OpenClaim

Dutasteride Side Effects

The most commonly reported side effects of dutasteride include dyspnoea, fatigue, and asthenia, based on 22,207 FDA adverse event reports from 2004 to 2025. 3.6% of reports found the drug to be ineffective.

Dutasteride side effects

Percentages show how often each reaction appears relative to total reports for dutasteride.

1
Dyspnoea4.9%1,096
2
Fatigue4.5%995
3
Asthenia3.7%811
4
Diarrhoea3.6%806
5
Drug Ineffective3.6%798
6
Off Label Use3.5%779
7
Fall3.4%762
8
Dizziness3.4%748
9
Drug Ineffective3.2%713
10
Malaise2.7%607
11
Death2.7%605
12
Nausea2.6%577
13
Cough2.5%553
14
Headache2.3%519
15
Arthralgia2.3%515

These are voluntary reports and do not establish that dutasteride caused these reactions.

Report severity

63.2%Serious14,030 reports
30.8%Hospitalizations6,840 reports
9.3%Fatal2,064 reports

Seriousness is determined by the reporter, not by OpenClaim.

Dutasteride drug interactions

Other drugs that appear in adverse event reports alongside dutasteride. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Tamsulosin-hydrochloride8.5%1,877
2
Lenalidomide3.1%690
3
Bisoprolol-fumarate2.8%616
4
Escitalopram-oxalate2.8%615
5
Apixaban2.7%601
6
Aspirin2.7%589
7
Atorvastatin-calcium2.6%583
8
Hydrochlorothiazide2.5%563
9
Diltiazem2.4%536
10
Furosemide2.3%519
11
Adalimumab2.2%495
12
Omeprazole2.1%476
13
Prednisone2.1%457
14
Metformin2.0%449
15
Fluticasone2.0%436

Taken alongside

1
Tamsulosin-hydrochloride22.9%5,088
2
Aspirin16.6%3,688
3
Atorvastatin-calcium12.4%2,754
4
Furosemide10.1%2,241
5
Amlodipine9.3%2,064
6
Acetaminophen8.6%1,906
7
Metoprolol8.3%1,833
8
Metformin8.0%1,771
9
Omeprazole7.7%1,707
10
Ergocalciferol7.6%1,687
11
Levothyroxine-sodium7.4%1,643
12
Rosuvastatin7.3%1,611
13
Pantoprazole-sodium7.0%1,547
14
Simvastatin6.8%1,517
15
Allopurinol6.1%1,350

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports dutasteride side effects

3.0% of dutasteride adverse event reports involve female patients and 89.0% involve male patients. The largest age group is elderly at 81%. These figures reflect who reports side effects, not underlying risk.

Sex

Female3.0%
Male89.0%
Unknown8.0%

Age group

< 20.1%
2–110.3%
12–17<0.1%
18–6418.1%
65+81.4%

What is dutasteride used for

Conditions and purposes for which patients were taking dutasteride when the adverse event was reported.

5-alpha Reductase Inhibition TherapyAccidental ExposureAccidental Exposure To ProductAcneAdenoma BenignAdverse EventAlopeciaAlopecia AreataAlopecia ScarringAlopecia TotalisAnaemia ProphylaxisAndrogen TherapyAndrogenetic AlopeciaAntiandrogen TherapyAntioestrogen Therapy

Showing 15 of 270 indications

Dutasteride brand names and reporting trend

Dutasteride is sold under the brand name Avodart.

Brand names

Avodart9,151

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking dutasteride with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.