Rituximab vs Golimumab: side effects in FDA adverse event reports
At a glance
| Rituximab | Golimumab | |
|---|---|---|
| Drug class | CD20-directed Cytolytic Antibody | Tumor Necrosis Factor Blocker |
| Brand names | Rituxan | Simponi Aria |
| FAERS reports | 210,132 | 12,299 |
| Serious | 89% | 76% |
| Death outcome | 37,069 | 2,587 |
| Boxed warning | Yes FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: FATAL I | Yes SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Serious infections lea |
Signals both drugs share
| Reaction | Rituximab | Golimumab | Label screen (A / B) |
|---|---|---|---|
| Duodenal ulcer perforation | 4,935 · PRR 208.1 | 4,452 · PRR 385.1 | Labeled — boxed warning / Not in label — unassessed |
| Rheumatic fever | 3,199 · PRR 280.1 | 3,014 · PRR 561.2 | Labeled (related wording) / Likely indication confounding |
| Sleep disorder due to general medical condition, insomnia type | 2,715 · PRR 72.7 | 2,885 · PRR 201.0 | Labeled (related wording) / Not in label — unassessed |
| Peripheral venous disease | 1,611 · PRR 67.4 | 1,317 · PRR 121.3 | Labeled (related wording) / Labeled (related wording) |
| Lupus vulgaris | 827 · PRR 231.6 | 743 · PRR 415.7 | Labeled (related wording) / Not in label — unassessed |
| Granuloma skin | 507 · PRR 158.9 | 288 · PRR 131.3 | Labeled (related wording) / Labeled (related wording) |
| Pemphigus | 9,375 · PRR 315.6 | 8,315 · PRR 508.1 | Likely indication confounding / Not in label — unassessed |
| Synovitis | 8,767 · PRR 94.5 | 7,401 · PRR 171.8 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 7,685 · PRR 143.3 | 7,128 · PRR 297.8 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 5,074 · PRR 99.1 | 4,593 · PRR 203.0 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 4,291 · PRR 70.8 | 4,315 · PRR 177.4 | Likely indication confounding / Not in label — unassessed |
| Muscle injury | 3,701 · PRR 82.0 | 3,841 · PRR 217.9 | Not in label — unassessed / Not in label — unassessed |
| Facet joint syndrome | 2,003 · PRR 176.0 | 1,618 · PRR 261.8 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,318 · PRR 207.9 | 1,186 · PRR 382.2 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,091 · PRR 96.2 | 981 · PRR 195.1 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 1,074 · PRR 114.3 | 978 · PRR 233.6 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 721 · PRR 75.8 | 617 · PRR 144.6 | Not in label — unassessed / Not in label — unassessed |
| Subcutaneous drug absorption impaired | 257 · PRR 89.1 | 212 · PRR 157.2 | Not in label — unassessed / Not in label — unassessed |
| Swollen joint count | 176 · PRR 256.0 | 130 · PRR 278.1 | Not in label — unassessed / Not in label — unassessed |
| Grip strength | 139 · PRR 150.5 | 115 · PRR 243.8 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Rituximab
- 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 Golimumab
- Hepatic enzyme — n=91, PRR 468.0 Labeled (related wording)
- Malignant mediastinal neoplasm — n=56, PRR 265.4 Labeled (related wording)
Common questions
Which has more reported side effects, Rituximab or Golimumab?
Rituximab has 210,132 FAERS reports and Golimumab 12,299. 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 76%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Rituximab and Golimumab share?
Both drugs carry disproportionality signals for duodenal ulcer perforation, rheumatic fever, sleep disorder due to general medical condition, insomnia type, peripheral venous disease, lupus vulgaris. Shared signals often reflect a shared drug class or the condition both are used for.
Is Rituximab or Golimumab 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.