Lenalidomide Celgene Europe

Application withdrawnHuman

Details

EMA number	EMEA/H/C/000688
ATC code	-
Authorisation	-
Revision	-

EMA page

Therapeutic indication

Not specified

MeSH: Myelodysplastic Syndromes

Active substances

lenalidomide

Marketing Authorisation Holder

Celgene Europe Limited

MAH

🇺🇸 Also approved in the US (FDA)

LENALIDOMIDE — ZYDUS PHARMS, approved 2026-04-27 (ANDA210154).

Most reported adverse events (US / FAERS)

239,325 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

diarrhoea

31,002

fatigue

26,436

death

26,431

pneumonia

18,620

off label use

🇺🇸 Also approved in the US (FDA)

LENALIDOMIDE — ZYDUS PHARMS, approved 2026-04-27 (ANDA210154).

Most reported adverse events (US / FAERS)

239,325 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

diarrhoea

31,002

fatigue

26,436

death

26,431

pneumonia

18,620

off label use

18,602

rash

17,969

plasma cell myeloma

16,976

neuropathy peripheral

12,002

white blood cell count decreased

11,766

constipation

10,965

nausea

10,749

asthenia

10,007

platelet count decreased

9,502

product dose omission issue

9,215

neutropenia

9,083