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Avodart

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Avodart

Avodart Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Avodart (dutasteride) is used to treat benign prostatic hyperplasia (BPH) in men with an enlarged prostate. It helps improve urinary flow and may also reduce the need for prostate surgery later. It is sometimes given with another medication called tamsulosin (Flomax). Avodart prevents the conversion of testosterone to dihydrotestosterone (DHT) in the body. This medication may be available in generic form. Common side effects include sexual problems (such as decreased sexual interest/ability, decrease in the amount of semen/sperm), 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 breast-feeding. 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Avodart in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Avodart Overview - Patient Information: Side Effects

SIDE EFFECTS: Sexual problems (such as decreased sexual interest/ability, decrease in the amount of semen/sperm), testicle pain/swelling, increased breast size, or breast tenderness may occur. Sexual problems have continued in some men even after stopping treatment. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Avodart (Dutasteride)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Avodart FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 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 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 Caucasian. 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%) [seeINDICATIONS 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 Caucasian. 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 Tamsulosin (CombAT) by Time of Onset

Adverse Reaction Adverse Reaction Time of Onset
Combinationa AVODART Tamsulosin Year 1 Year 2
(n = 1,428)
(n = 1,464)
(n = 1,468)
Year 3
(n = 1,283)
(n = 1,325)
(n = 1,281)
Year 4
(n = 1,200)
(n = 1,200)
(n = 1,112)
Months 0-6
(n = 1,610)
(n = 1,623)
(n = 1,611)
Months 7-12
(n = 1,527)
(n = 1,548)
(n = 1,545)
Ejaculation disordersb,c
  Combination 7.80% 1.60% 1.00% 0.50% < 0.1%
  AVODART 1.00% 0.50% 0.50% 0.20% 0.30%
  Tamsulosin 2.20% 0.50% 0.50% 0.20% 0.30%
Impotencec,d
  Combination 5.40% 1.10% 1.80% 0.90% 0.40%
  AVODART 4.00% 1.10% 1.60% 0.60% 0.30%
  Tamsulosin 2.60% 0.80% 1.00% 0.60% 1.10%
Decreased libidoc,e
  Combination 4.50% 0.90% 0.80% 0.20% 0.00%
  AVODART 3.10% 0.70% 1.00% 0.20% 0.00%
  Tamsulosin 2.00% 0.60% 0.70% 0.20% < 0.1%
Breast disordersf
  Combination 1.10% 1.10% 0.80% 0.90% 0.60%
  AVODART 0.90% 0.90% 1.20% 0.50% 0.70%
  Tamsulosin 0.40% 0.40% 0.40% 0.20% 0.00%
Dizziness
  Combination 1.10% 0.40% 0.10% < 0.1% 0.20%
  AVODART 0.50% 0.30% 0.10% < 0.1% < 0.1%
  Tamsulosin 0.90% 0.50% 0.40% < 0.1% 0.00%
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.
c These 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.
f Includes 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) »

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Avodart - User Reviews

Avodart User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Avodart sorted by most helpful. Patient Discussions FAQs

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.


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