Lenalidomide side effects: what 419,568 FDA adverse event reports show
Drug class
Thalidomide Analog
Who reports
419,568 reports · 64% serious · 53,763 with death outcome · 49% female
Used for
Lenalidomide 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 ).
What it is
Lenalidomide is a dicarboximide that consists of 1-oxoisoindoline bearing an amino substituent at position 4 and a 2,6-dioxopiperidin-3-yl group at position 2.
Boxed warning
EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Do not use lenalidomide capsules 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.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,184 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Human chorionic gonadotropin increased | 579 | 92.2 80.3–106.0ROR 92.3 · calibrated p 2e-7 ✓ | 32.3 EB05 30.2 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=344 · ♀ 100% (drug 49%) · 95% clinician | NCT00179647: 1/1,913 (0.1%) on Lenalidomide (serious AE) |
| Plasma cell leukaemia | 313 | 54.3 46.2–63.9ROR 54.4 · calibrated p 9e-6 ✓ | 26.1 EB05 23.7 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=309 | not reported in cached trials |
| Plasma cell myeloma recurrent | 1,693 | 53.3 49.7–57.1ROR 53.5 · calibrated p 9e-6 ✓ | 25.8 EB05 24.8 · IC025 +4.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=1,315 | not reported in cached trials |
| Monoclonal immunoglobulin present | 386 | 50.5 43.8–58.2ROR 50.5 · calibrated p 1e-5 ✓ | 25.2 EB05 23.1 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=183 | not reported in cached trials |
| Multiple myeloma | 2,370 | 49.7 47.0–52.7ROR 50.0 · calibrated p 1e-5 ✓ | 25.0 EB05 24.2 · IC025 +4.6 3/3 methods agree | Labeled — boxed warning exact term | serious n=2,362 · 96% clinician | NCT00179647: 50/1,913 (2.6%) on Lenalidomide (serious AE) |
| Monoclonal immunoglobulin increased | 141 | 49.3 39.0–62.3ROR 49.3 · calibrated p 2e-5 ✓ | 24.8 EB05 21.6 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=58 | not reported in cached trials |
| 5q minus syndrome | 80 | 48.9 35.8–66.7ROR 48.9 · calibrated p 2e-5 ✓ | 24.7 EB05 20.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=79 · ♀ 0% (drug 49%) · 100% clinician | not reported in cached trials |
| Plasma cell myeloma refractory | 625 | 46.1 41.3–51.5ROR 46.2 · calibrated p 2e-5 ✓ | 24.1 EB05 22.5 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious n=622 · 91% clinician | not reported in cached trials |
| Light chain analysis increased | 475 | 42.6 37.7–48.2ROR 42.7 · calibrated p 4e-5 ✓ | 23.1 EB05 21.4 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=240 | not reported in cached trials |
| B-cell type acute leukaemia | 317 | 39.0 33.7–45.3ROR 39.1 · calibrated p 7e-5 ✓ | 22.0 EB05 20.0 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=317 · 100% clinician | not reported in cached trials |
| Plasma cell myeloma | 17,121 | 38.5 37.7–39.3ROR 40.1 · calibrated p 5e-5 ✓ | 21.9 EB05 21.6 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 26.6 · serious PRR 19.4 | not reported in cached trials |
| Adult t-cell lymphoma/leukaemia | 189 | 33.9 28.2–40.8ROR 33.9 · calibrated p 2e-4 ✓ | 20.3 EB05 18.0 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=189 · 100% clinician | not reported in cached trials |
| Plasmacytoma | 728 | 31.2 28.4–34.2ROR 31.3 · calibrated p 2e-4 ✓ | 19.3 EB05 18.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=703 | NCT00179647: 2/1,913 (0.1%) on Lenalidomide (serious AE) |
| Full blood count decreased | 7,102 | 26.8 26.0–27.6ROR 27.2 · calibrated p 4e-4 ✓ | 17.6 EB05 17.2 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious PRR 16.1 | not reported in cached trials |
| Tumour flare | 237 | 26.2 22.3–30.7ROR 26.2 · calibrated p 6e-4 ✓ | 17.3 EB05 15.5 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=234 · 100% clinician | NCT00689936: 1/541 (0.2%) on Lenalidomide (serious AE) |
| Myelodysplastic syndrome transformation | 150 | 19.6 16.2–23.7ROR 19.6 · calibrated p 0.002 ✓ | 14.2 EB05 12.4 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=148 · 100% clinician | not reported in cached trials |
| Full blood count increased | 340 | 19.5 17.2–22.2ROR 19.5 · calibrated p 0.002 ✓ | 14.2 EB05 12.9 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| B precursor type acute leukaemia | 80 | 12.7 9.9–16.2ROR 12.7 · calibrated p 0.015 ✓ | 10.0 EB05 8.3 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=80 · ♀ 0% (drug 49%) · 100% clinician | not reported in cached trials |
| Mantle cell lymphoma | 257 | 10.0 8.7–11.4ROR 10.0 · calibrated p 0.033 ✓ | 8.4 EB05 7.5 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=242 · ♀ 26% (drug 49%) | not reported in cached trials |
| Protein total increased | 430 | 9.5 8.6–10.5ROR 9.5 · calibrated p 0.039 ✓ | 8.0 EB05 7.4 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious n=176 | not reported in cached trials |
| Amyloidosis | 271 | 9.1 8.0–10.4ROR 9.1 · calibrated p 0.045 ✓ | 7.8 EB05 7.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=255 | NCT00179647: 1/1,913 (0.1%) on Lenalidomide (serious AE) |
| Osteolysis | 319 | 9.0 8.0–10.2ROR 9.0 · calibrated p 0.046 ✓ | 7.7 EB05 7.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=307 | NCT00689936: 1/540 (0.2%) on Lenalidomide (serious AE) |
| Laboratory test abnormal | 4,488 | 8.8 8.5–9.1ROR 8.9 · calibrated p 0.048 ✓ | 7.6 EB05 7.4 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 5.6 · serious PRR 4.0 | not reported in cached trials |
| Myelodysplastic syndrome | 2,154 | 8.6 8.2–9.0ROR 8.6 · calibrated p 0.053 | 7.4 EB05 7.2 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning exact term | age-adj. PRR 6.4 · serious PRR 6.6 · 94% clinician | NCT00689936: 1/540 (0.2%) on Lenalidomide (serious AE) |
| Acute lymphocytic leukaemia | 406 | 8.2 7.4–9.1ROR 8.2 · calibrated p 0.062 | 7.1 EB05 6.5 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=404 · 100% clinician | NCT00689936: 1/532 (0.2%) on Lenalidomide (serious AE) |
| Follicular lymphoma | 114 | 7.6 6.2–9.2ROR 7.6 · calibrated p 0.082 | 6.5 EB05 5.6 · IC025 +2.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=107 · ♀ 0% (drug 49%) · 100% clinician | not reported in cached trials |
| Product distribution issue | 1,183 | 7.5 7.1–8.0ROR 7.6 · calibrated p 0.079 | 6.6 EB05 6.3 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious n=139 · 80% consumer | not reported in cached trials |
| Neuropathy peripheral (nerve damage in hands/feet) | 12,164 | 7.2 7.1–7.4ROR 7.4 · calibrated p 0.083 | 6.4 EB05 6.3 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 6.0 · serious PRR 5.9 | NCT00179647: 1/1,913 (0.1%) on Lenalidomide (serious AE) |
| Squamous cell carcinoma of skin | 761 | 7.1 6.6–7.7ROR 7.1 · calibrated p 0.095 | 6.3 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=746 · ♀ 24% (drug 49%) · 94% clinician | NCT00179647: 2/1,913 (0.1%) on Lenalidomide (serious AE) |
| Cardiac amyloidosis | 137 | 7.1 5.9–8.5ROR 7.1 · calibrated p 0.099 | 6.2 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=136 · 100% clinician | NCT00179647: 1/1,913 (0.1%) on Lenalidomide (serious AE) |
| Diffuse large b-cell lymphoma | 951 | 7.0 6.5–7.5ROR 7.0 · calibrated p 0.099 | 6.2 EB05 5.9 · IC025 +2.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.3 · 94% clinician | not reported in cached trials |
| Cytopenia | 1,476 | 6.9 6.5–7.3ROR 6.9 · calibrated p 0.102 | 6.2 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.3 · 92% clinician | NCT00179647: 31/1,913 (1.6%) on Lenalidomide (serious AE) |
| Lactose intolerance | 317 | 6.9 6.1–7.7ROR 6.9 · calibrated p 0.105 | 6.1 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=85 | not reported in cached trials |
| Bone lesion | 430 | 6.6 6.0–7.3ROR 6.6 · calibrated p 0.116 | 5.9 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=336 | NCT00179647: 1/1,913 (0.1%) on Lenalidomide (serious AE) |
| Pneumonia respiratory syncytial viral | 95 | 6.4 5.1–7.9ROR 6.4 · calibrated p 0.132 | 5.6 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious n=96 · 100% clinician | NCT00179647: 2/1,913 (0.1%) on Lenalidomide (serious AE) |
| Stem cell transplant | 278 | 6.2 5.5–7.0ROR 6.2 · calibrated p 0.139 | 5.6 EB05 5.0 · IC025 +2.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=262 | not reported in cached trials |
| Pneumonia influenzal | 132 | 6.1 5.1–7.3ROR 6.1 · calibrated p 0.148 | 5.4 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=131 · 100% clinician | not reported in cached trials |
| White blood cell count decreased | 11,893 | 6.0 5.9–6.1ROR 6.2 · calibrated p 0.139 | 5.5 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 5.0 · serious PRR 3.9 | NCT00179647: 2/1,913 (0.1%) on Lenalidomide (serious AE) |
| Adenocarcinoma of colon | 203 | 5.9 5.1–6.9ROR 6.0 · calibrated p 0.155 | 5.3 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=203 · 100% clinician | not reported in cached trials |
| Acute leukaemia | 171 | 5.8 4.9–6.8ROR 5.8 · calibrated p 0.168 | 5.2 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=171 · 92% clinician | NCT00179647: 2/1,913 (0.1%) on Lenalidomide (serious AE) |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Thrombocytopenia | 16,136 | 3.93.8–3.9 | signal |
| Venous thromboembolism | 14,813 | 3.63.5–3.7 | signal |
| Neutropenia / agranulocytosis | 14,432 | 3.03.0–3.1 | signal |
| Serious infection | 33,147 | 2.22.2–2.2 | signal |
| Anaemia | 12,790 | 2.22.1–2.2 | signal |
| Opportunistic infection | 3,283 | 1.21.2–1.2 | raised |
| Kidney injury | 10,845 | 1.21.2–1.2 | raised |
| Fall / fracture | 8,836 | 1.21.1–1.2 | raised |
| Arrhythmia / qt | 4,384 | 1.11.1–1.2 | raised |
| Heart failure | 3,919 | 1.11.1–1.1 | raised |
| Osteonecrosis | 1,079 | 0.90.9–1.0 | lower than other drugs |
| Stroke | 3,771 | 0.80.7–0.8 | lower than other drugs |
| Severe cutaneous reaction | 1,086 | 0.70.7–0.8 | lower than other drugs |
| Myocardial infarction | 2,758 | 0.70.6–0.7 | lower than other drugs |
| Malignancy | 4,431 | 0.60.6–0.6 | lower than other drugs |
| Hyponatraemia | 946 | 0.60.5–0.6 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Lenalidomide as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (16 of 40 signal terms matched).
- NCT00179647 — Expanded Access Program:Lenalidomide With or Without Dexamethasone In Previously Treated Subjects With Multipl (N=1913, PHASE3; 479 AE terms posted; arms: Lenalidomide)
- NCT00689936 — Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednison (N=1623, PHASE3; 705 AE terms posted; arms: Lenalidomide and Low-Dose Dexamethasone ; Lenalidomide and Dexamethasone (Rd18); Melphalan + Prednisone + Thalidomide (MP)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Diarrhoea (diarrhea) | 31,469 | 2.5 2.5–2.5ROR 2.6 · calibrated p 0.755 | 2.4 EB05 2.4 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.1 · serious PRR 1.7 | NCT00179647: 18/1,913 (0.9%) on Lenalidomide (serious AE) |
| Fatigue (tiredness) | 26,785 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.829 | 1.7 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | age-adj. PRR 1.6 · serious PRR 1.3 | NCT00179647: 29/1,913 (1.5%) on Lenalidomide (serious AE) |
| Death | 26,684 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.708 | 1.5 EB05 1.5 · IC025 +0.6 | Outcome field, not a reaction boxed warning mentions mortality | age-adj. PRR 1.2 · serious PRR 1.4 | NCT00179647: 3/1,913 (0.2%) on Lenalidomide (serious AE) |
| Off label use (used outside approved label) | 18,983 | 1.1 1.1–1.1ROR 1.1 · calibrated p 0.371 | 1.1 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | age-adj. PRR 1.5 · serious PRR 1.0 | not reported in cached trials |
| Pneumonia (lung infection) | 18,841 | 3.0 3.0–3.1ROR 3.1 · calibrated p 0.587 | 2.9 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.4 · serious PRR 2.7 | NCT00179647: 4/1,913 (0.2%) on Lenalidomide (serious AE) |
| Rash | 18,227 | 2.1 2.1–2.2ROR 2.2 · calibrated p 0.952 | 2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.4 · serious PRR 1.7 | NCT00179647: 5/1,913 (0.3%) on Lenalidomide (serious AE) |
| Plasma cell myeloma | 17,121 | 38.5 37.7–39.3ROR 40.1 · calibrated p 5e-5 ✓ | 21.9 EB05 21.6 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 26.6 · serious PRR 19.4 | not reported in cached trials |
| Neuropathy peripheral (nerve damage in hands/feet) | 12,164 | 7.2 7.1–7.4ROR 7.4 · calibrated p 0.083 | 6.4 EB05 6.3 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 6.0 · serious PRR 5.9 | NCT00179647: 1/1,913 (0.1%) on Lenalidomide (serious AE) |
| White blood cell count decreased | 11,893 | 6.0 5.9–6.1ROR 6.2 · calibrated p 0.139 | 5.5 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 5.0 · serious PRR 3.9 | NCT00179647: 2/1,913 (0.1%) on Lenalidomide (serious AE) |
| Constipation | 11,086 | 2.6 2.6–2.7ROR 2.7 · calibrated p 0.737 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.2 · serious PRR 1.8 | NCT00179647: 5/1,913 (0.3%) on Lenalidomide (serious AE) |
| Nausea | 10,891 | 0.7 0.7–0.7ROR 0.7 · calibrated p 0.119 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | age-adj. PRR 0.7 · serious PRR 0.6 | NCT00179647: 11/1,913 (0.6%) on Lenalidomide (serious AE) |
| Asthenia (weakness) | 10,124 | 1.4 1.3–1.4ROR 1.4 · calibrated p 0.550 | 1.3 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | age-adj. PRR 1.0 · serious PRR 1.1 | NCT00179647: 35/1,913 (1.8%) on Lenalidomide (serious AE) |
| Product dose omission issue | 9,600 | 1.7 1.7–1.7ROR 1.7 · calibrated p 0.784 | 1.7 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | age-adj. PRR 2.6 · serious PRR 1.2 | not reported in cached trials |
| Platelet count decreased | 9,592 | 4.8 4.7–4.9ROR 4.9 · calibrated p 0.241 | 4.5 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning synonym match | age-adj. PRR 3.9 · serious PRR 3.4 | not reported in cached trials |
| Neutropenia (low neutrophils (infection-fighting cells)) | 9,297 | 3.6 3.5–3.7ROR 3.7 · calibrated p 0.446 | 3.4 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled — boxed warning exact term | age-adj. PRR 3.1 · serious PRR 2.8 · 92% clinician | NCT00179647: 64/1,913 (3.3%) on Lenalidomide (serious AE) |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Human chorionic gonadotropin increased — n=579, PRR 92.2 (also seen in trial arm)
- 5q minus syndrome — n=80, PRR 48.9
- Light chain analysis increased — n=475, PRR 42.6
- Plasmacytoma — n=728, PRR 31.2 (also seen in trial arm)
- Amyloidosis — n=271, PRR 9.1 (also seen in trial arm)
- Osteolysis — n=319, PRR 9.0 (also seen in trial arm)
- Cardiac amyloidosis — n=137, PRR 7.1 (also seen in trial arm)
- Lactose intolerance — n=317, PRR 6.9
- Bone lesion — n=430, PRR 6.6 (also seen in trial arm)
- Pneumonia influenzal — n=132, PRR 6.1
✓ A hand-written Bradford Hill causality assessment exists for this drug: Lenalidomide (IMiDs) ↔ Venous thromboembolism.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Lenalidomide?
In FDA FAERS, the most frequently co-reported reaction terms for Lenalidomide are diarrhoea, fatigue, pneumonia, rash, plasma cell myeloma, neuropathy peripheral. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Lenalidomide have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Do not use lenalidomide capsules 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.
Do FAERS signals prove that Lenalidomide causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 682e8a86-9f49-45db-a2ea-403ee1dc62d2, effective 20240621; matched on
openfda.generic_name.exact:"LENALIDOMIDE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 216326 description (ChEBI)
- Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,224 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
LENALIDOMIDE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.