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Avodart

Last reviewed on RxList: 6/13/2018
Avodart Side Effects Center

Last reviewed on RxList 6/13/2018

Avodart (dutasteride) is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase used to treat benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Avodart helps improve urinary flow and may also reduce the need for prostate surgery later. Avodart is sometimes given with another medication called tamsulosin (Flomax). Avodart prevents the conversion of testosterone to dihydrotestosterone (DHT) in the body. Avodart may be available in generic form. Common side effects of Avodart include:

  • sexual problems (such as decreased sexual interest/ability, decrease in the amount of semen/sperm released during sex),
  • impotence (trouble getting or keeping an erection),
  • testicle pain or swelling,
  • increased breast size, or
  • breast tenderness.

The recommended dose of Avodart is 1 capsule (0.5 mg) taken once daily. Avodart may interact with conivaptan, imatinib, isoniazid, antibiotics, antifungal medications, antidepressants, heart or blood pressure medications, or HIV/AIDS medicine. Tell your doctor all medications you use. Avodart is not usually used in women. Therefore, it is unlikely to be used during pregnancy or breastfeeding. Consult your doctor if you have questions.

Our Avodart (dutasteride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avodart Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

  • decreased libido (sex drive);
  • decreased amount of semen released during sex;
  • impotence (trouble getting or keeping an erection); or
  • breast tenderness or enlargement.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Avodart (Dutasteride)

Avodart Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trial of another drug and may not reflect the rates observed in practice.

From clinical trials with AVODART as monotherapy or in combination with tamsulosin:

  • The most common adverse reactions reported in subjects receiving AVODART were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), and ejaculation disorders. The most common adverse reactions reported in subjects receiving combination therapy (AVODART plus tamsulosin) were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders, and dizziness. Ejaculation disorders occurred significantly more in subjects receiving combination therapy (11%) compared with those receiving AVODART (2%) or tamsulosin (4%) as monotherapy.
  • Trial withdrawal due to adverse reactions occurred in 4% of subjects receiving AVODART, and 3% of subjects receiving placebo in placebo-controlled trials with AVODART. The most common adverse reaction leading to trial withdrawal was impotence (1%).
  • In the clinical trial evaluating the combination therapy, trial withdrawal due to adverse reactions occurred in 6% of subjects receiving combination therapy (AVODART plus tamsulosin) and 4% of subjects receiving AVODART or tamsulosin as monotherapy. The most common adverse reaction in all treatment arms leading to trial withdrawal was erectile dysfunction (1% to 1.5%).

Monotherapy

Over 4,300 male subjects with BPH were randomly assigned to receive placebo or 0.5-mg daily doses of AVODART in 3 identical 2-year, placebo-controlled, double-blind, Phase 3 treatment trials, each followed by a 2-year open-label extension. During the double-blind treatment period, 2,167 male subjects were exposed to AVODART, including 1,772 exposed for 1 year and 1,510 exposed for 2 years. When including the open-label extensions, 1,009 male subjects were exposed to AVODART for 3 years and 812 were exposed for 4 years. The population was aged 47 to 94 years (mean age: 66 years) and greater than 90% were white. Table 1 summarizes clinical adverse reactions reported in at least 1% of subjects receiving AVODART and at a higher incidence than subjects receiving placebo.

Table 1. Adverse Reactions Reported in ≥1% of Subjects over a 24-Month Period and More Frequently in the Group Receiving AVODART than the Placebo Group (Randomized, Double- blind, Placebo-controlled Trials Pooled) by Time of Onset

Adverse Reaction AVODART (n) Placebo (n) Adverse Reaction Time of Onset
Months 0 6
(n = 2,167)
(n = 2,158)
Months 7 12
(n = 1,901)
(n = 1,922)
Months 13 18
(n = 1,725)
(n = 1,714)
Months 19 24
(n = 1,605)
(n = 1,555)
Impotencea
  AVODART 4.7% 1.4% 1.0% 0.8%
  Placebo 1.7% 1.5% 0.5% 0.9%
Decreased libidoa
  AVODART 3.0% 0.7% 0.3% 0.3%
  Placebo 1.4% 0.6% 0.2% 0.1%
Ejaculation disordersa
  AVODART 1.4% 0.5% 0.5% 0.1%
  Placebo 0.5% 0.3% 0.1% 0.0%
Breast disordersb
  AVODART 0.5% 0.8% 1.1% 0.6%
  Placebo 0.2% 0.3% 0.3% 0.1%
aThese sexual adverse reactions are associated with dutasteride treatment (including monotherapy and combination with tamsulosin). These adverse reactions may persist after treatment discontinuation. The role of dutasteride in this persistence is unknown.
bIncludes breast tenderness and breast enlargement.

Long-Term Treatment (Up To 4 Years)

High-grade Prostate Cancer

The REDUCE trial was a randomized, double-blind, placebo-controlled trial that enrolled 8,231 men aged 50 to 75 years with a serum PSA of 2.5 ng/mL to 10 ng/mL and a negative prostate biopsy within the previous 6 months. Subjects were randomized to receive placebo (n = 4,126) or 0.5-mg daily doses of AVODART (n = 4,105) for up to 4 years. The mean age was 63 years and 91% were white. Subjects underwent protocol-mandated scheduled prostate biopsies at 2 and 4 years of treatment or had “for-cause biopsies” at non-scheduled times if clinically indicated. There was a higher incidence of Gleason score 8-10 prostate cancer in men receiving AVODART (1.0%) compared with men on placebo (0.5%) [see INDICATIONS AND USAGE, WARNINGS AND PRECAUTIONS]. In a 7-year placebo-controlled clinical trial with another 5 alpha-reductase inhibitor (finasteride 5 mg, PROSCAR), similar results for Gleason score 8-10 prostate cancer were observed (finasteride 1.8% versus placebo 1.1%).

No clinical benefit has been demonstrated in patients with prostate cancer treated with AVODART.

Reproductive And Breast Disorders

In the 3 pivotal placebo-controlled BPH trials with AVODART, each 4 years in duration, there was no evidence of increased sexual adverse reactions (impotence, decreased libido, and ejaculation disorder) or breast disorders with increased duration of treatment. Among these 3 trials, there was 1 case of breast cancer in the dutasteride group and 1 case in the placebo group. No cases of breast cancer were reported in any treatment group in the 4-year CombAT trial or the 4-year REDUCE trial.

The relationship between long-term use of dutasteride and male breast neoplasia is currently unknown.

Combination With Alpha-Blocker Therapy (CombAT)

Over 4,800 male subjects with BPH were randomly assigned to receive 0.5-mg AVODART, 0.4-mg tamsulosin, or combination therapy (0.5-mg AVODART plus 0.4-mg tamsulosin) administered once daily in a 4-year double-blind trial. Overall, 1,623 subjects received monotherapy with AVODART; 1,611 subjects received monotherapy with tamsulosin; and 1,610 subjects received combination therapy. The population was aged 49 to 88 years (mean age: 66 years) and 88% were white. Table 2 summarizes adverse reactions reported in at least 1% of subjects in the combination group and at a higher incidence than subjects receiving monotherapy with AVODART or tamsulosin.

Table 2. Adverse Reactions Reported over a 48-Month Period in ≥1% of Subjects and More Frequently in the Coadministration Therapy Group than the Groups Receiving Monotherapy with AVODART or Tamsulos in (CombAT) by Time of Onset

Adverse Reaction Adverse Reaction Time of Onset
Year 1Year 2 Year 3 Year 4
Months 0 6 Months 7 12
Combination3 (n = 1,610) (n = 1,527) (n = 1,428) (n = 1,283) (n = 1,200)
AVODART (n = 1,623) (n = 1,548) (n = 1,464) (n = 1,325) (n = 1,200)
Tamsulosin (n = 1,611) (n = 1,545) (n = 1,468) (n = 1,281) (n = 1,112)
Ejaculation disordersb,c          
Combination 7.8% 1.6% 1.0% 0.5% <0.1%
AVODART 1.0% 0.5% 0.5% 0.2% 0.3%
Tamsulosin 2.2% 0.5% 0.5% 0.2% 0.3%
Impotencec,d          
Combination 5.4% 1.1% 1.8% 0.9% 0.4%
AVODART 4.0% 1.1% 1.6% 0.6% 0.3%
Tamsulosin 2.6% 0.8% 1.0% 0.6% 1.1%
Decreased libidoc,e          
Combination 4.5% 0.9% 0.8% 0.2% 0.0%
AVODART 3.1% 0.7% 1.0% 0.2% 0.0%
Tamsulosin 2.0% 0.6% 0.7% 0.2% <0.1%
Breast disordersf          
Combination 1.1% 1.1% 0.8% 0.9% 0.6%
AVODART 0.9% 0.9% 1.2% 0.5% 0.7%
Tamsulosin 0.4% 0.4% 0.4% 0.2% 0.0%
Dizziness          
Combination 1.1% 0.4% 0.1% <0.1% 0.2%
AVODART 0.5% 0.3% 0.1% <0.1% <0.1%
Tamsulosin 0.9% 0.5% 0.4% <0.1% 0.0%
aCombination = AVODART 0.5 mg once daily plus tamsulosin 0.4 mg once daily.
bIncludes anorgasmia, retrograde ejaculation, semen volume decreased, orgasmic sensation decreased, orgasm abnormal, ejaculation delayed, ejaculation disorder, ejaculation failure, and premature ejaculation.
cThese sexual adverse reactions are associated with dutasteride treatment (including monotherapy and combination with tamsulosin). These adverse reactions may persist after treatment discontinuation. The role of dutasteride in this persistence is unknown.
dIncludes erectile dysfunction and disturbance in sexual arousal.
eIncludes libido decreased, libido disorder, loss of libido, sexual dysfunction, and male sexual dysfunction.
fIncludes breast enlargement, gynecomastia, breast swelling, breast pain, breast tenderness, nipple pain, and nipple swelling.

Cardiac Failure

In CombAT, after 4 years of treatment, the incidence of the composite term cardiac failure in the combination therapy group (12/1,610; 0.7%) was higher than in either monotherapy group: AVODART, 2/1,623 (0.1%) and tamsulosin, 9/1,611 (0.6%). Composite cardiac failure was also examined in a separate 4-year placebo-controlled trial evaluating AVODART in men at risk for development of prostate cancer. The incidence of cardiac failure in subjects taking AVODART was 0.6% (26/4,105) compared with 0.4% (15/4,126) in subjects on placebo. A majority of subjects with cardiac failure in both trials had comorbidities associated with an increased risk of cardiac failure. Therefore, the clinical significance of the numerical imbalances in cardiac failure is unknown. No causal relationship between AVODART alone or in combination with tamsulosin and cardiac failure has been established. No imbalance was observed in the incidence of overall cardiovascular adverse events in either trial.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of AVODART. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to AVODART.

Immune System Disorders

Hypersensitivity reactions, including rash, pruritus, urticaria, localized edema, serious skin reactions, and angioedema.

Neoplasms

Male breast cancer.

Psychiatric Disorders

Depressed mood.

Reproductive System And Breast Disorders

Testicular pain and testicular swelling.

Read the entire FDA prescribing information for Avodart (Dutasteride)

Related Resources for Avodart

Read the Avodart User Reviews »

© Avodart Patient Information is supplied by Cerner Multum, Inc. and Avodart Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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