← All drugs
Drug · FAERS side-effect profile with label screen

Belimumab side effects: what 31,397 FDA adverse event reports show

Belimumab · Benlysta · 1,129 reaction terms · 96,281 drug–reaction co-reports · data 2026-09-14
Share: X Facebook Reddit Email

Drug class

B Lymphocyte Stimulator-specific Inhibitor

FDA label (Established Pharmacologic Class)

Brand names

Benlysta

openFDA label

Who reports

31,397 reports · 43% serious · 893 with death outcome · 93% female

openFDA FAERS counts, all years, deduplication not applied

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.

FDA label, Indications and Usage

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.

FDA label, Description section

Boxed warning

None in the current 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 (related wording) 3Likely indication confounding 5Reporting / coding artifact 5Lab value / disease marker 5Not in label — unassessed 22
What the badges mean

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.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Antinuclear antibody negative17620.0
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 artifactserious n=17not reported in cached trials
Sle arthritis85283.2
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 — unassessedserious n=85NCT01705977: 4/2,001 (0.2%) control (serious AE)
Pericarditis lupus10243.1
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 — unassessedserious n=9NCT00424476: 1/290 (0.3%) on Belimumab; 1/287 (0.3%) control (serious AE)
Lupus pneumonitis25195.4
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 — unassessedserious n=25 · 100% clinicianNCT01705977: 1/2,002 (0.0%) on Belimumab; 1/2,001 (0.0%) control (serious AE)
Lupus nephritis409191.1
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=408NCT01705977: 6/2,002 (0.3%) on Belimumab; 11/2,001 (0.5%) control (serious AE)
Personality change due to a general medical condition25165.8
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 — unassessedserious n=25 · 100% consumernot reported in cached trials
Central nervous system lupus43165.1
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=43NCT01705977: 1/2,002 (0.0%) on Belimumab (serious AE)
Lupus endocarditis11150.4
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 — unassessedserious n=11not reported in cached trials
Complement factor increased14135.2
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 markerserious n=14not reported in cached trials
Lupus vasculitis1283.8
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 — unassessedserious n=12NCT01705977: 1/2,002 (0.0%) on Belimumab; 1/2,001 (0.0%) control (serious AE)
Systemic lupus erythematosus3,92483.1
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% consumerNCT01705977: 5/2,002 (0.2%) on Belimumab; 11/2,001 (0.5%) control (serious AE)
Neuropsychiatric lupus1382.1
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 — unassessedserious n=13NCT01705977: 1/2,002 (0.0%) on Belimumab (serious AE)
Complement factor decreased1876.7
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 markerserious n=16not reported in cached trials
Double stranded dna antibody positive3274.5
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 markerserious n=25not reported in cached trials
Systemic lupus erythematosus rash7669.7
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=61NCT01705977: 2/2,002 (0.1%) on Belimumab; 1/2,001 (0.0%) control (serious AE)
Hypocomplementaemia1356.5
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 — unassessedserious n=13not reported in cached trials
Meningitis meningococcal1146.9
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 — unassessedserious n=11not reported in cached trials
Neutrophil count1344.2
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 — unassessedserious n=13not reported in cached trials
Butterfly rash5941.6
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 — unassessedserious n=34 · 84% consumernot reported in cached trials
Product complaint1,34037.8
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 artifactserious n=85 · 83% consumernot reported in cached trials
Quarantine1033.8
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 contact99030.5
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 artifactserious n=59 · 90% consumernot reported in cached trials
Herpes zoster cutaneous disseminated1030.1
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 — unassessedserious n=10not reported in cached trials
Coombs positive haemolytic anaemia2030.0
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 — unassessedserious n=20not reported in cached trials
Herpes simplex reactivation1629.7
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 — unassessedserious n=16not reported in cached trials
Disseminated varicella zoster virus infection1325.5
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 — unassessedserious n=13not reported in cached trials
Biopsy kidney1024.5
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 — unassessedserious n=9not reported in cached trials
Wrong technique in device usage process1,56923.6
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 artifactserious n=90 · 91% consumernot reported in cached trials
Mixed connective tissue disease1321.2
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 — unassessedserious n=13not reported in cached trials
Vein collapse2018.0
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 cholesterol1217.2
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 — unassessedserious n=12not reported in cached trials
Coronavirus test positive2516.4
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 markerserious n=11not reported in cached trials
Urine protein/creatinine ratio increased2116.1
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 markerserious n=20not reported in cached trials
Antiphospholipid syndrome3715.8
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 — unassessedserious n=37NCT01705977: 1/2,001 (0.0%) control (serious AE)
Cutaneous lupus erythematosus4415.3
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=42NCT01705977: 3/2,002 (0.1%) on Belimumab; 1/2,001 (0.0%) control (serious AE)
Serositis1214.8
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 — unassessedserious n=12NCT01705977: 1/2,002 (0.0%) on Belimumab (serious AE)
Social problem8714.3
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 artifactserious n=71 · 76% consumernot 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).

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.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Product dose omission issue5,08012.1
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 artifactserious PRR 13.0 · 82% consumernot reported in cached trials
Systemic lupus erythematosus3,92483.1
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% consumerNCT01705977: 5/2,002 (0.2%) on Belimumab; 11/2,001 (0.5%) control (serious AE)
Fatigue (tiredness)2,0681.8
1.7–1.9ROR 1.8 · χ² 725 / p 6e-160
1.8 EB05 1.7 · IC025 +0.8Labeled adverse reaction
exact term
serious PRR 2.1 · 77% consumerNCT00424476: 18/290 (6.2%) on Belimumab; 12/287 (4.2%) control
Drug ineffective (drug did not work)1,8440.9
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 artifactserious PRR 1.8not reported in cached trials
Pain1,7611.9
1.8–2.0ROR 2.0 · χ² 783 / p 2e-172
1.9 EB05 1.8 · IC025 +0.9Labeled adverse reaction
exact term
serious PRR 2.0 · 79% consumerNCT01705977: 1/2,002 (0.0%) on Belimumab; 2/2,001 (0.1%) control (serious AE)
Wrong technique in device usage process1,56923.6
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 artifactserious n=90 · 91% consumernot reported in cached trials
Headache1,5601.7
1.6–1.7ROR 1.7 · χ² 422 / p 5e-94
1.7 EB05 1.6 · IC025 +0.6Labeled adverse reaction
exact term
serious PRR 2.0 · 74% consumerNCT01705977: 3/2,002 (0.1%) on Belimumab; 1/2,001 (0.0%) control (serious AE)
Nausea1,4991.3
1.2–1.3ROR 1.3 · χ² 87 / p 6e-21
1.3 EB05 1.2 · IC025 +0.3Labeled adverse reaction
exact term
serious PRR 1.5 · 70% consumerNCT00424476: 23/290 (7.9%) on Belimumab; 31/287 (10.8%) control
Malaise (feeling unwell)1,4162.1
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 — unassessedserious PRR 2.3 · 77% consumernot reported in cached trials
Arthralgia (joint pain)1,3632.2
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 — unassessedserious PRR 3.0 · 71% consumerNCT01705977: 1/2,002 (0.0%) on Belimumab; 1/2,001 (0.0%) control (serious AE)
Product complaint1,34037.8
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 artifactserious n=85 · 83% consumernot reported in cached trials
Off label use (used outside approved label)1,0890.8
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 artifactserious PRR 0.9not reported in cached trials
Accidental exposure to product1,0166.8
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 artifactserious PRR 5.0 · 88% consumernot reported in cached trials
Condition aggravated9902.2
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 artifactserious PRR 2.9not 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.

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

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.