Drug Landscape ›
LENALIDOMIDE ›
Regulatory · United States
Marketing authorisation
FDA
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
Window: 20 April 2025 – 20 April 2026
Total reports: 33,448
Most-reported reactions
Off Label Use — 5,986 reports (17.9%) Diarrhoea — 4,333 reports (12.95%) Pneumonia — 3,634 reports (10.86%) Plasma Cell Myeloma — 3,629 reports (10.85%) Fatigue — 3,589 reports (10.73%) Death — 2,789 reports (8.34%) Neutropenia — 2,698 reports (8.07%) Rash — 2,525 reports (7.55%) Thrombocytopenia — 2,151 reports (6.43%) Drug Ineffective — 2,114 reports (6.32%)
Source database →
LENALIDOMIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is LENALIDOMIDE approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for LENALIDOMIDE in United States?
Marketing authorisation holder not available in our data.