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Lysodren (Mitotane) - Side Effect Reports to FDA

 
 



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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