Rituximab vs Rituximab-Pvvr: side effects in FDA adverse event reports
At a glance
| Rituximab | Rituximab-Pvvr | |
|---|---|---|
| Drug class | CD20-directed Cytolytic Antibody | CD20-directed Cytolytic Antibody |
| Brand names | Rituxan | Ruxience |
| FAERS reports | 210,132 | 5,068 |
| Serious | 89% | 90% |
| Death outcome | 37,069 | 471 |
| Boxed warning | Yes FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: FATAL I | Yes FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Infusion-Related |
Signals both drugs share
| Reaction | Rituximab | Rituximab-Pvvr | Label screen (A / B) |
|---|---|---|---|
| Synovitis | 8,767 · PRR 94.5 | 30 · PRR 6.9 | Not in label — unassessed / Not in label — unassessed |
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 Rituximab-Pvvr
- Throat irritation — n=313, PRR 29.2 Labeled adverse reaction
- Infusion related reaction — n=185, PRR 11.6 Labeled — boxed warning
- Throat tightness — n=101, PRR 15.5 Labeled (related wording)
- Drug effective for unapproved indication — n=89, PRR 12.6 Labeled (related wording)
- Localised infection — n=42, PRR 7.2 Labeled (related wording)
- Vasculitis — n=39, PRR 13.9 Labeled adverse reaction
- Paraesthesia oral — n=32, PRR 9.2 Labeled (related wording)
- Dry throat — n=23, PRR 9.4 Labeled (related wording)
Common questions
Which has more reported side effects, Rituximab or Rituximab-Pvvr?
Rituximab has 210,132 FAERS reports and Rituximab-Pvvr 5,068. 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 90%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Rituximab and Rituximab-Pvvr share?
Both drugs carry disproportionality signals for synovitis. Shared signals often reflect a shared drug class or the condition both are used for.
Is Rituximab or Rituximab-Pvvr 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.