Dutasteride Side Effects

Brand Names: Avodart

Please note - some side effects for Dutasteride may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Dutasteride - for the Consumer

Dutasteride

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 Dutasteride:

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).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Dutasteride/Tamsulosin

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 Dutasteride/Tamsulosin:

Back pain; breast enlargement and/or tenderness; cough; decreased amount of semen released during sex; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; headache; light-headedness; runny or stuffy nose; sinus inflammation; sore throat; trouble sleeping; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); blurred vision; chest pain; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; prolonged, painful erection; red, swollen, blistered, or peeling skin; severe or persistent dizziness or light-headedness; shortness of breath.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

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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