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Avodart Side Effects

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Common Avodart Side Effects


The most commonly reported Avodart side effects (click to view or check a box to report):

Erectile Dysfunction (148)
Breast Enlargement (140)
Breast Tenderness (132)
Libido Decreased (110)
Pollakiuria (107)
Gynaecomastia (106)
Dizziness (97)
Rash (94)
Breast Pain (81)
Semen Volume Decreased (79)
Prostatic Specific Antigen Increased (75)
Dysuria (74)
Product Quality Issue (73)
Fatigue (68)
Pruritus (67)
Breast Swelling (63)
Nipple Pain (58)
Asthenia (58)
Urine Flow Decreased (57)
Prostate Cancer (54)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Avodart Side Effects Reported to FDA



Avodart Side Effect Report#9983769
Eye Swelling, Ocular Hyperaemia, Vision Blurred, Back Pain, Headache, Iritis, Iris Adhesions, Eyelid Oedema, Visual Acuity Reduced
This is a report of a 54-year-old male patient (weight: NA) from CA, suffering from the following health symptoms/conditions: benign prostatic hyperplasia, who was treated with Avodart (dosage: 1cap Per Day, start time:
Feb 14, 2014), combined with:
  • Tamsulosin
and developed a serious reaction and side effect(s): Eye Swelling, Ocular Hyperaemia, Vision Blurred, Back Pain, Headache, Iritis, Iris Adhesions, Eyelid Oedema, Visual Acuity Reduced after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Avodart treatment in male patients, resulting in Eye Swelling side effect.
Avodart Side Effect Report#9974062
Plasma Cell Myeloma, Bone Marrow Transplant, Plasma Cell Myeloma In Remission
This report suggests a potential Avodart Plasma Cell Myeloma side effect(s) that can have serious consequences. A 70-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: benign prostatic hyperplasia and used Avodart (dosage: .5mg Per Day) starting NS. After starting Avodart the patient began experiencing various side effects, including: Plasma Cell Myeloma, Bone Marrow Transplant, Plasma Cell Myeloma In RemissionAdditional drugs used concurrently:
  • Tamsulosin
  • Isosorbide
  • Loratadine
  • Pantoprazole
  • Glipizide
The patient was hospitalized. Although Avodart demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Plasma Cell Myeloma, may still occur.
Avodart Side Effect Report#9964321
Cardiac Failure Congestive, Atrial Fibrillation
This Cardiac Failure Congestive problem was reported by a consumer or non-health professional from US. A 82-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: metabolic disorder. On
Mar 03, 2006 this consumer started treatment with Avodart (dosage: NA). The following drugs were being taken at the same time: NA. When using Avodart, the patient experienced the following unwanted symptoms/side effects: Cardiac Failure Congestive, Atrial FibrillationThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cardiac Failure Congestive, may become evident only after a product is in use by the general population.
Avodart Side Effect Report#9929507
Diabetes Mellitus Inadequate Control
This Diabetes Mellitus Inadequate Control side effect was reported by a consumer or non-health professional from FR. A 70-year-old male patient (weight:NA) experienced the following symptoms/conditions: benign prostatic hyperplasia,urinary tract infection,type 2 diabetes mellitus.The patient was prescribed Avodart (drug dosage: .5mg Per Day), which was initiated on
Feb 07, 2014. Concurrently used drugs:
  • Amoxicilline
  • Humalog Mix 25 (18iu Per Day)
  • Haldol (50mg Every Two Weeks)
  • Alfuzosine (10mg Per Day)
  • Stagid (700mg Three Times Per Day)
.After starting to take Avodart the consumer reported adverse symptoms, such as: Diabetes Mellitus Inadequate ControlThese side effects may potentially be related to Avodart. The patient was hospitalized.
Avodart Side Effect Report#9917030
Knee Arthroplasty, Eye Operation
This is a report of a 67-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Avodart (dosage: NA, start time:
Jan 26, 2011), combined with: NA. and developed a serious reaction and side effect(s): Knee Arthroplasty, Eye Operation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Avodart treatment in male patients, resulting in Knee Arthroplasty side effect.
Avodart Side Effect Report#9905480
Pain, Hypotension, Heart Rate Increased, Dehydration, Hospice Care
This report suggests a potential Avodart Pain side effect(s) that can have serious consequences. A 63-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: benign prostatic hyperplasia and used Avodart (dosage: .5mg Per Day) starting
Apr 17, 2012. After starting Avodart the patient began experiencing various side effects, including: Pain, Hypotension, Heart Rate Increased, Dehydration, Hospice CareAdditional drugs used concurrently:
  • Senokot
  • Oxygen
  • Digoxin
  • Prednisone
  • Magnesium Oxide
  • Atrovent/albuterol Nebulizer
  • Flomax
  • Mucinex
The patient was hospitalized. Although Avodart demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pain, may still occur.
Avodart Side Effect Report#9898957
Prostate Cancer, Prostate Ablation, Breast Enlargement, Erectile Dysfunction, Prostatic Specific Antigen Increased, Biopsy Prostate
This Prostate Cancer problem was reported by a consumer or non-health professional from US. A 70-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: prostatomegaly. On 200909 this consumer started treatment with Avodart (dosage: .5mg Per Day). The following drugs were being taken at the same time:
  • Flomax
  • Calcium Channel Blocker
  • Beta Blocker
When using Avodart, the patient experienced the following unwanted symptoms/side effects: Prostate Cancer, Prostate Ablation, Breast Enlargement, Erectile Dysfunction, Prostatic Specific Antigen Increased, Biopsy ProstateAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Prostate Cancer, may become evident only after a product is in use by the general population.
Avodart Side Effect Report#9894246
Gestational Diabetes, Premature Delivery, Live Birth, Accidental Exposure To Product, Exposure During Pregnancy
This Gestational Diabetes side effect was reported by a consumer or non-health professional from US. A 30-year-old female patient (weight:NA) experienced the following symptoms/conditions: ill-defined disorder.The patient was prescribed Avodart (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Prenatal Vitamins
  • Betamethasone
.After starting to take Avodart the consumer reported adverse symptoms, such as: Gestational Diabetes, Premature Delivery, Live Birth, Accidental Exposure To Product, Exposure During PregnancyThese side effects may potentially be related to Avodart.
Avodart Side Effect Report#9892060
Urinary Bladder Haemorrhage, Urinary Bladder Haemorrhage, Haemorrhage, Aneurysm, Prostatic Disorder
This is a report of a 85-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: benign prostatic hyperplasia, who was treated with Avodart (dosage: .5mg Per Day, start time: 2013), combined with:
  • Vytorin
  • Rapaflo
  • Baby Aspirin
and developed a serious reaction and side effect(s): Urinary Bladder Haemorrhage, Urinary Bladder Haemorrhage, Haemorrhage, Aneurysm, Prostatic Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Avodart treatment in male patients, resulting in Urinary Bladder Haemorrhage side effect. The patient was hospitalized.
Avodart Side Effect Report#9850253
Suicidal Ideation, Depressed Mood, Crying, Ill-defined Disorder
This report suggests a potential Avodart Suicidal Ideation side effect(s) that can have serious consequences. A 58-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: benign prostatic hyperplasia and used Avodart (dosage: .5mg Per Day) starting
Jan 09, 2014. After starting Avodart the patient began experiencing various side effects, including: Suicidal Ideation, Depressed Mood, Crying, Ill-defined DisorderAdditional drugs used concurrently:
  • Klonopin
  • Cymbalta
  • Ambien
  • Buspirone
  • Flonase
  • Zyrtec
  • Uroxatral
  • Viibryd
Although Avodart demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Suicidal Ideation, may still occur.
Avodart Side Effect Report#9828386
Retroperitoneal Fibrosis, Dizziness
This Retroperitoneal Fibrosis problem was reported by a physician from NL. A 81-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: benign prostatic hyperplasia. On
Apr 27, 2009 this consumer started treatment with Avodart (dosage: .5mg Per Day). The following drugs were being taken at the same time: NA. When using Avodart, the patient experienced the following unwanted symptoms/side effects: Retroperitoneal Fibrosis, DizzinessThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Retroperitoneal Fibrosis, may become evident only after a product is in use by the general population.
Avodart Side Effect Report#9816971
Visual Impairment, Iiird Nerve Paralysis, Cerebral Atrophy, Headache, Diplopia, Eye Pain, Eyelid Disorder, Strabismus, Arachnoid Cyst
This Visual Impairment side effect was reported by a consumer or non-health professional from FR. A 78-year-old male patient (weight:NA) experienced the following symptoms/conditions: benign prostatic hyperplasia,hypertension,headache.The patient was prescribed Avodart (drug dosage: .5mg At Night), which was initiated on 201309. Concurrently used drugs:
  • Indapamide + Perindopril (.5tab In The Morning)
  • Lamaline
.After starting to take Avodart the consumer reported adverse symptoms, such as: Visual Impairment, Iiird Nerve Paralysis, Cerebral Atrophy, Headache, Diplopia, Eye Pain, Eyelid Disorder, Strabismus, Arachnoid CystThese side effects may potentially be related to Avodart.
Avodart Side Effect Report#9796877
Weight Increased, Frustration, Rash, Rash, Rash, Rash
This is a report of a 62-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: alopecia, who was treated with Avodart (dosage: 1 Pill, start time:
Aug 06, 2013), combined with: NA. and developed a serious reaction and side effect(s): Weight Increased, Frustration, Rash, Rash, Rash, Rash after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Avodart treatment in female patients, resulting in Weight Increased side effect.
Avodart Side Effect Report#9780000
Atrial Fibrillation, Heart Rate Irregular, Medical Device Pain, Stress, Tension, Insomnia, Dyspnoea
This report suggests a potential Avodart Atrial Fibrillation side effect(s) that can have serious consequences. A 65-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: prostatomegaly,catheter placement and used Avodart (dosage: 1cap Per Day) starting 2011. After starting Avodart the patient began experiencing various side effects, including: Atrial Fibrillation, Heart Rate Irregular, Medical Device Pain, Stress, Tension, Insomnia, DyspnoeaAdditional drugs used concurrently: NA. Although Avodart demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Atrial Fibrillation, may still occur.
Avodart Side Effect Report#9775831
Haemorrhage, Underdose
This Haemorrhage problem was reported by a consumer or non-health professional from US. A 70-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: benign prostatic hyperplasia. On 201305 this consumer started treatment with Avodart (dosage: .5mg Alternate Days). The following drugs were being taken at the same time:
  • Flomax
  • Simvastatin
  • Quinapril
  • Hctz
  • Vitamin D3
  • Ocuvite
  • Echinacea
  • Fish Oil
When using Avodart, the patient experienced the following unwanted symptoms/side effects: Haemorrhage, UnderdoseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Haemorrhage, may become evident only after a product is in use by the general population.
Avodart Side Effect Report#9775074
Diarrhoea, Flatulence
This Diarrhoea side effect was reported by a consumer or non-health professional from US. A 65-year-old male patient (weight:NA) experienced the following symptoms/conditions: benign prostatic hyperplasia.The patient was prescribed Avodart (drug dosage: 1cap Per Day), which was initiated on
Sep 28, 2013. Concurrently used drugs:
  • Metformin
  • Metoprolol
  • Diovan
  • Zetia
  • Warfarin
  • Digoxin
  • Furosemide
  • Vitamin C
.After starting to take Avodart the consumer reported adverse symptoms, such as: Diarrhoea, FlatulenceThese side effects may potentially be related to Avodart.
Avodart Side Effect Report#9775072
Accidental Exposure To Product, Exposure During Pregnancy
This is a report of a 29-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: ill-defined disorder, who was treated with Avodart (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Accidental Exposure To Product, Exposure During Pregnancy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Avodart treatment in female patients, resulting in Accidental Exposure To Product side effect.
Avodart Side Effect Report#9775064
Genital Burning Sensation, Diarrhoea, Defaecation Urgency, Hypersensitivity
This report suggests a potential Avodart Genital Burning Sensation side effect(s) that can have serious consequences. A 73-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: benign prostatic hyperplasia and used Avodart (dosage: .5mg Per Day) starting
Sep 01, 2013. After starting Avodart the patient began experiencing various side effects, including: Genital Burning Sensation, Diarrhoea, Defaecation Urgency, HypersensitivityAdditional drugs used concurrently:
  • Uroxatral
  • Temazepam
  • Ecotrin
Although Avodart demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Genital Burning Sensation, may still occur.
Avodart Side Effect Report#9775059
Epistaxis, Off Label Use
This Epistaxis problem was reported by a consumer or non-health professional from US. A 95-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: blood urine present. On 201309 this consumer started treatment with Avodart (dosage: 1cap Per Day). The following drugs were being taken at the same time:
  • Coumadin
When using Avodart, the patient experienced the following unwanted symptoms/side effects: Epistaxis, Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Epistaxis, may become evident only after a product is in use by the general population.
Avodart Side Effect Report#9775057
Myalgia, Joint Stiffness, Off Label Use
This Myalgia side effect was reported by a consumer or non-health professional from US. A 28-year-old male patient (weight:NA) experienced the following symptoms/conditions: alopecia.The patient was prescribed Avodart (drug dosage: .5mg Per Day), which was initiated on 201103. Concurrently used drugs:
  • Advil
  • Ritalin
.After starting to take Avodart the consumer reported adverse symptoms, such as: Myalgia, Joint Stiffness, Off Label UseThese side effects may potentially be related to Avodart.
Avodart Side Effect Report#9775048
Influenza, Pyrexia
This is a report of a 71-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: prostatomegaly, who was treated with Avodart (dosage: NA, start time:
Apr 01, 2011), combined with: NA. and developed a serious reaction and side effect(s): Influenza, Pyrexia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Avodart treatment in male patients, resulting in Influenza side effect.
Avodart Side Effect Report#9775047
Dysuria, Product Quality Issue
This report suggests a potential Avodart Dysuria side effect(s) that can have serious consequences. A 78-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: micturition disorder and used Avodart (dosage: .5mg Per Day) starting 1998. After starting Avodart the patient began experiencing various side effects, including: Dysuria, Product Quality IssueAdditional drugs used concurrently:
  • Flomax (1tab At Night)
Although Avodart demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dysuria, may still occur.
Avodart Side Effect Report#9775041
Loss Of Libido
This Loss Of Libido problem was reported by a consumer or non-health professional from US. A 68-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Sep 09, 2013 this consumer started treatment with Avodart (dosage: .5mg Per Day). The following drugs were being taken at the same time:
  • Rapaflo
When using Avodart, the patient experienced the following unwanted symptoms/side effects: Loss Of LibidoAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Loss Of Libido, may become evident only after a product is in use by the general population.
Avodart Side Effect Report#9775040
Erectile Dysfunction, Loss Of Libido
This Erectile Dysfunction side effect was reported by a consumer or non-health professional from US. A 73-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Avodart (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Insulin
  • Losartan
.After starting to take Avodart the consumer reported adverse symptoms, such as: Erectile Dysfunction, Loss Of LibidoThese side effects may potentially be related to Avodart.
Avodart Side Effect Report#9775038
Dizziness, Chest Discomfort, Arrhythmia, Heart Rate Increased, Heart Rate Irregular, Hypotension, Syncope
This is a report of a 58-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: benign prostatic hyperplasia, who was treated with Avodart (dosage: .5mg Per Day, start time:
Sep 09, 2013), combined with:
  • Tamsulosin (.4mg Per Day)
  • Vitamin
and developed a serious reaction and side effect(s): Dizziness, Chest Discomfort, Arrhythmia, Heart Rate Increased, Heart Rate Irregular, Hypotension, Syncope after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Avodart treatment in male patients, resulting in Dizziness side effect.


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The appearance of Avodart on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.


What are common Avodart Side Effects for Men?

Men Side EffectsReports
Erectile Dysfunction 148
Breast Enlargement 137
Breast Tenderness 131
Libido Decreased 108
Pollakiuria 107
Gynaecomastia 106
Dizziness 93
Rash 89
Breast Pain 80
Semen Volume Decreased 78

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Avodart reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Avodart Safety Alerts, Active Ingredients, Usage Information

    NDC0173-0712
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameAVODART
    Namedutasteride
    Dosage FormCAPSULE, LIQUID FILLED
    RouteORAL
    On market since20021210
    LabelerGlaxoSmithKline LLC
    Active Ingredient(s)DUTASTERIDE
    Strength(s)0.5
    Unit(s)mg/1
    Pharma Class5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]

    Avodart Dosage, Warnings, Usage.

    Side Effects reported to FDA: 2571

    Avodart safety alerts: No

    Reported deaths: 70

    Reported hospitalizations: 249

    Latest Avodart clinical trials