Prescription medicine
Mitotane Brand names: Lysodren
Mitotane (Lysodren) is a prescription medicine with an FDA approval on record since 1970. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the mitotane FDA label on DailyMed (effective March 3, 2026, ESTEVE PHARMACEUTICALS, S.A.); the NDA 16885 record on Drugs@FDA; every mitotane label on DailyMed.
Highlights of the record
FDA label of March 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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. Monitor patients closely for infections and instruct patients to contact their physician immediately if injury, infection, or any other concomitant illness occurs [see Dosage and Administration (2.3) and Warnings and Precautions (5.1)]. WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK, SEVERE TRAUMA OR INFECTION See full prescribing information for complete boxed warning. 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. Monitor patients closely for infections and instruct patients to contact their physician immediately if injury, infection, or any other concomitant illness occurs ( 2.3 , 5.1 ).
Used for
From the label: indications and usageLYSODREN is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC).
Forms and strengths
- 500 mg
Tablet.
On the market
- Earliest approval on file
- July 8, 1970 Lysodren, Esteve; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,782 through July 30, 2026
What is mitotane used for?
From the label: indications and usageLYSODREN 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: FDA drug label (Lysodren), ESTEVE PHARMACEUTICALS, S.A., effective March 3, 2026 (SPL set 4046a224-8832-daa2-e063-6294a90a11d7), via openFDA; the full label on DailyMed
What does the patient leaflet for mitotane say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about LYSODREN?LYSODREN can cause serious side effects including: Adrenal Insufficiency and Adrenal Crisis. Adrenal Insufficiency. LYSODREN can cause your adrenal glands to stop making enough corticosteroid hormones (adrenal insufficiency) or make this problem worse in people with cancer of the adrenal glands (adrenocortical carcinoma). Your healthcare provider may temporarily stop, reduce your dose, or permanently stop treatment with LYSODREN if you develop adrenal insufficiency during treatment. Adrenal Crisis. LYSODREN can cause your adrenal glands to suddenly stop making enough corticosteroid hormones (adrenal crisis). You are at increased risk for developing adrenal crisis if you experience shock, severe injury, or infection during treatment with LYSODREN. Adrenal crisis may lead to death. Tell your healthcare provider right away if you get an injury, infection, or other illness during treatment with LYSODREN. Your healthcare provider will temporarily stop LYSODREN if shock, severe injury, or infections happen during treatment. Tell your healthcare provider if you have any planned surgery. Your healthcare provider will check your levels of corticosteroid hormones during treatment and may give you corticosteroid medicine if you develop adrenal gland problems. Tell your healthcare provider right away if you develop any signs or symptoms of adrenal gland problems, including: severe weakness confusion pain in the lower back and legs stomach (abdominal) pain nausea, vomiting, or diarrhea feeling lightheaded or dizzy passing out feeling very tired decreased appetite weight loss areas of darkened skin craving salt low blood sugar feeling irritable or depressed hair loss See "What are the possible side effects of LYSODREN?" for more information about side effects.
From the patient leaflet: What should I avoid while taking LYSODREN?Do not drive or operate machinery until you know how LYSODREN affects you. LYSODREN may cause sleepiness, decreased energy, and dizziness, which may affect your ability to drive and operate machinery.
From the patient leaflet: How should I store LYSODREN?Store LYSODREN at 77°F (25°C). Keep LYSODREN and all medicines out of the reach of children.
Source: FDA drug label (Lysodren), ESTEVE PHARMACEUTICALS, S.A., effective March 3, 2026 (SPL set 4046a224-8832-daa2-e063-6294a90a11d7), via openFDA; the full label on DailyMed
Is there a generic for mitotane (Lysodren)?
No generic mitotane is approved (Drugs@FDA, October 8, 2026).
- 1970 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the mitotane label say about other medicines?
The mitotane label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 11 other medicines name mitotane. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Adenosine | warnings and precautions | Prolonged Bleeding Time LYSODREN can cause platelet function disorders due to abnormal adenosine diphosphate (ADP)-induced platelet aggregation. |
| Corticotropin | warnings and precautions | Due to increased steroid clearance and increase of steroid-binding protein, high-dose replacement therapy may be required and free cortisol and corticotropin (ACTH) should be monitored to adapt the systemic corticosteroids. |
| Spironolactone | drug interactions | DRUG INTERACTIONS Spironolactone: Avoid concomitant use with LYSODREN. |
| Warfarin | drug interactions | Warfarin Mitotane may induce the metabolism of warfarin, which may reduce its level and its efficacy [see Clinical Pharmacology (12.3) ]. |
Other labels that name mitotane
Source: FDA drug label (Lysodren), ESTEVE PHARMACEUTICALS, S.A., effective March 3, 2026 (SPL set 4046a224-8832-daa2-e063-6294a90a11d7), via openFDA; the full label on DailyMed
What do FAERS reports show for mitotane?
The FDA Adverse Event Reporting System holds 1,782 reports that list mitotane among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 230 are coded as a death and 474 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Mitotane side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other