What the label lists and what reports show
Pomalidomide side effects
Pomalidomide's FDA label: “Most common adverse reactions (≥30%) included fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain, and pyrexia ( 6.1 ).” FAERS holds 102,194 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is plasma cell myeloma (8,060 reports).
- Generic listed
- Boxed warning
Check it at the source: the pomalidomide FDA label on DailyMed (effective February 26, 2025, Celgene Corporation); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of POMALYST?POMALYST can cause serious side effects, including: • See "What is the most important information I should know about POMALYST?" • Low white blood cells (neutropenia), low platelets (thrombocytopenia), and low red blood cells (anemia) are common with POMALYST, but can also be serious. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your blood counts should be checked weekly for the first 8 weeks of treatment and monthly after that. • Severe liver problems, including liver failure and death. Your healthcare provider should do blood tests to check your liver function during your treatment with POMALYST. […]
Source: FDA drug label, NDA204026 (Bristol), as published by Celgene Corporation, effective February 26, 2025 (SPL set 2b25ef01-5c9e-11e1-b86c-0800200c9a66), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥30%) included fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain, and pyrexia ( 6.1 ).
Table 3: Adverse Reactions in Any POMALYST Treatment Arm in Trial 1*
| Body System Adverse Reaction | POMALYST a (N=107) | POMALYST + Low-dose Dex (N=112) | POMALYST (N=107) | POMALYST + Low-dose Dex (N=112) |
|---|---|---|---|---|
| Number (%) of patients with at least one adverse reaction | 107 (100) | 112 (100) | 98 (92) | 102 (91) |
| Neutropenia b | 57 (53) | 55 (49) | 51 (48) | 46 (41) |
| Anemia b | 41 (38) | 47 (42) | 25 (23) | 24 (21) |
| Thrombocytopenia b | 28 (26) | 26 (23) | 24 (22) | 21 (19) |
| Leukopenia | 14 (13) | 22 (20) | 7 (7) | 11 (10) |
| Febrile neutropenia b | <10% | <10% | 6 (6) | 3 (3) |
| Lymphopenia | 4 (4) | 17 (15) | 2 (2) | 8 (7) |
| Fatigue and asthenia b | 62 (58) | 70 (63) | 13 (12) | 19 (17) |
| Edema peripheral | 27 (25) | 19 (17) | 0 (0.0) | 0 (0.0) |
| Pyrexia b | 25 (23) | 36 (32) | <5% | <5% |
| Chills | 11 (10) | 14 (13) | 0 (0.0) | 0 (0.0) |
| Nausea b | 39 (36) | 27 (24) | <5% | <5% |
| Constipation b | 38 (36) | 41 (37) | <5% | <5% |
| Diarrhea | 37 (35) | 40 (36) | <5% | <5% |
| Vomiting b | 15 (14) | 16 (14) | <5% | 0 (0.0) |
| Back pain b | 37 (35) | 36 (32) | 15 (14) | 11 (10) |
| Musculoskeletal chest pain | 25 (23) | 22 (20) | <5% | 0 (0.0) |
| Muscle spasms | 23 (21) | 22 (20) | <5% | <5% |
| Arthralgia | 18 (17) | 17 (15) | <5% | <5% |
| Muscular weakness | 15 (14) | 15 (13) | 6 (6) | 4 (4) |
| Bone pain | 13 (12) | 8 (7) | <5% | <5% |
| Musculoskeletal pain | 13 (12) | 19 (17) | <5% | <5% |
| Pain in extremity | 8 (7) | 16 (14) | 0 (0.0) | <5% |
| Upper respiratory tract infection | 40 (37) | 32 (29) | <5% | <5% |
| Pneumonia b | 30 (28) | 38 (34) | 21 (20) | 32 (29) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described in detail in other labeling sections: • Embryo-Fetal Toxicity [see Warnings and Precautions (5.1 , 5.2) ] • Venous and Arterial Thromboembolism [see Warnings and Precautions (5.3) ] • Increased Mortality in Patients with Multiple Myeloma When Pembrolizumab Is Added to a Thalidomide Analogue and Dexamethasone [see Warnings and Precautions (5.4) ] • Hematologic Toxicity [see Warnings and Precautions (5.5)] • Hepatotoxicity [see Warnings and Precautions (5.6) ] • Severe Cutaneous Reactions [see Warnings and Precautions (5.7) ] • Dizziness and Confusional State [see Warnings and Precautions (5.8) ] • Neuropathy [see Warnings and Precautions (5.9) ] • Risk of Second Primary Malignancies [see Warnings and Precautions (5.10) ] • Tumor Lysis Syndrome [see Warnings and Precautions (5.11) ] • Hypersensitivity [see Warnings and Precautions (5.12) ] • MM: Most common adverse reactions (≥30%) included fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain, and pyrexia ( 6.1 ). …
Source: FDA drug label, NDA204026 (Bristol), as published by Celgene Corporation, effective February 26, 2025 (SPL set 2b25ef01-5c9e-11e1-b86c-0800200c9a66), via openFDA; the full label on DailyMed
What do FAERS reports show?
102,194 reports list pomalidomide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 14,025 are coded as a death and 27,241 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Pomalidomide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions