Adalimumab vs Certolizumab Pegol: side effects in FDA adverse event reports
At a glance
| Adalimumab | Certolizumab Pegol | |
|---|---|---|
| Drug class | – | Tumor Necrosis Factor Blocker |
| Brand names | Humira | Cimzia |
| FAERS reports | 703,389 | 116,499 |
| Serious | 51% | 65% |
| Death outcome | 30,045 | 6,589 |
| Boxed warning | Yes WARNING: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with HUMIRA are at increased risk for developing serious infections that may lead | Yes SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospi |
Signals both drugs share
| Reaction | Adalimumab | Certolizumab Pegol | Label screen (A / B) |
|---|---|---|---|
| Synovitis | 11,430 · PRR 50.9 | 7,397 · PRR 125.4 | Labeled adverse reaction / Not in label — unassessed |
| Duodenal ulcer perforation | 4,928 · PRR 60.4 | 4,669 · PRR 320.0 | Labeled (related wording) / Not in label — unassessed |
| Muscle injury | 3,785 · PRR 24.9 | 3,918 · PRR 165.4 | Labeled (related wording) / Not in label — unassessed |
| Rheumatic fever | 3,220 · PRR 83.8 | 2,988 · PRR 398.6 | Likely indication confounding / Labeled (related wording) |
| Pemphigus | 9,240 · PRR 86.7 | 8,765 · PRR 441.6 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 8,490 · PRR 54.5 | 7,256 · PRR 226.5 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 5,291 · PRR 31.5 | 4,758 · PRR 158.4 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 4,615 · PRR 23.5 | 4,447 · PRR 136.6 | Not in label — unassessed / Not in label — unassessed |
| Facet joint syndrome | 1,918 · PRR 45.6 | 1,708 · PRR 214.8 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,428 · PRR 79.9 | 1,249 · PRR 321.1 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,248 · PRR 37.4 | 892 · PRR 120.8 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 1,172 · PRR 40.7 | 938 · PRR 157.5 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 888 · PRR 87.9 | 755 · PRR 317.5 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 809 · PRR 27.4 | 611 · PRR 104.1 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Adalimumab
- Injection site papule — n=3,181, PRR 70.5 Labeled (related wording)
- Rheumatoid nodule — n=1,249, PRR 23.7 Labeled (related wording)
- Injection site burning — n=562, PRR 73.3 Labeled (related wording)
- Granuloma skin — n=539, PRR 54.9 Labeled (related wording)
Labeled signals distinctive to Certolizumab Pegol
- Pericarditis — n=5,784, PRR 95.8 Labeled adverse reaction
- Peripheral venous disease — n=1,261, PRR 83.1 Labeled (related wording)
Common questions
Which has more reported side effects, Adalimumab or Certolizumab Pegol?
Adalimumab has 703,389 FAERS reports and Certolizumab Pegol 116,499. 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 (51% vs 65%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Adalimumab and Certolizumab Pegol share?
Both drugs carry disproportionality signals for synovitis, duodenal ulcer perforation, muscle injury, rheumatic fever, pemphigus. Shared signals often reflect a shared drug class or the condition both are used for.
Is Adalimumab or Certolizumab Pegol 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.