Table 3.
Number and Frequency of Adverse Drug Reactions During Tadalafil Treatment
| Variable | n (%) | |||||
|---|---|---|---|---|---|---|
| Total | <75 Years | ≥75 Years | ||||
| Number of patients analyzed | 1393 | 976 | 417 | |||
| Number of patients experienced ADR | 115 | 75 | 40 | |||
| Incidence* (%) (b/a × 100) | 8.3 | 7.7 | 9.6 | |||
| MedDRA PT†, n (%) | ||||||
| Headache | 21 | (1.5) | 16 | (1.6) | 5 | (1.2) |
| Dyspepsia | 7 | (0.5) | 6 | (0.6) | 1 | (0.2) |
| Spontaneous penile erection | 7 | (0.5) | 6 | (0.6) | 1 | (0.2) |
| Palpitations | 5 | (0.4) | 2 | (0.2) | 3 | (0.7) |
| Diarrhea | 5 | (0.4) | 3 | (0.3) | 2 | (0.5) |
| Pollakiuria | 5 | (0.4) | 3 | (0.3) | 2 | (0.5) |
| Blood pressure decreased | 5 | (0.4) | 2 | (0.2) | 3 | (0.7) |
| Dizziness | 4 | (0.3) | 2 | (0.2) | 2 | (0.5) |
| Vision blurred | 3 | (0.2) | 3 | (0.3) | 0 | (0.0) |
| Dysuria | 3 | (0.2) | 2 | (0.2) | 1 | (0.2) |
| Malaise | 3 | (0.2) | 2 | (0.2) | 1 | (0.2) |
Notes: *Fisher exact test or chi-square test was performed between the two age groups. †Frequently reported ADRs (≥3 incidence) in total population were selected.
Abbreviations: ADRs, adverse drug reactions; MedDRA, Medical Dictionary for Regulatory Activities version 20.0; PT, preferred term.