Dutasteride / Tamsulosin Side Effects
Medically reviewed by Drugs.com. Last updated on Sep 18, 2024.
Applies to dutasteride / tamsulosin: oral capsule.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
Women and children should not use this medicine. Pregnant women or women who may become pregnant should not handle or touch the capsules. Dutasteride can be absorbed through the skin and can cause birth defects in male fetuses. If a pregnant woman does come in contact with this medicine, the affected area should be washed right away with soap and water, especially if the capsule is broken.
Because this medicine may cause some people to become dizzy or feel faint, make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.
Dizziness, lightheadedness, or fainting may occur after you take this medicine, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help with this problem. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.
If you plan to have cataract surgery, tell your eye doctor (ophthalmologist) that you are taking this medicine or that you used this medicine in the previous 9 months. A serious eye problem called Intraoperative Floppy Iris Syndrome (IFIS) has occurred in some patients who were taking this medicine or who had recently taken this medicine when they had cataract surgery.
This medicine may affect the results of the prostate specific antigen (PSA) test, which may be used to detect prostate cancer. Make sure you tell all of your doctors that you are using this medicine.
This medicine will not prevent prostate cancer but may increase your risk of developing high-grade prostate cancer. Tell your doctor if you have concerns about this risk.
You should seek medical attention right away if you experience a prolonged erection while using this medicine. This is an extremely rare unwanted effect that must be treated right away to prevent permanent erectile damage (impotence).
Men who have taken this medicine should not donate blood until 6 months have passed since the last dose. Dutasteride can remain in your blood for a long time and be passed on to a pregnant woman who receives a blood transfusion.
This medicine does not usually affect normal sexual abilities for most men. You may notice that you ejaculate less fluid when you have sex.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Serious side effects
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 side effects
- chills
- cold sweats
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
Less common side effects
- 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
- sweating
- trouble breathing
- unusual tiredness or weakness
Other side effects
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 side effects
- 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 side effects
- 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
- sleepiness or unusual drowsiness
- sleeplessness
- sneezing
- stuffy nose
- tender, swollen glands in the neck
- tightness of the chest
- trouble sleeping
- trouble with swallowing
- unable to sleep
- voice changes
Incidence not known
- bloody nose
- constipation
- hives or welts, itching, skin rash
- joint or muscle pain
- red irritated eyes
- red skin lesion, often with a purple center
- redness of the skin
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- vomiting
For healthcare professionals
Applies to dutasteride / tamsulosin: oral capsule.
General adverse events
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]
See also:
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References
1. (2010) "Product Information. Jalyn (dutasteride-tamsulosin)." GlaxoSmithKline
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Further information
Dutasteride/tamsulosin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.