Secukinumab side effects: what 160,389 FDA adverse event reports show
Drug class
Interleukin-17A Antagonist
Brand names
Cosentyx
Who reports
160,389 reports · 40% serious · 8,611 with death outcome · 62% female
Used for
COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. ( 1.1 ) active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older.
What it is
Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- 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.
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,207 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 |
|---|---|---|---|---|---|---|
| Rebound psoriasis | 389 | 260.7 219.2–309.9ROR 261.3 · calibrated p 5e-11 ✓ | 86.2 EB05 79.2 · IC025 +6.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=116 · 82% consumer | not reported in cached trials |
| Hepatic enzyme | 91 | 247.8 174.3–352.4ROR 248.0 · calibrated p 2e-10 ✓ | 83.6 EB05 70.2 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=91 · ♀ 100% (drug 62%) · 100% clinician | NCT02409667: 3/1,647 (0.2%) on Secukinumab (serious AE) |
| C-reactive protein | 582 | 237.2 206.8–272.1ROR 238.1 · calibrated p 1e-10 ✓ | 83.6 EB05 78.0 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious n=582 · ♀ 100% (drug 62%) · 100% clinician | not reported in cached trials |
| Grip strength | 147 | 229.4 175.1–300.6ROR 229.7 · calibrated p 2e-10 ✓ | 81.9 EB05 71.4 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=145 · ♀ 100% (drug 62%) · 100% clinician | not reported in cached trials |
| Facet joint syndrome | 1,958 | 217.2 202.0–233.5ROR 219.8 · calibrated p 2e-10 ✓ | 81.1 EB05 78.1 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=1,957 · ♀ 100% (drug 62%) · 95% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 1,207 | 211.9 193.3–232.3ROR 213.5 · calibrated p 2e-10 ✓ | 80.3 EB05 76.6 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=1,207 · ♀ 100% (drug 62%) · 95% clinician | not reported in cached trials |
| Lupus vulgaris | 726 | 207.0 184.0–232.8ROR 207.9 · calibrated p 3e-10 ✓ | 79.5 EB05 74.8 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=726 · ♀ 100% (drug 62%) · 96% clinician | not reported in cached trials |
| Rheumatic fever | 2,562 | 187.4 176.4–199.1ROR 190.4 · calibrated p 6e-10 ✓ | 76.6 EB05 74.1 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=2,562 · ♀ 100% (drug 62%) · 95% clinician | not reported in cached trials |
| Swollen joint count increased | 1,749 | 168.3 156.8–180.7ROR 170.2 · calibrated p 2e-9 ✓ | 73.2 EB05 70.4 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious n=1,748 · ♀ 100% (drug 62%) · 95% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 365 | 158.9 136.3–185.3ROR 159.3 · calibrated p 3e-9 ✓ | 71.2 EB05 65.3 · IC025 +5.9 3/3 methods agree | Lab value / disease marker | serious n=365 · ♀ 100% (drug 62%) · 100% clinician | not reported in cached trials |
| Swollen joint count | 132 | 152.2 118.3–195.9ROR 152.3 · calibrated p 7e-9 ✓ | 69.4 EB05 60.0 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=132 · ♀ 100% (drug 62%) · 100% clinician | not reported in cached trials |
| Hypocholesterolaemia | 154 | 131.4 104.9–164.5ROR 131.5 · calibrated p 2e-8 ✓ | 64.8 EB05 56.7 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=154 · ♀ 100% (drug 62%) · 100% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 943 | 115.3 105.6–125.9ROR 116.0 · calibrated p 4e-8 ✓ | 61.1 EB05 57.9 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=943 · ♀ 100% (drug 62%) · 96% clinician | not reported in cached trials |
| Dislocation of vertebra | 1,022 | 111.4 102.5–121.1ROR 112.1 · calibrated p 5e-8 ✓ | 60.0 EB05 56.9 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=1,022 · ♀ 100% (drug 62%) · 95% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 244 | 106.2 89.6–125.9ROR 106.4 · calibrated p 9e-8 ✓ | 58.2 EB05 52.4 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=243 · ♀ 100% (drug 62%) · 100% clinician | not reported in cached trials |
| X-ray abnormal | 782 | 102.1 93.0–112.2ROR 102.6 · calibrated p 1e-7 ✓ | 57.2 EB05 53.9 · IC025 +5.7 3/3 methods agree | Lab value / disease marker | serious n=782 · ♀ 100% (drug 62%) · 96% clinician | not reported in cached trials |
| Red blood cell sedimentation rate | 117 | 93.0 73.3–118.0ROR 93.1 · calibrated p 3e-7 ✓ | 53.8 EB05 46.1 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=117 · ♀ 100% (drug 62%) · 100% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 3,024 | 91.7 87.5–96.0ROR 93.4 · calibrated p 2e-7 ✓ | 53.8 EB05 52.2 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 77.2 · ♀ 100% (drug 62%) · 95% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 2,901 | 90.3 86.1–94.6ROR 91.9 · calibrated p 2e-7 ✓ | 53.3 EB05 51.7 · IC025 +5.7 3/3 methods agree | Lab value / disease marker | serious PRR 76.8 · ♀ 99% (drug 62%) · 95% clinician | not reported in cached trials |
| Retinitis | 675 | 88.8 80.5–97.9ROR 89.2 · calibrated p 3e-7 ✓ | 52.8 EB05 49.5 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=675 · ♀ 100% (drug 62%) · 96% clinician | not reported in cached trials |
| Peripheral venous disease | 1,577 | 85.3 80.1–90.9ROR 86.2 · calibrated p 3e-7 ✓ | 51.6 EB05 49.5 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=1,575 · ♀ 100% (drug 62%) · 94% clinician | not reported in cached trials |
| Rheumatoid factor positive | 2,232 | 82.5 78.2–87.0ROR 83.6 · calibrated p 4e-7 ✓ | 50.5 EB05 48.8 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious n=2,231 · ♀ 100% (drug 62%) · 96% clinician | not reported in cached trials |
| Neurologic neglect syndrome | 193 | 68.6 57.6–81.7ROR 68.7 · calibrated p 2e-6 ✓ | 44.8 EB05 39.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=193 · ♀ 100% (drug 62%) · 100% clinician | not reported in cached trials |
| C-reactive protein abnormal | 2,058 | 61.7 58.6–65.1ROR 62.5 · calibrated p 3e-6 ✓ | 42.0 EB05 40.5 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious n=2,048 · ♀ 96% (drug 62%) · 92% clinician | not reported in cached trials |
| Pemphigus | 3,846 | 58.4 56.3–60.7ROR 59.8 · calibrated p 4e-6 ✓ | 40.4 EB05 39.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 58.2 · ♀ 100% (drug 62%) · 95% clinician | not reported in cached trials |
| Seronegative arthritis | 346 | 58.1 51.2–66.0ROR 58.2 · calibrated p 5e-6 ✓ | 40.2 EB05 36.8 · IC025 +5.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=345 · ♀ 88% (drug 62%) | not reported in cached trials |
| Helicobacter infection | 3,048 | 55.6 53.3–58.0ROR 56.7 · calibrated p 6e-6 ✓ | 39.1 EB05 37.9 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 59.2 · ♀ 99% (drug 62%) · 94% clinician | not reported in cached trials |
| Dactylitis | 288 | 54.1 47.2–62.1ROR 54.2 · calibrated p 9e-6 ✓ | 38.2 EB05 34.7 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=256 | not reported in cached trials |
| Folliculitis | 3,017 | 53.8 51.6–56.1ROR 54.8 · calibrated p 8e-6 ✓ | 38.2 EB05 37.0 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 63.4 · ♀ 98% (drug 62%) · 95% clinician | NCT02409667: 31/1,647 (1.9%) on Secukinumab |
| Muscle injury | 2,384 | 53.4 50.9–56.0ROR 54.2 · calibrated p 8e-6 ✓ | 37.9 EB05 36.7 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 58.8 · ♀ 99% (drug 62%) · 95% clinician | not reported in cached trials |
| Nail psoriasis | 179 | 53.2 44.7–63.3ROR 53.2 · calibrated p 1e-5 ✓ | 37.7 EB05 33.3 · IC025 +4.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=90 | not reported in cached trials |
| Enthesopathy | 451 | 52.2 46.8–58.2ROR 52.3 · calibrated p 1e-5 ✓ | 37.3 EB05 34.5 · IC025 +5.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=406 | not reported in cached trials |
| Hand deformity | 3,628 | 50.0 48.1–52.0ROR 51.1 · calibrated p 1e-5 ✓ | 36.2 EB05 35.3 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 56.2 · ♀ 98% (drug 62%) · 94% clinician | not reported in cached trials |
| Macule | 747 | 48.0 44.1–52.2ROR 48.2 · calibrated p 2e-5 ✓ | 35.2 EB05 33.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=225 | not reported in cached trials |
| Psoriatic arthropathy | 10,208 | 44.3 43.4–45.3ROR 47.3 · calibrated p 2e-5 ✓ | 33.2 EB05 32.6 · IC025 +5.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 59.0 | not reported in cached trials |
| Skin plaque | 2,098 | 43.2 41.1–45.3ROR 43.7 · calibrated p 3e-5 ✓ | 32.5 EB05 31.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=830 | not reported in cached trials |
| Breast cancer stage iii | 1,503 | 39.7 37.5–42.0ROR 40.0 · calibrated p 5e-5 ✓ | 30.5 EB05 29.2 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=1,503 · ♀ 100% (drug 62%) · 94% clinician | not reported in cached trials |
| Synovitis | 4,134 | 38.7 37.4–40.0ROR 39.7 · calibrated p 5e-5 ✓ | 29.9 EB05 29.2 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 44.9 · ♀ 94% (drug 62%) · 92% clinician | not reported in cached trials |
| Bone erosion | 806 | 38.3 35.4–41.5ROR 38.5 · calibrated p 7e-5 ✓ | 29.7 EB05 28.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=801 · ♀ 94% (drug 62%) · 92% clinician | not reported in cached trials |
| Lip dry | 2,026 | 38.0 36.2–40.0ROR 38.5 · calibrated p 7e-5 ✓ | 29.5 EB05 28.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=1,998 · ♀ 100% (drug 62%) · 94% clinician | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Liver injury | 6,521 | 2.92.8–2.9 | signal |
| Tendon disorder | 719 | 2.52.3–2.7 | signal |
| Interstitial lung disease | 1,646 | 2.32.2–2.4 | signal |
| Serious infection | 12,478 | 2.12.1–2.2 | signal |
| Opportunistic infection | 2,003 | 1.91.9–2.0 | raised |
| Hyperglycaemia / diabetes | 4,665 | 1.81.7–1.8 | raised |
| Depression | 3,259 | 1.51.5–1.6 | raised |
| Fall / fracture | 2,968 | 1.01.0–1.1 | no difference |
| Pancreatitis | 538 | 0.90.8–0.9 | lower than other drugs |
| Malignancy | 2,216 | 0.80.7–0.8 | lower than other drugs |
| Stroke | 1,244 | 0.70.6–0.7 | lower than other drugs |
| Anaphylaxis / angioedema | 624 | 0.60.6–0.7 | lower than other drugs |
| Myocardial infarction | 905 | 0.60.5–0.6 | lower than other drugs |
| Gi bleeding | 753 | 0.50.5–0.6 | lower than other drugs |
| Rhabdomyolysis / myopathy | 321 | 0.50.5–0.6 | lower than other drugs |
| Venous thromboembolism | 759 | 0.50.4–0.5 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Secukinumab 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 (2 of 40 signal terms matched).
- NCT02409667 — Plaque Psoriasis Efficacy and Safety With Secukinumab (N=16487, PHASE3; 160 AE terms posted; arms: Treatment Period 1: All Participants; Treatment Period 2: Group 1; Treatment Period 2: Group 2; Treatment Period 2: Group 3)
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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 29,187 | 2.9 2.9–3.0ROR 3.4 · calibrated p 0.517 | 2.9 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 3.1 · serious PRR 4.8 | not reported in cached trials |
| Psoriasis | 22,826 | 27.5 27.1–27.9ROR 31.9 · calibrated p 2e-4 ✓ | 22.8 EB05 22.6 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications | age-adj. PRR 23.4 · serious PRR 33.7 | NCT02409667: 3/114 (2.6%) on Secukinumab |
| Pain | 16,628 | 3.6 3.6–3.7ROR 3.9 · calibrated p 0.396 | 3.5 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 4.2 · serious PRR 5.2 | NCT02409667: 1/644 (0.2%) on Secukinumab (serious AE) |
| Arthralgia (joint pain) | 14,911 | 4.8 4.8–4.9ROR 5.2 · calibrated p 0.210 | 4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | age-adj. PRR 5.2 · serious PRR 7.8 | NCT02409667: 50/1,647 (3.0%) on Secukinumab |
| Fatigue (tiredness) | 10,590 | 1.8 1.8–1.8ROR 1.8 · calibrated p 0.859 | 1.8 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | age-adj. PRR 2.4 · serious PRR 3.7 | NCT02409667: 41/1,647 (2.5%) on Secukinumab |
| Psoriatic arthropathy | 10,208 | 44.3 43.4–45.3ROR 47.3 · calibrated p 2e-5 ✓ | 33.2 EB05 32.6 · IC025 +5.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 59.0 | not reported in cached trials |
| Malaise (feeling unwell) | 9,466 | 2.9 2.8–2.9ROR 3.0 · calibrated p 0.635 | 2.8 EB05 2.8 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | age-adj. PRR 3.9 · serious PRR 4.8 | not reported in cached trials |
| Pruritus (itching) | 9,443 | 3.3 3.3–3.4ROR 3.5 · calibrated p 0.492 | 3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | age-adj. PRR 3.6 · serious PRR 6.0 | NCT02409667: 5/1,647 (0.3%) on Secukinumab |
| Rash | 9,122 | 2.8 2.7–2.8ROR 2.9 · calibrated p 0.661 | 2.7 EB05 2.7 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | age-adj. PRR 3.4 · serious PRR 5.3 | not reported in cached trials |
| Condition aggravated | 8,527 | 3.8 3.7–3.9ROR 3.9 · calibrated p 0.392 | 3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 3.6 · serious PRR 4.5 | not reported in cached trials |
| Diarrhoea (diarrhea) | 8,007 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.750 | 1.6 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | age-adj. PRR 2.3 · serious PRR 2.9 | NCT02409667: 74/1,647 (4.5%) on Secukinumab |
| Nasopharyngitis (common cold) | 7,818 | 5.7 5.6–5.9ROR 6.0 · calibrated p 0.151 | 5.5 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 7.2 · serious PRR 11.2 | NCT02409667: 6/1,647 (0.4%) on Secukinumab |
| Pain in extremity | 7,313 | 3.3 3.2–3.4ROR 3.4 · calibrated p 0.508 | 3.2 EB05 3.2 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | age-adj. PRR 4.0 · serious PRR 5.9 | not reported in cached trials |
| Headache | 7,264 | 1.5 1.5–1.6ROR 1.5 · calibrated p 0.672 | 1.5 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | age-adj. PRR 2.0 · serious PRR 3.4 | NCT02409667: 1/1,647 (0.1%) on Secukinumab (serious AE) |
| Off label use (used outside approved label) | 6,787 | 1.0 1.0–1.0ROR 1.0 · calibrated p 0.322 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | age-adj. PRR 1.7 · serious PRR 2.4 | 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.
- Hepatic enzyme — n=91, PRR 247.8 (also seen in trial arm)
- Grip strength — n=147, PRR 229.4
- Facet joint syndrome — n=1,958, PRR 217.2
- Deep vein thrombosis postoperative — n=1,207, PRR 211.9
- Lupus vulgaris — n=726, PRR 207.0
- Rheumatic fever — n=2,562, PRR 187.4
- Swollen joint count — n=132, PRR 152.2
- Hypocholesterolaemia — n=154, PRR 131.4
- Adjustment disorder with depressed mood — n=943, PRR 115.3
- Dislocation of vertebra — n=1,022, PRR 111.4
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 Secukinumab?
In FDA FAERS, the most frequently co-reported reaction terms for Secukinumab are psoriasis, pain, arthralgia, fatigue, psoriatic arthropathy, 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 Secukinumab have an FDA boxed warning?
No. The FDA label retrieved for Secukinumab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Secukinumab 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 77c4b13e-7df3-42d4-81db-3d0cddb7f67a, effective 20260825; matched on
openfda.generic_name.exact:"SECUKINUMAB" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 1,247 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
SECUKINUMAB, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.