6 ADVERSE REACTIONS
6.1 Clinical Studies 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Tadalafil was administered to over 6550 men during clinical trials worldwide. In trials of CIALIS for once daily use, a total of 716, 389, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively. For CIALIS for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively.
CIALIS for Use as Needed
?In eight primary placebo-controlled Phase 3 studies of 12 weeks duration, mean age was 59 years (range 22 to 88) and the discontinuation rate due to adverse events in patients treated with tadalafil 10 or 20 mg was 3.1%, compared to 1.4% in placebo treated patients.
When taken as recommended in the placebo-controlled clinical trials, the following adverse events were reported (see Table 1) for CIALIS for use as needed:
Table 1: Treatment-Emergent Adverse Events Reported by ≥2% of Patients Treated with CIALIS (10 or 20 mg) and More
Frequent on Drug than Placebo in the Eight Primary Placebo-Controlled Phase 3 Studies (Including a Study in Patients with Diabetes) for CIALIS for Use as Needed
?
|
Adverse Event |
Placebo (N=476) |
Tadalafil 5 mg (N=151) |
Tadalafil 10 mg (N=394) |
Tadalafil 20 mg (N=635) |
|
Headache |
5% |
11% |
11% |
15% |
|
Dyspepsia ??? |
1% |
4% |
8% |
10% |
|
Back pain |
3% |
3% |
5% |
6% |
|
Myalgia |
1% |
1% |
4% |
3% |
|
Nasal congestion |
1% |
2% |
3% |
3% |
|
Flushinga ?? |
1% |
2% |
3% |
3% |
|
Pain in limb |
1%?? |
1% |
3% |
3% |
?
a The term flushing includes: facial flushing and flushing
CIALIS for Once Daily Use
In three placebo-controlled Phase 3 clinical trials of 12 or 24 weeks duration, mean age was 58 years (range 21 to 82) and the discontinuation rate due to adverse events in patients treated with tadalafil was 4.1%, compared to 2.8% in placebo-treated patients.
The following adverse events were reported (see Table 2) in clinical trials of 12 weeks duration:
Table 2: Treatment-Emergent Adverse Events Reported by ≥2% of Patients Treated with CIALIS for Once Daily Use (2.5 or 5 mg) and More Frequent on Drug than Placebo in the Three Primary Placebo-Controlled Phase 3 Studies at 12 weeks (Including a Study in Patients with Diabetes) for CIALIS for Once Daily Use
?
|
Adverse Event |
Placebo (N=248) |
Tadalafil 2.5 mg (N=196) |
Tadalafil 5 mg (N=304) |
|
Headache |
5% |
3% |
6% |
|
Dyspepsia |
2% |
3% |
5% |
|
Nasopharyngitis |
4% |
4% |
3% |
|
Back pain |
1% |
3% |
3% |
|
Upper respiratory tract infection |
1% |
3% |
3% |
|
Flushing |
1% |
1% |
3% |
|
Influenza |
2% |
3% |
2% |
|
Myalgia |
1% |
2% |
2% |
|
Cough |
0% |
4% |
2% |
|
Diarrhea |
0% |
1% |
2% |
|
Nasal congestion |
0% |
2% |
2% |
|
Pain in extremity |
0% |
1% |
2% |
|
Bronchitis |
1% |
2% |
0% |
|
Gastroesophageal reflux |
0% |
2% |
1% |
|
Abdominal pain |
0% |
2% |
1% |
?
The following adverse events were reported (see Table 3) over 24 weeks treatment duration in one placebo-controlled Phase 3 clinical study:
?
Table 3: Treatment-Emergent Adverse Events Reported by ≥2% of Patients Treated with CIALIS for Once Daily Use (2.5 or 5 mg) and More Frequent on Drug than Placebo in One Placebo-Controlled Phase 3 Study of 24 Weeks Treatment Duration for CIALIS for Once Daily Use
?
|
Adverse Event |
Placebo (N=94) |
Tadalafil 2.5 mg (N=96) |
Tadalafil 5 mg (N=97) |
|
Nasopharyngitis |
5% |
6% |
6% |
|
Gastroenteritis viral |
2% |
3% |
5% |
|
Influenza |
3% |
5% |
3% |
|
Back Pain |
3% |
5% |
2% |
|
Upper Respiratory Tract Infection |
0% |
3% |
4% |
|
Dyspepsia |
1% |
4% |
1% |
|
Gastroesophageal Reflux Disease |
|