Applies to dutasteride: oral capsule liquid filled.

Serious side effects of Dutasteride

Along with its needed effects, dutasteride may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dutasteride:

Rare

• Chest pain or discomfort
• dilated neck veins
• extreme fatigue
• irregular breathing
• irregular heartbeat
• swelling of the face, fingers, feet, or lower legs
• trouble breathing
• weight gain

Incidence not known

• Blistering, flaking, or peeling of the skin
• cough
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives or welts, itching skin, rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• tightness in the chest
• unusual tiredness or weakness

Other side effects of Dutasteride

Some side effects of dutasteride may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Abnormal ejaculation
• decreased interest in sexual intercourse
• decreased sexual performance or desire
• impotence
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• pain, soreness, swelling, or discharge from the breast or breasts

For Healthcare Professionals

Applies to dutasteride: oral capsule.

Other

Common (1% to 10%): Impotence, decreased libido, ejaculation disorders, breast disorders

Postmarketing reports: Testicular pain and swelling^[Ref]

-Impotence, decreased libido, and ejaculation disorders may persist after treatment discontinuation; this drug's role in this persistence is unknown.

-Ejaculation disorders included anorgasmia, retrograde ejaculation, decreased semen volume, decreased orgasmic sensation, abnormal orgasm, delayed ejaculation, ejaculation failure, and premature ejaculation.

-Breast disorders include breast enlargement, gynecomastia, breast swelling, breast pain, breast tenderness, nipple pain, and nipple swelling.^[Ref]

Oncologic

Common (1% to 10%): High-grade prostate cancer

Frequency not reported: Male breast cancer^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Cardiac failure^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Alopecia (primarily body hair loss), hypertrichosis^[Ref]

Nervous system

Uncommon (0.1% to 1%): Dizziness, nervous system disorders^[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions (e.g., rash, pruritus, urticaria, localized edema, serious skin reactions, angioedema)^[Ref]

Psychiatric

Postmarketing reports: Depressed mood^[Ref]