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 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 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 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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