Lysodren (mitotane) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Lysodren
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Mitotane
Also reported as: Lysodren Tabs

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From April 2004 to June 2026, FDA received 973 adverse event reports that name Lysodren. In these reports the drug is a suspect or interacting product.

In the same period, 147 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 183 reports in the 12 months to June 2026 and 91 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 183 (under 0.1%) name Lysodren. Reports from consumers or other non-health professionals were 70% of the reports that name Lysodren and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Lysodren is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 18 reports that name Lysodren.
In January to March 2026, FDA received 150.
In April to June 2025, FDA received 6.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 87 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 954 of the 973 reports (98%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 87 terms.

Reaction terms in the reports that name Lysodren, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 973 reports
Nauseafeeling sick	235	24.2%
Fatiguetiredness	234	24%
Diarrhoealoose or frequent stools	145	14.9%
Product dose omission issuea dose was missed	130	13.4%
Vomitingbeing sick	107	11%
Off label useused for a purpose or in a way not on the label	103	10.6%
Dizzinesslight-headedness or unsteadiness	102	10.5%
Decreased appetitereduced appetite	91	9.4%
Astheniaweakness or lack of energy	64	6.6%
Weight decreasedweight loss	47	4.8%
Deaththe patient died; cause not stated by this term	45	4.6%
Adrenal insufficiencythe adrenal glands produce too little hormone	43	4.4%
Headachehead pain	43	4.4%
Drug ineffectivethe medicine did not work as expected	41	4.2%
Malignant neoplasm progression	41	4.2%
Abdominal discomfortstomach discomfort	34	3.5%
Somnolencedrowsiness	34	3.5%
Rashskin rash	31	3.2%
Product use complaint	28	2.9%
Drug interactionan interaction between medicines	26	2.7%
Balance disorderproblems with balance	25	2.6%
Constipation	22	2.3%
Adverse eventan unwanted medical event, type not specified	21	2.2%
Depressionlow mood	21	2.2%
Pyrexiafever	21	2.2%
Dehydration	19	2%
Wrong technique in product usage processthe product was used in the wrong way	19	2%
Drug level above therapeutic	18	1.8%
Abdominal pain upperupper stomach pain	17	1.7%
Brain fog	17	1.7%
Dyspnoeashortness of breath	16	1.6%
Malaisegeneral feeling of being unwell	16	1.6%
Memory impairmentmemory problems	16	1.6%
Alopeciahair loss	15	1.5%
Overdosea dose above the recommended amount	15	1.5%
Syncopefainting	15	1.5%
Abdominal painstomach or belly pain	14	1.4%
Accidental exposure to product	14	1.4%
Sepsisa severe body-wide response to infection	14	1.4%
Hospitalisationadmission to hospital	13	1.3%
Arthralgiajoint pain	12	1.2%
Adrenocortical insufficiency acute	11	1.1%
Disturbance in attentiondifficulty concentrating	11	1.1%
Dysgeusiaaltered taste	11	1.1%
Hypothyroidismunderactive thyroid	11	1.1%
Muscular weaknessmuscle weakness	11	1.1%
Neutropenialow neutrophils, a type of white blood cell	11	1.1%
Paraesthesiatingling or pins and needles	11	1.1%
Confusional stateconfusion	10	1%
Electrocardiogram QT prolongeda QT prolongation on the ECG	10	1%

Download all 87 terms of Lysodren (CSV)

The counts add to more than 973 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Mitotane with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Mitotane	Generic name	518
Lysodren (this page)	Brand name	973

Sum of the separately reported names: 1,491. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Lysodren, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Other Serious (Important Medical Events)	Not serious
2004	10	10	6	2	10	0	4	0
2005	4	1	0	0	1	0	0	3
2006	3	3	1	0	1	0	1	0
2007	26	23	9	1	6	0	15	3
2008	25	19	6	1	11	0	12	6
2009	17	15	0	0	10	1	7	2
2010	14	10	1	0	5	1	6	4
2011	27	25	5	0	11	2	12	2
2012	20	20	6	2	7	0	11	0
2013	14	13	3	0	11	1	5	1
2014	19	11	0	0	10	0	4	8
2015	22	14	2	2	8	1	11	8
2016	24	16	2	0	6	1	13	8
2017	21	9	1	1	4	2	9	12
2018	51	49	17	0	19	0	39	2
2019	19	19	2	0	7	1	13	0
2020	23	23	0	0	13	0	15	0
2021	49	26	6	0	9	0	16	23
2022	83	31	2	0	24	0	16	52
2023	90	41	2	1	22	1	29	49
2024	91	34	7	0	24	0	27	57
2025	89	37	2	0	15	0	29	52
2026	232	76	19	0	33	1	37	156

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Lysodren, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Lysodren, by the year in which FDA received them
Year	Reports
2004	10
2005	1
2006	6
2007	22
2008	24
2009	20
2010	12
2011	31
2012	27
2013	15
2014	13
2015	23
2016	22
2017	23
2018	49
2019	21
2020	27
2021	60
2022	101
2023	111
2024	92
2025	94
2026	168

Reports that name Lysodren, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Lysodren
Age	Reports	Share
Under 2	2	0.2%
2 to 11	32	3.3%
12 to 17	13	1.3%
18 to 44	201	20.7%
45 to 64	336	34.5%
65 to 74	139	14.3%
75 and over	48	4.9%
Age not given	202	20.8%

Sex of the patient in the reports that name Lysodren
Sex	Reports	Share
Female	614	63.1%
Male	317	32.6%
Unknown or not given	42	4.3%

Type of reporter in the reports that name Lysodren
Reporter	Reports	Share
Physician	103	10.6%
Pharmacist	45	4.6%
Other health professional	141	14.5%
Lawyer	0	0%
Consumer or non-health professional	681	70%
Not given	3	0.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 66.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Lysodren record
Indication as recorded (MedDRA)	Reports	Share
Adrenal gland cancer	343	35.3%
Adrenocortical carcinoma	294	30.2%
Adrenal carcinoma	23	2.4%
Adjuvant therapy	8	0.8%
Neoplasm malignant	4	0.4%
Adrenal disorder	3	0.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 973 reports.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for LysodrenThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Lysodren: adverse event reports that FDA received. https://reportedreactions.com/drug/lysodren/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Lysodren as a suspect or interacting product. The 147 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Lysodren was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Lysodren?

No. It is a count of what people reported to FDA: 973 reports from April 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (70%), other health professional (14.5%) and physician (10.6%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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