Is Mitotane approved by the US FDA?

Drugs@FDA lists 1 application product line for Mitotane, including LYSODREN (Prescription).

Is Mitotane authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Mitotane: Lysodren.

Are there safety signals or safety updates for Mitotane?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2024-10-28).

Active substance

Mitotane

US FDA 1
EMA 1
Health Canada 1
NHS prices 1
Safety 4

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
LYSODREN	500MG	tablet · oral	ESTEVE	Prescription	8 Jul 1970

EMA European Union — centrally authorised medicines

Lysodren Esteve Pharmaceuticals, S.A. · Authorised · authorised 28 Apr 2004 · ATC L01XX23

Therapeutic indication (EMA)

Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma. The effect of Lysodren on non-functional adrenal cortical carcinoma is not established.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
LYSODREN	00463221	500 MG	TABLET · ORAL	ESTEVE PHARMACEUTICALS S.A.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Mitotane 500mg tablets	£780.08	100 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 28 Oct 2024 LYSODREN — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 11 Feb 2016 PRAC signal: Sex hormone disturbances and development of ovarian macrocysts
Action for MAH: update of the product information: Yes
EMA PRAC 8 Oct 2015 PRAC signal: Sex hormone disturbances and development of ovarian macrocysts
Action for MAH: update of the product information: No
EMA PRAC 7 May 2015 PRAC signal: Sex hormone disturbances and development of ovarian macrocysts
Action for MAH: update of the product information: No

All safety entries for mitotane →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.