What the label lists and what reports show
Lenalidomide side effects
Lenalidomide's FDA label: “Most common adverse reactions (≥20%) include diarrhea, fatigue, anemia, constipation, neutropenia, leukopenia, peripheral edema, insomnia, muscle cramp/spasms, abdominal pain, back pain, nausea, asthenia, pyrexia, upper respiratory tract infection …” FAERS holds 420,082 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 diarrhoea (31,468 reports).
- Generic listed
- Boxed warning
Check it at the source: the lenalidomide FDA label on DailyMed (effective March 24, 2023, 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 REVLIMID?REVLIMID can cause serious side effects, including: • See "What is the most important information I should know about REVLIMID?" • Increased risk of death in people who have chronic lymphocytic leukemia (CLL). People with CLL who take REVLIMID have an increased risk of death compared with people who take the medicine chlorambucil. REVLIMID may cause you to have serious heart problems that can lead to death, including atrial fibrillation, heart attack, or heart failure. You should not take REVLIMID if you have CLL unless you are participating in a controlled clinical trial. • Risk of new cancers (malignancies). […]
Source: FDA drug label, NDA021880 (Bristol Myers Squibb), as published by Celgene Corporation, effective March 24, 2023 (SPL set 5fa97bf5-28a2-48f1-8955-f56012d296be), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥20%) include diarrhea, fatigue, anemia, constipation, neutropenia, leukopenia, peripheral edema, insomnia, muscle cramp/spasms, abdominal pain, back pain, nausea, asthenia, pyrexia, upper respiratory tract infection, bronchitis, nasopharyngitis, gastroenteritis, cough, rash, dyspnea, dizziness, decreased appetite, thrombocytopenia, and tremor ( 6.1 ).
Table 4: All Adverse Reactions in ≥5% and Grade 3/4 Adverse Reactions in ≥1% of Patients with MM in the Rd Continuous or Rd18 Arms*
| Reaction | Rd Continuous (N = 532) | Rd18 (N = 540) | MPT (N = 541) | Rd Continuous (N = 532) | Rd18 (N = 540) | MPT (N = 541) |
|---|---|---|---|---|---|---|
| Fatigue % | 173 (33) | 177 (33) | 154 (28) | 39 ( 7) | 46 ( 9) | 31 ( 6) |
| Asthenia | 150 (28) | 123 (23) | 124 (23) | 41 ( 8) | 33 ( 6) | 32 ( 6) |
| Pyrexia c | 114 (21) | 102 (19) | 76 (14) | 13 ( 2) | 7 ( 1) | 7 ( 1) |
| Non-cardiac chest pain f | 29 ( 5) | 31 ( 6) | 18 ( 3) | <1% | < 1% | < 1% |
| Diarrhea | 242 (45) | 208 (39) | 89 (16) | 21 ( 4) | 18 ( 3) | 8 ( 1) |
| Abdominal pain % f | 109 (20) | 78 (14) | 60 (11) | 7 ( 1) | 9 ( 2) | < 1% |
| Dyspepsia f | 57 (11) | 28 ( 5) | 36 ( 7) | <1% | < 1% | 0 ( 0) |
| Back pain c | 170 (32) | 145 (27) | 116 (21) | 37 ( 7) | 34 ( 6) | 28 ( 5) |
| Muscle spasms f | 109 (20) | 102 (19) | 61 (11) | < 1% | < 1% | < 1% |
| Arthralgia f | 101 (19) | 71 (13) | 66 (12) | 9 ( 2) | 8 ( 1) | 8 ( 1) |
| Bone pain f | 87 (16) | 77 (14) | 62 (11) | 16 ( 3) | 15 ( 3) | 14 ( 3) |
| Pain in extremity f | 79 (15) | 66 (12) | 61 (11) | 8 ( 2) | 8 ( 1) | 7 ( 1) |
| Musculoskeletal pain f | 67 (13) | 59 (11) | 36 ( 7) | < 1% | < 1% | < 1% |
| Musculoskeletal chest pain f | 60 (11) | 51 ( 9) | 39 ( 7) | 6 ( 1) | < 1% | < 1% |
| Muscular weakness f | 43 ( 8) | 35 ( 6) | 29 ( 5) | < 1% | 8 ( 1) | < 1% |
| Neck pain f | 40 ( 8) | 19 ( 4) | 10 ( 2) | < 1% | < 1% | < 1% |
| Bronchitis c | 90 (17) | 59 (11) | 43 ( 8) | 9 ( 2) | 6 ( 1) | < 1% |
| Nasopharyngitis f | 80 (15) | 54 (10) | 33 ( 6) | 0 ( 0) | 0 ( 0) | 0 ( 0) |
| Urinary tract infection f | 76 (14) | 63 (12) | 41 ( 8) | 8 ( 2) | 8 ( 1) | < 1% |
| Upper respiratory tract infection c% f | 69 (13) | 53 ( 10) | 31 ( 6) | < 1% | 8 ( 1) | < 1% |
| Pneumonia c@ | 93 (17) | 87 (16) | 56 (10) | 60 (11) | 57 (11) | 41 ( 8) |
| Respiratory tract infection % | 35 ( 7) | 25 ( 5) | 21 ( 4) | 7 ( 1) | < 1% | < 1% |
| Influenza f | 33 ( 6) | 23 ( 4) | 15 ( 3) | < 1% | < 1% | 0 ( 0) |
| Gastroenteritis f | 32 ( 6) | 17 ( 3) | 13 ( 2) | 0 ( 0) | < 1% | < 1% |
| Lower respiratory tract infection | 29 ( 5) | 14 ( 3) | 16 ( 3) | 10 ( 2) | < 1% | < 1% |
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 sections of the prescribing information: o Embryo-Fetal Toxicity [see Boxed Warning, Warnings and Precautions (5.1 , 5.2) ] o Hematologic Toxicity [see Boxed Warning, Warnings and Precautions (5.3) ] o Venous and Arterial Thromboembolism [see Boxed Warning, Warnings and Precautions (5.4) ] o Increased Mortality in Patients with CLL [see Warnings and Precautions (5.5) ] o Second Primary Malignancies [see Warnings and Precautions (5.6) ] o Increased Mortality in Patients with MM When Pembrolizumab Is Added to a Thalidomide Analogue and Dexamethasone [see Warnings and Precautions (5.7) ] o Hepatotoxicity [see Warnings and Precautions (5.8) ] o Severe Cutaneous Reactions [see Warnings and Precautions (5.9) ] o Tumor Lysis Syndrome [see Warnings and Precautions (5.10) ] o Tumor Flare Reactions [see Warnings and Precautions (5.11) ] o Impaired Stem Cell Mobilization [see Warnings and Precautions (5.12) ] o Thyroid Disorders [see Warnings and Precautions (5.13) ] o Early Mortality in Patients with MCL [see Warnings and Precautions (5.14) ] o Hypersensitivity [see Warnings and Precautions (5.15) ] • MM: Most common adverse reactions (≥20%) include diarrhea, fatigue, anemia, constipation, neutropenia, leukopenia, peripheral edema, insomnia, muscle cramp/spasms, abdominal pain, back pain, nausea …
Source: FDA drug label, NDA021880 (Bristol Myers Squibb), as published by Celgene Corporation, effective March 24, 2023 (SPL set 5fa97bf5-28a2-48f1-8955-f56012d296be), via openFDA; the full label on DailyMed
What do FAERS reports show?
420,082 reports list lenalidomide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 53,763 are coded as a death and 109,169 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 22 reactions below, 15 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?
- Lenalidomide: 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