What the label lists and what reports show
Dutasteride side effects
Dutasteride's FDA label: “The most common adverse reactions, reported in ≥1% of subjects treated with dutasteride and more commonly than in subjects treated with placebo, are impotence, decreased libido, ejaculation disorders, and breast disorders.” FAERS holds 8,084 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (803 reports).
- Generic listed
Check it at the source: the dutasteride FDA label on DailyMed (effective September 11, 2025, Aurobindo Pharma Limited); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of dutasteride capsules?Dutasteride capsules may cause serious side effects, including: Rare and serious allergic reactions, including: Swelling of your face, tongue, or throat Serious skin reactions, such as skin peeling Get medical help right away if you have these serious allergic reactions. Higher chance of a more serious form of prostate cancer. The most common side effects of dutasteride capsules include: trouble getting or keeping an erection (impotence)* a decrease in sex drive (libido)* ejaculation problems* enlarged or painful breasts. If you notice breast lumps or nipple discharge, you should talk to your healthcare provider. *Some of these events may continue after you stop taking dutasteride capsules. Depressed mood has been reported in patients receiving dutasteride capsules. Dutasteride capsules have been shown to reduce sperm count, semen volume, and sperm movement. […]
Source: FDA drug label, Aurobindo Pharma Limited, effective September 11, 2025 (SPL set b32611f3-50ec-45bb-a671-ea10cec7829d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions, reported in ≥1% of subjects treated with dutasteride and more commonly than in subjects treated with placebo, are impotence, decreased libido, ejaculation disorders, and breast disorders.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
This table is printed in the Dutasteride label published by Amneal Pharmaceuticals LLC of August 24, 2023; the label quoted above does not print one.
| Combination a Dutasteride Tamsulosin | (n = 1,610) (n = 1,623) (n = 1,611) | (n = 1,527) (n = 1,548) (n = 1,545) | (n = 1,428) (n = 1,464) (n = 1,468) | (n = 1,283) (n = 1,325) (n = 1,281) | (n = 1,200) (n = 1,200) (n = 1,112) |
|---|---|---|---|---|---|
| Combination | 7.8% | 1.6% | 1% | 0.5% | <0.1% |
| Dutasteride | 1.0% | 0.5% | 0.5% | 0.2% | 0.3% |
| Tamsulosin | 2.2% | 0.5% | 0.5% | 0.2% | 0.3% |
| Combination | 5.4% | 1.1% | 1.8% | 0.9% | 0.4% |
| Dutasteride | 4.0% | 1.1% | 1.6% | 0.6% | 0.3% |
| Tamsulosin | 2.6% | 0.8% | 1.0% | 0.6% | 1.1% |
| Combination | 4.5% | 0.9% | 0.8% | 0.2% | 0.0% |
| Dutasteride | 3.1% | 0.7% | 1.0% | 0.2% | 0.0% |
| Tamsulosin | 2.0% | 0.6% | 0.7% | 0.2% | <0.1% |
| Combination | 1.1% | 1.1% | 0.8% | 0.9% | 0.6% |
| Dutasteride | 0.9% | 0.9% | 1.2% | 0.5% | 0.7% |
| Tamsulosin | 0.4% | 0.4% | 0.4% | 0.2% | 0.0% |
| Combination | 1.1% | 0.4% | 0.1% | <0.1% | 0.2% |
| Dutasteride | 0.5% | 0.3% | 0.1% | <0.1% | <0.1% |
| Tamsulosin | 0.9% | 0.5% | 0.4% | <0.1% | 0.0% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe most common adverse reactions, reported in ≥1% of subjects treated with dutasteride and more commonly than in subjects treated with placebo, are impotence, decreased libido, ejaculation disorders, and breast disorders. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trial of another drug and may not reflect the rates observed in practice. From clinical trials with dutasteride as monotherapy or in combination with tamsulosin: The most common adverse reactions reported in subjects receiving dutasteride were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), and ejaculation disorders. The most common adverse reactions reported in subjects receiving combination therapy (dutasteride plus tamsulosin) were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders, and dizziness. Ejaculation disorders occurred significantly more in subjects receiving combination therapy (11%) compared with those receiving dutasteride (2%) or tamsulosin (4%) as monotherapy. …
Source: FDA drug label, Aurobindo Pharma Limited, effective September 11, 2025 (SPL set b32611f3-50ec-45bb-a671-ea10cec7829d), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,084 reports list dutasteride among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,106 are coded as a death and 3,080 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Dutasteride: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions