Enzalutamide Accordpharma

AuthorisedHuman

Details

EMA number	EMEA/H/C/006612
ATC code	L02BB04
Authorisation	-
Revision	-

EMA page

Therapeutic indication

Treatment of prostate cancer.

MeSH: Prostatic Neoplasms

Group: Endocrine therapy

Active substances

enzalutamide

Marketing Authorisation Holder

Accord Healthcare

MAH

🇺🇸 Also approved in the US (FDA)

XTANDI — ASTELLAS, approved 2026-07-24 (NDA213674).

Most reported adverse events (US / FAERS)

60,556 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.

fatigue

10,208

death

7,681

malignant neoplasm progression

5,440

prostatic specific antigen increased

4,325

🇺🇸 Also approved in the US (FDA)

XTANDI — ASTELLAS, approved 2026-07-24 (NDA213674).

Most reported adverse events (US / FAERS)

60,556 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.

fatigue

10,208

death

7,681

malignant neoplasm progression

5,440

prostatic specific antigen increased

4,325

asthenia

4,137

drug ineffective

4,043

hot flush

3,850

decreased appetite

3,394

nausea

3,247

dizziness

3,124

diarrhoea

2,790

back pain

2,290

arthralgia

2,137

underdose

2,073

constipation

1,817