Table 3.
Treatment-emergent adverse events occurring in ≥5 % of subjects following oral administration of metformin alone, trospium chloride XR alone, or metformin and trospium chloride XR in combination [n (%)]
Adverse event | Metformin (n = 43) | Trospium chloride XR (n = 44) | Trospium chloride XR + metformin (n = 44) | Total (N = 44) |
---|---|---|---|---|
Headache | 4 (9) | 3 (7) | 7 (16) | 12 (27) |
Diarrhoea | 3 (7) | 0 (0) | 3 (7) | 6 (14) |
Abdominal distension | 1 (2) | 2 (5) | 0 (0) | 3 (7) |
Abdominal pain, upper | 3 (7) | 0 (0) | 0 (0) | 3 (7) |
Constipation | 1 (2) | 1 (2) | 1 (2) | 3 (7) |
Dizziness | 1 (2) | 1 (2) | 1 (2) | 3 (7) |
Dry throat | 1 (2) | 2 (5) | 0 (0) | 3 (7) |
Nasal congestion | 0 (0) | 0 (0) | 3 (7) | 3 (7) |
Abdominal pain | 0 (0) | 1 (2) | 2 (5) | 2 (5) |
Dry lip | 2 (5) | 0 (0) | 0 (0) | 2 (5) |
Metrorrhagia | 2 (5) | 0 (0) | 0 (0) | 2 (5) |
Nausea | 2 (5) | 0 (0) | 1 (2) | 2 (5) |
Oropharyngeal pain | 0 (0) | 1 (2) | 1 (2) | 2 (5) |
Upper respiratory tract infection | 0 (0) | 0 (0) | 2 (5) | 2 (5) |
Vomiting | 1 (2) | 0 (0) | 1 (2) | 2 (5) |
White blood cells urine positive | 1 (2) | 1 (2) | 0 (0) | 2 (5) |
XR extended release