Lenalidomide vs Bortezomib: side effects in FDA adverse event reports
At a glance
| Lenalidomide | Bortezomib | |
|---|---|---|
| Drug class | Thalidomide Analog | Proteasome Inhibitor |
| Brand names | – | – |
| FAERS reports | 419,568 | 88,896 |
| Serious | 64% | 84% |
| Death outcome | 53,763 | 14,068 |
| 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 | Bortezomib | Label screen (A / B) |
|---|---|---|---|
| Plasma cell myeloma | 17,121 · PRR 38.5 | 9,117 · PRR 71.7 | Labeled (related wording) / Likely indication confounding |
| Neuropathy peripheral | 12,164 · PRR 7.2 | 6,473 · PRR 17.3 | Labeled adverse reaction / Labeled (related wording) |
| Multiple myeloma | 2,370 · PRR 49.7 | 679 · PRR 39.4 | Labeled — boxed warning / Likely indication confounding |
| Plasma cell myeloma refractory | 625 · PRR 46.1 | 744 · PRR 322.3 | Labeled (related wording) / Likely indication confounding |
| Plasma cell leukaemia | 313 · PRR 54.3 | 205 · PRR 123.1 | Labeled (related wording) / Not in label — unassessed |
| Amyloidosis | 271 · PRR 9.1 | 230 · PRR 36.1 | Not in label — unassessed / Labeled adverse reaction |
| Cardiac amyloidosis | 137 · PRR 7.1 | 128 · PRR 31.4 | Not in label — unassessed / Labeled adverse reaction |
| Plasma cell myeloma recurrent | 1,693 · PRR 53.3 | 1,265 · PRR 149.4 | Likely indication confounding / Likely indication confounding |
| Plasmacytoma | 728 · PRR 31.2 | 493 · PRR 83.9 | Not in label — unassessed / Not in label — unassessed |
| Light chain analysis increased | 475 · PRR 42.6 | 177 · PRR 49.1 | Not in label — unassessed / Not in label — unassessed |
| Bone lesion | 430 · PRR 6.6 | 206 · PRR 14.2 | Not in label — unassessed / Not in label — unassessed |
| Stem cell transplant | 278 · PRR 6.2 | 259 · PRR 27.5 | Likely indication confounding / Not in label — unassessed |
| Osteolysis | 319 · PRR 9.0 | 198 · PRR 25.1 | Not in label — unassessed / Not in label — unassessed |
| Mantle cell lymphoma | 257 · PRR 10.0 | 212 · PRR 38.2 | Likely indication confounding / Likely indication confounding |
| B-cell type acute leukaemia | 317 · PRR 39.0 | 104 · PRR 39.8 | Likely indication confounding / Not in label — unassessed |
| B precursor type acute leukaemia | 80 · PRR 12.7 | 44 · PRR 30.0 | Likely indication confounding / Not in label — unassessed |
Labeled signals distinctive to Lenalidomide
- 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
- Tumour flare — n=237, PRR 26.2 Labeled adverse reaction
- Adult t-cell lymphoma/leukaemia — n=189, PRR 33.9 Labeled (related wording)
- Acute leukaemia — n=171, PRR 5.8 Labeled adverse reaction
- Pneumonia respiratory syncytial viral — n=95, PRR 6.4 Labeled (related wording)
Labeled signals distinctive to Bortezomib
- Polyneuropathy — n=1,073, PRR 23.3 Labeled adverse reaction
- Peripheral sensory neuropathy — n=430, PRR 18.7 Labeled adverse reaction
- Primary amyloidosis — n=132, PRR 259.2 Labeled (related wording)
- Peripheral sensorimotor neuropathy — n=111, PRR 23.1 Labeled (related wording)
- Peripheral motor neuropathy — n=105, PRR 19.1 Labeled (related wording)
- Neuropathy — n=99, PRR 14.3 Labeled adverse reaction
- Chalazion — n=61, PRR 25.0 Labeled adverse reaction
- Herpes zoster disseminated — n=60, PRR 19.3 Labeled (related wording)
Common questions
Which has more reported side effects, Lenalidomide or Bortezomib?
Lenalidomide has 419,568 FAERS reports and Bortezomib 88,896. 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 84%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Lenalidomide and Bortezomib share?
Both drugs carry disproportionality signals for plasma cell myeloma, neuropathy peripheral, multiple myeloma, plasma cell myeloma refractory, plasma cell leukaemia. Shared signals often reflect a shared drug class or the condition both are used for.
Is Lenalidomide or Bortezomib 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.