Lenalidomide vs Pomalidomide: side effects in FDA adverse event reports
At a glance
| Lenalidomide | Pomalidomide | |
|---|---|---|
| Drug class | Thalidomide Analog | Thalidomide Analog |
| Brand names | – | – |
| FAERS reports | 419,568 | 101,956 |
| Serious | 64% | 62% |
| Death outcome | 53,763 | 14,025 |
| Boxed warning | Yes EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Do not use lenalidomide capsules during pregnancy. Le | Yes EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM See full prescribing inform |
Signals both drugs share
| Reaction | Lenalidomide | Pomalidomide | Label screen (A / B) |
|---|---|---|---|
| Plasma cell myeloma | 17,121 · PRR 38.5 | 8,060 · PRR 53.2 | Labeled (related wording) / Likely indication confounding |
| Cytopenia | 1,476 · PRR 6.9 | 401 · PRR 7.1 | Labeled — boxed warning / Labeled adverse reaction |
| Plasma cell myeloma refractory | 625 · PRR 46.1 | 358 · PRR 78.3 | Labeled (related wording) / Likely indication confounding |
| Plasma cell leukaemia | 313 · PRR 54.3 | 102 · PRR 42.0 | Labeled (related wording) / Not in label — unassessed |
| Pneumonia respiratory syncytial viral | 95 · PRR 6.4 | 62 · PRR 16.6 | Labeled (related wording) / Labeled adverse reaction |
| Plasma cell myeloma recurrent | 1,693 · PRR 53.3 | 513 · PRR 38.1 | Likely indication confounding / Likely indication confounding |
| Plasmacytoma | 728 · PRR 31.2 | 301 · PRR 39.1 | Not in label — unassessed / Not in label — unassessed |
| Human chorionic gonadotropin increased | 579 · PRR 92.2 | 110 · PRR 28.7 | Not in label — unassessed / Not in label — unassessed |
| Light chain analysis increased | 475 · PRR 42.6 | 171 · PRR 40.9 | Not in label — unassessed / Not in label — unassessed |
| Bone lesion | 430 · PRR 6.6 | 128 · PRR 7.5 | Not in label — unassessed / Not in label — unassessed |
| Osteolysis | 319 · PRR 9.0 | 85 · PRR 8.8 | Not in label — unassessed / Not in label — unassessed |
| Amyloidosis | 271 · PRR 9.1 | 69 · PRR 8.5 | Not in label — unassessed / Not in label — unassessed |
| Pneumonia influenzal | 132 · PRR 6.1 | 52 · PRR 9.3 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Lenalidomide
- 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
- 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
Labeled signals distinctive to Pomalidomide
- Jc virus infection — n=50, PRR 6.6 Labeled (related wording)
Common questions
Which has more reported side effects, Lenalidomide or Pomalidomide?
Lenalidomide has 419,568 FAERS reports and Pomalidomide 101,956. 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 62%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Lenalidomide and Pomalidomide share?
Both drugs carry disproportionality signals for plasma cell myeloma, cytopenia, plasma cell myeloma refractory, plasma cell leukaemia, pneumonia respiratory syncytial viral. Shared signals often reflect a shared drug class or the condition both are used for.
Is Lenalidomide or Pomalidomide 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.