Drug information for LYSODREN

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
TABLET; ORAL	500MG	Prescription	(Reference Drug)	MITOTANE	Mitotane	BRISTOL MYERS SQUIBB	16885 2009-02-13 Letter 2009-02-12 Label 2009-01-12 Review 2003-07-28 Letter

Drug Adverse Effects information for LYSODREN

Role code	Indications	Reaction	# Reports
PS	ADRENAL INSUFFICIENCY	NEUTROPENIA	2
PS	ADRENOCORTICAL CARCINOMA	CONFUSIONAL STATE	1
PS	ADRENOCORTICAL CARCINOMA	DISORIENTATION	1
PS	ADRENOCORTICAL CARCINOMA	DISTURBANCE IN ATTENTION	1
PS	ADRENOCORTICAL CARCINOMA	DYSPEPSIA	1
PS	ADRENOCORTICAL CARCINOMA	FEELING DRUNK	1
PS	ADRENOCORTICAL CARCINOMA	GAMMA-GLUTAMYLTRANSFERASE INCREASED	1
PS	ADRENOCORTICAL CARCINOMA	HEPATITIS	1
PS	ADRENOCORTICAL CARCINOMA	HYPERLIPIDAEMIA	1
PS	ADRENOCORTICAL CARCINOMA	IMPAIRED GASTRIC EMPTYING	1
PS	ADRENOCORTICAL CARCINOMA	NEUTROPENIA	2
PS	ADRENOCORTICAL CARCINOMA	PANCYTOPENIA	1
PS	ADRENOCORTICAL CARCINOMA	TRANSAMINASES INCREASED	1
PS	ADRENOCORTICAL CARCINOMA	WEIGHT DECREASED	1
PS	BENIGN PROSTATIC HYPERPLASIA	CONFUSIONAL STATE	1
PS	BENIGN PROSTATIC HYPERPLASIA	DISORIENTATION	1
PS	BENIGN PROSTATIC HYPERPLASIA	FEELING DRUNK	1
PS	DIARRHOEA	CONFUSIONAL STATE	1
PS	DIARRHOEA	DISORIENTATION	1
PS	DIARRHOEA	FEELING DRUNK	1
PS	HYPOTHYROIDISM	CONFUSIONAL STATE	1
PS	HYPOTHYROIDISM	DISORIENTATION	1
PS	HYPOTHYROIDISM	FEELING DRUNK	1
PS	LUNG DISORDER	CONFUSIONAL STATE	1
PS	LUNG DISORDER	DISORIENTATION	1
PS	LUNG DISORDER	FEELING DRUNK	1
SS	CHEMOTHERAPY	ADRENOCORTICAL CARCINOMA	4
SS	CHEMOTHERAPY	CUSHING'S SYNDROME	4
SS	CHEMOTHERAPY	METASTASES TO ADRENALS	4
SS	CHEMOTHERAPY	OPPORTUNISTIC INFECTION	4
SS	CHEMOTHERAPY	PNEUMONIA	4

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