Ixekizumab side effects: what 36,769 FDA adverse event reports show
Drug class
Interleukin-17A Antagonist
Brand names
Taltz
Who reports
36,769 reports · 21% serious · 547 with death outcome · 61% female
Used for
TALTZ ® is a humanized interleukin-17A antagonist indicated for the treatment of: patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ( 1.1 ) adults with active psoriatic arthritis. ( 1.2 ) adults with active ankylosing spondylitis. ( 1.3 ) adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.
What it is
Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
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.
- 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. 1,010 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 |
|---|---|---|---|---|---|---|
| Meningoradiculitis | 10 | 57.3 29.9–109.8ROR 57.3 · χ² 452 / p 1e-100 | 47.7 EB05 27.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Chronic disease | 20 | 48.8 30.9–77.1ROR 48.9 · χ² 819 / p 2e-180 | 43.3 EB05 29.6 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=19 | NCT01646177: 2/360 (0.6%) on Ixekizumab (serious AE) |
| Injection site plaque | 15 | 44.6 26.3–75.4ROR 44.6 · χ² 552 / p 2e-122 | 39.5 EB05 25.4 · IC025 +3.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=4 | not reported in cached trials |
| Alopecia scarring | 10 | 36.0 19.0–68.2ROR 36.0 · χ² 288 / p 8e-65 | 32.0 EB05 18.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Removal of internal fixation | 10 | 33.6 17.8–63.7ROR 33.6 · χ² 269 / p 1e-60 | 30.1 EB05 17.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=9 | not reported in cached trials |
| Cutaneous lymphoma | 11 | 32.7 17.8–60.0ROR 32.7 · χ² 290 / p 2e-65 | 29.5 EB05 17.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Carbon dioxide abnormal | 15 | 28.6 17.0–48.0ROR 28.6 · χ² 354 / p 3e-79 | 26.4 EB05 16.9 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious n=15 | not reported in cached trials |
| Granuloma skin | 35 | 25.1 17.9–35.2ROR 25.1 · χ² 752 / p 6e-166 | 23.8 EB05 17.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=35 · ♀ 100% (drug 61%) · 100% clinician | not reported in cached trials |
| Skin candida | 19 | 21.7 13.7–34.4ROR 21.7 · χ² 342 / p 1e-76 | 20.5 EB05 13.7 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=15 | not reported in cached trials |
| Enthesopathy | 55 | 20.6 15.7–26.9ROR 20.6 · χ² 969 / p 5e-213 | 19.8 EB05 15.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=41 · ♀ 85% (drug 61%) | not reported in cached trials |
| Dactylitis | 34 | 20.4 14.5–28.8ROR 20.4 · χ² 587 / p 5e-130 | 19.5 EB05 14.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Wrong schedule | 28 | 17.3 11.9–25.2ROR 17.3 · χ² 401 / p 1e-89 | 16.5 EB05 11.8 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Palmoplantar pustulosis | 15 | 17.2 10.3–28.8ROR 17.2 · χ² 207 / p 3e-47 | 16.0 EB05 9.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=8 | not reported in cached trials |
| Paradoxical psoriasis | 12 | 16.7 9.4–29.6ROR 16.7 · χ² 157 / p 3e-36 | 15.1 EB05 8.3 · IC025 +2.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | not reported in cached trials |
| Injection site urticaria | 670 | 16.2 15.0–17.4ROR 16.5 · χ² 9,265 / p <1e-300 | 15.7 EB05 14.8 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=37 · 80% consumer | NCT01646177: 1/369 (0.3%) on Ixekizumab (serious AE) |
| Blood parathyroid hormone decreased | 39 | 15.3 11.1–21.0ROR 15.3 · χ² 493 / p 2e-109 | 14.7 EB05 11.1 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=39 · ♀ 100% (drug 61%) · 92% clinician | not reported in cached trials |
| Injection site reaction | 1,785 | 15.2 14.5–15.9ROR 15.9 · χ² 23,124 / p <1e-300 | 14.8 EB05 14.3 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.7 · 70% consumer | NCT01646177: 37/384 (9.6%) on Ixekizumab; 3/193 (1.6%) control |
| Nail psoriasis | 16 | 15.1 9.2–24.9ROR 15.1 · χ² 192 / p 6e-44 | 13.9 EB05 8.5 · IC025 +2.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | not reported in cached trials |
| Injection site hypersensitivity | 77 | 14.6 11.7–18.3ROR 14.7 · χ² 939 / p 1e-206 | 14.2 EB05 11.7 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=8 · 81% consumer | NCT01646177: 1/362 (0.3%) on Ixekizumab (serious AE) |
| Psoriasis | 3,254 | 14.5 14.1–15.0ROR 15.8 · χ² 40,202 / p <1e-300 | 14.2 EB05 13.8 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 20.3 · 71% consumer | NCT01646177: 1/183 (0.5%) on Ixekizumab; 1/193 (0.5%) control (serious AE) |
| Injection site warmth | 497 | 14.1 12.9–15.4ROR 14.3 · χ² 5,882 / p <1e-300 | 13.7 EB05 12.8 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=39 · 77% consumer | not reported in cached trials |
| Manufacturing product shipping issue | 13 | 14.0 8.1–24.3ROR 14.0 · χ² 141 / p 8e-33 | 12.4 EB05 6.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Injection site cellulitis | 44 | 13.9 10.3–18.8ROR 14.0 · χ² 503 / p 9e-112 | 13.4 EB05 10.3 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | NCT01646177: 3/183 (1.6%) on Ixekizumab; 1/193 (0.5%) control (serious AE) |
| Cirrhosis alcoholic | 10 | 12.7 6.8–23.7ROR 12.7 · χ² 94 / p 2e-22 | 10.4 EB05 5.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Injection site swelling | 1,650 | 12.7 12.1–13.3ROR 13.2 · χ² 17,400 / p <1e-300 | 12.4 EB05 11.9 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.0 · 76% consumer | not reported in cached trials |
| Tinea infection | 24 | 12.7 8.4–19.0ROR 12.7 · χ² 241 / p 1e-54 | 11.8 EB05 7.9 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | 71% consumer | not reported in cached trials |
| Antibiotic therapy | 20 | 12.2 7.8–18.9ROR 12.2 · χ² 190 / p 2e-43 | 11.1 EB05 7.1 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Erythrodermic psoriasis | 17 | 12.1 7.5–19.5ROR 12.1 · χ² 159 / p 1e-36 | 10.8 EB05 6.6 · IC025 +2.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=14 | not reported in cached trials |
| Tinea cruris | 10 | 11.8 6.3–22.0ROR 11.8 · χ² 86 / p 8e-21 | 9.5 EB05 4.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Psoriatic arthropathy | 791 | 11.4 10.7–12.2ROR 11.6 · χ² 7,375 / p <1e-300 | 11.2 EB05 10.6 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 18.3 | NCT01646177: 1/183 (0.5%) on Ixekizumab (serious AE) |
| Rheumatoid nodule | 53 | 11.0 8.4–14.5ROR 11.1 · χ² 465 / p 2e-103 | 10.5 EB05 8.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=53 | not reported in cached trials |
| Mycobacterium tuberculosis complex test positive | 45 | 11.0 8.2–14.8ROR 11.0 · χ² 393 / p 1e-87 | 10.4 EB05 8.0 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious n=9 · ♀ 39% (drug 61%) | not reported in cached trials |
| Injection site oedema | 32 | 10.9 7.7–15.4ROR 10.9 · χ² 272 / p 2e-61 | 10.1 EB05 7.3 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | NCT01646177: 1/369 (0.3%) on Ixekizumab (serious AE) |
| Rebound psoriasis | 11 | 10.9 6.0–19.7ROR 10.9 · χ² 87 / p 5e-21 | 8.8 EB05 4.8 · IC025 +1.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=4 | not reported in cached trials |
| Guttate psoriasis | 15 | 10.5 6.3–17.6ROR 10.5 · χ² 118 / p 9e-28 | 9.0 EB05 5.4 · IC025 +2.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=6 | not reported in cached trials |
| Injection site rash | 544 | 10.4 9.6–11.3ROR 10.5 · χ² 4,530 / p <1e-300 | 10.2 EB05 9.5 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=41 · 75% consumer | not reported in cached trials |
| Injection site erythema (redness where injected) | 2,200 | 10.3 9.9–10.8ROR 10.9 · χ² 18,301 / p <1e-300 | 10.2 EB05 9.8 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.0 · 75% consumer | not reported in cached trials |
| Local reaction | 13 | 10.2 5.9–17.7ROR 10.2 · χ² 98 / p 3e-23 | 8.5 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=7 | not reported in cached trials |
| Tinea pedis | 28 | 10.2 7.0–14.7ROR 10.2 · χ² 218 / p 1e-49 | 9.3 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Dyshidrotic eczema | 12 | 10.1 5.7–17.8ROR 10.1 · χ² 88 / p 4e-21 | 8.2 EB05 4.6 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=7 | 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 Ixekizumab 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 (8 of 40 signal terms matched).
- NCT01646177 — A Study in Participants With Moderate to Severe Psoriasis (UNCOVER-3) (N=1346, PHASE3; 327 AE terms posted; arms: Placebo; 50 mg Etanercept; 80 mg Ixekizumab Dosing Regimen 2 (Q4W); 80 mg Ixekizumab Dosing Regimen 1 (Q2W))
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 |
|---|---|---|---|---|---|---|
| Injection site pain (pain where injected) | 3,901 | 7.4 7.2–7.6ROR 8.2 · χ² 21,660 / p <1e-300 | 7.3 EB05 7.1 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 · 83% consumer | NCT01646177: 1/360 (0.3%) on Ixekizumab (serious AE) |
| Psoriasis | 3,254 | 14.5 14.1–15.0ROR 15.8 · χ² 40,202 / p <1e-300 | 14.2 EB05 13.8 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 20.3 · 71% consumer | NCT01646177: 1/183 (0.5%) on Ixekizumab; 1/193 (0.5%) control (serious AE) |
| Drug ineffective (drug did not work) | 3,253 | 1.4 1.4–1.5ROR 1.4 · χ² 412 / p 8e-92 | 1.4 EB05 1.4 · IC025 +0.4 | Reporting / coding artifact | serious PRR 2.4 | not reported in cached trials |
| Injection site erythema (redness where injected) | 2,200 | 10.3 9.9–10.8ROR 10.9 · χ² 18,301 / p <1e-300 | 10.2 EB05 9.8 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.0 · 75% consumer | not reported in cached trials |
| Injection site reaction | 1,785 | 15.2 14.5–15.9ROR 15.9 · χ² 23,124 / p <1e-300 | 14.8 EB05 14.3 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.7 · 70% consumer | NCT01646177: 37/384 (9.6%) on Ixekizumab; 3/193 (1.6%) control |
| Injection site swelling | 1,650 | 12.7 12.1–13.3ROR 13.2 · χ² 17,400 / p <1e-300 | 12.4 EB05 11.9 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.0 · 76% consumer | not reported in cached trials |
| Incorrect dose administered | 1,179 | 3.0 2.8–3.2ROR 3.1 · χ² 1,578 / p <1e-300 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 1.1 · 83% consumer | not reported in cached trials |
| Product dose omission issue | 947 | 1.9 1.8–2.0ROR 1.9 · χ² 406 / p 1e-90 | 1.9 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 1.5 · 82% consumer | not reported in cached trials |
| Pain | 923 | 0.9 0.8–0.9ROR 0.9 · χ² 23 / p 7e-7 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.4 | NCT01646177: 1/360 (0.3%) on Ixekizumab (serious AE) |
| Covid-19 | 921 | 3.0 2.8–3.2ROR 3.0 · χ² 1,212 / p 7e-266 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 | not reported in cached trials |
| Arthralgia (joint pain) | 888 | 1.2 1.1–1.3ROR 1.2 · χ² 36 / p 8e-10 | 1.2 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | serious PRR 2.3 | NCT01646177: 1/183 (0.5%) on Ixekizumab (serious AE) |
| Therapy interrupted | 835 | 7.0 6.5–7.5ROR 7.1 · χ² 4,228 / p <1e-300 | 6.9 EB05 6.5 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · 97% clinician | not reported in cached trials |
| Rash | 830 | 1.1 1.0–1.2ROR 1.1 · χ² 6 / p 0.006 | 1.1 EB05 1.0 · IC025 +0.0 | Not in label — unassessed | serious PRR 1.5 | not reported in cached trials |
| Diarrhoea (diarrhea) | 826 | 0.7 0.7–0.8ROR 0.7 · χ² 83 / p 3e-20 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.1 | NCT01646177: 1/360 (0.3%) on Ixekizumab (serious AE) |
| Pruritus (itching) | 801 | 1.2 1.1–1.3ROR 1.2 · χ² 29 / p 3e-8 | 1.2 EB05 1.1 · IC025 +0.2 | Not in label — unassessed | serious PRR 2.3 | NCT01646177: 7/384 (1.8%) on Ixekizumab; 1/193 (0.5%) control |
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.
- Granuloma skin — n=35, PRR 25.1
- Enthesopathy — n=55, PRR 20.6
- Dactylitis — n=34, PRR 20.4
- Rheumatoid nodule — n=53, PRR 11.0
- Tinea pedis — n=28, PRR 10.2
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 Ixekizumab?
In FDA FAERS, the most frequently co-reported reaction terms for Ixekizumab are injection site pain, psoriasis, injection site erythema, injection site reaction, injection site swelling, 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 Ixekizumab have an FDA boxed warning?
No. The FDA label retrieved for Ixekizumab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ixekizumab 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 ac96658a-d7dc-4c7c-8928-2adcdf4318b2, effective 20260122; matched on
openfda.generic_name.exact:"IXEKIZUMAB") - 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, 1,050 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
IXEKIZUMAB, 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.