Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Lysodren (Mitotane). If you are concerned about side effects, discuss the risks and benefits of Lysodren (Mitotane) with your doctor.

The following side effects have been reported by at least 1% of people taking Lysodren (Mitotane). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• decreased appetite
• Diarrhea
• dizziness
• headache
• nausea
• tiredness or drowsiness
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• blood in urine
• confusion
• darkening of skin
• Fever
• flushing
• lethargy
• loss of appetite
• mental Depression
• muscle incoordination
• muscle weakness
• shortness of breath
• skin rash
• sweating, cold clammy skin
• tremor
• unexplained bruising
• unusual tiredness
• vision changes
• wheezing

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of allergic reaction (swelling of the mouth, face or tongue or difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Lysodren (Mitotane).

Each one-half inch, biconvex, round, compressed white tablet, bisected on one side and impressed with "BL" over "L1" on the other side, contains Lysodren (Mitotane) 500 mg. Nonmedicinal ingredients: microcrystalline cellulose, polyethylene glycol, silicon dioxide, and starch.

Do not take Lysodren (Mitotane) if you are allergic to Lysodren (Mitotane) or any ingredients of the medication.

There may be an interaction between Lysodren (Mitotane) and any of the following:

• Abiraterone
• alpha blockers (e.g., Alfuzosin, Doxazosin, Tamsulosin)
• amiodaroneanti-cancer medications (e.g., Docetaxel, Doxorubicin, Irinotecan, Vincristine)
• antipsychotics (e.g., Aripiprazole, Clozapine, Haloperidol)
• Apixaban
• Apremilast
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• benzodiazepines (e.g., Alprazolam, Clonazepam, Diazepam)
• Bisoprolol
• Buspirone
• Calcitriol
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• cannabis
• Carbamazepine
• chloroquine
• Cobicistat
• conivaptan
• corticosteroids (e.g., beclomethasone, Dexamethasone, Prednisone)
• Cyclosporine
• Dapsone
• Darifenacin
• Disopyramide
• Dronedarone
• Enzalutamide
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Fesoterodine
• "gliptin" Diabetes medications (e.g., Linagliptin, Saxagliptin, Sitagliptin)
• hepatitis medications (e.g., asunaprevir, boceprevir, daclatasvir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Idelalisib
• Losartan
• macrolide antibiotics (e.g., clarithromycin, azithromycin)
• maraviroc
• Mefloquine
• Methadone
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• nefazodone
• nitrates (isosorbide dinitrate, isosorbide mononitrate)
• Ondansetron
• Perampanel
• phosphodiesterase 5 inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil)
• praziquantel
• Primaquine
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• protein kinase inhibitors (e.g., Dabrafenib, Dasatinib, imatinib)
• proton pump inhibitors (e.g., Lansoprazole, Omeprazole)
• quinidine
• quinine
• rifabutin
• rivroxaban
• Roflumilast
• Romidepsin
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin-norepinephrine reuptake inhibitors (SNRIs; Desvenlafaxine, Duloxetine, Venlafaxine)
• Solifenacin
• Spironolactone
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• Tamoxifen
• Tetracycline
• Ticlopidine
• Ticagrelor
• tofactitinib
• Tolvaptan
• Trazodone
• Trimethoprim
• Ulipristal
• warfrain
• Zolpidem
• Zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Lysodren (Mitotane). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take Lysodren (Mitotane).

Drowsiness/reduced alertness: Lysodren (Mitotane) may cause sedation, lethargy, or dizziness. You should exercise caution when driving, operating machinery, or performing other tasks requiring mental alertness.

Liver disease: If you have liver disease, discuss with your doctor how Lysodren (Mitotane) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Lysodren (Mitotane), and whether any special monitoring is needed.

Risk of adrenal insufficiency: Lysodren (Mitotane)'s effect on the adrenal gland may result in the need for steroid replacement therapy during times when your body is under significant stress (e.g., during surgery, trauma, or severe illness).

Pregnancy: The safety of Lysodren (Mitotane) during pregnancy has not been established. Lysodren (Mitotane) should not be used during pregnancy unless the benefits outweigh the risks.

Breast-feeding: Lysodren (Mitotane) passes into breast milk. If you are a breast-feeding mother and are taking Lysodren (Mitotane), it may affect your baby. Lysodren (Mitotane) should not be used during breast-feeding unless the benefits outweigh the risks.

Children: The safety and effectiveness of using Lysodren (Mitotane) have not been established for children under the age of 18 years.