Adalimumab vs Rituximab: side effects in FDA adverse event reports
At a glance
| Adalimumab | Rituximab | |
|---|---|---|
| Drug class | – | CD20-directed Cytolytic Antibody |
| Brand names | Humira | Rituxan |
| FAERS reports | 703,389 | 210,132 |
| Serious | 51% | 89% |
| Death outcome | 30,045 | 37,069 |
| 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 FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: FATAL I |
Signals both drugs share
| Reaction | Adalimumab | Rituximab | Label screen (A / B) |
|---|---|---|---|
| Synovitis | 11,430 · PRR 50.9 | 8,767 · PRR 94.5 | Labeled adverse reaction / Not in label — unassessed |
| Duodenal ulcer perforation | 4,928 · PRR 60.4 | 4,935 · PRR 208.1 | Labeled (related wording) / Labeled — boxed warning |
| Muscle injury | 3,785 · PRR 24.9 | 3,701 · PRR 82.0 | Labeled (related wording) / Not in label — unassessed |
| Rheumatic fever | 3,220 · PRR 83.8 | 3,199 · PRR 280.1 | Likely indication confounding / Labeled (related wording) |
| Lupus vulgaris | 888 · PRR 87.9 | 827 · PRR 231.6 | Not in label — unassessed / Labeled (related wording) |
| Granuloma skin | 539 · PRR 54.9 | 507 · PRR 158.9 | Labeled (related wording) / Labeled (related wording) |
| Pemphigus | 9,240 · PRR 86.7 | 9,375 · PRR 315.6 | Not in label — unassessed / Likely indication confounding |
| Hand deformity | 8,490 · PRR 54.5 | 7,685 · PRR 143.3 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 5,291 · PRR 31.5 | 5,074 · PRR 99.1 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 4,615 · PRR 23.5 | 4,291 · PRR 70.8 | Not in label — unassessed / Likely indication confounding |
| Facet joint syndrome | 1,918 · PRR 45.6 | 2,003 · PRR 176.0 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,428 · PRR 79.9 | 1,318 · PRR 207.9 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,248 · PRR 37.4 | 1,091 · PRR 96.2 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 1,172 · PRR 40.7 | 1,074 · PRR 114.3 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 809 · PRR 27.4 | 721 · PRR 75.8 | 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)
Labeled signals distinctive to Rituximab
- Sleep disorder due to general medical condition, insomnia type — n=2,715, PRR 72.7 Labeled (related wording)
- Peripheral venous disease — n=1,611, PRR 67.4 Labeled (related wording)
- Diffuse large b-cell lymphoma recurrent — n=1,437, PRR 205.1 Labeled (related wording)
- Follicular lymphoma — n=383, PRR 81.3 Labeled adverse reaction
Common questions
Which has more reported side effects, Adalimumab or Rituximab?
Adalimumab has 703,389 FAERS reports and Rituximab 210,132. 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 89%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Adalimumab and Rituximab share?
Both drugs carry disproportionality signals for synovitis, duodenal ulcer perforation, muscle injury, rheumatic fever, lupus vulgaris. Shared signals often reflect a shared drug class or the condition both are used for.
Is Adalimumab or Rituximab 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.