Rituximab vs Nivolumab: side effects in FDA adverse event reports
At a glance
| Rituximab | Nivolumab | |
|---|---|---|
| Drug class | CD20-directed Cytolytic Antibody | Programmed Death Receptor-1 Blocking Antibody |
| Brand names | Rituxan | Opdivo |
| FAERS reports | 210,132 | 96,082 |
| Serious | 89% | 89% |
| Death outcome | 37,069 | 24,663 |
| Boxed warning | Yes FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: FATAL I | No |
Signals both drugs share
No strong shared signal after removing coding and lab terms.
Labeled signals distinctive to Rituximab
- Duodenal ulcer perforation — n=4,935, PRR 208.1 Labeled — boxed warning
- Rheumatic fever — n=3,199, PRR 280.1 Labeled (related wording)
- 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)
- Lupus vulgaris — n=827, PRR 231.6 Labeled (related wording)
- Granuloma skin — n=507, PRR 158.9 Labeled (related wording)
- Follicular lymphoma — n=383, PRR 81.3 Labeled adverse reaction
Labeled signals distinctive to Nivolumab
- Immune-mediated enterocolitis — n=1,471, PRR 156.9 Labeled adverse reaction
- Hypophysitis — n=796, PRR 143.3 Labeled adverse reaction
- Immune-mediated hepatitis — n=731, PRR 129.8 Labeled adverse reaction
- Immune-mediated lung disease — n=706, PRR 148.5 Labeled (related wording)
- Fulminant type 1 diabetes mellitus — n=597, PRR 312.0 Labeled (related wording)
- Immune-mediated hepatic disorder — n=581, PRR 95.3 Labeled (related wording)
- Immune-mediated myocarditis — n=497, PRR 104.2 Labeled (related wording)
- Hypopituitarism — n=465, PRR 79.4 Labeled adverse reaction
Common questions
Which has more reported side effects, Rituximab or Nivolumab?
Rituximab has 210,132 FAERS reports and Nivolumab 96,082. 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 89%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Rituximab and Nivolumab share?
They share no strong flagged signal after artifacts and lab terms are removed.
Is Rituximab or Nivolumab 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.