Lysodren (Mitotane) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

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:

1. Gastrointestinal disturbances, which consist of anorexia, nausea or vomiting, and in some cases diarrhea, occur in about 80% of the patients.
2. 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%).
3. 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).

REPORTS OF SUSPECTED LYSODREN SIDE EFFECTS / ADVERSE REACTIONS

Possible Lysodren side effects / adverse reactions in 74 year old female

Reported by a physician from France on 2011-10-17

Patient: 74 year old female

Reactions: Biliary Cirrhosis Primary

Suspect drug(s):
Lysodren

Other drugs received by patient: Primperan TAB; Hydrocortisone; Voltaren; Oxycodone HCL; Zolpidem Tartrate; Fragmin; Inderal

Possible Lysodren side effects / adverse reactions in 72 year old male

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2011-11-15

Patient: 72 year old male

Reactions: Adrenocortical Carcinoma, Pneumonia, Metastases TO Adrenals, Opportunistic Infection, Cushing's Syndrome

Adverse event resulted in: death

Suspect drug(s):
Cisplatin
    Indication: Chemotherapy

Doxorubicin HCL
    Indication: Chemotherapy

Etoposide
    Indication: Chemotherapy

Lysodren
    Indication: Chemotherapy

Possible Lysodren side effects / adverse reactions in 60 year old female

Reported by a consumer/non-health professional from France on 2011-11-16

Patient: 60 year old female

Reactions: Neutropenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Lysodren

Other drugs received by patient: Hydrocortisone; Fludrocortisone Acetate