Infliximab vs Infliximab-Dyyb: side effects in FDA adverse event reports
At a glance
| Infliximab | Infliximab-Dyyb | |
|---|---|---|
| Drug class | Tumor Necrosis Factor Blocker | Tumor Necrosis Factor Blocker |
| Brand names | Renflexis | Inflectra |
| FAERS reports | 217,056 | 29,058 |
| Serious | 89% | 83% |
| Death outcome | 13,761 | 703 |
| 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 WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning • Increased risk of ser |
Signals both drugs share
| Reaction | Infliximab | Infliximab-Dyyb | Label screen (A / B) |
|---|---|---|---|
| Vaginal flatulence | 159 · PRR 104.9 | 24 · PRR 61.4 | Not in label — unassessed / Not in label — unassessed |
| Ileocaecal resection | 139 · PRR 69.4 | 29 · PRR 69.0 | 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
- Rheumatic fever — n=3,038, PRR 224.9 Labeled (related wording)
- Hepatosplenic t-cell lymphoma — n=184, PRR 94.3 Labeled — boxed warning
- Swollen joint count — n=135, PRR 117.9 Labeled (related wording)
Labeled signals distinctive to Infliximab-Dyyb
- Anal fistula — n=388, PRR 56.6 Labeled (related wording)
- Sinusitis bacterial — n=199, PRR 167.1 Labeled (related wording)
- Treatment delayed — n=179, PRR 89.8 Labeled (related wording)
- Suspected off label use — n=139, PRR 62.8 Labeled (related wording)
- Bronchitis bacterial — n=96, PRR 103.3 Labeled (related wording)
- Ear infection bacterial — n=59, PRR 200.7 Labeled (related wording)
- Anal fistula infection — n=24, PRR 138.7 Labeled (related wording)
- Pharyngitis bacterial — n=24, PRR 73.2 Labeled (related wording)
Common questions
Which has more reported side effects, Infliximab or Infliximab-Dyyb?
Infliximab has 217,056 FAERS reports and Infliximab-Dyyb 29,058. 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 83%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Infliximab and Infliximab-Dyyb share?
Both drugs carry disproportionality signals for vaginal flatulence, ileocaecal resection. Shared signals often reflect a shared drug class or the condition both are used for.
Is Infliximab or Infliximab-Dyyb 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.