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Dutasteride side effects

Approved for an enlarged prostate and used off-label for hair loss. What the Avodart label and the hair loss trials show, and where it differs from finasteride.

By the RxLineup editorial team · Fact-checked against provider sites and FDA labels · Updated  · 7 min read

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In short

  1. Dutasteride (Avodart) is FDA-approved only for an enlarged prostate (BPH); prescribing it for hair loss is off-label in the US, and many hair products sold online are compounded.
  2. In BPH trials of over 4,300 men, impotence affected 4.7% on dutasteride vs 1.7% on placebo in the first 6 months, decreased libido 3.0% vs 1.4% and ejaculation disorders 1.4% vs 0.5%, and rates fell after that.
  3. The label says these sexual effects may persist after stopping, and that dutasteride’s role in that persistence is unknown.
  4. In a 24-week trial of 917 men with hair loss, adverse events were similar in number and severity on dutasteride, finasteride and placebo, and a meta-analysis of 3 trials (576 men) found no significant difference in sexual side effects between the two drugs.
  5. Dutasteride’s half-life is about 5 weeks and it stays detectable for 4 to 6 months after the last dose, so the label says not to donate blood for 6 months.
  6. In healthy men, total sperm count was 23% lower after 52 weeks and still 23% lower 24 weeks after stopping.

The most common dutasteride side effects are sexual: impotence, lower libido and ejaculation problems, plus breast enlargement or tenderness. On the Avodart label, impotence affected 4.7% of men in the first 6 months against 1.7% on placebo, and the rates dropped after that; in hair loss trials, side effects were similar to finasteride’s.

Dutasteride is FDA-approved only for symptoms of an enlarged prostate (BPH), so prescribing it for hair loss in the US is off-label, and many of the hair products sold online are compounded. Most of the side effect data come from older men in prostate trials, with smaller and shorter hair loss trials in younger men. Here is what each shows.

Side effects on the label, by time on the drug

The label’s main table pools three 2-year BPH trials of more than 4,300 men (mean age 66). It shows drug-related side effects by when they started:

Scroll sideways to see the full table

Side effectMonths 0 to 6Months 7 to 12Months 13 to 18Months 19 to 24
Impotence, dutasteride4.7%1.4%1.0%0.8%
Impotence, placebo1.7%1.5%0.5%0.9%
Decreased libido, dutasteride3.0%0.7%0.3%0.3%
Decreased libido, placebo1.4%0.6%0.2%0.1%
Ejaculation disorders, dutasteride1.4%0.5%0.5%0.1%
Ejaculation disorders, placebo0.5%0.3%0.1%0.0%
Breast enlargement or tenderness, dutasteride0.5%0.8%1.1%0.6%
Breast enlargement or tenderness, placebo0.2%0.3%0.3%0.1%

Two patterns stand out. The sexual effects were concentrated in the first 6 months, and after the first year new cases on dutasteride were close to placebo. Breast changes ran the other way, appearing later and staying above placebo through year 2. Across the three 4-year trials, the label found no rise in sexual effects or breast disorders with longer treatment. Withdrawal for side effects was 4% on dutasteride and 3% on placebo, most often for impotence (1%).

Dutasteride sexual side effects

Two points on the label matter most here. First, it says these sexual effects “may persist after treatment discontinuation” and that dutasteride’s role in that persistence is unknown. Second, they were more common when dutasteride was combined with tamsulosin for BPH: in a 4-year trial, ejaculation disorders affected 11% on the combination against 2% on dutasteride alone.

The hair loss trials, in younger men, found less difference from placebo:

  • Gubelin Harcha, 2014: 917 men aged 20 to 50 took dutasteride (0.02, 0.1 or 0.5 mg), finasteride 1 mg or placebo for 24 weeks. The number and severity of adverse events were similar across groups (study).
  • Eun, 2010: 153 men aged 18 to 49 took 0.5 mg or placebo for 6 months, with no major difference in adverse events (study).
  • Tsunemi, 2016: 120 Japanese men took 0.5 mg for 52 weeks without a placebo group. Drug-related adverse events affected 17%, none led to withdrawal, and the most frequent events were colds, erectile dysfunction and decreased libido, mostly mild (study).

A 2016 meta-analysis of 17 randomized trials of both drugs found the same split. In men with BPH, the drugs raised the risk of sexual dysfunction (relative risk 2.56); in men with hair loss, the increase was not statistically significant (1.21) (Liu et al.). The hair loss trials were smaller and the men younger, so rare effects are harder to detect in them.

Semen and fertility

The label reports a study of healthy men aged 18 to 52 who took dutasteride 0.5 mg or placebo for 52 weeks. Compared with placebo, total sperm count fell 23%, semen volume 26% and sperm motility 18%, while sperm concentration and shape were unchanged. Twenty-four weeks after stopping, total sperm count was still 23% below baseline, and 2 men had drops of more than 90% at 52 weeks with only partial recovery. Average values stayed in the normal range, and the label says the effect on any one man’s fertility is not known. If you are trying to conceive, tell your prescriber before starting.

Breast changes

Breast enlargement and tenderness are listed as common, and male breast cancer appears among reports received after approval. In the three 4-year BPH trials there was 1 case of breast cancer on dutasteride and 1 on placebo, and none in two other 4-year trials. The label says the link between long-term use and male breast tumors is unknown. Tell your prescriber about any breast lump or change.

Mood and other reported effects

Since approval, the label lists reports of depressed mood, testicular pain and swelling, and allergic reactions including rash, itching, hives, swelling, serious skin reactions and angioedema. These reports show a problem has occurred, not how often or that the drug caused it. Contact a clinician the same day about thoughts of self-harm, or call or text 988 in the US.

PSA and prostate cancer

Dutasteride lowers PSA, the prostate cancer screening test, by about 50% within 3 to 6 months. The label says a PSA result in a man on dutasteride for 3 months or more should be doubled before comparing it with normal ranges, and any confirmed rise from the lowest value should be checked. In the 4-year REDUCE trial of 8,231 men aged 50 to 75, high-grade (Gleason 8 to 10) prostate cancer was found in 1.0% on dutasteride against 0.5% on placebo. Finasteride carries the same class warning.

Pregnancy, handling and blood donation

  • Pregnancy: dutasteride is contraindicated in women who are pregnant, because it can affect the genital development of a male fetus.
  • Handling: women who are or may be pregnant should not handle the capsules, because dutasteride can be absorbed through the skin. A pregnant woman who touches a leaking capsule should wash the area right away with soap and water.
  • Swallow whole: the capsule contents can irritate the mouth and throat, so don’t chew or open them.
  • Blood donation: wait at least 6 months after your last dose, so donated blood can’t reach a pregnant woman.
  • Semen: dutasteride is found in semen, but the label estimates a female partner’s exposure at about 100 times below the levels that harmed male fetuses in animal studies.
  • Interactions: the label advises caution with strong, long-term CYP3A4 inhibitors such as ritonavir, because the body clears dutasteride through CYP3A4 and CYP3A5 enzymes.

Dutasteride vs finasteride side effects

Dutasteride 0.5 mgFinasteride 1 mg
Approved for hair lossNo; off-label in the USYes, men only
Enzyme blocked5-alpha reductase types 1 and 2Type 2
Blood DHTDown 85% after 1 week and 90% after 2 weeksDown 65% within 24 hours of a dose
Half-lifeAbout 5 weeksAbout 5 to 6 hours in men 18 to 60
Early sexual effectsImpotence 4.7% vs 1.7% placebo, months 0 to 6 (BPH trials)Erectile dysfunction 1.3% vs 0.7% placebo, year 1 (hair loss trials)
Persisting after stoppingLabel says may persist; role unknownPostmarketing reports of persisting sexual problems
Mood reportsDepressed moodDepression, suicidal ideation and behavior
Blood donation wait6 monthsNone on the label

The rows on sexual effects come from different trial populations, so they aren’t a direct comparison. Head to head, the 917-man trial found similar adverse events, and a 2019 meta-analysis of 3 trials with 576 men found no significant difference in altered libido, erectile dysfunction or ejaculation disorders between the two drugs (Zhou et al.). The practical differences are how deeply and how long dutasteride acts: it suppresses more DHT, takes months to clear, and needs the blood donation wait. See finasteride side effects and dutasteride vs finasteride for results and cost.

Compounded and topical dutasteride

The trials above tested oral dutasteride capsules. Online, dutasteride for hair loss is often sold as a compounded capsule at low or custom strengths, or as a topical gel or solution, and those products are not FDA-approved and were not part of these trials. At the providers we compare that publish a monthly price, dutasteride hair products cost $39 to $69 a month as of October 2026, from Strut Health’s compounded oral capsule at $39 to its topical at $69. In between, Happy Head lists compounded oral dutasteride at $42 a month ($34 a month on a 12-month supply), and RxSpan MD lists dutasteride capsules at $59 a month with the consult, shipping and support included. Compare them on our hair loss providers list.

The bottom line

Dutasteride’s side effects look much like finasteride’s: uncommon sexual effects that cluster in the first months, breast tenderness, lower PSA and the same pregnancy rules. What sets it apart is how long it lasts, with a 5-week half-life, a 6-month blood donation wait and a sperm count drop still present 24 weeks after stopping. It is off-label for hair loss in the US. See the dutasteride page for the full label summary, compare finasteride 1 mg vs 5 mg, or compare providers on our hair loss providers list and hair loss hub.

Highest-scored hair loss providers

The three hair loss providers with our highest overall scores right now.

  1. 01

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    MyDrHank

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Questions, answered

What are the most common side effects of dutasteride?

The label lists impotence, decreased libido, ejaculation disorders and breast disorders (enlargement and tenderness) as the most common, each reported in at least 1% of men and more often than on placebo. In the BPH trials, impotence affected 4.7% of men on dutasteride vs 1.7% on placebo in the first 6 months.

Are dutasteride sexual side effects permanent?

For most men in the trials they were not: new reports fell sharply after the first 6 months, and longer treatment did not raise them. The label does say the sexual effects may persist after stopping, and that dutasteride’s role in that persistence is unknown, so raise any lasting change with your prescriber.

Does dutasteride have more side effects than finasteride?

In hair loss trials, not measurably. In a 24-week trial of 917 men, adverse events were similar across dutasteride, finasteride and placebo, and a 2019 meta-analysis found no significant difference in altered libido, erectile dysfunction or ejaculation disorders. Dutasteride lowers DHT more and lasts much longer in the body, which is why it carries a 6-month blood donation wait.

How long does dutasteride stay in your system?

Its half-life is about 5 weeks, and blood levels stay detectable for 4 to 6 months after the last dose, according to the label. In a study of healthy men, total sperm count was still 23% below baseline 24 weeks after stopping.

Does dutasteride cause depression?

The label lists depressed mood among reports received after approval. Those reports can’t show how often it happens or prove the drug caused it. Tell your prescriber about any history of depression, and contact them about any change in mood; in the US, call or text 988 in a crisis.

Is topical dutasteride safer than the capsule?

It is sold as a way to cut exposure in the rest of the body, but the compounded topicals sold online are not FDA-approved and were not part of the trials described here, which tested oral dutasteride. Their side effects haven’t been measured the same way.

Sources

  1. Avodart (dutasteride) prescribing information, Waylis Therapeutics, DailyMed (published Mar 17, 2025, read Oct 27, 2026)
  2. Propecia (finasteride 1 mg) prescribing information, DailyMed (updated Oct 14, 2024, read Oct 27, 2026)
  3. Gubelin Harcha et al., dutasteride vs finasteride and placebo in 917 men, J Am Acad Dermatol 2014
  4. Eun et al., dutasteride 0.5 mg vs placebo in 153 men with hair loss, J Am Acad Dermatol 2010
  5. Tsunemi et al., 52-week safety of dutasteride in 120 men with hair loss, J Dermatol 2016
  6. Zhou et al., dutasteride vs finasteride for androgenetic alopecia, a meta-analysis, Clin Interv Aging 2019
  7. Liu et al., 5-alpha reductase inhibitors and sexual function, a meta-analysis of randomized trials, J Sex Med 2016
  8. 988 Suicide & Crisis Lifeline

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