What the label lists and what reports show
Mitotane side effects
Mitotane's FDA label: “Most common adverse reactions include: anorexia, epigastric discomfort, nausea, vomiting, diarrhea, dizziness, vertigo, rash, hypercholesterolemia, hypertriglyceridemia, hypothyroidism, and decreased blood free testosterone in males.” FAERS holds 1,782 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (302 reports).
- 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 FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of LYSODREN?LYSODREN can cause serious side effects including: See “What is the most important information I should know about LYSODREN?” Neurological problems (central nervous system toxicity). LYSODREN can cause decreased awareness and alertness. See “What should I avoid while taking LYSODREN?” Tell your healthcare provider if you develop any of the following signs and symptoms during treatment or if they get worse: slow thinking slow movement or decreased coordination confusion difficulty concentrating memory loss trouble talking sleepiness dizziness feelings of pins and needles in your hands and feet feeling very tired Your healthcare provider may test your blood to make sure your thyroid is producing enough thyroid hormone and to check the mitotane level if you develop any of these signs and symptoms during treatment. Ovarian cysts in premenopausal women. […]
Source: FDA drug label, 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 label list?
From the label: adverse reactionsMost common adverse reactions include: anorexia, epigastric discomfort, nausea, vomiting, diarrhea, dizziness, vertigo, rash, hypercholesterolemia, hypertriglyceridemia, hypothyroidism, and decreased blood free testosterone in males.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: • Adrenal Insufficiency and Adrenal Crisis [see Warnings and Precautions (5.1)] • Central Nervous System Toxicity [see Warnings and Precautions (5.2)] • Ovarian Macrocysts in Premenopausal Women [see Warnings and Precautions (5.3)] • Hepatotoxicity [see Warnings and Precautions (5.4)] • Hematologic Toxicity [see Warnings and Precautions (5.5)] • Prolonged Bleeding Time [see Warnings and Precautions (5.6)] • Hormone Binding Protein [see Warnings and Precautions (5.7)] • Embryo-Fetal Toxicity [see Warnings and Precautions (5.8)] Most common adverse reactions include: anorexia, epigastric discomfort, nausea, vomiting, diarrhea, dizziness, vertigo, rash, hypercholesterolemia, hypertriglyceridemia, hypothyroidism, and decreased blood free testosterone in males. (6) To report SUSPECTED ADVERSE REACTIONS, contact Esteve Pharmaceuticals, S.A. at 1-888-306-6259 or FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Source: FDA drug label, 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?
1,782 reports list mitotane among the medicines taken, 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. Of the 19 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Mitotane: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions