This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Lysodren (Mitotane) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (30)
Death (6)
Life Threatening Events (4)
Reports by Reaction Type
Altered State of Consciousness (5),
Adrenal Insufficiency (4),
Cholestasis (3),
Coma (3),
Somnolence (3),
Off Label Use (3),
Gamma-Glutamyltransferase Increased (3),
Cytolytic Hepatitis (3),
Aggression (3),
Neoplasm Progression (2),
Dizziness (2),
Hepatitis Acute (2)
Possible Lysodren side effects in 47 year old female
Reported by a physician from France on 2012-08-17
Patient: 47 year old female, weighing 44.0 kg (96.8 pounds)
Reactions: Peliosis Hepatis, Gamma-Glutamyltransferase Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Hydrocortisone
Administration route: Oral
Start date: 2011-09-01
Lysodren
Administration route: Oral
Indication: Adrenocortical Carcinoma
Start date: 2011-09-01
End date: 2012-05-10
Other drugs received by patient: Lutenyl; Folic Acid; Amlodipine Besylate
Possible Lysodren side effects in 58 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-08
Patient: 58 year old male
Reactions: Pancreatitis Acute, Thrombotic Microangiopathy, Septic Shock, Renal Failure Acute, Arrhythmia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lysodren
Possible Lysodren side effects in 47 year old female
Reported by a consumer/non-health professional from France on 2012-08-06
Patient: 47 year old female, weighing 44.0 kg (96.8 pounds)
Reactions: Gamma-Glutamyltransferase Increased
Drug(s) suspected as cause:
Lysodren
Other drugs received by patient: Hyperium; Hydrocortisone
Possible Lysodren side effects in 46 year old male
Reported by a consumer/non-health professional from France on 2012-07-31
Patient: 46 year old male
Reactions: Coma, Adrenal Insufficiency, Altered State of Consciousness, Somnolence, Cardiac Arrest, Metabolic Encephalopathy, Aggression
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Lysodren
Other drugs received by patient: Furosemide; Hydrocortisone; Fludrocortisone Acetate; Crestor; Tranxene; Citalopram Hydrobromide; Tazobactam; Calciparine; Pantoprazole
Possible Lysodren side effects in 65 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-17
Patient: 65 year old female
Reactions: Drug Ineffective, Nausea, Diarrhoea, Drug Interaction
Drug(s) suspected as cause:
Lysodren
Other drugs received by patient possibly interacting with the suspect drug: Aldactone
Other drugs received by patient: Furosemide; Digoxin; Chlorpropamide
Possible Lysodren side effects in 61 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-24
Patient: 61 year old male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Lysodren
Possible Lysodren side effects in
Reported by a consumer/non-health professional from United States on 2012-05-11
Patient:
Reactions: Skin Exfoliation, Sepsis
Drug(s) suspected as cause:
Lysodren
Possible Lysodren side effects in 72 year old female
Reported by a physician from France on 2012-04-27
Patient: 72 year old female
Reactions: Dizziness, Asphyxia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lysodren
Other drugs received by patient: Hydrocortisone
Possible Lysodren side effects in
Reported by a pharmacist from United States on 2012-04-20
Patient:
Reactions: Endotracheal Intubation
Drug(s) suspected as cause:
Lysodren
Possible Lysodren side effects in 12 year old female
Reported by a physician from France on 2012-04-02
Patient: 12 year old female
Reactions: Off Label Use, Hepatic Encephalopathy, Hepatitis Acute, Cytolytic Hepatitis, Cholestasis, Altered State of Consciousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lysodren
Other drugs received by patient: Vitamin K TAB; Hydrocortisone; Ursolvan; Vitamin B Complex CAP; Alpha-Tocopherol CAP
Possible Lysodren side effects in 12 year old female
Reported by a physician from France on 2012-03-19
Patient: 12 year old female
Reactions: Off Label Use, Hepatitis Acute, Cytolytic Hepatitis, Cholestasis, Hepatic Failure, Altered State of Consciousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lysodren
Possible Lysodren side effects in 46 year old male
Reported by a consumer/non-health professional from France on 2012-03-16
Patient: 46 year old male
Reactions: Coma, Adrenal Insufficiency, Somnolence, Cardiac Arrest, Altered State of Consciousness, Aggression
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Lysodren
Possible Lysodren side effects in 59 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-16
Patient: 59 year old male
Reactions: Shock Haemorrhagic, Colitis, Adrenal Insufficiency, Septic Shock
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fludrocortisone Acetate
Dosage: 1df:50mcg; stopped and restarted on 7aug11
Administration route: Oral
Indication: Adrenocortical Carcinoma
Start date: 2010-09-01
Lysodren
Dosage: stopped and restarted on 9aug11; stopped on 11-nov-2011
Administration route: Oral
Indication: Adrenocortical Carcinoma
Start date: 2010-09-01
End date: 2011-11-11
Possible Lysodren side effects in 46 year old male
Reported by a consumer/non-health professional from France on 2012-03-09
Patient: 46 year old male
Reactions: Adrenal Insufficiency, Coma, Somnolence, Altered State of Consciousness, Aggression
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lysodren
Possible Lysodren side effects in 12 year old female
Reported by a consumer/non-health professional from France on 2012-02-24
Patient: 12 year old female
Reactions: Off Label Use, Cytolytic Hepatitis, Cholestasis
Drug(s) suspected as cause:
Lysodren
Possible Lysodren side effects in 64 year old male
Reported by a physician from France on 2012-02-19
Patient: 64 year old male
Reactions: Renal Failure, Neoplasm Progression
Adverse event resulted in: death
Drug(s) suspected as cause:
Lysodren
Possible Lysodren side effects in male
Reported by a pharmacist from United States on 2012-02-13
Patient: male
Reactions: Drug Administration Error
Drug(s) suspected as cause:
Lysodren
Possible Lysodren side effects in female
Reported by a pharmacist from United States on 2012-02-13
Patient: female
Reactions: Dysphagia
Drug(s) suspected as cause:
Lysodren
Possible Lysodren side effects in 64 year old male
Reported by a consumer/non-health professional from France on 2012-02-13
Patient: 64 year old male
Reactions: Renal Failure, Neoplasm Progression
Adverse event resulted in: death
Drug(s) suspected as cause:
Lysodren
Possible Lysodren side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-13
Patient: female
Reactions: Pregnancy, Accidental Exposure
Drug(s) suspected as cause:
Lysodren
Possible Lysodren side effects in female
Reported by a consumer/non-health professional from France on 2012-02-05
Patient: female
Reactions: Medication Error, Pleural Effusion
Drug(s) suspected as cause:
Lysodren
Other drugs received by patient: Spironolactone
Possible Lysodren side effects in 42 year old male
Reported by a consumer/non-health professional from France on 2012-02-05
Patient: 42 year old male
Reactions: Drug Level Above Therapeutic, Fatigue, Muscular Weakness, Dizziness, Pyrexia, Infection, Inflammatory Marker Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lysodren
Possible Lysodren side effects in 10 year old female
Reported by a consumer/non-health professional from France on 2012-01-25
Patient: 10 year old female
Reactions: Electrocardiogram QT Prolonged, Thrombosis, Vertigo
Drug(s) suspected as cause:
Lysodren
Possible Lysodren side effects in 51 year old female
Reported by a consumer/non-health professional from France on 2011-12-28
Patient: 51 year old female
Reactions: Transaminases Increased, Hepatitis
Drug(s) suspected as cause:
Lysodren
Possible Lysodren side effects in 63 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2011-11-30
Patient: 63 year old male
Reactions: Confusional State, Disorientation, Feeling Drunk
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lysodren
Other drugs received by patient: Arestal; Fludrocortisone Acetate; Levothyroxine Sodium; Rocephin; Hydrocortisone; Omeprazole; Silodosin
Possible Lysodren side effects in 79 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2011-11-18
Patient: 79 year old female
Reactions: Hyperlipidaemia, Gamma-Glutamyltransferase Increased, Neutropenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lysodren
Other drugs received by patient: Hydrocortisone
Possible Lysodren side effects in 35 year old female
Reported by a consumer/non-health professional from France on 2011-11-16
Patient: 35 year old female
Reactions: Weight Decreased, Dyspepsia, Pancytopenia, Disturbance in Attention, Impaired Gastric Emptying
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lysodren
Other drugs received by patient: Fludrocortisone Acetate; Hydrocortisone
Possible Lysodren side effects 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
Drug(s) suspected as cause:
Lysodren
Other drugs received by patient: Hydrocortisone; Fludrocortisone Acetate
Possible Lysodren side effects 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
Drug(s) suspected as cause:
Cisplatin
Indication: Chemotherapy
Doxorubicin HCL
Indication: Chemotherapy
Etoposide
Indication: Chemotherapy
Lysodren
Indication: Chemotherapy
Possible Lysodren side effects in 74 year old female
Reported by a physician from France on 2011-10-17
Patient: 74 year old female
Reactions: Biliary Cirrhosis Primary
Drug(s) suspected as cause:
Lysodren
Other drugs received by patient: Primperan TAB; Hydrocortisone; Voltaren; Oxycodone HCL; Zolpidem Tartrate; Fragmin; Inderal
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