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Dutasteride / tamsulosin Side Effects

For the Consumer

Applies to dutasteride / tamsulosin: oral capsule

Along with its needed effects, dutasteride/tamsulosin 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 / tamsulosin:

More Common

  • Chills
  • cold sweats
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

Less Common

  • Chest pain
  • cough or hoarseness
  • fever
  • lower back or side pain
  • painful or difficult urination

Incidence Not Known

  • Blistering, flaking, or peeling of the skin
  • blurred vision
  • difficulty with breathing
  • fast, irregular, pounding, or racing heartbeat or pulse
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • pain or swelling of the treated skin
  • painful or prolonged erection of the penis
  • shortness of breath
  • sweating
  • unusual tiredness or weakness

Some side effects of dutasteride / tamsulosin 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:

More Common

  • Change or problem with discharge of semen
  • decreased interest in sexual intercourse
  • dizziness
  • enlarged and painful breasts
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance

Less Common

  • Back pain
  • body aches or pain
  • congestion
  • diarrhea
  • dryness or soreness of the throat
  • headache
  • increased cough
  • lack or loss of strength
  • pain or tenderness around the eyes and cheekbones
  • runny nose
  • shortness of breath or troubled breathing
  • sleepiness or unusual drowsiness
  • sleeplessness
  • sneezing
  • stuffy nose
  • tender, swollen glands in the neck
  • tightness of the chest or wheezing
  • trouble sleeping
  • trouble with swallowing
  • unable to sleep
  • voice changes

Incidence Not Known

For Healthcare Professionals

Applies to dutasteride / tamsulosin: oral capsule

General

The most common adverse reactions were ejaculation disorders, impotence, decreased libido, breast disorders, and dizziness.[Ref]

Genitourinary

Very common (10% or more): Ejaculation disorders (up to 11%)

Common (1% to 10%): Impotence

Dutasteride:

Common (1% to 10%): Ejaculation disorders, impotence

Postmarketing reports: Testicular pain, testicular swelling

Tamsulosin:

Common (1% to 10%): Ejaculation disorders, impotence

Postmarketing reports: Priapism[Ref]

Psychiatric

Common (1% to 10%): Libido decreased

Dutasteride:

Common (1% to 10%): Libido decreased

Postmarketing reports: Depressed mood

Tamsulosin:

Common (1% to 10%): Libido decreased, insomnia[Ref]

Other

Common (1% to 10%): Breast disorders

Dutasteride:

Common (1% to 10%): Breast disorders

Postmarketing reports: Localized edema

Tamsulosin:

Common (1% to 10%): Asthenia, chest pain

Uncommon (0.1% to 1%): Breast disorders[Ref]

Nervous system

Common (1% to 10%): Dizziness

Dutasteride:

Uncommon (0.1% to 1%): Dizziness

Tamsulosin:

Common (1% to 10%): Somnolence

Uncommon (0.1% to 1%): Dizziness[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Cardiac failure

Dutasteride:

Uncommon (0.1% to 1%): Cardiac failure

Tamsulosin:

Very common (10% or more): Orthostatic hypotension (up to 16%)

Uncommon (0.1% to 1%): Cardiac failure

Postmarketing reports: Palpitations, atrial fibrillation, arrhythmia, tachycardia, hypotension[Ref]

Immunologic

Dutasteride:

Postmarketing reports: Hypersensitivity reactions

Tamsulosin:

Common (1% to 10%): Infection

Postmarketing reports: Hypersensitivity reactions[Ref]

Oncologic

Dutasteride:

Common (1% to 10%): Gleason score 8 to 10 prostate cancer

Frequency not reported: Male breast cancer[Ref]

Respiratory

Tamsulosin:

Common (1% to 10%): Rhinitis, pharyngitis, cough increased, sinusitis

Postmarketing reports: Respiratory problems, dyspnea, epistaxis[Ref]

Gastrointestinal

Tamsulosin:

Common (1% to 10%): Diarrhea

Postmarketing reports: Constipation, vomiting, dry mouth[Ref]

Musculoskeletal

Tamsulosin:

Common (1% to 10%): Back pain[Ref]

Dermatologic

Dutasteride:

Postmarketing reports: Rash, pruritus, urticaria, serious skin reactions, angioedema

Tamsulosin:

Postmarketing reports: Rash, urticaria, pruritus, angioedema, skin desquamation, Stevens-Johnson syndrome, erythema multiforme, dermatitis exfoliative[Ref]

Ocular

Tamsulosin:

Postmarketing reports: Blurred vision, visual impairment[Ref]

References

1. "Product Information. Jalyn (dutasteride-tamsulosin)." GlaxoSmithKline, Research Triangle Park, NC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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