Secukinumab vs Ustekinumab: side effects in FDA adverse event reports
At a glance
| Secukinumab | Ustekinumab | |
|---|---|---|
| Drug class | Interleukin-17A Antagonist | Interleukin-12 Antagonist, Interleukin-23 Antagonist |
| Brand names | Cosentyx | – |
| FAERS reports | 160,389 | 101,629 |
| Serious | 40% | 59% |
| Death outcome | 8,611 | 5,950 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Secukinumab | Ustekinumab | Label screen (A / B) |
|---|---|---|---|
| Peripheral venous disease | 1,577 · PRR 85.3 | 1,058 · PRR 74.2 | Not in label — unassessed / Labeled (related wording) |
| Synovitis | 4,134 · PRR 38.7 | 4,564 · PRR 69.7 | Not in label — unassessed / Not in label — unassessed |
| Pemphigus | 3,846 · PRR 58.4 | 3,867 · PRR 93.1 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 3,628 · PRR 50.0 | 3,970 · PRR 89.8 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 3,048 · PRR 55.6 | 3,183 · PRR 93.6 | Not in label — unassessed / Not in label — unassessed |
| Duodenal ulcer perforation | 3,024 · PRR 91.7 | 3,088 · PRR 150.3 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 3,017 · PRR 53.8 | 2,544 · PRR 67.3 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 2,562 · PRR 187.4 | 2,495 · PRR 277.9 | Not in label — unassessed / Not in label — unassessed |
| Muscle injury | 2,384 · PRR 53.4 | 2,157 · PRR 73.4 | Not in label — unassessed / Not in label — unassessed |
| Facet joint syndrome | 1,958 · PRR 217.2 | 1,380 · PRR 161.2 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,207 · PRR 211.9 | 1,039 · PRR 234.4 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,022 · PRR 111.4 | 798 · PRR 115.5 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 943 · PRR 115.3 | 846 · PRR 149.7 | Not in label — unassessed / Not in label — unassessed |
| Bone erosion | 806 · PRR 38.3 | 767 · PRR 56.9 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 726 · PRR 207.0 | 661 · PRR 260.2 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 675 · PRR 88.8 | 637 · PRR 127.5 | Not in label — unassessed / Not in label — unassessed |
| Seronegative arthritis | 346 · PRR 58.1 | 279 · PRR 68.1 | Likely indication confounding / Likely indication confounding |
| Subcutaneous drug absorption impaired | 244 · PRR 106.2 | 215 · PRR 134.7 | Not in label — unassessed / Not in label — unassessed |
| Neurologic neglect syndrome | 193 · PRR 68.6 | 175 · PRR 93.7 | Not in label — unassessed / Not in label — unassessed |
| Grip strength | 147 · PRR 229.4 | 114 · PRR 200.6 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Secukinumab
- None stood out among the strongest labeled signals.
Labeled signals distinctive to Ustekinumab
- Contraindication to vaccination — n=42, PRR 57.8 Labeled (related wording)
Common questions
Which has more reported side effects, Secukinumab or Ustekinumab?
Secukinumab has 160,389 FAERS reports and Ustekinumab 101,629. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (40% vs 59%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Secukinumab and Ustekinumab share?
Both drugs carry disproportionality signals for peripheral venous disease, synovitis, pemphigus, hand deformity, helicobacter infection. Shared signals often reflect a shared drug class or the condition both are used for.
Is Secukinumab or Ustekinumab safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.