Lenalidomide vs Bendamustine: side effects in FDA adverse event reports
At a glance
| Lenalidomide | Bendamustine | |
|---|---|---|
| Drug class | Thalidomide Analog | – |
| Brand names | – | – |
| FAERS reports | 419,568 | 15,416 |
| Serious | 64% | 96% |
| Death outcome | 53,763 | 3,338 |
| Boxed warning | Yes EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Do not use lenalidomide capsules during pregnancy. Le | No |
Signals both drugs share
| Reaction | Lenalidomide | Bendamustine | Label screen (A / B) |
|---|---|---|---|
| Diffuse large b-cell lymphoma | 951 · PRR 7.0 | 414 · PRR 78.0 | Likely indication confounding / Labeled (related wording) |
| Mantle cell lymphoma | 257 · PRR 10.0 | 101 · PRR 97.0 | Likely indication confounding / Likely indication confounding |
| Follicular lymphoma | 114 · PRR 7.6 | 121 · PRR 225.1 | Likely indication confounding / Likely indication confounding |
Labeled signals distinctive to Lenalidomide
- Plasma cell myeloma — n=17,121, PRR 38.5 Labeled (related wording)
- Neuropathy peripheral — n=12,164, PRR 7.2 Labeled adverse reaction
- Multiple myeloma — n=2,370, PRR 49.7 Labeled — boxed warning
- Myelodysplastic syndrome — n=2,154, PRR 8.6 Labeled — boxed warning
- Cytopenia — n=1,476, PRR 6.9 Labeled — boxed warning
- Squamous cell carcinoma of skin — n=761, PRR 7.1 Labeled adverse reaction
- Plasma cell myeloma refractory — n=625, PRR 46.1 Labeled (related wording)
- Plasma cell leukaemia — n=313, PRR 54.3 Labeled (related wording)
Labeled signals distinctive to Bendamustine
- Progressive multifocal leukoencephalopathy — n=321, PRR 55.0 Labeled adverse reaction
- Diffuse large b-cell lymphoma recurrent — n=293, PRR 215.1 Labeled (related wording)
- Cytomegalovirus infection reactivation — n=156, PRR 51.6 Labeled (related wording)
- Jc virus infection — n=68, PRR 60.4 Labeled (related wording)
- Chronic lymphocytic leukaemia recurrent — n=59, PRR 126.6 Labeled (related wording)
- Diffuse large b-cell lymphoma refractory — n=58, PRR 90.5 Labeled (related wording)
- Neutropenic infection — n=34, PRR 49.6 Labeled (related wording)
- Peripheral t-cell lymphoma unspecified — n=19, PRR 45.5 Labeled (related wording)
Common questions
Which has more reported side effects, Lenalidomide or Bendamustine?
Lenalidomide has 419,568 FAERS reports and Bendamustine 15,416. 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 (64% vs 96%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Lenalidomide and Bendamustine share?
Both drugs carry disproportionality signals for diffuse large b-cell lymphoma, mantle cell lymphoma, follicular lymphoma. Shared signals often reflect a shared drug class or the condition both are used for.
Is Lenalidomide or Bendamustine 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.