Infliximab vs Abatacept: side effects in FDA adverse event reports
At a glance
| Infliximab | Abatacept | |
|---|---|---|
| Drug class | Tumor Necrosis Factor Blocker | Selective T Cell Costimulation Modulator |
| Brand names | Renflexis | Orencia |
| FAERS reports | 217,056 | 137,367 |
| Serious | 89% | 60% |
| Death outcome | 13,761 | 9,239 |
| Boxed warning | Yes SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Increased risk of seri | No |
Signals both drugs share
| Reaction | Infliximab | Abatacept | Label screen (A / B) |
|---|---|---|---|
| Rheumatic fever | 3,038 · PRR 224.9 | 2,990 · PRR 337.7 | Labeled (related wording) / Likely indication confounding |
| Swollen joint count | 135 · PRR 117.9 | 122 · PRR 150.5 | Labeled (related wording) / Not in label — unassessed |
| Synovitis | 9,005 · PRR 96.4 | 10,370 · PRR 208.0 | Not in label — unassessed / Not in label — unassessed |
| Pemphigus | 8,799 · PRR 239.1 | 8,847 · PRR 385.9 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 7,477 · PRR 129.7 | 7,748 · PRR 224.0 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 4,856 · PRR 88.0 | 4,729 · PRR 132.4 | Not in label — unassessed / Not in label — unassessed |
| Duodenal ulcer perforation | 4,679 · PRR 171.9 | 4,534 · PRR 249.6 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 4,112 · PRR 63.8 | 4,372 · PRR 112.1 | Not in label — unassessed / Not in label — unassessed |
| Muscle injury | 3,385 · PRR 67.7 | 3,966 · PRR 143.2 | Not in label — unassessed / Not in label — unassessed |
| Sleep disorder due to general medical condition, insomnia type | 2,692 · PRR 69.3 | 2,944 · PRR 128.9 | Not in label — unassessed / Not in label — unassessed |
| Facet joint syndrome | 1,773 · PRR 124.9 | 1,671 · PRR 173.1 | Not in label — unassessed / Not in label — unassessed |
| Bone erosion | 1,235 · PRR 51.5 | 1,361 · PRR 95.1 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,228 · PRR 163.6 | 1,171 · PRR 228.5 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,023 · PRR 82.3 | 1,010 · PRR 127.1 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 964 · PRR 88.6 | 935 · PRR 132.3 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 713 · PRR 145.6 | 763 · PRR 276.5 | Not in label — unassessed / Not in label — unassessed |
| Granuloma skin | 530 · PRR 173.6 | 504 · PRR 239.6 | Not in label — unassessed / Not in label — unassessed |
| Grip strength | 136 · PRR 137.9 | 134 · PRR 210.6 | Not in label — unassessed / Not in label — unassessed |
| Musculoskeletal deformity | 129 · PRR 117.0 | 136 · PRR 209.3 | 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 Abatacept
- None stood out among the strongest labeled signals.
Common questions
Which has more reported side effects, Infliximab or Abatacept?
Infliximab has 217,056 FAERS reports and Abatacept 137,367. 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 60%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Infliximab and Abatacept share?
Both drugs carry disproportionality signals for rheumatic fever, swollen joint count, synovitis, pemphigus, hand deformity. Shared signals often reflect a shared drug class or the condition both are used for.
Is Infliximab or Abatacept 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.