Mitotane is a prescription medicine indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). It is available as tablets for oral use. MedsAcross supplies Mitotane for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
LYSODREN is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). LYSODREN is an adrenal cytotoxic agent indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC).
Source: US FDA prescribing information
Mitotane is an adrenal cytotoxic agent with an unknown mechanism of action. Mitotane modifies the peripheral metabolism of steroids and directly suppresses the adrenal cortex. A reduction in 17-hydroxycorticosteroids in the absence of decreased corticosteroid levels and increased formation of 6-β-hydroxycortisol have been reported.
Source: US FDA prescribing information
The recommended initial dose of LYSODREN is 2000 mg to 6000 mg orally, in three or four divided doses per day with food. Titrate LYSODREN dose to achieve a plasma level of 14 to 20 mg/L. LYSODREN is lipophilic and accumulates in adipose tissue.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Boxed warning (adrenal crisis in the setting of shock, severe trauma or infection): Patients treated with LYSODREN are at increased risk for developing adrenal crisis in the setting of shock, severe trauma or infection that may lead to death. If shock, severe trauma or infection occurs or develops, temporarily discontinue LYSODREN and administer exogenous steroids. Adrenal Insufficiency and Adrenal Crisis: Temporarily withhold LYSODREN during shock, trauma, infection or adrenal insufficiency. Steroid replacement may be necessary. Central Nervous System (CNS) Toxicity: Monitor behavioral and neurologic assessments and mitotane plasma levels at regular intervals. Mitotane plasma levels exceeding 20 mg/L are associated with a greater incidence of toxicity. Advise patients not to drive or operate hazardous machinery if experiencing CNS adverse reactions.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: • Adrenal Insufficiency and Adrenal Crisis • Central Nervous System Toxicity • Ovarian Macrocysts in Premenopausal Women • Hepatotoxicity • Hematologic Toxicity • Prolonged Bleeding Time • Hormone Binding Protein • Embryo-Fetal Toxicity Most common adverse reactions include: anorexia, epigastric discomfort, nausea, vomiting, diarrhea, dizziness, vertigo, rash, hypercholesterolemia, hypertriglyceridemia, hypothyroidism, and decreased blood free testosterone in males.
Source: US FDA prescribing information
Spironolactone: Avoid concomitant use with LYSODREN. Certain CYP3A Substrates: Avoid concomitant use with LYSODREN. Hormonal contraceptives: Avoid concomitant use with LYSODREN. Warfarin: Avoid concomitant use with LYSODREN.
Source: US FDA prescribing information
Store bottles at 25°C (77°F), excursions permitted between 15°C and 30°C (59°F-86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Mitotane, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Lysodren 500 mg tabletOral | Esteve Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Mitotane in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Mitotane and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Mitotane, including Lysodren.
Yes. The US FDA first approved Mitotane on 8 July 1970, according to Drugs@FDA.
Yes. Mitotane has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Mitotane is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Mitotane is classified under ATC code L01XX23 (Mitotane).
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