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Avodart Side Effects

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.

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.

Avodart Side Effects Reported to FDA

The following 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.


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.
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 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). The consumer presented with:
  • Eye Swelling
  • Ocular Hyperaemia
  • Vision Blurred
  • Back Pain
  • Headache
  • Iritis
  • Iris Adhesions
  • Eyelid Oedema
  • Visual Acuity Reduced
which developed 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.

Plasma Cell Myeloma, Bone Marrow Transplant, Plasma Cell Myeloma In Remission
This report suggests a potential Avodart Plasma Cell Myeloma, Bone Marrow Transplant, Plasma Cell Myeloma In Remission 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. Soon after starting Avodart the patient began experiencing various side effects, including:
  • Plasma Cell Myeloma
  • Bone Marrow Transplant
  • Plasma Cell Myeloma In Remission
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.

Cardiac Failure Congestive, Atrial Fibrillation
This Cardiac Failure Congestive, Atrial Fibrillation 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 commencing Avodart, the patient experienced the following unwanted symptoms/side effects:
  • Cardiac Failure Congestive
  • Atrial Fibrillation
The 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.

Diabetes Mellitus Inadequate Control
This is a report of a 70-year-old male patient (weight: NA) from FR. The patient developed the following symptoms/conditions: benign prostatic hyperplasia,urinary tract infection,type 2 diabetes mellitus and was treated with Avodart (dosage: .5mg Per Day) starting 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)
Soon after that, the consumer experienced the following side effects:
  • Diabetes Mellitus Inadequate Control
The patient was hospitalized. This opens a possibility that Avodart treatment could cause the above reactions, including diabetes mellitus inadequate control, and some male subjects may be more susceptible.


Knee Arthroplasty, Eye Operation
A 67-year-old male patient (weight: NA) from US with the following symptoms/conditions: NA started Avodart treatment (dosage: NA) on Jan 26, 2011. Soon after starting Avodart treatment, the subject experienced various side effects, including:
  • Knee Arthroplasty
  • Eye Operation
Concurrently used drugs: NA. This finding indicates that some male patients could be more vulnerable to Avodart.

Pain, Hypotension, Heart Rate Increased, Dehydration, Hospice Care
A 63-year-old male patient from US (weight: NA) experienced symptoms, such as: benign prostatic hyperplasia and was treated with Avodart(dosage: .5mg Per Day). The treatment was initiated on Apr 17, 2012. After that a consumer reported the following side effect(s):
  • Pain
  • Hypotension
  • Heart Rate Increased
  • Dehydration
  • Hospice Care
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Avodart efficacy:
  • Senokot
  • Oxygen
  • Digoxin
  • Prednisone
  • Magnesium Oxide
  • Atrovent/albuterol Nebulizer
  • Flomax
  • Mucinex
The patient was hospitalized.

Prostate Cancer, Prostate Ablation, Breast Enlargement, Erectile Dysfunction, Prostatic Specific Antigen Increased, Biopsy Prostate
In this report, Avodart was administered for the following condition: prostatomegaly.A 70-year-old male consumer from US (weight: NA) started Avodart treatment (dosage: .5mg Per Day) on 200909.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Prostate Cancer
  • Prostate Ablation
  • Breast Enlargement
  • Erectile Dysfunction
  • Prostatic Specific Antigen Increased
  • Biopsy Prostate
A possible interaction with other drugs could have contributed to this reaction:
  • Flomax
  • Calcium Channel Blocker
  • Beta Blocker
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Avodart treatment could be related to the listed above side effect(s).

Gestational Diabetes, Premature Delivery, Live Birth, Accidental Exposure To Product, Exposure During Pregnancy
This is a report of the following Avodart side effect(s):
  • Gestational Diabetes
  • Premature Delivery
  • Live Birth
  • Accidental Exposure To Product
  • Exposure During Pregnancy
A 30-year-old female patient from US (weight: NA) presented with the following condition: ill-defined disorder and received a treatment with Avodart (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions:
  • Prenatal Vitamins
  • Betamethasone
This report suggests that a Avodart treatment could be associated with the listed above side effect(s).

Urinary Bladder Haemorrhage, Aneurysm, Prostatic Disorder
This Avodart report was submitted by a 85-year-old male consumer from US (weight: NA). The patient was diagnosed with: benign prostatic hyperplasia and Avodart was administered (dosage: .5mg Per Day) starting: 2013. The consumer developed a set of symptoms:
  • Urinary Bladder Haemorrhage
  • Aneurysm
  • Prostatic Disorder
Other drugs used simultaneously:
  • Vytorin
  • Rapaflo
  • Baby Aspirin
The patient was hospitalized.Those unexpected symptoms could be linked to a Avodart treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Suicidal Ideation, Depressed Mood, Crying, Ill-defined Disorder
This is a report of a possible correlation between Avodart use and the following symptoms/side effect(s):
  • Suicidal Ideation
  • Depressed Mood
  • Crying
  • Ill-defined Disorder
which could contribute to an assessment of Avodart risk profile.A 58-year-old male consumer from US (weight: NA) was suffering from benign prostatic hyperplasia and was treated with Avodart (dosage: .5mg Per Day) starting Jan 09, 2014.Other concurrent medications:
  • Klonopin
  • Cymbalta
  • Ambien
  • Buspirone
  • Flonase
  • Zyrtec
  • Uroxatral
  • Viibryd


Retroperitoneal Fibrosis, Dizziness
A 81-year-old male patient from NL (weight: NA) presented with the following symptoms: benign prostatic hyperplasia and after a treatment with Avodart (dosage: .5mg Per Day) experienced the following side effect(s):
  • Retroperitoneal Fibrosis
  • Dizziness
The treatment was started on Apr 27, 2009. Avodart was used in combination with the following drugs: NA.The patient was hospitalized.This report could alert potential Avodart consumers.

Visual Impairment, Iiird Nerve Paralysis, Cerebral Atrophy, Headache, Diplopia, Eye Pain, Eyelid Disorder, Strabismus, Arachnoid Cyst
In this report, a 78-year-old male patient from FR (weight: NA) was affected by a possible Avodart side effect.The patient was diagnosed with benign prostatic hyperplasia,hypertension,headache. After a treatment with Avodart (dosage: .5mg At Night, start date: 201309), the patient experienced the following side effect(s):
  • Visual Impairment
  • Iiird Nerve Paralysis
  • Cerebral Atrophy
  • Headache
  • Diplopia
  • Eye Pain
  • Eyelid Disorder
  • Strabismus
  • Arachnoid Cyst
The following simultaneously used drugs could have led to this reaction:
  • Indapamide + Perindopril (.5tab In The Morning)
  • Lamaline
The findings here stress that side effects should be taken into consideration when evaluating a Avodart treatment.

Weight Increased, Frustration, Rash
This is a report of a 62-year-old female patient from US (weight: NA), who used Avodart (dosage: 1 Pill) for a treatment of alopecia. After starting a treatment on Aug 06, 2013, the patient experienced the following side effect(s):
  • Weight Increased
  • Frustration
  • Rash
The following drugs could possibly have interacted with the Avodart treatment NA.Taken together, these observations suggest that a Avodart treatment could be related to side effect(s), such as Weight Increased, Frustration, Rash.

Atrial Fibrillation, Heart Rate Irregular, Medical Device Pain, Stress, Tension, Insomnia, Dyspnoea
This atrial fibrillation side effect was reported by a pharmacist from US. A 65-year-old male patient (weight:NA) experienced the following symptoms/conditions: prostatomegaly,catheter placement. The patient was prescribed Avodart (dosage: 1cap Per Day), which was started on 2011. Concurrently used drugs: NA. When starting to take Avodart the consumer reported the following symptoms:
  • Atrial Fibrillation
  • Heart Rate Irregular
  • Medical Device Pain
  • Stress
  • Tension
  • Insomnia
  • Dyspnoea
These side effects may potentially be related to Avodart.

Haemorrhage, Underdose
This is a Avodart side effect report of a 70-year-old male patient (weight:NA) from US, suffering from the following symptoms/conditions: benign prostatic hyperplasia, who was treated with Avodart (dosage:.5mg Alternate Days, start time: 201305), combined with:
  • Flomax
  • Simvastatin
  • Quinapril
  • Hctz
  • Vitamin D3
  • Ocuvite
  • Echinacea
  • Fish Oil
, and developed a serious reaction and a haemorrhage side effect. The patient presented with:
  • Haemorrhage
  • Underdose
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Avodart treatment in male patients suffering from benign prostatic hyperplasia, resulting in haemorrhage.

Diarrhoea, Flatulence
This report suggests a potential Avodart diarrhoea side effect(s) that can have serious consequences. A 65-year-old male patient from US (weight:NA) was diagnosed with the following health condition(s): benign prostatic hyperplasia and used Avodart (dosage: 1cap Per Day) starting Sep 28, 2013. Soon after starting Avodart the patient began experiencing various side effects, including:
  • Diarrhoea
  • Flatulence
Drugs used concurrently:
  • Metformin
  • Metoprolol
  • Diovan
  • Zetia
  • Warfarin
  • Digoxin
  • Furosemide
  • Vitamin C
Although Avodart demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as diarrhoea, may still occur.

Accidental Exposure To Product, Exposure During Pregnancy
This accidental exposure to product problem was reported by a consumer or non-health professional from US. A 29-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): ill-defined disorder.On NS a consumer started treatment with Avodart (dosage: NA). The following drugs/medications were being taken at the same time: NA. When commencing Avodart, the patient experienced the following unwanted symptoms /side effects:
  • Accidental Exposure To Product
  • Exposure During Pregnancy
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as accidental exposure to product, may become evident only after a product is in use by the general population.

Genital Burning Sensation, Diarrhoea, Defaecation Urgency, Hypersensitivity
This is a Avodart side effect report of a 73-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: benign prostatic hyperplasia and was treated with Avodart (dosage: .5mg Per Day) starting Sep 01, 2013. Concurrently used drugs:
  • Uroxatral
  • Temazepam
  • Ecotrin
Soon after that, the consumer experienced the following of symptoms:
  • Genital Burning Sensation
  • Diarrhoea
  • Defaecation Urgency
  • Hypersensitivity
This opens a possibility that Avodart could cause genital burning sensation and that some male patients may be more susceptible.

Epistaxis, Off Label Use
A 95-year-old male patient (weight: NA) from US with the following symptoms: blood urine present started Avodart treatment (dosage: 1cap Per Day) on 201309. Soon after starting Avodart treatment, the consumer experienced several side effects, including:
  • Epistaxis
  • Off Label Use
. Concurrently used drugs:
  • Coumadin
This finding indicates that some patients can be more vulnerable to developing Avodart side effects, such as epistaxis.

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 (dosage: .5mg Per Day), which was started on 201103. Concurrently used drugs:
  • Advil
  • Ritalin
.When starting to take Avodart the consumer reported symptoms, such as:
  • Myalgia
  • Joint Stiffness
  • Off Label Use
These side effects may potentially be related to Avodart.

Influenza, Pyrexia
This is a report of a 71-year-old male patient (weight: NA) from US, suffering from the following 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). The consumer presented with:
  • Influenza
  • Pyrexia
which developed 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.

Dysuria, Product Quality Issue
This report suggests a potential Avodart Dysuria, Product Quality Issue 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. Soon after starting Avodart the patient began experiencing various side effects, including:
  • Dysuria
  • Product Quality Issue
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.

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 commencing Avodart, the patient experienced the following unwanted symptoms/side effects:
  • Loss Of Libido
Although 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.

Erectile Dysfunction, Loss Of Libido
This is a report of a 73-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Avodart (dosage: NA) starting NS. Concurrently used drugs:
  • Insulin
  • Losartan
Soon after that, the consumer experienced the following side effects:
  • Erectile Dysfunction
  • Loss Of Libido
This opens a possibility that Avodart treatment could cause the above reactions, including erectile dysfunction, and some male subjects may be more susceptible.

Dizziness, Chest Discomfort, Arrhythmia, Heart Rate Increased, Heart Rate Irregular, Hypotension, Syncope
A 58-year-old male patient (weight: NA) from US with the following symptoms/conditions: benign prostatic hyperplasia started Avodart treatment (dosage: .5mg Per Day) on Sep 09, 2013. Soon after starting Avodart treatment, the subject experienced various side effects, including:
  • Dizziness
  • Chest Discomfort
  • Arrhythmia
  • Heart Rate Increased
  • Heart Rate Irregular
  • Hypotension
  • Syncope
Concurrently used drugs:
  • Tamsulosin (.4mg Per Day)
  • Vitamin
This finding indicates that some male patients could be more vulnerable to Avodart.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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

    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.


    Discuss Avodart Side Effects

    Did You Have a Avodart Side Effect?

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    Yes, Moderate
    Yes, Minor
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    How Effective is Avodart for You?

    Exceeded Expectations
    Effective
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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