Rituximab vs Tocilizumab: side effects in FDA adverse event reports
At a glance
| Rituximab | Tocilizumab | |
|---|---|---|
| Drug class | CD20-directed Cytolytic Antibody | Interleukin-6 Receptor Antagonist |
| Brand names | Rituxan | Actemra, Actemra Actpen |
| FAERS reports | 210,132 | 113,340 |
| Serious | 89% | 77% |
| Death outcome | 37,069 | 12,342 |
| Boxed warning | Yes FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: FATAL I | Yes RISK OF SERIOUS INFECTIONS Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death [see |
Signals both drugs share
| Reaction | Rituximab | Tocilizumab | Label screen (A / B) |
|---|---|---|---|
| Duodenal ulcer perforation | 4,935 · PRR 208.1 | 5,011 · PRR 406.8 | Labeled — boxed warning / Labeled — boxed warning |
| Rheumatic fever | 3,199 · PRR 280.1 | 3,320 · PRR 607.2 | Labeled (related wording) / Likely indication confounding |
| Sleep disorder due to general medical condition, insomnia type | 2,715 · PRR 72.7 | 3,133 · PRR 176.4 | Labeled (related wording) / Labeled (related wording) |
| Lupus vulgaris | 827 · PRR 231.6 | 807 · PRR 397.8 | Labeled (related wording) / Not in label — unassessed |
| Granuloma skin | 507 · PRR 158.9 | 525 · PRR 325.1 | Labeled (related wording) / Not in label — unassessed |
| Synovitis | 8,767 · PRR 94.5 | 10,546 · PRR 263.3 | Not in label — unassessed / Not in label — unassessed |
| Pemphigus | 9,375 · PRR 315.6 | 9,201 · PRR 543.9 | Likely indication confounding / Not in label — unassessed |
| Hand deformity | 7,685 · PRR 143.3 | 7,961 · PRR 291.7 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 5,074 · PRR 99.1 | 5,103 · PRR 186.7 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 4,291 · PRR 70.8 | 4,662 · PRR 152.9 | Likely indication confounding / Not in label — unassessed |
| Muscle injury | 3,701 · PRR 82.0 | 4,172 · PRR 192.6 | Not in label — unassessed / Not in label — unassessed |
| Facet joint syndrome | 2,003 · PRR 176.0 | 1,954 · PRR 306.1 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,318 · PRR 207.9 | 1,381 · PRR 451.4 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,091 · PRR 96.2 | 1,043 · PRR 164.1 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 1,074 · PRR 114.3 | 1,018 · PRR 190.0 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 721 · PRR 75.8 | 672 · PRR 124.9 | Not in label — unassessed / Not in label — unassessed |
| Subcutaneous drug absorption impaired | 257 · PRR 89.1 | 218 · PRR 123.6 | Not in label — unassessed / Not in label — unassessed |
| Swollen joint count | 176 · PRR 256.0 | 150 · PRR 292.6 | Not in label — unassessed / Not in label — unassessed |
| Grip strength | 139 · PRR 150.5 | 137 · PRR 270.2 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Rituximab
- 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
Labeled signals distinctive to Tocilizumab
- Hepatic enzyme — n=85, PRR 291.0 Labeled (related wording)
Common questions
Which has more reported side effects, Rituximab or Tocilizumab?
Rituximab has 210,132 FAERS reports and Tocilizumab 113,340. 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 77%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Rituximab and Tocilizumab share?
Both drugs carry disproportionality signals for duodenal ulcer perforation, rheumatic fever, sleep disorder due to general medical condition, insomnia type, lupus vulgaris, granuloma skin. Shared signals often reflect a shared drug class or the condition both are used for.
Is Rituximab or Tocilizumab 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.