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The following adverse reactions are discussed in greater detail in other sections of the label:
- Adrenal Crisis in the Setting of Shock or Severe Trauma [see WARNINGS AND PRECAUTIONS]
- CNS Toxicity [see WARNINGS AND PRECAUTIONS]
- Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
The following adverse reactions associated with the use of LYSODREN were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
Common adverse reactions occurring with LYSODREN treatment include:
- Anorexia, nausea, vomiting, and diarrhea (80%)
- Depression, dizziness, or vertigo (15%-40%)
- Rash (15%)
- Growth retardation, hypothyroidism
- Confusion, headache, ataxia, mental impairment, weakness, dysarthria
- Hepatitis, elevation of liver enzymes
- Hypercholesterolemia, hypertriglyceridemia
Less common adverse reactions include: visual blurring, diplopia, lens opacity, retinopathy, prolonged bleeding time, hematuria, hemorrhagic cystitis, albuminuria, hypertension, orthostatic hypotension, flushing, generalized aching, and fever.
Read the Lysodren (mitotane) Side Effects Center for a complete guide to possible side effects
Mitotane is a strong inducer of cytochrome P450 3A4 (CYP3A4). Monitor patients for a change in dosage requirements for the concomitant drug when administering LYSODREN to patients receiving drugs that are substrates of CYP3A4.
Read the Lysodren Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 3/28/2016
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