Two medicines, side by side
Lenalidomide vs pomalidomide
Lenalidomide and pomalidomide are both labeled for leukemia and lymphoma and myeloma. Drugs@FDA records approvals of lenalidomide since 2005 and of pomalidomide since 2013. How each works, in its label's words: Lenalidomide, “Lenalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties.”; Pomalidomide, “Pomalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties.”
Check it at the source: the lenalidomide FDA label on DailyMed (effective March 24, 2023); the pomalidomide FDA label on DailyMed (effective February 26, 2025).
Highlights of the lenalidomide record
Lenalidomide (Revlimid) · label of March 24, 2023
EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death.
Used for
From the label: indicationsREVLIMID is a thalidomide analogue indicated for the treatment of adult patients with: • Multiple myeloma (MM), in combination with dexamethasone ( 1.1 ). • MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) ( 1.1 ). […]
On the market
- Earliest approval on file
- December 27, 2005
- Generic labelers
- 18 labelers
- Pharmacy cost
- Not in the survey
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Highlights of the pomalidomide record
Pomalidomide (Pomalyst) · label of February 26, 2025
EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM See full prescribing information for complete boxed warning EMBRYO-FETAL TOXICITY
POMALYST is contraindicated in pregnancy. POMALYST is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe life-threatening birth defects ( 4 , 5.1 , 8.1 ).
For females of reproductive potential: Exclude pregnancy before start of treatment.
Used for
From the label: indicationsPOMALYST is a thalidomide analogue indicated for the treatment of adult patients: • in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy ( 1.1 ). […]
On the market
- Earliest approval on file
- February 8, 2013
- Generic labelers
- 11 labelers
- Pharmacy cost
- Not in the survey
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Source: FDA drug labels via openFDA (Lenalidomide label of March 24, 2023, Pomalidomide label of February 26, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do lenalidomide and pomalidomide differ on the record?
How each works, in its label's words: Lenalidomide, “Lenalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties.”; Pomalidomide, “Pomalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties.”
Both are in FDA's class thalidomide analogs.
Half-life, in each label's words: Lenalidomide, “Elimination The mean half-life of lenalidomide is 3 hours in healthy subjects and 3 to 5 hours in patients with MM, MDS …”; Pomalidomide, “Pomalidomide is eliminated with a median plasma half-life of 9.5 hours in healthy subjects and 7.5 hours in patients …”
Both labels carry a boxed warning; the records quote them.
Generics: lenalidomide since 2021; pomalidomide since 2020 (Drugs@FDA).
| Lenalidomide | Pomalidomide | |
|---|---|---|
| Labeled for | Leukemia, lymphoma and myeloma, Anemia | Leukemia, lymphoma and myeloma |
| Pharmacologic class | Thalidomide Analog | Thalidomide Analog |
| How it works (label) | Lenalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. | Pomalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. |
| Half-life (label) | Elimination The mean half-life of lenalidomide is 3 hours in healthy subjects and 3 to 5 hours in patients with MM, MDS or MCL. | Pomalidomide is eliminated with a median plasma half-life of 9.5 hours in healthy subjects and 7.5 hours in patients with MM or KS. |
| Earliest approval on file (Drugs@FDA) | December 27, 2005 | February 8, 2013 |
| First generic approved | May 21, 2021 | October 30, 2020 |
| Generic labelers (NDC) | 18 labelers | 11 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | n/a | n/a |
| 12-month price change | n/a | n/a |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 0 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 420,082 | 102,194 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to lenalidomide
- every medicine labeled for the same conditions