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Avodart Side Effects

Please note - some side effects for Avodart may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

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 to rates in the clinical trial of another drug and may not reflect the rates observed in practice.

Monotherapy:

The most common adverse reactions reported in subjects receiving Avodart were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), and ejaculation disorders.
Study withdrawal due to adverse reactions occurred in 4% of subjects receiving Avodart and 3% of subjects receiving placebo. The most common adverse reaction leading to study withdrawal was impotence (1%).

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 studies, each with 2-year open-label extensions. 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% Caucasian. 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 Studies Pooled) by Time of Onset
* Includes breast tenderness and breast enlargement.
Adverse Reactions	Adverse Reaction Time of Onset
Adverse Reactions	Month 0-6	Month 7-12	Month 13-18	Month 19-24
Avodart (n)	(n = 2,167)	(n = 1,901)	(n = 1,725)	(n = 1,605)
Placebo (n)	(n = 2,158)	(n = 1,922)	(n = 1,714)	(n = 1,555)
Impotence
Avodart	4.7%	1.4%	1.0%	0.8%
Placebo	1.7%	1.5%	0.5%	0.9%
Decreased libido
Avodart	3.0%	0.7%	0.3%	0.3%
Placebo	1.4%	0.6%	0.2%	0.1%
Ejaculation disorders
Avodart	1.4%	0.5%	0.5%	0.1%
Placebo	0.5%	0.3%	0.1%	0.0%
Breast disorders*
Avodart	0.5%	0.8%	1.1%	0.6%
Placebo	0.2%	0.3%	0.3%	0.1%

Long-Term Treatment (Up to 4 Years): There is no evidence of increased drug-related sexual adverse reactions (impotence, decreased libido, and ejaculation disorder) or breast disorders with increased duration of treatment. The relationship between long-term use of Avodart and male breast neoplasia is currently unknown.

Combination with Alpha-Blocker Therapy (CombAT):

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. Over 2 years of treatment, drug-related ejaculation disorders occurred more frequently in subjects receiving combination therapy (9%) compared to Avodart (2%) or tamsulosin (3%) as monotherapy.
Study withdrawal due to adverse reactions occurred in 5% of subjects receiving combination therapy (Avodart plus tamsulosin) and 3% of subjects receiving Avodart or tamsulosin as monotherapy. The most common adverse reaction leading to study withdrawal in subjects receiving combination therapy was impotence (1%).

Over 4,800 male subjects with BPH were randomly assigned to receive either 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 study. Adverse reaction information over the first 2 years of treatment is presented below; information for years 2 to 4 is not yet available as the study is ongoing. During the first 2 years, 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% Caucasian. Table 2 summarizes adverse reactions reported in at least 1% of subjects in any treatment group.

Table 2. Adverse Reactions Reported Over a 24-Month Period in ≥1% of Subjects in Any Treatment Group (CombAT) by Time of Onset
* Combination = Avodart 0.5 mg once daily plus tamsulosin 0.4 mg once daily.
† Includes breast tenderness and breast enlargement.
Adverse Reactions	Adverse Reaction Time of Onset
Adverse Reactions	Month 0-6	Month 7-12	Month 13-18	Month 19-24
Combination (n)*	(n = 1,610)	(n = 1,524)	(n = 1,424)	(n = 1,345)
Avodart (n)	(n = 1,623)	(n = 1,547)	(n = 1,457)	(n = 1,378)
Tamsulosin (n)	(n = 1,611)	(n = 1,542)	(n = 1,468)	(n = 1,363)
Impotence
Combination	5.5%	1.2%	0.8%	0.3%
Avodart	3.9%	1.2%	0.6%	0.7%
Tamsulosin	2.7%	0.8%	0.4%	0.4%
Decreased libido
Combination	4.5%	0.9%	0.4%	<0.1%
Avodart	3.3%	0.6%	0.7%	0.2%
Tamsulosin	1.9%	0.6%	0.4%	0.2%
Ejaculation disorders
Combination	7.6%	1.6%	0.4%	<0.1%
Avodart	1.1%	0.6%	0.1%	0.1%
Tamsulosin	2.2%	0.5%	0.4%	0.1%
Breast disorders†
Combination	1.0%	1.1%	0.7%	0.3%
Avodart	0.9%	1.0%	0.8%	0.5%
Tamsulosin	0.4%	0.4%	0.2%	0.1%
Dizziness
Combination	1.1%	0.4%	0.2%	0.0%
Avodart	0.4%	0.2%	<0.1%	<0.1%
Tamsulosin	0.9%	0.5%	0.3%	0.1%

Postmarketing Experience

The following adverse reactions have been identified during postapproval 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.