- Side Effects
- Drug Interactions
- Pregnancy & Breastfeeding
- What Else to Know
Generic Name: dutasteride
Brand Name: Avodart
Drug Class: 5-alpha reductase inhibitors
What is dutasteride, and what is it used for?
Dutasteride is a medication used to treat prostate enlargement (benign prostatic hyperplasia) in adult males. Dutasteride helps shrink and slow down the growth of prostate tissue and relieves associated urinary symptoms. Dutasteride works by inhibiting 5-alpha reductase, the enzyme that catalyzes the conversion of testosterone into dihydrotestosterone.
Dihydrotestosterone is the male hormone (androgen) that is primarily responsible for the development and growth of the external male genitals and prostate gland, the male reproductive organ, while testosterone is mainly responsible for growth in puberty, male hair pattern, and increased muscle mass. The enzyme 5-alpha reductase exists in two isoforms, type-1 that is found mainly in the liver and skin, and type-2, the major form in the prostate tissue.
Dutasteride forms a stable complex with both types of 5-alpha reductase and blocks their catalytic activity, which results in lower levels of dihydrotestosterone and inhibition of prostate tissue growth.
Dutasteride is approved by the FDA in the treatment of symptomatic benign prostatic hyperplasia (BPH) to improve symptoms, reduce the risk of acute urinary retention, and the need for prostate surgery. It may also be used off-label to treat male pattern baldness.
- Do not use dutasteride in patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors or any of the components of dutasteride
- Dutasteride is not intended for use in women or children
- Exposure to dutasteride during pregnancy can cause harm to male fetus
- Prior to initiating dutasteride therapy, rule out other urological conditions such as obstructive uropathy; patients with high amount of residual urine or severely reduced urine flow may not be good candidates for dutasteride therapy
- Use with caution in patients with liver disease
- Men treated with dutasteride should not donate blood for at least 6 months after receiving their last dose
- Patients should be evaluated for prostate cancer before initiating dutasteride therapy, and periodically thereafter; dutasteride reduces prostate-specific antigen (PSA) levels by 40-50%; new PSA baseline level should be determined after 3-6 months of treatment; increase in PSA levels during dutasteride therapy, even within normal limits, may indicate the presence of prostate cancer
- Dutasteride may increase the risk for high-grade prostate cancer
What are the side effects of dutasteride?
Common side effects of dutasteride include:
- Reduced sexual drive (libido)
- Ejaculation disorder
- Breast tissue enlargement (gynecomastia) and tenderness
- Increase in the levels of hormones including:
- Luteinizing hormone
- Thyroid stimulating hormone
- Testicular pain and swelling
Less common side effects of dutasteride include:
- Hypersensitivity reactions including:
- Depressed mood
- Rare and serious side effects of dutasteride include:
This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug.
Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.
What are the dosages of dutasteride?
- 0.5 mg
Benign Prostatic Hyperplasia (BPH)
- 0.5 mg orally once/day
- Renal impairment: Dose adjustment is not necessary
- Hepatic impairment: Dose adjustment is not necessary
- Safety and efficacy not established
- In volunteer studies, single doses of up to 80 times the therapeutic dose, and daily doses of 10 times the therapeutic dose have not revealed any significant adverse effects.
- There is no specific antidote for dutasteride. Overdosage may be treated with symptomatic and supportive therapy as appropriate.
What drugs interact with dutasteride?
Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.
- Dutasteride has no known severe interactions with other drugs.
- Dutasteride has no known serious interactions with other drugs.
- Moderate interactions of dutasteride include:
- erythromycin base
- erythromycin ethylsuccinate
- erythromycin lactobionate
- erythromycin stearate
- St John's Wort
- Dutasteride has mild interactions with at least 73 different drugs.
The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.
It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information.
Check with your doctor or health care provider if you have any questions about the medication.
Pregnancy and breastfeeding
- Dutasteride is not intended for use in women
- Dutasteride is absorbed through the skin; pregnant women should not handle dutasteride capsules; may cause harm to male fetus
- Breastfeeding women should avoid exposure to dutasteride; there is no information whether the drug is present in milk, or its effects on milk production or on the breastfed infant
- If pregnant or breastfeeding women come into contact with leaking capsules, the contact area should be washed immediately with soap and water
What else should I know about dutasteride?
- Take dutasteride exactly as prescribed
- Handle dutasteride carefully and avoid exposing children and women to the drug; dutasteride exposure during pregnancy can harm male fetus
- Keep dutasteride safely out of reach of children
- Do not donate blood for at least 6 months after the last dose of dutasteride to prevent pregnant women from receiving dutasteride in blood transfusions
Dutasteride is a medication used to treat prostate enlargement (benign prostatic hyperplasia) in adult males by shrinking and slowing the growth of prostate tissue, and relieving urinary symptoms. Dutasteride is not intended for use in women or children. Common side effects of dutasteride include impotence, reduced sexual drive (libido), ejaculation disorder, breast tissue enlargement (gynecomastia) and tenderness, increase in the levels of hormones (luteinizing hormone, testosterone, thyroid stimulating hormone), and testicular pain and swelling.
Multimedia: Slideshows, Images & Quizzes
Signs of Prostate Cancer: Symptoms, PSA Test, Treatments
What is prostate cancer? Prostate cancer is the most common cancer in men. Learn the signs and symptoms of prostate cancer, along...
Enlarged Prostate (BPH) Symptoms, Diagnosis, Treatment
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Prostate Cancer Quiz
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Benign Prostatic Hyperplasia (Enlarged Prostate) Quiz
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Picture of Prostate Gland
A gland within the male reproductive system that is located just below the bladder. See a picture of Prostate Gland and learn...
Picture of Prostate
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Things That May Slow Prostate Cancer Progression
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Related Disease Conditions
How Does Prostate Cancer Kill You in the End?
Prostate cancer is cancer of the prostate gland in men. Death from prostate cancer most often happens when cancer has spread (metastasized) to other organs in the body.
How Quickly Does Prostate Cancer Spread?
Prostate cancer is a cancer that develops in the prostate gland in men and it is one of the most common types of cancer. In some cases, it can take up to eight years to spread from the prostate to other parts of the body (metastasis), typically the bones. In other cases, it may be more aggressive.
Prostate Cancer: Erectile Dysfunction
Second Source article from The Cleveland Clinic
Prostate Cancer Staging and Survival Rates
The prognosis for prostate cancer, as with any cancer, depends on how advanced the cancer has become, according to established stage designations. The patient's PSA score at diagnosis, as well as their Gleason score (the grading system used to determine the aggressiveness of prostate cancer) determines the prognosis and final stage designation. Prostate cancer has a high survival rate in general, but your chances depend on the stage of the cancer.
Is Drinking a Lot of Water Good for Your Prostate?
Doctors recommend drinking six to eight glasses of water (or 1.5 to 2 liters) daily. For prostate problems, limit water intake before going to bed at night. This will keep you from waking up at night to urinate repeatedly.
Prostatitis (Inflammation of the Prostate Gland)
Prostatitis is an inflammation of the prostate gland. Signs and symptoms of prostatitis include painful or difficulty urinating; fever; chills; body aches; blood in the urine; pain in the rectum, groin, abdomen, or low back; and painful ejaculation or sexual dysfunction. Causes of prostatitis include STDs, bacteria from urinary tract infections, or E. coli. Treatment for prostatitis depends on if it is a bacterial infection or chronic inflammation of the prostate gland.
What Are the First Signs of Prostate Problems?
The first signs and symptoms of prostate disorder usually include problems with urination. Please consult your doctor if you experience any of the signs and symptoms to avoid the worsening of the prostate problems.
Prostatitis vs. BPH (Enlarged Prostate): What Is the Difference?
Prostatitis and BPH (benign prostatic hyperplasia, enlarged prostate gland) are both conditions of the prostate gland. Check out the center below for more medical references on prostate gland conditions, including multimedia (slideshows, images, and quizzes), related disease conditions, treatment and diagnosis, medications, and prevention or wellness.
What Happens If You Don't Treat Prostate Cancer?
If prostate cancer is left untreated, it may grow and possibly spread out of the prostate gland to the local tissues or distant sites such as liver and lungs.
How Do You Check for Prostate Cancer at Home?
Prostate cancer is highly treatable in its early stages. Thanks to the increase in cancer screening, cancer is also being diagnosed early.
Enlarged Prostate (BPH, Benign Prostatic Hyperplasia)
Benign prostatic hyperplasia (BPH or enlarged prostate) is very common in men over 50 years of age. Half of all men over the age of 50 develop symptoms of BPH, but few need medical treatment. This noncancerous enlargement of the prostate can impede urine flow, slow the flow of urine, create the urge to urinate frequently and cause other symptoms like complete blockage of urine and urinary tract infections. More serious symptoms are urinary tract infections (UTIs) and complete blockage of the urethra, which may be a medical emergency. BPH is not cancer. Not all men with the condition need treatment, and usually is closely monitored if no symptoms are present. Treatment measures usually are reserved for men with significant symptoms, and can include medications, surgery, microwave therapy, and laser procedures. Men can prevent prostate problems by having regular medical checkups that include a prostate exam.
What Are the 5 Warning Signs of Prostate Cancer?
Prostate cancer rarely produces symptoms in the early stage; however, few signs can help in detecting prostate cancer.
Does an Enlarged Prostate Affect a Man Sexually?
An enlarged prostate can cause sexual problems in men. Sexual problems, such as erectile dysfunction or ejaculation problems, may occur in men with noncancerous enlargement of the prostate (benign prostatic hyperplasia or BPH).
What Is Stage IV Prostate Cancer Life Expectancy?
The survival rate in most people with advanced prostate cancer is 30 percent at the fifth year of diagnosis. This means around 70 percent of the diagnosed men are not alive in the fifth year after diagnosis.
Prostate cancer is the most common cancer in men after skin cancer. Risk factors include age, family history, ethnicity, and diet. Prostate cancer is diagnosed by a digital rectal exam, prostate-specific antigen (PSA) test, and prostate biopsy. Symptoms may include frequent need to urinate, incontinence, pain, blood in the urine, fatigue, and more. Prognosis and treatment depend on cancer staging. Watchful waiting, surgery, radiation, cryotherapy, and other management strategies are available. Research and clinical trials strive to find new and better treatments for prostate cancer.
What Foods Kill Prostate Cancer?
Prostate cancer refers to the uncontrolled growth of cells in the prostate gland. There is no particular food or recipe that can directly kill prostate cancer cells. Some foods that may be helpful in prostate cancer recovery and relapse prevention include foods containing lycopene, beans, green tea, cruciferous vegetables and fruit like cranberries, strawberries, blueberries and pomegranates.
Prostate Cancer Treatment: Focal Therapy and Other Experimental Treatments
Several new and experimental treatments for prostate cancer are under study, including treatments that use ultrasound, lasers, tissue-freezing gas, and new ways of administering radiation. These new methods are types of focal therapy, that is, treatment focused on the cancer cells in the prostate, rather than systemic therapy that administers medications or other treatments to the whole body with the aim of treating the prostate.
Can Prostate Cancer Be Completely Cured?
Prostate cancer is the second most common cancer in men. Due to routine screening of prostate-specific antigen (PSA) levels in the United States, nearly 90% of prostate cancers get detected in early stages. When found early, there are several treatment options available and prostate cancer has a high chance of getting cured.
Prostate Cancer Early Signs and Symptoms
Difficulty with urination – frequency, weak stream, trouble getting started, etc. – is usually the first sign of prostate cancer. But these and other early symptoms of prostatic cancer can also come from benign prostate conditions, so diagnostic testing is important, including PSA tests and digital rectal exam.
What Are the Five Stages of Prostate Cancer?
The Gleason grading system grades prostate cancer from 1 to 5. According to cells’ appearances under a microscope, this system grades the most common (primary) and second most common (secondary) patterns of cells in a tissue sample collected via biopsy.
Prostate Cancer Facts
Prostate cancer is a leading cause of cancer and cancer death in males; in some men, identifying it early may prevent or delay metastasis and death from prostate cancer. The prostate is a walnut-shaped gland that is a part of the male reproductive system that wraps around the male urethra at it exits the bladder. Prostate cancer is common in men over 50 years of age, with the risk of developing prostate cancer increases with aging.
How Is Prostate Cancer Diagnosed?
Prostate cancer is largely a disease of men over 40, so it’s around this age doctors recommend the first prostate screening. The first exam is a blood test to determine if there are abnormal prostate specific antigen (PSA) levels in your blood – PSA is produced by the prostate. If the PSA is high, your doctor will perform a digital rectal exam, during which the doctor feels your prostate from inside your rectum with a gloved finger. Other diagnostic tests include an endoscopic biopsy of tumor tissue for analysis in a lab.
Early-Stage Prostate Cancer Treatment
If prostate cancer is detected early and appears to be slow-growing, invasive procedures, chemotherapy, radiation and other approaches can sometimes do more harm than good. Many prostate cancer treatments come with side effects, like incontinence or impotence, so it’s in the patient’s interest to put off invasive treatments as long as is medically safe. Active surveillance is where doctors "watch and wait" for changes that could prompt medical intervention.
What Is the Most Accurate Test for Prostate Cancer?
The most accurate test for detecting prostate cancer is a prostate biopsy, which involves taking a tissue sample from the prostate and examining it under a microscope.
Can Prostate Cancer Kill You?
Yes. Like any other cancer, prostate cancer is a potential killer. However, this is true of the metastasized prostate cancer that has remained undiagnosed for a long time. The disease is vastly curable when diagnosed early.
What Are the Key Signs of Prostate Cancer?
Learn the 23 key signs that may indicate the presence of prostate cancer below.
Prostate Cancer Treatment: Chemotherapy, Bone-Targeted and Immune Therapy
Doctors may introduce chemotherapy and immune therapy if other measures fail to cure a case of prostate cancer. However, unlike with other forms of cancer, chemotherapy isn’t the first choice for early prostate cancer. Immune therapy uses the body's own immune system to attack the prostate tumor, while bone-targeted therapy aims to preserve bone and prevent metastasis.
Can Prostate Cancer Be Detected by a Blood Test?
Prostate cancer develops in the prostate gland of men. It is one of the most common types of cancer. It is usually seen in men older than 50 years of age. The prostate is a small walnut-shaped gland that produces seminal fluid required to nourish and transports sperm. Prostate cancer develops slowly. More often, it is confined to the prostate gland, requiring minimal or no treatment.
Prostate Cancer Treatment: Hormonal Therapy
Prostate cancer is highly sensitive to, and dependent on, the level of the male hormone testosterone, which drives the growth of prostate cancer cells. Testosterone belongs to a family of hormones called androgens, and today front-line hormonal therapy for advanced and metastatic prostate cancer is called androgen deprivation therapy (ADT).
Prostate Cancer: Radical Prostatectomy Surgery
Radical prostatectomy, or surgical removal of the entire prostate gland, isn’t typically the first choice in prostate cancer treatment. Sometimes a radical approach is necessary to keep the cancer from metastasizing, however. Some cases are too severe or diagnosed too late for drugs or radiation to have much effect. In these cases, treatment teams may opt for a radical prostatectomy, despite potential side effects like impotence and incontinence.
Where Is the Prostate?
The prostate gland, commonly known as the prostate, is one of the male reproductive organs located just below the bladder, above the penis, and in front of the rectum. It is connected to the penis by a tube (urethra) that empties urine from the bladder. The size and shape of the prostate are similar to a walnut.
How Can I Make My Prostate Strong?
You can strengthen a weak prostate by eating healthy, staying active, maintaining a healthy weight, managing stress, and getting enough sleep.
Prostate Cancer: Radiation, Brachytherapy and Radiopharmaceuticals
Radiation treatment for prostate cancer is a powerful tool at doctors’ disposal. Using radiation vs. surgery or other invasive treatments to kill cancer cells may still cause side effects, but ideally they are less severe. Radiation therapy can be performed via external beam therapy (EBRT) or the placement of radioactive seeds into the prostate (prostate brachytherapy) or using radioactive drugs (radiopharmaceuticals).
What Are the 4 Stages of Prostate Cancer?
Prostate cancer is cancer that develops in the prostate glands of men. It is one of the most common types of cancer. It is usually seen in men older than 50 years of age. The prostate is a small walnut-shaped gland in men that produces seminal fluid. This fluid nourishes and transports sperm.
What Is the Latest Treatment for Prostate Cancer?
Prostate cancer affects 1 in 5 men. Learn how it is diagnosed and treated by doctors.
Prostate Infection: Causes, Symptoms, and Remedies
If the prostate gland becomes swollen and tender, it is called prostatitis or prostate infection. The prostate gland is a walnut-shaped organ that lies just below a man's urinary bladder.
When Should You Screen for Prostate Cancer?
Screening for prostate cancer helps detecta tumor early, enabling timely treatment and prevention of any complications. According to the American Cancer Society (ACS), the decision to get screened should be made by men in consultation with their doctor. The doctor needs to counsel the men about the uncertainties involved in the screening process, the risks and potential benefits of getting screened for prostate cancer.
What Are the Main Causes of Prostate Cancer?
The exact cause of prostate cancer is not known. Studies have revealed that prostate cancer occurs when the deoxyribonucleic acid (DNA) or genetic material of a normal prostate cell undergoes a sudden and abnormal change called a mutation.
What Are the Risk Factors for Prostate Cancer?
All men are at risk of prostate cancer; however, some men are at more risk than others. Apart from being male, current risk factors for prostate cancer include the following.
What Is Open Retropubic Prostatectomy?
Retropubic prostatectomy is a surgical treatment for patients with localized to advanced prostate cancer, in which the prostate and surrounding tissues are removed during the treatment.
How Does a Doctor Diagnose Prostate Cancer?
The prostate gland or prostate is a part of the male reproductive system. It is a small (almost walnut-sized) gland located just below the bladder and in front of the rectum (the last part of the large bowel), surrounding the urethra (the tube carrying urine out of the bladder). The prostate has two main functions: producing and storing fluid that helps make semen and regulating bladder control.
What Happens If You Are Diagnosed With Prostate Cancer?
A diagnosis with prostate cancer does not mean that a person’s life has come to a full stop. Many people with prostate cancer, if diagnosed early, go on to live for many years. If the disease is diagnosed in very early stages, the doctor may only keep the patient under surveillance and treat as required. However, the patient must make some changes in their life during and after the treatment.
How Is Prostate Cancer Screening Done?
There are no standard or routine screening tests for prostate cancer. Studies are being done to find ways to make prostate-specific antigen (PSA) testing more accurate for early cancer detection.
The Early Signs of Prostate Cancer
Prostate cancer in its early stages usually causes no signs and symptoms. Screening can help detect the cancer early.
Treatment & Diagnosis
- Enlarged Prostate BPH FAQs
- Prostate Cancer FAQs
- Prostate Cancer - New Criteria
- Prostate Cancer Risk May Be Lowered By Vitamin E
- Is Prostate Cancer Genetic?
- What Is the Prostate Cancer TNM Stage?
- What Does Prostate Cancer Do to You?
- How Do You Develop Prostate Cancer?
- What Are the Early Signs of Prostate Cancer?
- Prostatitis Symptoms
- Prostatitis Treatment
Medications & Supplements
Report Problems to the Food and Drug Administration
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.