Brodalumab side effects: what 2,000 FDA adverse event reports show
Drug class
Interleukin-17 Receptor A Antagonist
Brand names
Siliq
Who reports
2,000 reports · 88% serious · 139 with death outcome · 47% female
Used for
SILIQ ® (brodalumab) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. SILIQ is .
What it is
Brodalumab is a human monoclonal IgG2κ antibody directed against human interleukin-17 receptor A (IL-17RA). It is expressed in a Chinese Hamster Ovary (CHO) cell line. Brodalumab is comprised of 1312 amino acids and has an estimated molecular mass of 144,000 Daltons.
Boxed warning
SUICIDAL IDEATION AND BEHAVIOR Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. Prior to prescribing SILIQ, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior.
Causality screen of the 40 strongest signals
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 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.
- 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.
- 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. 91 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 |
|---|---|---|---|---|---|---|
| Psoriatic arthropathy | 173 | 45.3 39.3–52.2ROR 49.5 · χ² 7,431 / p <1e-300 | 44.9 EB05 39.5 · IC025 +5.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 36.1 | no trial data cached |
| Psoriasis | 498 | 40.1 37.1–43.3ROR 53.0 · χ² 18,986 / p <1e-300 | 39.9 EB05 37.0 · IC025 +5.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 66.7 | no trial data cached |
| Disease recurrence | 137 | 30.2 25.7–35.5ROR 32.3 · χ² 3,835 / p <1e-300 | 30.0 EB05 26.0 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 37.3 · 78% consumer | no trial data cached |
| Oral candidiasis (oral thrush) | 27 | 21.8 15.0–31.7ROR 22.1 · χ² 514 / p 3e-114 | 21.5 EB05 15.4 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 19.2 | no trial data cached |
| Intentional dose omission | 56 | 21.5 16.6–27.9ROR 22.1 · χ² 1,074 / p 7e-236 | 21.3 EB05 17.0 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 28.9 · 87% consumer | no trial data cached |
| Therapy interrupted | 136 | 20.7 17.6–24.4ROR 22.1 · χ² 2,534 / p <1e-300 | 20.6 EB05 17.9 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 28.6 · 76% consumer | no trial data cached |
| Intentional product use issue | 172 | 20.5 17.8–23.7ROR 22.4 · χ² 3,185 / p <1e-300 | 20.5 EB05 18.0 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 18.7 · 84% consumer | no trial data cached |
| Insurance issue | 28 | 19.8 13.7–28.6ROR 20.1 · χ² 480 / p 8e-107 | 19.5 EB05 14.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 20.0 · 79% consumer | no trial data cached |
| Therapy cessation | 87 | 17.9 14.6–22.0ROR 18.6 · χ² 1,371 / p 2e-300 | 17.8 EB05 14.9 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 25.0 · 82% consumer | no trial data cached |
| Skin infection | 19 | 17.9 11.4–28.0ROR 18.0 · χ² 286 / p 2e-64 | 17.4 EB05 11.5 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.4 | no trial data cached |
| Skin laceration | 13 | 12.6 7.3–21.7ROR 12.7 · χ² 128 / p 6e-30 | 11.2 EB05 6.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 | no trial data cached |
| Pharyngitis streptococcal | 12 | 11.6 6.6–20.5ROR 11.7 · χ² 106 / p 3e-25 | 9.9 EB05 5.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Therapeutic product effect decreased | 47 | 11.1 8.4–14.7ROR 11.4 · χ² 423 / p 3e-94 | 10.7 EB05 8.3 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 13.7 | no trial data cached |
| Dermatitis contact | 12 | 11.1 6.3–19.5ROR 11.2 · χ² 100 / p 7e-24 | 9.4 EB05 5.2 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | no trial data cached |
| Dizziness postural | 10 | 10.9 5.9–20.3ROR 11.0 · χ² 80 / p 1e-19 | 8.8 EB05 4.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Uveitis | 13 | 10.1 5.9–17.4ROR 10.2 · χ² 98 / p 3e-23 | 8.5 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Localised infection | 23 | 10.0 6.6–15.0ROR 10.1 · χ² 177 / p 1e-40 | 9.1 EB05 6.1 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.5 | no trial data cached |
| Gait inability | 30 | 9.5 6.7–13.6ROR 9.6 · χ² 220 / p 4e-50 | 8.8 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · 83% consumer | no trial data cached |
| Pharyngitis | 11 | 9.3 5.1–16.7ROR 9.3 · χ² 73 / p 6e-18 | 7.4 EB05 4.2 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.8 | no trial data cached |
| Cellulitis (skin infection) | 42 | 8.7 6.5–11.8ROR 8.9 · χ² 280 / p 3e-63 | 8.2 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Skin haemorrhage | 12 | 8.7 5.0–15.3ROR 8.8 · χ² 75 / p 3e-18 | 7.1 EB05 4.1 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | no trial data cached |
| Candida infection (yeast infection) | 13 | 8.2 4.8–14.1ROR 8.2 · χ² 75 / p 3e-18 | 6.7 EB05 4.1 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 | no trial data cached |
| Product dose omission in error | 20 | 7.8 5.1–12.1ROR 7.9 · χ² 112 / p 2e-26 | 6.9 EB05 4.6 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 19.1 · 95% consumer | no trial data cached |
| Gout | 13 | 7.6 4.4–13.1ROR 7.6 · χ² 68 / p 8e-17 | 6.2 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Ear infection | 19 | 7.5 4.8–11.7ROR 7.6 · χ² 101 / p 5e-24 | 6.5 EB05 4.4 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.0 | no trial data cached |
| Product availability issue | 16 | 7.5 4.6–12.2ROR 7.5 · χ² 84 / p 3e-20 | 6.4 EB05 4.1 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 10.2 | no trial data cached |
| Musculoskeletal chest pain | 11 | 7.4 4.1–13.4ROR 7.5 · χ² 55 / p 6e-14 | 5.9 EB05 3.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Therapeutic product effect incomplete | 50 | 7.4 5.6–9.8ROR 7.6 · χ² 272 / p 2e-61 | 7.0 EB05 5.5 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 | no trial data cached |
| Inappropriate schedule of product administration | 120 | 7.1 6.0–8.5ROR 7.5 · χ² 630 / p 2e-139 | 7.0 EB05 6.0 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 11.2 · 77% consumer | no trial data cached |
| Ill-defined disorder | 39 | 6.7 4.9–9.2ROR 6.8 · χ² 185 / p 2e-42 | 6.3 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 90% consumer | no trial data cached |
| Oropharyngeal pain (sore throat) | 58 | 6.6 5.1–8.5ROR 6.7 · χ² 269 / p 8e-61 | 6.3 EB05 5.0 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.3 | no trial data cached |
| Feeling cold | 17 | 6.4 4.0–10.3ROR 6.4 · χ² 72 / p 1e-17 | 5.5 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Skin disorder | 20 | 6.3 4.1–9.8ROR 6.4 · χ² 84 / p 2e-20 | 5.6 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.1 | no trial data cached |
| Stress | 43 | 6.3 4.7–8.4ROR 6.4 · χ² 186 / p 1e-42 | 5.9 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Skin lesion | 16 | 6.2 3.8–10.0ROR 6.2 · χ² 64 / p 6e-16 | 5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Skin fissures | 11 | 6.1 3.4–11.0ROR 6.1 · χ² 42 / p 4e-11 | 5.0 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Knee arthroplasty | 12 | 6.0 3.4–10.6ROR 6.1 · χ² 46 / p 7e-12 | 5.0 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Surgery | 33 | 6.0 4.3–8.4ROR 6.1 · χ² 132 / p 8e-31 | 5.5 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 · 78% consumer | no trial data cached |
| Treatment failure | 46 | 5.9 4.4–7.8ROR 6.0 · χ² 182 / p 9e-42 | 5.6 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 · 91% clinician | no trial data cached |
| Arthritis | 44 | 5.9 4.4–7.8ROR 6.0 · χ² 173 / p 8e-40 | 5.5 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 75% consumer | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Psoriasis | 498 | 40.1 37.1–43.3ROR 53.0 · χ² 18,986 / p <1e-300 | 39.9 EB05 37.0 · IC025 +5.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 66.7 | no trial data cached |
| Arthralgia (joint pain) | 191 | 4.8 4.2–5.5ROR 5.2 · χ² 588 / p 3e-130 | 4.8 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Psoriatic arthropathy | 173 | 45.3 39.3–52.2ROR 49.5 · χ² 7,431 / p <1e-300 | 44.9 EB05 39.5 · IC025 +5.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 36.1 | no trial data cached |
| Intentional product use issue | 172 | 20.5 17.8–23.7ROR 22.4 · χ² 3,185 / p <1e-300 | 20.5 EB05 18.0 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 18.7 · 84% consumer | no trial data cached |
| Product dose omission issue | 142 | 5.2 4.5–6.1ROR 5.6 · χ² 488 / p 2e-108 | 5.1 EB05 4.5 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 11.6 · 82% consumer | no trial data cached |
| Disease recurrence | 137 | 30.2 25.7–35.5ROR 32.3 · χ² 3,835 / p <1e-300 | 30.0 EB05 26.0 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 37.3 · 78% consumer | no trial data cached |
| Therapy interrupted | 136 | 20.7 17.6–24.4ROR 22.1 · χ² 2,534 / p <1e-300 | 20.6 EB05 17.9 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 28.6 · 76% consumer | no trial data cached |
| Inappropriate schedule of product administration | 120 | 7.1 6.0–8.5ROR 7.5 · χ² 630 / p 2e-139 | 7.0 EB05 6.0 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 11.2 · 77% consumer | no trial data cached |
| Covid-19 | 87 | 5.2 4.2–6.3ROR 5.3 · χ² 290 / p 3e-65 | 5.0 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · 70% consumer | no trial data cached |
| Therapy cessation | 87 | 17.9 14.6–22.0ROR 18.6 · χ² 1,371 / p 2e-300 | 17.8 EB05 14.9 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 25.0 · 82% consumer | no trial data cached |
| Injection site pain (pain where injected) | 66 | 2.3 1.8–2.9ROR 2.3 · χ² 47 / p 4e-12 | 2.3 EB05 1.8 · IC025 +0.8 | Labeled (related wording) related wording | serious PRR 8.7 · ♀ 80% (drug 47%) · 71% consumer | no trial data cached |
| Hospitalisation | 62 | 4.3 3.3–5.5ROR 4.4 · χ² 153 / p 2e-35 | 4.1 EB05 3.4 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Oropharyngeal pain (sore throat) | 58 | 6.6 5.1–8.5ROR 6.7 · χ² 269 / p 8e-61 | 6.3 EB05 5.0 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.3 | no trial data cached |
| Intentional dose omission | 56 | 21.5 16.6–27.9ROR 22.1 · χ² 1,074 / p 7e-236 | 21.3 EB05 17.0 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 28.9 · 87% consumer | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 51 | 5.8 4.5–7.7ROR 6.0 · χ² 200 / p 9e-46 | 5.6 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.0 | no trial data cached |
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.
- Insurance issue — n=28, PRR 19.8
- Gait inability — n=30, PRR 9.5
- Cellulitis — n=42, PRR 8.7
- Ill-defined disorder — n=39, PRR 6.7
- Stress — n=43, PRR 6.3
- Arthritis — n=44, PRR 5.9
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 Brodalumab?
In FDA FAERS, the most frequently co-reported reaction terms for Brodalumab are psoriasis, arthralgia, psoriatic arthropathy, covid-19, injection site pain, oropharyngeal pain. 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 Brodalumab have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SUICIDAL IDEATION AND BEHAVIOR Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. Prior to prescribing SILIQ, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior.
Do FAERS signals prove that Brodalumab 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 1a550c33-456a-4833-814e-8591aea7c688, effective 20260528; matched on
openfda.generic_name.exact:"BRODALUMAB") - 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, 131 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
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.