Bimekizumab side effects: what 18,978 FDA adverse event reports show

Bimekizumab · Bimzelx · 1,008 reaction terms · 55,554 drug–reaction co-reports · data 2026-09-14

Drug class

Humanized interleukin-17a and f antagonist

FDA label, Indications wording

Brand names

Bimzelx

openFDA label

Who reports

18,978 reports · 38% serious · 147 with death outcome · 62% female

openFDA FAERS counts, all years, deduplication not applied

Used for

BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: Moderate to severe plaque psoriasis (PSO) in adults who are candidates for systemic therapy or phototherapy. ( 1.1 ) Adults with active psoriatic arthritis (PsA) . ( 1.2 ) Adults with active non-radiographic axial spondyloarthritis ( nr-axSpA ) with objective signs of inflammation.

FDA label, Indications and Usage

What it is

Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa.

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 adverse reaction 10Likely indication confounding 6Reporting / coding artifact 8Not in label — unassessed 16

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
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.
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. 968 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hidradenitis	1,587	221.6 210.2–233.6ROR 239.4 · χ² 283,937 / p <1e-300	180.4 EB05 173.0 · IC025 +7.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=393	not reported in cached trials
Axial spondyloarthritis	51	63.7 48.0–84.5ROR 63.8 · χ² 2,895 / p <1e-300	58.6 EB05 46.3 · IC025 +4.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=37	not reported in cached trials
Oral candidiasis (oral thrush)	691	55.5 51.5–59.9ROR 57.4 · χ² 34,975 / p <1e-300	52.5 EB05 49.3 · IC025 +5.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 54.6	NCT03598790: 127/1,217 (10.4%) on Bimekizumab
Oesophageal candidiasis	169	44.2 37.9–51.5ROR 44.5 · χ² 6,785 / p <1e-300	42.1 EB05 37.1 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	serious n=168	not reported in cached trials
Abscess drainage	36	43.2 30.9–60.3ROR 43.2 · χ² 1,380 / p <1e-300	40.6 EB05 30.6 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=35	not reported in cached trials
Psoriatic arthropathy	1,622	41.6 39.7–43.6ROR 45.0 · χ² 61,712 / p <1e-300	39.9 EB05 38.3 · IC025 +5.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 85.5	NCT03598790: 26/1,217 (2.1%) on Bimekizumab
Renal stone removal	21	39.4 25.5–61.0ROR 39.5 · χ² 719 / p 9e-159	36.8 EB05 25.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=21 · 71% consumer	not reported in cached trials
Insurance issue	548	37.9 34.8–41.2ROR 38.9 · χ² 18,932 / p <1e-300	36.5 EB05 34.0 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 52.8	not reported in cached trials
Product availability issue	805	36.9 34.4–39.5ROR 38.3 · χ² 27,057 / p <1e-300	35.5 EB05 33.5 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	serious PRR 26.2	not reported in cached trials
Skin candida	17	33.7 20.8–54.6ROR 33.7 · χ² 490 / p 8e-109	31.5 EB05 20.8 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious n=17	not reported in cached trials
Fungal foot infection	13	31.1 17.9–54.0ROR 31.1 · χ² 338 / p 7e-76	29.0 EB05 18.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=9	not reported in cached trials
Candida infection (yeast infection)	461	28.1 25.7–30.8ROR 28.7 · χ² 11,702 / p <1e-300	27.3 EB05 25.3 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 22.8	not reported in cached trials
Ankylosing spondylitis	335	26.1 23.4–29.1ROR 26.5 · χ² 7,858 / p <1e-300	25.4 EB05 23.2 · IC025 +4.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 49.5	not reported in cached trials
Intertrigo	13	25.0 14.4–43.4ROR 25.0 · χ² 269 / p 8e-61	23.6 EB05 14.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=12	not reported in cached trials
Product distribution issue	214	24.5 21.4–28.0ROR 24.7 · χ² 4,682 / p <1e-300	23.9 EB05 21.3 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious n=106	not reported in cached trials
Drainage	11	23.6 13.0–42.9ROR 23.6 · χ² 211 / p 4e-48	22.0 EB05 12.7 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=8	not reported in cached trials
Fungal oesophagitis	16	23.4 14.3–38.4ROR 23.4 · χ² 314 / p 2e-70	22.3 EB05 14.4 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=16	not reported in cached trials
Cyst removal	11	21.4 11.8–38.9ROR 21.4 · χ² 190 / p 1e-43	20.0 EB05 11.3 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=11	not reported in cached trials
Psoriasis	2,646	20.4 19.7–21.2ROR 23.2 · χ² 48,197 / p <1e-300	20.0 EB05 19.4 · IC025 +4.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 29.6	NCT03598790: 1/1,217 (0.1%) on Bimekizumab (serious AE)
Vulvovaginal candidiasis	27	20.4 14.0–29.9ROR 20.5 · χ² 470 / p 2e-104	19.8 EB05 14.2 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious n=17	not reported in cached trials
Oropharyngeal candidiasis	18	20.2 12.6–32.1ROR 20.2 · χ² 302 / p 5e-68	19.3 EB05 12.7 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious n=14	not reported in cached trials
Cancer surgery	19	20.1 12.7–31.6ROR 20.1 · χ² 319 / p 1e-71	19.2 EB05 12.8 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=19	not reported in cached trials
Tongue coated	30	17.5 12.2–25.1ROR 17.5 · χ² 442 / p 2e-98	17.0 EB05 12.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=10	not reported in cached trials
Product leakage	83	15.6 12.6–19.4ROR 15.7 · χ² 1,106 / p 1e-242	15.3 EB05 12.7 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious n=17	not reported in cached trials
Therapy interrupted	992	14.4 13.6–15.3ROR 15.1 · χ² 12,249 / p <1e-300	14.2 EB05 13.5 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 24.6	not reported in cached trials
Oral fungal infection	38	13.9 10.1–19.1ROR 13.9 · χ² 435 / p 6e-97	13.4 EB05 10.0 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious n=22	not reported in cached trials
Carpal tunnel decompression	14	13.4 7.9–22.8ROR 13.4 · χ² 147 / p 4e-34	12.1 EB05 6.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=14	not reported in cached trials
Product dose omission issue	3,781	13.3 12.9–13.7ROR 16.0 · χ² 43,061 / p <1e-300	13.1 EB05 12.8 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 12.0	not reported in cached trials
Skin neoplasm excision	10	12.8 6.9–23.9ROR 12.8 · χ² 96 / p 5e-23	10.7 EB05 5.4 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=10	not reported in cached trials
Breast abscess	13	12.8 7.4–22.1ROR 12.8 · χ² 128 / p 6e-30	11.2 EB05 6.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Tinea pedis	20	12.5 8.1–19.5ROR 12.6 · χ² 198 / p 2e-45	11.6 EB05 7.4 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious n=11	NCT03598790: 16/1,217 (1.3%) on Bimekizumab
Therapeutic response shortened	375	11.8 10.7–13.0ROR 12.0 · χ² 3,656 / p <1e-300	11.6 EB05 10.7 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 37.7	not reported in cached trials
Oral mucosal eruption	18	11.8 7.4–18.7ROR 11.8 · χ² 165 / p 5e-38	10.6 EB05 6.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	–	not reported in cached trials
Vulvovaginal mycotic infection	42	10.7 7.9–14.5ROR 10.7 · χ² 356 / p 1e-79	10.2 EB05 7.7 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious n=25	not reported in cached trials
Ankle operation	15	10.3 6.2–17.1ROR 10.3 · χ² 115 / p 4e-27	8.8 EB05 5.3 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious n=15	not reported in cached trials
Intentional dose omission	268	9.8 8.7–11.0ROR 9.9 · χ² 2,088 / p <1e-300	9.6 EB05 8.7 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 28.0	not reported in cached trials
Pustular psoriasis	32	9.3 6.5–13.1ROR 9.3 · χ² 226 / p 3e-51	8.5 EB05 6.2 · IC025 +2.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=25	NCT03598790: 1/10 (10.0%) on Bimekizumab (serious AE)
Fungal infection	299	9.0 8.0–10.0ROR 9.1 · χ² 2,092 / p <1e-300	8.8 EB05 8.0 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.3 · ♀ 88% (drug 62%)	not reported in cached trials
Hernia repair	23	8.9 5.9–13.4ROR 8.9 · χ² 152 / p 4e-35	7.9 EB05 5.4 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=23	not reported in cached trials
Groin abscess	10	8.6 4.6–15.9ROR 8.6 · χ² 59 / p 8e-15	6.6 EB05 3.7 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious n=10	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 Bimekizumab 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 (5 of 40 signal terms matched).

NCT03598790 — A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic P (N=1353, PHASE3; 324 AE terms posted; arms: Cohort A: BKZ 320 mg Q8W; Cohort A: BKZ 320 mg Q4W; Cohort A: Group A BKZ 320 mg Q8W; Cohort A: Group B BKZ 320 mg Q8W)
NCT03895203 — A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arth (N=852, PHASE3; 72 AE terms posted; arms: Placebo; BKZ 160 mg Q4W; ADA 40 mg Q2W; Placebo/BKZ 160 mg Q4W)

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	3,781	13.3 12.9–13.7ROR 16.0 · χ² 43,061 / p <1e-300	13.1 EB05 12.8 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 12.0	not reported in cached trials
Psoriasis	2,646	20.4 19.7–21.2ROR 23.2 · χ² 48,197 / p <1e-300	20.0 EB05 19.4 · IC025 +4.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 29.6	NCT03598790: 1/1,217 (0.1%) on Bimekizumab (serious AE)
Drug ineffective (drug did not work)	2,001	1.5 1.4–1.6ROR 1.6 · χ² 362 / p 7e-81	1.5 EB05 1.5 · IC025 +0.5	Reporting / coding artifact	serious PRR 2.5	not reported in cached trials
Off label use (used outside approved label)	1,683	1.9 1.8–2.0ROR 2.0 · χ² 774 / p 1e-170	1.9 EB05 1.8 · IC025 +0.9	Reporting / coding artifact	serious PRR 2.3	not reported in cached trials
Psoriatic arthropathy	1,622	41.6 39.7–43.6ROR 45.0 · χ² 61,712 / p <1e-300	39.9 EB05 38.3 · IC025 +5.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 85.5	NCT03598790: 26/1,217 (2.1%) on Bimekizumab
Hidradenitis	1,587	221.6 210.2–233.6ROR 239.4 · χ² 283,937 / p <1e-300	180.4 EB05 173.0 · IC025 +7.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=393	not reported in cached trials
Condition aggravated	1,343	4.4 4.2–4.7ROR 4.7 · χ² 3,586 / p <1e-300	4.4 EB05 4.2 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 3.2	not reported in cached trials
Injection site pain (pain where injected)	1,231	4.0 3.8–4.3ROR 4.2 · χ² 2,829 / p <1e-300	4.0 EB05 3.8 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 17.8	NCT03598790: 1/1,217 (0.1%) on Bimekizumab (serious AE)
Therapy interrupted	992	14.4 13.6–15.3ROR 15.1 · χ² 12,249 / p <1e-300	14.2 EB05 13.5 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 24.6	not reported in cached trials
Inappropriate schedule of product administration	976	5.5 5.2–5.8ROR 5.7 · χ² 3,591 / p <1e-300	5.5 EB05 5.2 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 10.6	not reported in cached trials
Pain	817	1.3 1.2–1.4ROR 1.3 · χ² 63 / p 9e-16	1.3 EB05 1.2 · IC025 +0.3	Labeled adverse reaction exact term	serious PRR 1.0	NCT03598790: 1/1,217 (0.1%) on Bimekizumab (serious AE)
Pruritus (itching)	805	2.1 2.0–2.3ROR 2.2 · χ² 478 / p 4e-106	2.1 EB05 2.0 · IC025 +1.0	Not in label — unassessed	serious PRR 2.0	not reported in cached trials
Product availability issue	805	36.9 34.4–39.5ROR 38.3 · χ² 27,057 / p <1e-300	35.5 EB05 33.5 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	serious PRR 26.2	not reported in cached trials
Incorrect dose administered	707	3.1 2.9–3.4ROR 3.2 · χ² 1,024 / p 6e-225	3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 6.9	not reported in cached trials
Oral candidiasis (oral thrush)	691	55.5 51.5–59.9ROR 57.4 · χ² 34,975 / p <1e-300	52.5 EB05 49.3 · IC025 +5.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 54.6	NCT03598790: 127/1,217 (10.4%) on Bimekizumab

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.

Abscess drainage — n=36, PRR 43.2
Renal stone removal — n=21, PRR 39.4
Insurance issue — n=548, PRR 37.9
Tongue coated — n=30, PRR 17.5
Hernia repair — n=23, PRR 8.9

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 Bimekizumab?

In FDA FAERS, the most frequently co-reported reaction terms for Bimekizumab are psoriasis, psoriatic arthropathy, hidradenitis, injection site pain, pain, pruritus. 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 Bimekizumab have an FDA boxed warning?

No. The FDA label retrieved for Bimekizumab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Bimekizumab 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 26b88358-871f-4c80-9d80-b2fb16477f81, effective 20250616; matched on openfda.generic_name.exact:"BIMEKIZUMAB")
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, field patient.drug.openfda.generic_name.exact, 1,008 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 BIMEKIZUMAB, 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.