Infliximab vs Certolizumab Pegol: side effects in FDA adverse event reports
At a glance
| Infliximab | Certolizumab Pegol | |
|---|---|---|
| Drug class | Tumor Necrosis Factor Blocker | Tumor Necrosis Factor Blocker |
| Brand names | Renflexis | Cimzia |
| FAERS reports | 217,056 | 116,499 |
| Serious | 89% | 65% |
| Death outcome | 13,761 | 6,589 |
| Boxed warning | Yes SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Increased risk of seri | 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 | Infliximab | Certolizumab Pegol | Label screen (A / B) |
|---|---|---|---|
| Pericarditis | 6,271 · PRR 58.1 | 5,784 · PRR 95.8 | Not in label — unassessed / Labeled adverse reaction |
| Rheumatic fever | 3,038 · PRR 224.9 | 2,988 · PRR 398.6 | Labeled (related wording) / Labeled (related wording) |
| Swollen joint count | 135 · PRR 117.9 | 123 · PRR 181.0 | Labeled (related wording) / Not in label — unassessed |
| Pemphigus | 8,799 · PRR 239.1 | 8,765 · PRR 441.6 | Not in label — unassessed / Not in label — unassessed |
| Glossodynia | 8,347 · PRR 57.4 | 8,125 · PRR 102.9 | Not in label — unassessed / Not in label — unassessed |
| Synovitis | 9,005 · PRR 96.4 | 7,397 · PRR 125.4 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 7,477 · PRR 129.7 | 7,256 · PRR 226.5 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 4,856 · PRR 88.0 | 4,758 · PRR 158.4 | Not in label — unassessed / Not in label — unassessed |
| Duodenal ulcer perforation | 4,679 · PRR 171.9 | 4,669 · PRR 320.0 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 4,112 · PRR 63.8 | 4,447 · PRR 136.6 | Not in label — unassessed / Not in label — unassessed |
| Muscle injury | 3,385 · PRR 67.7 | 3,918 · PRR 165.4 | Not in label — unassessed / Not in label — unassessed |
| Sleep disorder due to general medical condition, insomnia type | 2,692 · PRR 69.3 | 2,918 · PRR 149.9 | Not in label — unassessed / Not in label — unassessed |
| Facet joint syndrome | 1,773 · PRR 124.9 | 1,708 · PRR 214.8 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,228 · PRR 163.6 | 1,249 · PRR 321.1 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,023 · PRR 82.3 | 892 · PRR 120.8 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 964 · PRR 88.6 | 938 · PRR 157.5 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 713 · PRR 145.6 | 755 · PRR 317.5 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 660 · PRR 63.0 | 611 · PRR 104.1 | Not in label — unassessed / Not in label — unassessed |
| Subcutaneous drug absorption impaired | 219 · PRR 64.8 | 185 · PRR 92.6 | Not in label — unassessed / Not in label — unassessed |
| Grip strength | 136 · PRR 137.9 | 139 · PRR 272.7 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Infliximab
- Lupus-like syndrome — n=3,336, PRR 56.5 Labeled adverse reaction
- Hepatosplenic t-cell lymphoma — n=184, PRR 94.3 Labeled — boxed warning
Labeled signals distinctive to Certolizumab Pegol
- Peripheral venous disease — n=1,261, PRR 83.1 Labeled (related wording)
Common questions
Which has more reported side effects, Infliximab or Certolizumab Pegol?
Infliximab has 217,056 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 (89% vs 65%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Infliximab and Certolizumab Pegol share?
Both drugs carry disproportionality signals for pericarditis, rheumatic fever, swollen joint count, pemphigus, glossodynia. Shared signals often reflect a shared drug class or the condition both are used for.
Is Infliximab 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.