Mitotane

Pronunciation: MY-toe-tane.

Generic name: mitotane
Drug class: Adrenal cytotoxic (adrenolytic) antineoplastic agent
Form: Tablet
Route: Oral
Legal status: Prescription-only, specialist (oncology/endocrinology) initiated

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada

Boxed warning: Adrenal crisis in the setting of shock or severe trauma

Mitotane carries a boxed warning (the US FDA's strongest safety warning): in patients taking mitotane, adrenal crisis can occur in the setting of shock, severe trauma, or serious infection, and the body's normal response to shock is impaired because mitotane suppresses the adrenal glands' ability to produce stress-response hormones. If a severe physical stress event occurs, hydrocortisone (or another corticosteroid) must be given and mitotane must be temporarily stopped until the patient has recovered. This is why every patient taking mitotane needs a clear, individualised emergency steroid-replacement plan agreed with their treatment team. (1)

What mitotane is and how it works

Mitotane is a prescription oncology medicine that works by directly damaging and destroying cells of the adrenal cortex (the outer layer of the adrenal gland), including adrenocortical carcinoma (adrenal cortex cancer) cells. It is used to treat this rare cancer when it cannot be fully removed by surgery, has spread, or has come back after treatment. (1) (2)

Because mitotane damages normal adrenal tissue as well as cancerous tissue, nearly everyone taking it needs corticosteroid (steroid hormone) replacement, and needs a clear plan for extra steroid coverage during any serious illness, injury, surgery, or infection -- this is a genuine, potentially life-threatening risk (adrenal crisis) covered by the medicine's boxed warning. Mitotane also commonly affects the nervous system (causing tiredness, unsteadiness, or confusion), so treatment requires regular blood level monitoring and close specialist supervision throughout.

Mechanism of action: how mitotane works

Mitotane is an adrenal cytotoxic (adrenolytic) agent, structurally related to the insecticide DDT, that selectively damages and destroys cells of the adrenal cortex (zona fasciculata and reticularis in particular), suppressing steroidogenesis and reducing tumour burden in adrenocortical carcinoma; it is also a strong inducer of hepatic CYP3A metabolism. (1)

What mitotane is used for

Adrenocortical carcinoma (adrenal cortex cancer)

Used to treat inoperable, functional (hormone-producing) or non-functional adrenocortical carcinoma, including cancer that cannot be removed by surgery, has spread to other parts of the body, or has relapsed after earlier treatment. (1) (2) (3)

Before taking mitotane

Do not take / not appropriate for

No absolute contraindications are listed on the current US label -- given the seriousness of the cancer being treated, the decision to use mitotane is always made individually with a specialist oncologist, weighing the real risks described in this page against the alternative of not treating the cancer. (United States) (1)

Tell your clinician about

Any history of adrenal problems, or any current infection, injury, surgery, or illness -- your steroid replacement plan may need to change.
All other medicines, especially warfarin or other blood thinners, spironolactone, and hormonal contraceptives -- mitotane changes how several other medicines work in the body.
Whether you are pregnant, trying to become pregnant, or breastfeeding.
Any driving or machine-operating responsibilities, given the real risk of dizziness, drowsiness, and unsteadiness on this medicine.

(1) (3)

How to take mitotane

Take mitotane exactly as prescribed by the specialist team managing your cancer treatment -- the dose is individually titrated based on regular blood tests, not a fixed standard dose.
You will need regular corticosteroid (steroid hormone) replacement alongside mitotane, and a clear emergency plan for extra steroid coverage during illness, injury, or surgery.
Do not drive or operate machinery if you are experiencing dizziness, drowsiness, or unsteadiness -- mitotane has a major effect on the ability to drive and use machines.

(1) (3)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7)

Missed dose

Contact the specialist team managing your treatment for guidance if you miss a dose. Do not double up on a dose or otherwise change your schedule on your own -- mitotane dosing is individually titrated against blood levels.

Overdose

Seek urgent medical attention immediately if too much mitotane may have been taken, or if severe confusion, extreme drowsiness, difficulty walking or speaking, or seizures occur -- an emergency medical team can assess and manage these symptoms, including checking adrenal function and blood mitotane levels. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Nausea, vomiting, diarrhoea, and loss of appetite -- reported in more than 80% of patients at some point, and generally reversible with dose reduction.

What to notice: Nausea, vomiting, diarrhoea, and loss of appetite -- reported in more than 80% of patients at some point, and generally reversible with dose reduction.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (3)

Dizziness, drowsiness, and low mood.

What to notice: Dizziness, drowsiness, and low mood.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Skin changes, such as rash.

What to notice: Skin changes, such as rash.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (3)

Serious warnings

Signs of adrenal crisis during shock, severe trauma, infection, or illness — boxed_warning

Symptoms: Severe weakness, very low blood pressure, fainting, confusion, vomiting, or collapse occurring during a serious illness, injury, infection, or surgery.

Action: Seek emergency medical help immediately. Mitotane suppresses the adrenal glands, impairing the body's normal stress response -- during shock or severe trauma, hydrocortisone (or another corticosteroid) must be given urgently and mitotane temporarily stopped until recovery; every patient on mitotane should carry information about this risk and have an agreed emergency steroid plan with their treatment team. (1)

Signs of significant central nervous system toxicity — high_caution

Symptoms: New or worsening severe dizziness, marked drowsiness, difficulty walking or keeping balance (ataxia), slurred speech, memory problems, or seeing/hearing things that are not there (hallucinations).

Action: Contact the clinician or oncology team managing your treatment promptly -- these effects occur in around 40% of patients and are strongly linked to blood mitotane levels, especially above 20 mg/L; your team may need to check your mitotane level and adjust your dose. Seek emergency medical help immediately for sudden severe confusion, loss of consciousness, or seizures. (1)

Signs of inadequate steroid replacement (adrenal insufficiency) — high_caution

Symptoms: Ongoing fatigue, weakness, dizziness on standing, weight loss, or low blood pressure between doses.

Action: Contact the clinician managing your treatment -- your corticosteroid replacement dose may need adjusting; do not change your steroid dose on your own. (1)

Interactions

Warfarin and other vitamin K antagonist blood thinners: mitotane speeds up their breakdown, so more frequent INR monitoring and dose adjustment (often an increase) are usually needed. (1)
Spironolactone may block mitotane's action on the adrenal gland and concurrent use should generally be avoided. (1)
Mitotane is a strong inducer of the CYP3A liver enzyme, which can lower blood levels of many other medicines processed by that pathway. (1)
Hormonal contraceptives may become less effective; non-hormonal contraception is generally recommended during treatment. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Mitotane can cause serious fetal harm and is generally not used in pregnancy; effective non-hormonal contraception is recommended during treatment given the interaction with hormonal contraceptives. (1) (2) (3) (4) (5) (6) (7)

Breastfeeding

Not recommended -- discuss with the treating oncology team given mitotane's long half-life and tissue accumulation. (1) (2) (3) (4) (5) (6) (7)

Children

Use in children is a specialist decision, individualised by the treating paediatric oncology team; standard dosing described here is for adults. (1) (2) (3) (4) (5) (6) (7)

Elderly

No specific age-based dose adjustment is described in the sources reviewed; the same monitoring principles apply, with attention to overall tolerability. (1) (2) (3) (4) (5) (6) (7)

Hepatic_impairment

Requires caution and closer monitoring given mitotane's extensive liver metabolism; managed individually by the treating specialist. (1) (2) (3) (4) (5) (6) (7)

Source_ids

US-FDA-LYSODREN-LABEL-2024 (1) (2) (3) (4) (5) (6) (7)

Monitoring

Before starting

Baseline adrenal function assessment
Baseline corticosteroid replacement plan agreed with the treatment team
Review of other medicines for interactions (warfarin, spironolactone, hormonal contraceptives)

During treatment

Blood (plasma) mitotane levels checked every 2 weeks initially, then monthly, targeting 14-20 mg/L.
Regular assessment for CNS toxicity (dizziness, unsteadiness, confusion, memory problems).
Ongoing corticosteroid replacement, with the dose reassessed during any illness, injury, infection, or surgery.
Free cortisol and ACTH levels checked to help optimise steroid replacement.

(1)

Storage

Store tablets at room temperature, protected from moisture, out of reach of children, exactly as directed on the product label.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information and UK emc SmPC; verify against the current full label before prescribing.

United States / United Kingdom / European Union / Canada

Indication: Adrenocortical carcinoma

Dose summary: Starting 2,000-6,000 mg/day (or 2-3 g/day per the UK SmPC) in 3-4 divided doses, titrated at roughly two-week intervals toward a target plasma mitotane level of 14-20 mg/L, typically reached over 3-5 months.

Renal context: No specific renal dose-adjustment schedule identified in the sources reviewed; mitotane is primarily hepatically metabolised. (1) (3)

Mechanism of action

Hepatic guidance

Extensively hepatically metabolised; strong CYP3A inducer affecting many co-administered drugs' levels.

Overdose note

Manage with supportive care, assessment of adrenal function, and monitoring of plasma mitotane levels; no specific antidote identified in the sources reviewed. (1)

Frequently asked questions

Is mitotane (Lysodren) available in the US, UK, Europe, Canada, Australia, and New Zealand?

It is confirmed authorised and marketed as Lysodren in the United States, the European Union (since 2004, as an orphan medicine), the United Kingdom (both the originator Lysodren and a generic Mitotane Esteve), and Canada. No current Australian TGA/ARTG listing or New Zealand Medsafe data sheet could be found -- these are honestly reported as unable to verify rather than assumed either way. (1) (2) (3) (4) (5) (6) (7)

Why do I need to carry emergency information about mitotane?

Mitotane damages the adrenal glands, which normally help your body cope with severe physical stress such as shock, serious infection, major injury, or surgery. This is the subject of the medicine's boxed warning: during such an event, your body's stress response is impaired, so emergency hydrocortisone (or another corticosteroid) treatment is needed and mitotane must be temporarily stopped until you recover. Carrying this information (and having an agreed plan with your treatment team) helps any emergency team treat you correctly and quickly. (1)

Why do I need regular blood tests while taking mitotane?

Mitotane's dose is adjusted based on your blood (plasma) mitotane level, targeting 14-20 mg/L -- levels above 20 mg/L are linked to a higher chance of central nervous system side effects such as dizziness, unsteadiness, and confusion. Levels are checked every 2 weeks at first, then monthly, so your treatment team can find the dose that controls the cancer while keeping side effects manageable. (1)

What is the mechanism of action of mitotane?

What is the generic name of Mitotane?

The generic name is mitotane. (1) (2)

What class of drug is mitotane?

Mitotane is classed as: Adrenal cytotoxic (adrenolytic) antineoplastic agent. (1) (2)

References

LYSODREN (mitotane) tablets, for oral use -- full prescribing informationU.S. Food and Drug Administration, full prescribing information · United States · accessed 2026-07-31 · source 1
Lysodren (mitotane) -- EPAR summary for the publicEuropean Medicines Agency (EMA), EPAR · European Union · accessed 2026-07-31 · source 2
Lysodren 500 mg tablets -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom · United Kingdom · accessed 2026-07-31 · source 3
Mitotane Esteve 500 mg Tablets -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom · United Kingdom · accessed 2026-07-31 · source 4
LYSODREN (mitotane 500 mg tablet) -- DPD product recordHealth Canada Drug Product Database (DPD) · Canada · accessed 2026-07-31 · source 5
TGA eBS Product and Consumer Medicine Information search for mitotane -- 0 documents availableTherapeutic Goods Administration (TGA) eBS (electronic Business Services) repository · Australia · accessed 2026-07-31 · source 6
No current Medsafe data sheet found for mitotane/LysodrenMedsafe (New Zealand regulator) · New Zealand · accessed 2026-07-31 · source 7

Brand names by country

Single-ingredient mitotane names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

Lysodren500 mg · hra pharma rare diseases

United Kingdom

Lysodren (3)mhra licensed emc smpc confirmed · 500 mg · See current emc SmPC listing
Mitotane Esteve (4)mhra licensed emc smpc confirmed · 500 mg · Laboratorios Esteve

Canada

LYSODREN

View brands in additional countries.

European Union

Lysodren (2)