What is Mitotane used for?

Mitotane (Lysodren) is used to treat people with inoperable adrenocortical carcinoma (ACC).

Can Mitotane cause an adrenal crisis?

Yes, Mitotane users are at a high risk of adrenal crisis during times of severe infection, shock, or trauma, which can be fatal.

How should I take Lysodren?

It should be taken orally in three or four divided doses per day, usually with food.

Is Mitotane safe to take while pregnant?

No, Mitotane can cause fetal harm and has been linked to early pregnancy loss and preterm birth.

What are the common side effects of Mitotane?

Common side effects include nausea, vomiting, diarrhea, loss of appetite, dizziness, and skin rashes.

Does Mitotane interact with birth control?

Yes, you should avoid using hormonal contraceptives while taking Mitotane.

What happens if my Mitotane levels are too high?

Levels above 20 mg/L can cause nervous system toxicity, including sedation, dizziness, and muscle weakness.

Mitotane | CAS 53-19-0 | JWBOIMRXGHLCPP

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Anti-cancer (adrenal cytotoxic agent)

MITOTANE (brand name Lysodren) is an oral medication used to treat patients with inoperable adrenocortical carcinoma (ACC), a type of cancer in the adrenal glands. It works by suppressing the adrenal cortex and changing how the body processes steroids. Because it can cause serious issues like adrenal crisis, especially during illness or injury, it must be used under strict medical supervision with regular blood tests to monitor drug levels.

How it worksMitotane works as an adrenal cytotoxic agent, meaning it helps destroy or suppress the cells in the adrenal cortex. It also changes how the body metabolizes steroids.

Brand names:LYSODREN

Used for

Inoperable adrenocortical carcinoma (ACC), whether it is functional or nonfunctional

Conditions

Adrenocortical carcinoma

Class

AntineoplasticAdrenal cytotoxic agentAnti-cancer (adrenal cytotoxic agent)Endocrine systemAdrenal glandsCentral nervous system

How to take

FormsOral tablet

RoutesOral

The starting dose is usually between 2000 mg and 6000 mg per day, split into three or four doses and taken with food. Doctors will adjust the dose to reach a specific target level in your blood.

Mitotane is taken with food. Because it builds up in body fat, your doctor will monitor your blood levels closely to ensure the dose is safe and effective.

Key warnings

There is a serious risk of adrenal crisis if you experience shock, severe trauma, or infection while taking Lysodren. This can be life-threatening. If you become severely ill or injured, stop the medication and contact your doctor immediately, as you may need steroid replacement.

·There is a serious risk of adrenal crisis if you experience shock, severe trauma, or infection while taking Lysodren. This can be life-threatening. If you become severely ill or injured, stop the medication and contact your doctor immediately, as you may need steroid replacement.
·Adrenal crisis can occur during infection or injury.
·High levels of Mitotane in the blood can cause brain and nerve toxicity.
·Women before menopause should have regular pelvic ultrasounds to check for ovarian cysts.
·This drug can cause harm to a fetus; use effective non-hormonal birth control.
·It may cause liver or blood-related toxicity.
·It can cause prolonged bleeding times.

Do not use if

·None listed

Side effects

Common

Loss of appetiteStomach discomfortNauseaVomitingDiarrheaDizzinessVertigoSkin rashHigh cholesterolHigh triglyceridesUnderactive thyroid (hypothyroidism)

Serious

·Adrenal crisis (which can be life-threatening)
·Central nervous system issues (like confusion or movement problems)
·Ovarian cysts in women before menopause
·Liver problems
·Blood count changes
·Increased bleeding time
·Harm to an unborn baby

Seek help if

·Signs of adrenal crisis (severe illness, injury, or shock)
·Severe neurological changes or confusion
·Symptoms of liver or blood issues

Interactions

·Spironolactone (can block the effect of Mitotane)
·Hormonal contraceptives (should be avoided)
·Warfarin (Mitotane may change how it works)
·Certain CYP3A substrates (Mitotane may lower the levels of these drugs, making them less effective)

FoodTaking Mitotane with high-fat food may increase how much of the drug your body absorbs.

Special populations

PregnancyMitotane can cause harm to a developing baby. There have been reports of preterm births and early pregnancy loss in women taking this drug. It is advised that women of reproductive age use effective, non-hormonal birth control.

PediatricThe effectiveness of Mitotane in children has not been proven. In some cases, it may affect a child's brain development, growth, or hormone levels. Use in children should be handled with extreme caution.

GeriatricThere is not enough data on patients over 65 to know if they respond differently. Doctors usually start older patients on a lower dose because they may have different liver, kidney, or heart functions.

Talk to your doctor

Monitor

·Plasma Mitotane levels
·Liver function
·Complete blood counts
·Pelvic ultrasounds (for premenopausal women)
·Behavioral and neurologic changes

Questions to ask

·How often will my Mitotane blood levels be checked?
·What should I do if I develop an infection or injury while on Lysodren?
·How will this medication affect my thyroid function?
·What non-hormonal birth control should I use while on this drug?

Pharmacokinetics

Half-lifeThe plasma terminal half-life is 18 to 159 days, with a median of 53 days.

Bioavailability40% of the dose is absorbed following oral administration.

MetabolismMitotane is converted to a water-soluble metabolite (o,p'-DDA) through hepatic and extrahepatic metabolism.

Practical

OverdoseAn overdose (blood levels above 20 mg/L) can cause sedation, lethargy, dizziness, muscle weakness, and trouble walking. Because the drug stays in fat, it can take weeks for levels to drop. It is not removed by dialysis.

StorageStore at room temperature between 15°C and 30°C (59°F to 86°F).

DisposalFollow special hazardous drug handling and disposal procedures.

Ingredients

Allergens

none

Inactive

microcrystalline cellulosepolyethylene glycol 3350silicon dioxidestarch, corn

Educational summary derived from FDA labeling, AI-assisted. Not medical advice — consult a healthcare professional. Updated 2026-04-25.