ² 283,006 / p <1e-300 | 73.9 EB05 72.0 · IC025 +6.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 100.7 · 75% consumer | NCT01705977: 5/2,002 (0.2%) on Belimumab; 11/2,001 (0.5%) control (serious AE) |
| Neuropsychiatric lupus | 13 | 82.1 46.1–146.0ROR 82.1 · χ² 854 / p 4e-188 | 66.3 EB05 41.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=13 | NCT01705977: 1/2,002 (0.0%) on Belimumab (serious AE) |
| Complement factor decreased | 18 | 76.7 47.1–125.0ROR 76.8 · χ² 1,138 / p 1e-249 | 64.3 EB05 43.0 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=16 | not reported in cached trials |
| Double stranded dna antibody positive | 32 | 74.5 51.7–107.4ROR 74.6 · χ² 2,018 / p <1e-300 | 64.5 EB05 47.9 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=25 | not reported in cached trials |
| Systemic lupus erythematosus rash | 76 | 69.7 55.0–88.2ROR 69.8 · χ² 4,589 / p <1e-300 | 62.2 EB05 51.3 · IC025 +5.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=61 | NCT01705977: 2/2,002 (0.1%) on Belimumab; 1/2,001 (0.0%) control (serious AE) |
| Hypocomplementaemia | 13 | 56.5 32.1–99.6ROR 56.5 · χ² 603 / p 2e-133 | 48.6 EB05 30.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Meningitis meningococcal | 11 | 46.9 25.4–86.4ROR 46.9 · χ² 419 / p 2e-93 | 41.0 EB05 24.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Neutrophil count | 13 | 44.2 25.2–77.5ROR 44.2 · χ² 475 / p 2e-105 | 39.3 EB05 24.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Butterfly rash | 59 | 41.6 32.0–54.2ROR 41.7 · χ² 2,163 / p <1e-300 | 38.8 EB05 31.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=34 · 84% consumer | not reported in cached trials |
| Product complaint | 1,340 | 37.8 35.8–39.9ROR 39.4 · χ² 45,376 / p <1e-300 | 35.8 EB05 34.2 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=85 · 83% consumer | not reported in cached trials |
| Quarantine | 10 | 33.8 17.9–63.9ROR 33.8 · χ² 273 / p 2e-61 | 30.5 EB05 17.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Exposure via skin contact | 990 | 30.5 28.6–32.4ROR 31.4 · χ² 26,969 / p <1e-300 | 29.2 EB05 27.7 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious n=59 · 90% consumer | not reported in cached trials |
| Herpes zoster cutaneous disseminated | 10 | 30.1 16.0–56.8ROR 30.1 · χ² 242 / p 7e-55 | 27.4 EB05 15.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Coombs positive haemolytic anaemia | 20 | 30.0 19.2–46.9ROR 30.0 · χ² 508 / p 7e-113 | 28.0 EB05 19.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Herpes simplex reactivation | 16 | 29.7 18.0–49.0ROR 29.7 · χ² 397 / p 1e-88 | 27.6 EB05 18.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Discontinued product administered | 13 | 27.8 16.0–48.4ROR 27.8 · χ² 297 / p 8e-67 | 25.8 EB05 15.9 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Disseminated varicella zoster virus infection | 13 | 25.5 14.6–44.3ROR 25.5 · χ² 271 / p 3e-61 | 23.7 EB05 14.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Biopsy kidney | 10 | 24.5 13.0–46.0ROR 24.5 · χ² 195 / p 1e-44 | 22.5 EB05 12.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=9 | not reported in cached trials |
| Wrong technique in device usage process | 1,569 | 23.6 22.5–24.8ROR 24.8 · χ² 32,899 / p <1e-300 | 22.9 EB05 21.9 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=90 · 91% consumer | not reported in cached trials |
| Mixed connective tissue disease | 13 | 21.2 12.2–36.9ROR 21.2 · χ² 224 / p 8e-51 | 19.8 EB05 11.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Vein collapse | 20 | 18.0 11.5–28.0ROR 18.0 · χ² 295 / p 2e-66 | 17.1 EB05 11.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Blood cholesterol | 12 | 17.2 9.7–30.6ROR 17.2 · χ² 163 / p 1e-37 | 15.8 EB05 8.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Coronavirus test positive | 25 | 16.4 11.0–24.4ROR 16.4 · χ² 337 / p 1e-75 | 15.7 EB05 10.9 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious n=11 | not reported in cached trials |
| Injection site dryness | 21 | 16.2 10.5–24.9ROR 16.2 · χ² 277 / p 1e-62 | 15.3 EB05 10.2 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | 76% consumer | not reported in cached trials |
| Urine protein/creatinine ratio increased | 21 | 16.1 10.4–24.8ROR 16.1 · χ² 275 / p 4e-62 | 15.2 EB05 10.2 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious n=20 | not reported in cached trials |
| Antiphospholipid syndrome | 37 | 15.8 11.4–21.8ROR 15.8 · χ² 485 / p 9e-108 | 15.2 EB05 11.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=37 | NCT01705977: 1/2,001 (0.0%) control (serious AE) |
| Cutaneous lupus erythematosus | 44 | 15.3 11.3–20.6ROR 15.3 · χ² 560 / p 5e-124 | 14.8 EB05 11.3 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=42 | NCT01705977: 3/2,002 (0.1%) on Belimumab; 1/2,001 (0.0%) control (serious AE) |
| Serositis | 12 | 14.8 8.4–26.2ROR 14.8 · χ² 138 / p 4e-32 | 13.2 EB05 7.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=12 | NCT01705977: 1/2,002 (0.0%) on Belimumab (serious AE) |
| Social problem | 87 | 14.3 11.5–17.6ROR 14.3 · χ² 1,038 / p 5e-228 | 13.9 EB05 11.6 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious n=71 · 76% consumer | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Belimumab 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 (13 of 40 signal terms matched).
- NCT01705977 — Belimumab Assessment of Safety in SLE (N=4019, PHASE4; 330 AE terms posted; arms: Placebo; Belimumab 10 mg/kg)
- NCT00424476 — A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) (N=865, PHASE3; 165 AE terms posted; arms: Placebo; Belimumab 1 mg/kg; Belimumab 10 mg/kg)
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 |
|---|---|---|---|---|---|---|
| Product dose omission issue | 5,080 | 12.1 11.8–12.4ROR 14.2 · χ² 51,417 / p <1e-300 | 11.9 EB05 11.6 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 13.0 · 82% consumer | not reported in cached trials |
| Systemic lupus erythematosus | 3,924 | 83.1 80.6–85.8ROR 94.8 · χ² 283,006 / p <1e-300 | 73.9 EB05 72.0 · IC025 +6.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 100.7 · 75% consumer | NCT01705977: 5/2,002 (0.2%) on Belimumab; 11/2,001 (0.5%) control (serious AE) |
| Fatigue (tiredness) | 2,068 | 1.8 1.7–1.9ROR 1.8 · χ² 725 / p 6e-160 | 1.8 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.1 · 77% consumer | NCT00424476: 18/290 (6.2%) on Belimumab; 12/287 (4.2%) control |
| Drug ineffective (drug did not work) | 1,844 | 0.9 0.9–1.0ROR 0.9 · χ² 9 / p 0.001 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.8 | not reported in cached trials |
| Pain | 1,761 | 1.9 1.8–2.0ROR 2.0 · χ² 783 / p 2e-172 | 1.9 EB05 1.8 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.0 · 79% consumer | NCT01705977: 1/2,002 (0.0%) on Belimumab; 2/2,001 (0.1%) control (serious AE) |
| Wrong technique in device usage process | 1,569 | 23.6 22.5–24.8ROR 24.8 · χ² 32,899 / p <1e-300 | 22.9 EB05 21.9 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=90 · 91% consumer | not reported in cached trials |
| Headache | 1,560 | 1.7 1.6–1.7ROR 1.7 · χ² 422 / p 5e-94 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.0 · 74% consumer | NCT01705977: 3/2,002 (0.1%) on Belimumab; 1/2,001 (0.0%) control (serious AE) |
| Nausea | 1,499 | 1.3 1.2–1.3ROR 1.3 · χ² 87 / p 6e-21 | 1.3 EB05 1.2 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.5 · 70% consumer | NCT00424476: 23/290 (7.9%) on Belimumab; 31/287 (10.8%) control |
| Malaise (feeling unwell) | 1,416 | 2.1 2.0–2.3ROR 2.2 · χ² 886 / p 7e-195 | 2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 · 77% consumer | not reported in cached trials |
| Injection site pain (pain where injected) | 1,369 | 3.0 2.9–3.2ROR 3.1 · χ² 1,859 / p <1e-300 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 · 89% consumer | NCT01705977: 1/2,002 (0.0%) on Belimumab; 2/2,001 (0.1%) control (serious AE) |
| Arthralgia (joint pain) | 1,363 | 2.2 2.1–2.3ROR 2.2 · χ² 901 / p 3e-198 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 · 71% consumer | NCT01705977: 1/2,002 (0.0%) on Belimumab; 1/2,001 (0.0%) control (serious AE) |
| Product complaint | 1,340 | 37.8 35.8–39.9ROR 39.4 · χ² 45,376 / p <1e-300 | 35.8 EB05 34.2 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=85 · 83% consumer | not reported in cached trials |
| Off label use (used outside approved label) | 1,089 | 0.8 0.8–0.9ROR 0.8 · χ² 36 / p 8e-10 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | not reported in cached trials |
| Accidental exposure to product | 1,016 | 6.8 6.4–7.3ROR 7.0 · χ² 5,028 / p <1e-300 | 6.8 EB05 6.4 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 · 88% consumer | not reported in cached trials |
| Condition aggravated | 990 | 2.2 2.1–2.3ROR 2.2 · χ² 645 / p 2e-142 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | 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.
- Sle arthritis — n=85, PRR 283.2 (also seen in trial arm)
- Lupus pneumonitis — n=25, PRR 195.4 (also seen in trial arm)
- Personality change due to a general medical condition — n=25, PRR 165.8
- Butterfly rash — n=59, PRR 41.6
- Coombs positive haemolytic anaemia — n=20, PRR 30.0
- Vein collapse — n=20, PRR 18.0
- Antiphospholipid syndrome — n=37, PRR 15.8 (also seen in trial arm)
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 Belimumab?
In FDA FAERS, the most frequently co-reported reaction terms for Belimumab are systemic lupus erythematosus, fatigue, pain, headache, nausea, malaise. 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 Belimumab have an FDA boxed warning?
No. The FDA label retrieved for Belimumab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Belimumab 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 2fa3c528-1777-4628-8a55-a69dae2381a3, effective 20260821; matched on
openfda.generic_name.exact:"BELIMUMAB") - 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, 1,129 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
BELIMUMAB, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. 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.