Table 3.
Occurrence of adverse side effects for each magistral formulation.
| Magistral formulation |
Total
N = 2,112 |
||||
|---|---|---|---|---|---|
| FM-001 | FM-002 | FM-003 | FM-004 | ||
| n = 4 | n = 856 | n = 1,241 | n = 11 | ||
| Gender, n (%) | |||||
| Female | 3 (75) | 586 (68.4) | 1,011 (81.4) | 8 (72.7) | 1.608 (76.1) |
| Male | 1 (25) | 270 (31.5) | 230 (18.5) | 3 (27.2) | 504 (23.8) |
| Adverse side effects, n (%) | |||||
| None | 3 (75) | 547 (63.9) | 954 (76.8) | 11 (100) | 1,515 (71.7) |
| Somnolence | 1 (25) | 145 (16.9) | 129 (10.3) | 0 (0) | 275 (13.0) |
| Dizziness | 0 (0) | 104 (12.1) | 67 (5.39) | 0 (0) | 171 (8.09) |
| Dry mouth | 0 (0) | 35 (4.08) | 55 (4.43) | 0 (0) | 90 (4.26) |
| Headache | 0 (0) | 7 (0.81) | 10 (0.80) | 0 (0) | 17 (0.80) |
| Anxiety | 0 (0) | 5 (0.58) | 9 (0.72) | 0 (0) | 14 (0.66) |
| Tachycardia | 0 (0) | 2 (0.23) | 6 (0.48) | 0 (0) | 8 (0.37) |
| Diarrhea | 0 (0) | 3 (0.35) | 3 (0.24) | 0 (0) | 6 (0.28) |
| Mild headache | 0 (0) | 2 (0.23) | 4 (0.32) | 0 (0) | 6 (0.28) |
| Cognitive side effects | 0 (0) | 2 (0.23) | 1 (0.08) | 0 (0) | 3 (0.14) |
| Euphoria | 0 (0) | 2 (0.23) | 1 (0.08) | 0 (0) | 3 (0.14) |
| Fatigue | 0 (0) | 2 (0.23) | 0 (0) | 0 (0) | 2 (0.09) |
| Hypotension | 0 (0) | 0 (0) | 2 (0.16) | 0 (0) | 2 (0.09) |
| Blurred vision | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |