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Table 4 Adverse effects reported in double blind, placebo controlled trials of 3–48 months duration Significantly fewer adverse effects with finasteride than with placebo.

From: Finasteride in the treatment of clinical benign prostatic hyperplasia: A systematic review of randomised trials

Adverse effect

Number of studies

Time point (months)

Harmed with finasteride 5 mg

Harmed with placebo

Relative risk (95% CI)

NNT (95% CI)

   

Number

Percent

Number

Percent

  

Serious adverse effects

2

12

437/3557

12

150/1175

13

1.0 (0.8 to 1.1)

n/c

Any sexual dysfunction

1

12

239/1736

14

38/579

7

2.1 (1.5 to 2.9)

14 (10 to 22)

Decreased libido

5

12

269/5688

5

86/3296

3

2.0 (1.6 to 2.5)

47 (35 to 74)

Impotence

6

12

439/5394

8

117/3551

3

2.2 (1.8 to 2.7)

24 (20 to 31)

Ejaculation disorder

5

12

137/5688

2

19/3296

0.6

3.6 (2.2 to 6.0)

55 (43 to 74)

Acute urinary retention

3

12

17/3803

0.4

9/1430

0.6

0.8 (0.4 to 1.9)

n/c

 

1

24

24/1450

2

54/1452

4

0.5 (0.3 to 0.7)

49 (31 to 112)

 

1

48

42/1542

3

99/1516

7

0.4 (0.3 to 0.6)

26 (19 to 44)

BPH related surgery

5

12

54/4410

1

24/2035

1

1.1 (0.7 to 1.7)

n/c

 

2

24

85/1760

5

142/1755

8

0.6 (0.5 to 0.8)

31 (21 to 61)

 

1

48

69/1542

4

152/1516

10

0.5 (0.3 to 0.6)

18 14 to 27)

Prostate cancer

2

12

9/3557

0.3

5/1175

0.4

0.6 (0.2 to 0.8)

n/c

 

1

24

3/310

1

6/303

2

0.5 (0.1 to 1.9)

n/c

 

1

48

76/1524

0.5

76/1516

0.5

1.0 (0.7 to 1.4)

n/c

  1. n/c Not calculable NB: For acute urinary retention, prostate surgery, and prostate cancer the NNT represents the number-needed-to-treat to prevent one episode of acute urinary retention or prostate surgery