Table 4.
Treatment-emergent adverse events after treatment with itopride
Adverse event | Itopride
|
||
---|---|---|---|
150 mg ER once daily (fasting) (n=24) | 150 mg ER once daily (fed) (n=23) | 50 mg IR three times daily (fasting) (n=23) | |
Any adverse event | 3 (12.5) | 4 (17.4) | 1 (4.3) |
Ear disorders | 1 (4.2) | 0 (0) | 0 (0) |
Ear disorder | 1 (4.2) | 0 (0) | 0 (0) |
Gastrointestinal disorders | 1 (4.2) | 0 (0) | 1 (4.3) |
Nausea | 1 (4.2) | 0 (0) | 0 (0) |
Abdominal pain | 1 (4.2) | 0 (0) | 0 (0) |
Diarrhea | 0 (0) | 0 (0) | 1 (4.3) |
General disorders and administration site conditions | 1 (4.2) | 0 (0) | 0 (0) |
General physical condition | 1 (4.2) | 0 (0) | 0 (0) |
Musculoskeletal and connective tissue disorders | 1 (4.2) | 1 (4.3) | 0 (0) |
Musculoskeletal stiffness | 0 (0) | 1 (4.3) | 0 (0) |
Muscle tightness | 1 (4.2) | 0 (0) | 0 (0) |
Nervous system disorders | 1 (4.2) | 2 (8.7) | 0 (0) |
Headache | 0 (0) | 1 (4.3) | 0 (0) |
Vasovagal syncope | 1 (4.2) | 0 (0) | 0 (0) |
Dizziness | 1 (4.2) | 1 (4.3) | 0 (0) |
Respiratory, thoracic, and mediastinal disorders | 2 (8.3) | 1 (4.3) | 0 (0) |
Dyspnea | 1 (4.2) | 0 (0) | 0 (0) |
Sputum | 1 (4.2) | 0 (0) | 0 (0) |
Rhinorrhea | 0 (0) | 1 (4.3) | 0 (0) |
Skin and subcutaneous tissue disorders | 0 (0) | 1 (4.3) | 0 (0) |
Rash | 0 (0) | 1 (4.3) | 0 (0) |
Note: Data are shown as number of subjects (%).
Abbreviations: ER, extended-release; IR, immediate-release.