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Index of reports
> Life Threatening Events (23)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Avodart (Dutasteride) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Avodart side effects in male
Reported by a pharmacist from Canada on 2012-07-20
Patient: male
Reactions: Breast Cancer, Pain, Local Swelling
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Avodart
Other drugs received by patient: Cardizem; Aspirin; Crestor; TNT; Perindopril Erbumine
Possible Avodart side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-23
Patient: male
Reactions: Breast Cancer, Breast Tenderness, Breast Induration, Breast Mass
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Avodart
Possible Avodart side effects in male
Reported by a physician from United States on 2012-05-10
Patient: male
Reactions: Breast Cancer, Breast Tenderness, Breast Induration
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Avodart
Possible Avodart side effects in male
Reported by a physician from France on 2012-04-17
Patient: male
Reactions: Anaemia Haemolytic Autoimmune
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Glucophage
Dosage: 500mg twice per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Mediatensyl
Dosage: 60mg twice per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Tramadol HCL
Dosage: 50mg three times per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Fluarix 2011-12 Season
Indication: Prophylaxis
Start date: 2011-11-04
End date: 2011-11-04
Thiamine Hydrochloride
Dosage: 3tab per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 1998-01-01
End date: 2011-11-22
Avodart
Dosage: .5mg per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Nexen
Dosage: 100mg twice per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Valsartan and Hydrochlorothiazide
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Befizal
Dosage: 400mg per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Other drugs received by patient: Zolpidem; Acetaminophen; Amlodipine Besylate; Carvedilol
Possible Avodart side effects in 89 year old male
Reported by a pharmacist from United States on 2012-04-13
Patient: 89 year old male, weighing 77.7 kg (170.9 pounds)
Reactions: Respiratory Disorder, Mouth Haemorrhage, Skin Exfoliation, Rash, Erythema, Oxygen Saturation Decreased, Cough, Blister
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Avodart
Possible Avodart side effects in 80 year old male
Reported by a consumer/non-health professional from Germany on 2012-04-06
Patient: 80 year old male
Reactions: Anaemia Haemolytic Autoimmune
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Glucophage
Administration route: Oral
End date: 2011-11-22
Befizal
Administration route: Oral
End date: 2011-11-22
Hexaquine
Administration route: Oral
Start date: 1998-01-01
End date: 2011-11-22
Nexen
Administration route: Oral
End date: 2011-11-22
Valsartan and Hydrochlorothiazide
Dosage: 1 df:160/25mg
Administration route: Oral
End date: 2011-11-22
Tramadol HCL
Administration route: Oral
End date: 2011-11-22
Mediatensyl
Administration route: Oral
End date: 2011-11-22
Influenza Vaccine
Start date: 2011-11-04
End date: 2011-11-04
Avodart
Dosage: capsule
Administration route: Oral
End date: 2011-11-22
Other drugs received by patient: Zolpidem; Dafalgan Caps; Amlodipine Besylate; Carvedilol
Possible Avodart side effects in male
Reported by a physician from France on 2012-04-04
Patient: male
Reactions: Anaemia Haemolytic Autoimmune
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Tramadol HCL
Dosage: 50mg three times per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Valsartan and Hydrochlorothiazide
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Glucophage
Dosage: 500mg twice per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Fluarix 2011-12 Season
Indication: Prophylaxis
Start date: 2011-11-04
End date: 2011-11-04
Nexen
Dosage: 100mg twice per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Hexaquine
Dosage: 3tab per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 1998-01-01
End date: 2011-11-22
Mediatensyl
Dosage: 60mg twice per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Avodart
Dosage: .5mg per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Befizal
Dosage: 400mg per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Other drugs received by patient: Acetaminophen; Amlodipine Besylate; Zolpidem; Carvedilol
Possible Avodart side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-31
Patient: male
Reactions: Death, Multi-Organ Failure, Renal Failure, Cardiac Failure, Malnutrition, Blood Albumin Decreased, Anaemia Haemolytic Autoimmune, Anaemia Macrocytic
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Valsartan and Hydrochlorothiazide
Dosage: 1 df, daily (160mg/25mg)
End date: 2011-11-22
Befizal
Dosage: 400 mg, daily
Administration route: Oral
End date: 2011-11-22
Tramadol HCL
Dosage: 50 mg, tid
Administration route: Oral
End date: 2011-11-22
Nexen
Dosage: 100 mg, bid
Administration route: Oral
End date: 2011-11-22
Hexaquine
Dosage: 3 df, daily
Start date: 1998-01-01
End date: 2011-11-22
Glucophage
Dosage: 500 mg, bid
Administration route: Oral
End date: 2011-11-22
Mediatensyl
Dosage: 60 mg, bid
Administration route: Oral
End date: 2011-11-22
Avodart
Dosage: 1 df, daily
Administration route: Oral
End date: 2011-11-22
Influenza Vaccine
Dosage: unk ukn, unk
Start date: 2011-11-04
Other drugs received by patient: Amlodipine Besylate; Zolpidem; Carvedilol; Acetaminophen
Possible Avodart side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-30
Patient: male
Reactions: Death, Multi-Organ Failure, Renal Failure, Cardiac Failure, Malnutrition, Blood Albumin Decreased, Anaemia Haemolytic Autoimmune, Anaemia Macrocytic
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Tramadol HCL
Dosage: 50 mg, tid
Administration route: Oral
End date: 2011-11-22
Hexaquine
Dosage: 3 df, daily
Start date: 1998-01-01
End date: 2011-11-22
Mediatensyl
Dosage: 60 mg, bid
Administration route: Oral
End date: 2011-11-22
Glucophage
Dosage: 500 mg, bid
Administration route: Oral
End date: 2011-11-22
Avodart
Dosage: 1 df, daily
Administration route: Oral
End date: 2011-11-22
Influenza Vaccine
Dosage: unk ukn, unk
Start date: 2011-11-04
Valsartan and Hydrochlorothiazide
Dosage: 1 df, daily (160mg/25mg)
End date: 2011-11-22
Nexen
Dosage: 100 mg, bid
Administration route: Oral
End date: 2011-11-22
Befizal
Dosage: 400 mg, daily
Administration route: Oral
End date: 2011-11-22
Other drugs received by patient: Carvedilol; Acetaminophen; Zolpidem; Amlodipine Besylate
Possible Avodart side effects in 64 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-28
Patient: 64 year old male
Reactions: Breast Cancer Male, Mastectomy
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Avodart
Other drugs received by patient: Diovan; Atenolol; Doxazosin; Minoxidil
Possible Avodart side effects in male
Reported by a physician from United States on 2012-01-19
Patient: male
Reactions: Metastases To Lymph Nodes
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Avodart
Other drugs received by patient: Unknown
Possible Avodart side effects in 80 year old male
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-01-06
Patient: 80 year old male
Reactions: Anaemia Haemolytic Autoimmune
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Metformin Hydrochloride
Dosage: 1000 mg;qd;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Avodart
Dosage: ;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Befizal (Bezafibrate)
Valsartan and Hydrochlorothiazide
Dosage: ;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Hexaquine (Hexaquine)
Dosage: ;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Nexen (Nimesulide)
Dosage: ;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Tramadol Hydrochloride
Dosage: ;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Mediatensyl (Urapidil)
Dosage: ;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Other drugs received by patient: Zolpidem; Acetaminophen; Carvedilol; Amlodipine Besylate
Possible Avodart side effects in male
Reported by a physician from France on 2012-01-04
Patient: male
Reactions: Anaemia Haemolytic Autoimmune
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Avodart
Dosage: .5mg unknown
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Nexen
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Valsartan and Hydrochlorothiazide
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Mediatensyl
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Glucophage
Dosage: 500mg twice per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Tramadol HCL
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Fluarix 2011-12 Season
Indication: Prophylaxis
Start date: 2011-11-04
End date: 2011-11-04
Hexaquine
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 1998-01-01
End date: 2011-11-22
Befizal
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-11-22
Other drugs received by patient: Carvedilol; Zolpidem; Acetaminophen; Amlodipine Besylate
Possible Avodart side effects in 80 year old male
Reported by a consumer/non-health professional from Germany on 2012-01-03
Patient: 80 year old male
Reactions: Anaemia Haemolytic Autoimmune
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Avodart
Dosage: capsule
Administration route: Oral
End date: 2011-11-22
Hexaquine
Administration route: Oral
Start date: 1998-01-01
End date: 2011-11-22
Nexen
Administration route: Oral
End date: 2011-11-22
Befizal
Administration route: Oral
End date: 2011-11-22
Tramadol HCL
Administration route: Oral
End date: 2011-11-22
Mediatensyl
Administration route: Oral
End date: 2011-11-22
Glucophage
Administration route: Oral
End date: 2011-11-22
Valsartan and Hydrochlorothiazide
Administration route: Oral
End date: 2011-11-22
FLU-Imune
Start date: 2011-11-04
End date: 2011-11-04
Other drugs received by patient: Amlodipine Besylate; Carvedilol; Zolpidem; Acetaminophen
Possible Avodart side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-02
Patient: male
Reactions: Anaemia Haemolytic Autoimmune, Anaemia Macrocytic
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Mediatensyl
Administration route: Oral
End date: 2011-11-22
FLU-Imune
Start date: 2011-11-04
Glucophage
Dosage: 500 mg, bid
Administration route: Oral
End date: 2011-11-22
Thiamine HCL
Start date: 1998-01-01
End date: 2011-11-22
Avodart
Administration route: Oral
End date: 2011-11-22
Nexen
Administration route: Oral
End date: 2011-11-22
Valsartan and Hydrochlorothiazide
End date: 2011-11-22
Befizal
Administration route: Oral
End date: 2011-11-22
Tramadol HCL
Administration route: Oral
End date: 2011-11-22
Other drugs received by patient: Zolpidem; Carvedilol; Amlodipine Besylate; Acetaminophen
Possible Avodart side effects in 64 year old male
Reported by a consumer/non-health professional from United States on 2011-12-23
Patient: 64 year old male, weighing 86.4 kg (190.1 pounds)
Reactions: Heart Valve Incompetence, Atrial Fibrillation, Cardiac Disorder
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Avodart
Possible Avodart side effects in 64 year old male
Reported by a consumer/non-health professional from United States on 2011-12-12
Patient: 64 year old male, weighing 86.4 kg (190.1 pounds)
Reactions: Heart Valve Incompetence, Atrial Fibrillation, Cardiac Disorder
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Avodart
Possible Avodart side effects in 75 year old male
Reported by a physician from Germany on 2011-11-28
Patient: 75 year old male, weighing 97.1 kg (213.6 pounds)
Reactions: Tubulointerstitial Nephritis, Dyspnoea, Fibrin D Dimer Increased, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Furosemide
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-02-01
End date: 2011-08-15
Avodart
Administration route: Oral
Indication: Benign Prostatic Hyperplasia
Start date: 2009-01-01
Lucentis
Indication: Macular Degeneration
Start date: 2011-07-07
Allopurinol
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2007-01-01
End date: 2011-08-15
Other drugs received by patient: Insulin Basal; Escor; Clopidogrel; Human Insulin; Ramipril
Possible Avodart side effects in 75 year old male
Reported by a physician from Germany on 2011-11-21
Patient: 75 year old male, weighing 97.0 kg (213.4 pounds)
Reactions: Tubulointerstitial Nephritis, Dyspnoea, Fibrin D Dimer Increased, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lucentis
Dosage: 1 df, unk
Indication: Macular Degeneration
Start date: 2011-07-07
Avodart
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Benign Prostatic Hyperplasia
Start date: 2009-01-01
Allopurinol
Dosage: 150 mg, qd
Administration route: Oral
Start date: 2007-01-01
End date: 2011-08-15
Furosemide
Dosage: 40 mg, qd
Administration route: Oral
Start date: 2010-02-01
End date: 2011-08-15
Other drugs received by patient: Human Insulin; Escor; Clopidogrel; Insulin Basal; Ramipril
Possible Avodart side effects in 75 year old male
Reported by a physician from Germany on 2011-11-16
Patient: 75 year old male, weighing 97.1 kg (213.6 pounds)
Reactions: Tubulointerstitial Nephritis, Dyspnoea, Fibrin D Dimer Increased, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Furosemide
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-02-01
End date: 2011-08-15
Allopurinol
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2007-01-01
End date: 2011-08-15
Lucentis
Indication: Macular Degeneration
Start date: 2011-07-07
Avodart
Administration route: Oral
Indication: Benign Prostatic Hyperplasia
Start date: 2009-01-01
End date: 2011-08-15
Other drugs received by patient: Clopidogrel; Insulin Basal; Human Insulin; Ramipril; Escor
Possible Avodart side effects in male
Reported by a consumer/non-health professional from United States on 2011-11-09
Patient: male, weighing 93.0 kg (204.6 pounds)
Reactions: Prostate Cancer
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Avodart
Dosage: daily oral
Administration route: Oral
Indication: Prostatomegaly
Proscar
Dosage: daily oral
Administration route: Oral
Indication: Prostatomegaly
Possible Avodart side effects in 75 year old male
Reported by a health professional (non-physician/pharmacist) from Germany on 2011-11-09
Patient: 75 year old male, weighing 97.0 kg (213.4 pounds)
Reactions: Tubulointerstitial Nephritis, Dyspnoea, Fibrin D Dimer Increased, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Furanthril
Dosage: 40 mg, qd
Administration route: Oral
Start date: 2010-02-01
End date: 2011-08-15
Allopurinol
Dosage: 150 mg, qd
Administration route: Oral
Start date: 2007-01-01
End date: 2011-08-15
Lucentis
Dosage: 1 df, unk
Indication: Macular Degeneration
Start date: 2011-07-07
Avodart
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Benign Prostatic Hyperplasia
Start date: 2009-01-01
End date: 2011-08-15
Other drugs received by patient: Human Insulin; Insulin Basal; Ramipril; Escor; Clopidogrel
Possible Avodart side effects in 62 year old male
Reported by a physician from Canada on 2011-10-21
Patient: 62 year old male, weighing 111.4 kg (245.1 pounds)
Reactions: Prostatic Specific Antigen Increased, Prostate Cancer, Prostate Cancer Metastatic
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Avodart
Other drugs received by patient: Proscar; Heart Medication; Pradaxa; Micardis HCT
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