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Avodart (Dutasteride) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Avodart (Dutasteride) 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 (374)
Death (17)
Life Threatening Events (23)
Disability (7)

Reports by Reaction Type

Drug Ineffective (34)Erectile Dysfunction (20)Gynaecomastia (18)Dizziness (16)Prostate Cancer (16)Prostatic Specific Antigen Increased (16)Breast Tenderness (15)Breast Enlargement (14)Product Quality Issue (14)Pruritus (13)Fatigue (12)Rash (12)

Below are a few examples of reports where side effects / adverse reactions may be related to Avodart (Dutasteride). For a complete list or a specific selection of reports, please use the links above.

Possible Avodart side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: male

Reactions: Pneumonia, Urinary Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avodart



Possible Avodart side effects in 67 year old male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 67 year old male

Reactions: Pneumonia, Dyspnoea

Drug(s) suspected as cause:
Avodart



Possible Avodart side effects in 73 year old male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 73 year old male

Reactions: Leukaemia

Adverse event resulted in: death

Drug(s) suspected as cause:
Avodart
    Dosage: .5mg unknown
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-06-05

Lovaza
    Dosage: 1g unknown
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-06-05



Possible Avodart side effects in 82 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-20

Patient: 82 year old male

Reactions: Orthostatic Hypotension, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alfuzosin
    Administration route: Oral
    Indication: Prostatic Adenoma
    End date: 2012-06-09

Avodart
    Administration route: Oral
    Indication: Prostatic Adenoma
    End date: 2012-06-09

Furosemide
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-01-01
    End date: 2012-06-09

Other drugs received by patient: Transipeg; Lantus; Aspirin; Zopiclone; Ramipril; Singulair; Molsidomine; Oxazepam; Digoxin; Memamtine Hydrochloride



Possible Avodart side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-10

Patient: male

Reactions: Breast Cancer Male, Gynaecomastia

Drug(s) suspected as cause:
Avodart
    Dosage: .5mg per day
    Administration route: Oral
    Indication: Benign Prostatic Hyperplasia
    Start date: 2010-04-15
    End date: 2011-10-15

Proscar
    Dosage: 5mg per day
    Administration route: Oral
    Indication: Benign Prostatic Hyperplasia
    Start date: 2007-06-01
    End date: 2011-06-10

Other drugs received by patient: Tadenan; Glucosamine; Oxazepam; Chondrosulf; Mirtazapine; Zolpidem Tartrate



Possible Avodart side effects in male

Reported by a physician from France on 2012-08-09

Patient: male

Reactions: Malaise, Head Injury, Orthostatic Hypotension, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alfuzosin HCL
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-06-09

Avodart
    Dosage: .5mg per day
    Administration route: Oral
    Indication: Prostatic Adenoma
    End date: 2012-06-09

Furosemide
    Dosage: 40mg per day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-01-01
    End date: 2012-06-09

Other drugs received by patient: Aspirin; Digoxin; Lantus; Zopiclone; Transipeg; Ramipril; Oxazepam; Memantine HCL; Molsidomine; Singulair



Possible Avodart side effects in 82 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-08

Patient: 82 year old male

Reactions: Orthostatic Hypotension, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alfuzosin Hydrochloride
    Administration route: Oral
    End date: 2012-06-09

Avodart
    Administration route: Oral
    Indication: Prostatic Adenoma
    End date: 2012-06-09

Furosemide
    Administration route: Oral
    Start date: 2011-01-01
    End date: 2012-06-09

Other drugs received by patient: Aspirin; Oxazepam; Polyethylene Glycol; Ramipril; Lantus; Digoxin; Molsidomine; Zopiclone; Singulair



Possible Avodart side effects in male

Reported by a physician from France on 2012-08-03

Patient: male

Reactions: Thrombocytopenia, Rash Pruritic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Allopurinol
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Gout
    End date: 2012-03-15

Avodart
    Dosage: .5mg per day
    Administration route: Oral
    Indication: Prostatic Adenoma
    Start date: 2009-01-01
    End date: 2012-03-15

Lorazepam
    Dosage: 1.5tab per day
    Administration route: Oral
    Indication: Anxiety
    End date: 2012-03-15

Pravastatin
    Dosage: 40mg twice per day
    Administration route: Oral
    Indication: Hypercholesterolaemia
    End date: 2012-03-15

Other drugs received by patient: Aspirin; Propranolol; Ramipril; Pantoprazole Sodium



Possible Avodart side effects in 59 year old male

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 59 year old male, weighing 126.4 kg (278.1 pounds)

Reactions: Fatigue, Prostate Cancer, Ill-Defined Disorder

Drug(s) suspected as cause:
Avodart

Other drugs received by patient: Medication FOR High Blood Pressure; Diabetes Medication; Anti-Anxiety MED Name Unknown



Possible Avodart side effects in 64 year old male

Reported by a pharmacist from France on 2012-07-30

Patient: 64 year old male

Reactions: Product Quality Issue, Priapism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alfuzosin Hydrochloride
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Benign Prostatic Hyperplasia
    Start date: 2012-07-15
    End date: 2012-07-19

Avodart
    Dosage: .5mg per day
    Administration route: Oral
    Indication: Benign Prostatic Hyperplasia
    Start date: 2012-07-17



Possible Avodart side effects in 78 year old male

Reported by a consumer/non-health professional from Italy on 2012-07-30

Patient: 78 year old male

Reactions: Adenocarcinoma, Tumour Marker Increased, Dizziness

Drug(s) suspected as cause:
Avodart

Other drugs received by patient: Tamsulosin Hydrochloride



Possible Avodart side effects in 75 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-25

Patient: 75 year old male

Reactions: Fatigue, Muscle Atrophy

Drug(s) suspected as cause:
Avodart
    Indication: Product Used FOR Unknown Indication

Flomax
    Indication: Product Used FOR Unknown Indication



Possible Avodart side effects in 81 year old male

Reported by a health professional (non-physician/pharmacist) on 2012-07-23

Patient: 81 year old male

Reactions: Drug Ineffective, Pain in Extremity, Wound, Sensation of Heaviness, Skin Fragility, Localised Oedema, Skin Induration, Erythema, Walking AID User, Hyperaesthesia, Insomnia, Oedema Peripheral, Gait Disturbance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atarax
    Dosage: 10 mg
    Indication: Product Used FOR Unknown Indication

Atorvastatin Calcium
    Dosage: 10 mg (10 mg, 1 in 1 d)
    Indication: Product Used FOR Unknown Indication

Avodart
    Dosage: 0.5 mg (0.5 mg, 1 in 1 d)
    Indication: Product Used FOR Unknown Indication

Codoliprane Adultes (Panadeine CO)
    Indication: Product Used FOR Unknown Indication

Ibuprofen
    Dosage: as needed
    Indication: Product Used FOR Unknown Indication

Irbesartan and Hydrochlorothiazide
    Dosage: 300 mg/15 mg
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-01-01

Metfformin Hydrochloride
    Dosage: 2 dosage forms (1 dosage forms, 2 in 1 d)
    Indication: Product Used FOR Unknown Indication

Mirtazapine
    Dosage: oral
    Indication: Depression
    Start date: 2012-01-02
    End date: 2012-02-04

Nabumetone
    Dosage: 1000 mg (500 mg, 2 in 1d)
    Start date: 2010-01-01

Nicardipine Hydrochloride
    Dosage: 2 tablets daily, oral; 20 mg
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-01-01

Nicardipine Hydrochloride
    Dosage: 2 tablets daily, oral; 20 mg
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-01-01

Piascledine (Piascledine / 01305801 / )
    Dosage: 600 mg to 900 mg daily
    Start date: 2007-01-01

Rabeprazole Sodium
    Dosage: 40 mg (20 mg, 2 in 1 d)
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-01-01

Sotalol HCL
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-01-01

Zopiclone (Zopiclone)
    Dosage: 7.5 mg in evening
    Indication: Product Used FOR Unknown Indication



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 26 year old male

Reported by a consumer/non-health professional from Canada on 2012-07-19

Patient: 26 year old male, weighing 75.0 kg (165.0 pounds)

Reactions: Off Label Use, Fatigue, Breast Enlargement, Breast Tenderness, Libido Decreased, Breast Disorder Male, Erectile Dysfunction, Asthenia, Ejaculation Disorder

Drug(s) suspected as cause:
Avodart



Possible Avodart side effects in 70 year old male

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: 70 year old male

Reactions: Prostate Cancer

Drug(s) suspected as cause:
Avodart

Other drugs received by patient: Calcium; Ascorbic Acid; Vitamin D; Doxazosin Mesylate; Simvastatin; Multi-Vitamins; Aspirin; Felodipine; Vitamin E



Possible Avodart side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-18

Patient: male

Reactions: Pain in Extremity, Oedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atarax
    Dosage: 10mg per day
    Indication: Product Used FOR Unknown Indication

Atorvastatin
    Dosage: 10mg per day
    Indication: Product Used FOR Unknown Indication

Avodart
    Dosage: .5mg per day
    Indication: Product Used FOR Unknown Indication

Codeine Phosphate and Acetaminophen
    Indication: Product Used FOR Unknown Indication

Ibuprofen
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-01-01

Irbesartan and Hydrochlorothiazide
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-01-01

Metformin Hydrochloride
    Dosage: 500mg twice per day
    Indication: Product Used FOR Unknown Indication

Mirtazapine
    Indication: Depression
    Start date: 2012-01-02
    End date: 2012-02-04

Nabumetone
    Dosage: 500mg twice per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-01-01

Nicardipine HCL
    Dosage: 20mg per day
    Indication: Product Used FOR Unknown Indication

Piascledine
    Dosage: 300mg twice per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-01-01

Rabeprazole Sodium
    Dosage: 20mg twice per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-01-01

Sotalol HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-01-01
    End date: 2011-01-01

Zoplicone
    Dosage: 7.5mg per day
    Indication: Product Used FOR Unknown Indication



Possible Avodart side effects in 81 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-17

Patient: 81 year old male

Reactions: Pain in Extremity, Wound, Insomnia, Oedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atarax
    Indication: Product Used FOR Unknown Indication

Atorvastatin
    Indication: Product Used FOR Unknown Indication

Avodart
    Indication: Product Used FOR Unknown Indication

Codeine Phosphate and Acetaminophen
    Indication: Product Used FOR Unknown Indication

Ibuprofen
    Dosage: unspecified dose as needed
    Indication: Product Used FOR Unknown Indication

Irbesartan and Hydrochlorothiazide
    Dosage: 300mg/25mg
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-01-01

Metformin HCL
    Dosage: 1 dosage form in morning and 1 dosage form in evening
    Indication: Product Used FOR Unknown Indication

Mirtazapine
    Administration route: Oral
    Indication: Depression
    Start date: 2012-01-02
    End date: 2012-02-04

Nabumetone
    Dosage: 500mg in the morning and 500mg in the evening
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-01-01

Nicardipine HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-01-01

Nicardipine HCL
    Administration route: Oral
    Start date: 2007-01-01

Piascledine
    Dosage: 300mg capsules, 600mg to 900mg daily
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-01-01

Rabeprazole Sodium
    Dosage: 20mg at mid day and 20mg in evening
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-01-01

Sotalol Hydrochloride
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-01-01

Zopiclone
    Dosage: 7.5mg in evening
    Indication: Product Used FOR Unknown Indication



Possible Avodart side effects in male

Reported by a physician from Italy on 2012-07-17

Patient: male

Reactions: Breast Cancer

Drug(s) suspected as cause:
Avodart

Other drugs received by patient: Alfuzosin Hydrochloride



Possible Avodart side effects in 81 year old male

Reported by a physician from France on 2012-07-16

Patient: 81 year old male

Reactions: Pain in Extremity, Insomnia, Oedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atarax

Atorvastatin
    Dosage: tahor 10 mg, film-coated tablet

Avodart
    Dosage: 0.5 mg, soft capsule (dutasteride

Codeine Phosphate and Acetaminophen
    Dosage: codoliprane adults, scored tablet

Ibuprofen

Irbesartan and Hydrochlorothiazide
    Dosage: coaprovel 300 mg/25 mg, film-coated tablet (irbesartan / hydrochlorothiazide) from 5-6 years
    Start date: 2006-01-01

Metformin HCL
    Dosage: metformin hydrochloride 500 uniuts nos (2 tablets daily (1-0-1)),

Mirtazapine
    Administration route: Oral
    Indication: Depression
    Start date: 2012-01-02
    End date: 2012-02-04

Nabumetone
    Dosage: nabucox 500 mg (500 mg twice daily (1-0-1) from 1-2 years),
    Start date: 2010-01-01

Nicardipine HCL
    Administration route: Oral
    Start date: 2007-01-01

Piascledine
    Dosage: piascledine 300 mg, capsule piascledine 300 mg (2-3 tablets daily
    Start date: 2007-01-01

Rabeprazole Sodium
    Dosage: gastro-resistant tablet (rabeprazole)
    Start date: 2010-01-01

Sotalol HCL
    Administration route: Oral
    Start date: 2009-01-01

Zopiclone



Possible Avodart side effects in 81 year old male

Reported by a consumer/non-health professional from United States on 2012-07-12

Patient: 81 year old male

Reactions: Breast Enlargement, Breast Tenderness, Anaemia, Breast Induration

Drug(s) suspected as cause:
Avodart

Other drugs received by patient: Warfarin Sodium; Metoprolol Tartrate; Digoxin; Cardizem; Iron



Possible Avodart side effects in 81 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-12

Patient: 81 year old male

Reactions: Pain in Extremity, Wound, Insomnia, Oedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atarax
    Dosage: 10 mg, unk

Atorvastatin
    Dosage: 10 mg, 1x/day

Avodart
    Dosage: 0.5 mg, 1x/day

Codoliprane Adultes
    Dosage: unk

Ibuprofen
    Dosage: unk, as needed

Irbesartan and Hydrochlorothiazide
    Dosage: 300 mg/25 mg
    Start date: 2006-01-01

Metformin HCL
    Dosage: 1 dosage form in morning and 1 dosage form in evening

Mirtazapine
    Dosage: unk
    Administration route: Oral
    Indication: Depression
    Start date: 2012-01-02
    End date: 2012-02-04

Nabumetone
    Dosage: 500 mg, 500 mg in the morning and 500 mg in the eveing
    Start date: 2010-01-01

Nicardipine HCL
    Dosage: 20 mg, unk
    End date: 2011-01-01

Nicardipine HCL
    Dosage: 2 tablets daily
    Administration route: Oral
    Start date: 2007-01-01

Piascledine
    Dosage: 300 mg capsules; 600 mg to 900 mg daily
    Start date: 2007-01-01

Rabeprazole Sodium
    Dosage: 20 mg at mid-day and 20 mg in evening
    Start date: 2010-01-01

Sotalol Hydrochloride
    Dosage: unk
    Administration route: Oral
    Start date: 2009-01-01

Zopiclone
    Dosage: 7.5 mg in evening



Possible Avodart side effects in male

Reported by a physician from France on 2012-07-10

Patient: male

Reactions: Weight Increased, Pain in Extremity, Insomnia, Induration, Wound, Oedema, Gait Disturbance, Erythema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atarax
    Indication: Product Used FOR Unknown Indication

Atorvastatin
    Dosage: 10mg per day
    Indication: Product Used FOR Unknown Indication

Avodart
    Dosage: .5mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Codeine Phosphate and Acetaminophen
    Indication: Product Used FOR Unknown Indication

Ibuprofen
    Indication: Product Used FOR Unknown Indication

Irbesartan and Hydrochlorothiazide
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-01-01

Metformin HCL
    Dosage: 500mg twice per day
    Indication: Product Used FOR Unknown Indication

Mirtazapine
    Administration route: Oral
    Indication: Depression
    Start date: 2012-01-02
    End date: 2012-02-04

Nabumetone
    Dosage: 500mg twice per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-01-01

Nicardipine HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-01-01

Piascledine
    Dosage: 300mg see dosage text
    Administration route: Oral
    Start date: 2007-01-01

Rabeprazole Sodium
    Dosage: 20mg twice per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-01-01

Sotalol HCL
    Dosage: 50mg unknown
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-01-01

Zopiclone
    Dosage: 7.5mg per day
    Indication: Product Used FOR Unknown Indication



Possible Avodart side effects in 93 year old male

Reported by a pharmacist from United States on 2012-07-06

Patient: 93 year old male, weighing 72.0 kg (158.4 pounds)

Reactions: Death, Pneumonia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Advair Diskus 100 / 50
    Dosage: 1puff twice per day
    Indication: Chronic Obstructive Pulmonary Disease
    End date: 2011-07-31

Avodart
    Dosage: .5mg per day
    Administration route: Oral
    Indication: Benign Prostatic Hyperplasia
    End date: 2011-07-31

Coreg
    Dosage: 6.25mg twice per day
    Administration route: Oral
    Indication: Cardiac Failure Congestive
    End date: 2011-07-31

Other drugs received by patient: Spiriva; Simvastatin; Concurrent Medications



Possible Avodart side effects in male

Reported by a physician from France on 2012-07-05

Patient: male

Reactions: Urticaria, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Allopurinol
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Gout
    End date: 2012-03-15

Avodart
    Dosage: .5mg per day
    Administration route: Oral
    Indication: Prostatic Adenoma
    Start date: 2009-01-01
    End date: 2012-03-15

Lorazepam
    Dosage: 1.5tab per day
    Administration route: Oral
    Indication: Anxiety
    End date: 2012-03-15

Pravastatin
    Dosage: 40mg twice per day
    Administration route: Oral
    Indication: Hypercholesterolaemia
    End date: 2012-03-15

Other drugs received by patient: Ramipril; Kardegic; Pantoprazole Sodium; Propranolol



Possible Avodart side effects in male

Reported by a physician from Italy on 2012-07-03

Patient: male

Reactions: Nausea, Tachycardia, Erythema, Hypertensive Crisis

Drug(s) suspected as cause:
Avodart

Other drugs received by patient: Crestor; Lercanidipine; Zofenopril + Hydrochlorothiazide; Aspirin; Kanrenol



Possible Avodart side effects in 59 year old male

Reported by a physician from United States on 2012-06-29

Patient: 59 year old male, weighing 126.4 kg (278.1 pounds)

Reactions: Fatigue, Prostate Cancer, Ill-Defined Disorder

Drug(s) suspected as cause:
Avodart

Other drugs received by patient: Anti-Anxiety MED Name Unknown; Medication FOR High Blood Pressure; Diabetes Medication



Possible Avodart side effects in 89 year old male

Reported by a consumer/non-health professional from United States on 2012-06-28

Patient: 89 year old male

Reactions: Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avodart

Other drugs received by patient: Unknown



Possible Avodart side effects in male

Reported by a physician from Canada on 2012-06-27

Patient: male, weighing 69.1 kg (152.0 pounds)

Reactions: Asthenia

Drug(s) suspected as cause:
Avodart

Other drugs received by patient: Metoprolol Tartrate; Doxazosin Mesylate



Possible Avodart side effects in 78 year old male

Reported by a consumer/non-health professional from Italy on 2012-06-27

Patient: 78 year old male

Reactions: Adenocarcinoma, Tumour Marker Increased, Dizziness

Drug(s) suspected as cause:
Avodart

Other drugs received by patient: Tamsulosin Hydrochloride

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