Avodart Side Effects

Generic Name: dutasteride

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).

Side Effects of Avodart - for the Consumer

Avodart

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Avodart:

Breast enlargement and/or tenderness; decreased sex drive; decreased volume of ejaculate; inability to have an erection.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness).

Avodart Side Effects - for the Professional

Avodart

The most common adverse reactions, reported in ≥1% of patients treated with Avodart and more commonly than in patients treated with placebo, are impotence, decreased libido, ejaculation disorders, and breast disorders. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Side Effects by Body System

General

In general, side effects have been mild and transient.

Genitourinary

The incidence of sexual adverse events has been reported to decrease with duration of treatment. After the first 6 months of treatment, the incidence of onset of impotence, decreased libido, ejaculation disorders, or gynecomastia was less than 1%. The adverse event profile for one two year study (n=677) reported that the onset of drug-related events was lower during the second year of treatment compared with the first , except for gynecomastia which was reported at 1% during the first year and 2 % during the second year.

Genitourinary side effects including impotence (up to 4.7%), decreased libido (up to 3.0%), ejaculation disorders (up to 1.4%), and gynecomastia (up to 1.1%) have been reported.

Hypersensitivity

Hypersensitivity side effects have been reported including allergic reactions such as angioedema, rash, pruritus, urticaria, and localized edema. Serious skin reactions have been reported during postmarketing experience.

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