result was observed in 16% (81/502) of subjects receiving 0.4 mg tamsulosin hydrochloride vs. 11% (54/493) of subjects receiving placebo. Because orthostasis was detected more frequently in the tamsulosin-treated subjects than in placebo recipients, there is a potential risk of syncope [see Warnings and Precaution (5.1)].
Table 1. Adverse Reactions Reported Over a 24-Month Period in ≥1% of Subjects in Any Treatment Group (CombAT) by Time of Onset
|
Adverse Reactions |
Adverse Reaction Time of Onset |
|
Months 0-6 |
Months 7-12 |
Months 13-18 |
Months 19-24 |
|
Coadministration (n)a |
(n = 1,610) |
(n = 1,524) |
(n = 1,424) |
(n = 1,345) |
|
Dutasteride (n) |
(n = 1,623) |
(n = 1,547) |
(n = 1,457) |
(n = 1,378) |
|
Tamsulosin (n) |
(n = 1,611) |
(n = 1,542) |
(n = 1,468) |
(n = 1,363) |
|
Ejaculation disorders |
|
|
|
|
|
Combination |
7.6% |
1.6% |
0.4% |
<0.1% |
|
Dutasteride |
1.1% |
0.6% |
0.1% |
0.1% |
|
Tamsulosin |
2.2% |
0.5% |
0.4% |
0.1% |
|
Impotence |
|
|
|
|
|
Combination |
5.5% |
1.2% |
0.8% |
0.3% |
|
Dutasteride |
3.9% |
1.2% |
0.6% |
0.7% |
|
Tamsulosin |
2.7% |
0.8% |
0.4% |
0.4% |
|
Decreased libido |
|
|
|
|
|
Combination |
4.5% |
0.9% |
0.4% |
<0.1% |
|
Dutasteride |
3.3% |
0.6% |
0.7% |
0.2% |
|
Tamsulosin |
1.9% |
0.6% |
0.4% |
0.2% |
|
Dizziness |
|
|
|
|
|
Combination |
1.1% |
0.4% |
0.2% |
0.0% |
|
Dutasteride |
0.4% |
0.2% |
<0.1% |
<0.1% |
|
Tamsulosin |
0.9% |
0.5% |
0.3% |
0.1% |
|
Breast disordersb |
|
|
|
|
|
Combination |
1.0% |
|
