Patient Medication Information: uses, side effects, how to take - Avodart

Serious warnings and precautions box

What AVODART is used for:

AVODART is used to treat Benign Prostatic Hyperplasia (BPH) in men with enlarged prostates. It can be used alone or in combination with another medication called tamsulosin. It can help reduce urinary system problems, such as:

having trouble emptying your bladder or a sudden inability to pass urine
the need for surgery

AVODART is not approved for use in the prevention of prostate cancer.

How AVODART works:

AVODART belongs to a group of medicines called testosterone-5-alpha reductase inhibitors. Prostate growth is caused by a hormone in the blood called dihydrotestosterone (DHT). AVODART lowers DHT levels, leading to shrinkage of the enlarged prostate in most men. This can lead to gradual improvements in urine flow and other symptoms related to BPH.

The ingredients in AVODART are:

Medicinal ingredient: dutasteride

Non-medicinal ingredients: butylated hydroxytoluene, gelatin, glycerin, iron oxide yellow, lecithin, medium chain triglycerides, monodiglycerides of caprylic/capric acid, purified water and titanium dioxide.

AVODART comes in the following dosage form:

Soft gelatin capsules: 0.5 mg

AVODART is for use by men only.
Exposure to Women: Dutasteride (the medicinal ingredient in AVODART) can pass through the skin. Women who are pregnant, or who may become pregnant, should not handle AVODART. AVODART may affect the normal development of the external genital organs in a male baby. Women should be careful when handling AVODART. If a woman comes into contact with a broken or leaking capsule, they should wash the area immediately with soap and water.

Do not use AVODART if:

you are a woman or child.
you are allergic to dutasteride, other alpha-reductase inhibitors, or any of the non-medicinal ingredients in AVODART (see The ingredients in AVODART are).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AVODART. Talk about any health conditions or problems you may have, including if you:

have or have had liver problems.
have or have had prostate cancer or urinary tract disease.
have or have had heart problems.

Other warnings you should know about:

Heart Failure: Heart failure (the heart does not pump blood as well as it should) has been reported more often in patients taking AVODART in combination with tamsulosin than in patients taking AVODART alone. It is not known if taking AVODART with tamsulosin caused heart failure. Talk to your healthcare professional if you have or have a history of heart problems.
Donating Blood: Do not donate blood while you are taking AVODART and for at least 6 months after your last dose. This is to prevent passing AVODART to a pregnant woman, or a woman who may become pregnant, receiving a blood transfusion.
Behaviour and Mood Changes: Suicidal thoughts have been reported in patients taking 5-alpha reductase inhibitors. Tell your healthcare professional if you have experienced extreme sadness (depression), injuries from hurting yourself on purpose (self-harm injury), and thoughts of suicide (suicidal ideation) before. They should check your mental health before, during and after your treatment with dutasteride. If you experience any thoughts or behaviours of self-harm or suicide, contact your healthcare professional for further medical advice as soon as possible.
Sexual Function: Taking medications like 5-alpha reductase inhibitors such as dutasteride, may cause symptoms of sexual dysfunction. In some cases, these symptoms have continued after stopping AVODART. Talk to your healthcare professional if you experience symptoms such as a decrease in sexual desire, performance or satisfaction.
Testing and Monitoring:
- In a clinical study of men at increased risk of prostate cancer, men taking AVODART had a serious form of prostate cancer more often than men who did not take AVODART. Your healthcare professional will do a blood test called Prostate-Specific Antigen (PSA). The PSA test is for the screening of prostate cancer. AVODART can alter PSA test results. If you have a PSA test done, you should tell the healthcare professional doing the test that you are taking AVODART.
- Your healthcare professional will check your PSA levels before you start treatment with AVODART. They will also do a digital rectal exam and other tests to check the health of your prostate. They will check your PSA levels again at least three months after you begin treatment and periodically thereafter.
- AVODART can cause breast changes. You should monitor your breasts regularly. Talk to your healthcare professional immediately if you notice any changes. This may include lumps, pain, nipple discharge, breast enlargement, and tenderness.
- You should see your healthcare professional regularly while you are taking AVODART.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with AVODART:

verapamil and diltiazem, used to treat high blood pressure
ritonavir, used to treat HIV and AIDS
ketaconazole, used to treat fungal infections
ciprofloxacin and troleandomycin, used to treat bacterial infections
cimetidine, used to treat heart burn and acid reflux
certain herbal medicines such as St. John’s Wort and Milk Thistle
grapefruit. Do not eat grapefruit or drink grapefruit juice while you are taking AVODART.

How to take AVODART:

Always take AVODART exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
AVODART can be taken with or without food.
Swallow the capsule whole with water.
Do NOT chew or open the capsule. Your mouth and throat can become sore if they come into contact with the contents of the capsule.

Usual dose:

Usual adult dose:

AVODART alone: Take 1 AVODART capsule (0.5 mg) once a day.

AVODART in combination tamsulosin: Take 1 AVODART capsule (0.5 mg) with one tamsulosin capsule (0.4 mg) once a day.

Overdose:

If you think you, or a person you are caring for, have taken too much AVODART, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you miss a dose of AVODART, take your next dose at your next scheduled time. Do not take two doses at the same time to make up for a missed dose

Possible side effects from using AVODART:

These are not all the possible side effects you may have when taking AVODART. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

inability to have an erection (impotence)
less desire to have sex (decreased libido)
problems with ejaculation, including a decrease in the amount of semen released
pain and swelling in the testicles
breast swelling or tenderness
loss of body hair or abnormal hair growth
dizziness

Serious side effects and what to do about them

Frequency/Side Effect/Symptom	Talk to your healthcare professional	Stop taking this drug and get immediate medical help
Only if severe	In all cases
Very rare
Allergic reaction: difficulty swallowing or breathing, wheezing, feeling sick to your stomach and throwing up, hives, itching, rash, swelling of the face, lips, tongue or throat			✓
Behaviour and mood changes: a sad mood that gets worse or doesn’t go away, extreme sadness (depression)		✓
Unknown
Heart failure (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise		✓
Male breast changes (including breast cancer): lumps, pain, nipple discharge		✓
Self-harm behaviours: injuries from deliberately hurting oneself (self-harm), thought of ending one’s life (suicidal ideation)			✓

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store AVODART capsules between 15°C and 30°C.
Return any cracked or leaking capsules to your pharmacist for replacement.
Return any unused capsules to a pharmacist.
Keep out of reach and sight of children.

If you want more information about AVODART:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.gsk.ca, or by calling the manufacturer 1-800-387-7374.

Date of Authorization: 2026-08-12

Trademarks are owned by or licensed to the GSK group of companies

Rx or OTC	Prescription (Rx)?
DIN	02247813
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Dutasteride 0.5 MG
Dosage form(s)	Capsule
Route(s) of administration	Oral
Drug class (WHO ATC)	G Genito urinary system and sex hormones G04 Urologicals G04C Drugs used in benign prostatic hypertrophy G04CB Testosterone-5-alpha reductase inhibitors for benign prostatic hypertrophy G04CB02 Dutasteride
Company	GLAXOSMITHKLINE INC
Current status	Marketed
Current status date	November 14, 2003

Avodart: Uses, Side Effects and Dosage