Medication Guide App

Lysodren Side Effects

Generic Name: mitotane

Note: This page contains information about the side effects of mitotane. Some of the dosage forms included on this document may not apply to the brand name Lysodren.

Not all side effects for Lysodren may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to mitotane: oral tablet

In addition to its needed effects, some unwanted effects may be caused by mitotane (the active ingredient contained in Lysodren). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking mitotane:

More common
  • Darkening of the skin
  • diarrhea
  • dizziness or lightheadedness
  • drowsiness
  • loss of appetite
  • mental depression
  • nausea or vomiting
  • skin rash
  • unusual tiredness or weakness
Less common
  • Blood in the urine
  • blurred vision
  • double vision
Rare
  • Shortness of breath
  • wheezing
Incidence not known
  • Chills
  • cloudy urine
  • cold sweats
  • confusion
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
  • feeling of warmth
  • fever
  • frequent urination
  • headache
  • lower abdominal cramping
  • nervousness
  • painful urination
  • pounding in the ears
  • redness of the face, neck, arms, and occasionally, upper chest
  • slow or fast heartbeat
  • vision changes
  • white area over the eye

Some of the side effects that can occur with mitotane may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Feeling of constant movement of self or surroundings
  • indigestion
  • passing of gas
  • sensation of spinning
  • sleepiness
  • stomach pain, fullness, or discomfort
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Less common
  • Aching muscles
  • flushing or redness of the skin
  • muscle twitching

For Healthcare Professionals

Applies to mitotane: oral tablet

General

In general, 80% of patients experience at least one side effect from mitotane (the active ingredient contained in Lysodren) Toxicity is usually reversible upon reduction of dosage or discontinuation of therapy.[Ref]

Gastrointestinal

Gastrointestinal side effects occur in approximately 80% of patients, and include anorexia in 24% to 36%, nausea in 39% to 65%, vomiting in 40%, and diarrhea in 13% to 49% of patients. Rarely, hypersialorrhea has been reported.[Ref]

Nervous system

Nervous system toxicity occurs in up to 50% of patients, and includes lethargy and somnolence in 25% to 44%, dizziness or vertigo in 18%, weakness in 12% to 23%, muscle tremors in 3%, headache in 5%, confusion in 3%, and irritability in 1% of patients. Prolonged administration may result in permanent brain damage. Frank encephalopathy, hallucinations, speech or memory impairment and ataxia have been rarely reported. Postmarketing nervous system side effects including neuropsychological disturbance, dysarthria, headache, ataxia, and mental impairment have been reported.[Ref]

Formal neuropsychiatric testing of patients taking mitotane for up to two years has revealed evidence of impairment, particularly in visual-spatial tasks, oral language, and memory. The incidence of impairment has been associated with serum mitotane levels exceeding 15 mg/L. Above this level, most patients develop cerebellar ataxia. The effects do not appear to be permanent, and often remit at serum levels below 5 to 15 mg/L.[Ref]

Dermatologic

The main dermatologic side effect is a transient maculopapular rash which appears in approximately 18% of patients. Rare side effects include urticaria, hyperpigmentation, facial swelling, and alopecia.[Ref]

Therapy can usually be continued despite the transient maculopapular rash.[Ref]

Hepatic

Mild elevations in hepatic enzymes have been reported in up to 23% of patients in some studies. Severe hepatotoxicity is rare. Limited data (using antipyrine clearance) have shown that mitotane (the active ingredient contained in Lysodren) can induce hepatic microsomal enzymes leading to enhanced steroid degradation. Ocular side effects are rare, and include visual blurring, diplopia, lens opacity/cataracts, toxic retinopathy with papilledema, or retinal hemorrhage in 3% of patients. Postmarketing hepatic side effects including hepatitis and elevation of liver enzymes have been reported.[Ref]

Ocular

Ocular side effects are rare, and include visual blurring, diplopia, lens opacity/cataracts, toxic retinopathy with papilledema, or retinal hemorrhage in 3% of patients. Postmarketing ocular side effects including maculopathy have been reported.[Ref]

Genitourinary

Genitourinary side effects are rare, and include hematuria, hemorrhagic cystitis, or albuminuria in 2% of patients. The use of mitotane (the active ingredient contained in Lysodren) has rarely been associated with (reversible) primary hypogonadism and impotence in males. Postmarketing genitourinary side effects including gynecomastia have been reported.[Ref]

Endocrine

Many patients require exogenous steroid replacement during mitotane (the active ingredient contained in Lysodren) therapy. The adequacy of corticosteroid replacement may be assessed by monitoring levels of adrenal corticotropic hormone [ACTH].[Ref]

Endocrine side effects are expected because of the effect of mitotane on the adrenal cortex. Reversible primary testicular dysfunction/hypogonadism has been associated with the use of mitotane in males. The use of mitotane has been associated with increases in both serum total cholesterol and triglycerides. Postmarketing endocrine side effects including growth retardation and hypothyroidism have been reported.[Ref]

Cardiovascular

Cardiovascular side effects are rare, and include hypertension, orthostatic hypotension, or flushing in 2% of patients.[Ref]

Hematologic

Hematologic side effects including prolonged bleeding times due to mitotane-induced platelet dysfunction have rarely been reported. Thrombocytopenia and leukopenia have also been noted. Postmarketing hematologic side effects including neutropenia have been reported.[Ref]

Data have revealed an aspirin-like ability of mitotane to inhibit platelet aggregation.[Ref]

Other

Other side effects found in 8% or less of patients include generalized aching, hyperpyrexia, and decreased protein bound iodine. Other postmarketing side effects have included asthenia.[Ref]

Respiratory

Respiratory side effects including wheezing and dyspnea have rarely been reported.[Ref]

Renal

Renal side effects including increased excretion of urate have rarely been reported.[Ref]

Psychiatric

Postmarketing psychiatric side effects including confusional state have been reported.

Metabolic

Postmarketing metabolic side effects including decreased blood uric acid, increased blood cholesterol, and increased blood triglycerides have been reported.

References

1. Gutierrez ML, Crooke ST "Mitotane (o,p'-DDD)." Cancer Treat Rev 7 (1980): 49-55

2. "Product Information. Lysodren (mitotane)." Bristol-Myers Squibb, Princeton, NJ.

3. Decker RA, Elson P, Hogan TF, Citrin DL, Westring DW, Banerjee TK, Gilchrist KW, Horton J "Eastern Cooperative Oncology Group study 1879: mitotane and adriamycin in patients with advanced adrenocortical carcinoma." Surgery 110 (1991): 1006-13

4. Luton JP, Mahoudeau JA, Bouchard P, Thieblot P, Hautecouverture M, Simon D, Laudat MH, Touitou Y, Bricaire H "Treatment of Cushing's disease by O,p'DDD. Survey of 62 cases." N Engl J Med 300 (1979): 459-64

5. Lubitz JA, Freeman L, Okun R "Mitotane use in inoperable adrenal cortical carcinoma." JAMA 223 (1973): 1109-12

6. Hogan TF, Citrin DL, Johnson BM, Nakamura S, Davis TE, Borden EC "o,p'-DDD (mitotane) therapy of adrenal cortical carcinoma: observations on drug dosage, toxicity, and steroid replacement." Cancer 42 (1978): 2177-81

7. McKiernan P, Doyle DA, Duffy GJ, Towers RP, Duff FA, O'Donovan DK "o,p'--DDD and adrenal carcinoma." Ir J Med Sci 147 (1978): 437-40

8. Lanser JB, van Seters AP, Moolenaar AJ, Haak HR, Bollen EL "Neuropsychologic and neurologic side effects of mitotane and reversibility of symptoms." J Clin Oncol 10 (1992): 1504

9. Zuehlke RL "Erythematous eruption of the palms and soles associated with mitotane therapy." Dermatologica 148 (1974): 90-2

10. Hague RV, May W, Cullen DR "Hepatic microsomal enzyme induction and adrenal crisis due to o,p'DDD therapy for metastatic adrenocortical carcinoma." Clin Endocrinol (Oxf) 31 (1989): 51-7

11. Fraunfelder FT, Meyer SM "OCULAR TOXICITY OF ANTINEOPLASTIC AGENTS." Ophthalmology 90 (1983): 1-31983

12. Vizel M, Oster MW "Ocular side effects of cancer chemotherapy." Cancer 49 (1982): 1999-2002

13. Sparagana M "Primary hypogonadism associated with o,p' DDD (mitotane) therapy." J Toxicol Clin Toxicol 25 (1987): 463-72

14. Azer PC, Braunstein GD "Malignant Leydig cell tumor: objective tumor response to o,p'-DDD." Cancer 47 (1981): 1251-5

15. Robinson BG, Hales IB, Henniker AJ, Ho K, Luttrell BM, Smee IR, Stiel JN "The effect of o,p'-DDD on adrenal steroid replacement therapy requirements." Clin Endocrinol (Oxf) 27 (1987): 437-44

16. Haak HR, Caekebeke-Peerlinck KM, van Seters AP, Briet E "Prolonged bleeding time due to mitotane therapy." Eur J Cancer 27 (1991): 638-41

17. Cuddy PG, Loftus LS "Influence of mitotane on the hypoprothrombinemic effect of warfarin." South Med J 79 (1986): 387-8

18. Reach G, Elkik F, Parry C, Corvol P, Milleiz P "Increased urate excretion after o,p'-DDD." Lancet 1 (1978): 1269

19. Zumoff B "The hypouricemic effect of o,p'-DDD." Am J Med Sci 278 (1979): 145-7

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