Dutasteride Side Effects

Some side effects of dutasteride may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to dutasteride: oral capsule

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

Less serious side effects of dutasteride 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.

For Healthcare Professionals

Applies to dutasteride: oral capsule

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.

Cardiovascular

In the CombAT study (to determine if combination therapy with dutasteride and tamsulosin is more effective than either monotherapy alone), 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: Dutasteride, 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 dutasteride in men at risk for development of prostate cancer. The incidence of cardiac failure in subjects taking dutasteride was 0.6% (26/4,105) compared to 0.4% (15/4,126) in subjects on placebo. A majority of subjects with cardiac failure in both studies had co-morbidities 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 dutasteride, 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 study.

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