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Lysodren Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Lysodren (mitotane) is used to treat cancer of the adrenal gland (adrenal cortical carcinoma). It is an antineoplastic (anticancer) medication. Common side effects include dizziness, drowsiness, nausea, diarrhea, loss of appetite, headache, or unusual weakness.
The recommended initial dose of Lysodren is 2 to 6 g per day in divided doses, either three or four times a day. Doses are usually increased incrementally to 9 to 10 g per day. Lysodren may interact with other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety), blood thinners, or spironolactone. Tell your doctor all medications you use. During pregnancy, Lysodren should be used only when prescribed. It is unknown if this drug passes into breast milk and could have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this drug.
Our Lysodren (mitotane) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Lysodren in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- feeling like you might pass out;
- fast or pounding heartbeats;
- warmth, redness, or tingly feeling under your skin;
- sweating, cold or clammy skin;
- high fever, chills, uncontrolled shaking;
- blurred or double vision;
- confusion, problems with speech, balance, or walking;
- pain or burning when you urinate;
- blood in your urine; or
- unexpected weight loss.
Less serious side effects may include:
- dizziness, spinning sensation;
- drowsiness, tired feeling;
- depressed mood;
- mild skin rash;
- nausea, vomiting, diarrhea; or
- loss of appetite.
Read the entire detailed patient monograph for Lysodren (Mitotane) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Lysodren Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: severe dizziness, flushing, fast/pounding heartbeat, shakiness (tremors), unusual/rapid weight loss, change in skin color/thickness, easy bleeding/bruising, breast tenderness/enlargement (males), unwanted facial/body hair (females), mental/mood changes (e.g., depression, irritability, difficulty concentrating, confusion), speech problems, numbness/tingling of hands/feet, unsteadiness, pink urine, vision problems.
This medication can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.
Mitotane can commonly cause a rash that usually goes away. However, you may not be able to tell it apart from a rash that could be a sign of a severe reaction. Therefore, seek immediate medical attention if you develop a rash.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Lysodren (Mitotane)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Lysodren FDA Prescribing Information: Side Effects
A very high percentage of patients treated with LYSODREN have shown at least one type of side effect. The main types of adverse reactions consist of the following:
- Gastrointestinal disturbances, which consist of anorexia, nausea or vomiting, and in some cases diarrhea, occur in about 80% of the patients.
- Central nervous system side effects occur in 40% of the patients. These consist primarily of depression as manifested by lethargy and somnolence (25%), and dizziness or vertigo (15%).
- Skin toxicity has been observed in about 15% of the cases. These skin changes consist primarily of transient skin rashes which do not seem to be dose related. In some instances, this side effect subsided while the patients were maintained on the drug without a change of dose.
Infrequently occurring side effects involve the eye (visual blurring, diplopia, lens opacity, toxic retinopathy); the genitourinary system (hematuria, hemorrhagic cystitis, and albuminuria); cardiovascular system (hypertension, orthostatic hypotension, and flushing); and some miscellaneous effects including generalized aching, hyperpyrexia, and lowered protein bound iodine (PBI).
The following additional adverse reactions have been identified during postapproval use of LYSODREN. Because reports are voluntary from a population of unknown size, an estimate of frequency cannot be made.
Blood and lymphatic system disorders: neutropenia
Endocrine disorders: growth retardation, hypothyroidism
Psychiatric disorders: confusional state
Eye disorders: maculopathy
Hepatobiliary disorders: hepatitis, elevation of liver enzymes
Reproductive system and breast disorders: gynecomastia
General disorders and administration site conditions: asthenia
Investigations: blood uric acid decreased, blood cholesterol increased, blood triglycerides increased
Read the entire FDA prescribing information for Lysodren (Mitotane) »
Additional Lysodren Information
Lysodren - User Reviews
Lysodren User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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