Table 5.
List of ADRs for respiratory, thoracic, and mediastinal disorders, gastrointestinal disorders, hepatobiliary disorders, skin and subcutaneous tissue disorders, musculoskeletal and connective tissue disorders, reproductive system and breast disorders.
| Types of ADRs | Number (%) |
|---|---|
| Respiratory, thoracic, and mediastinal disorders | 12 (0.32) |
| Asthma | 1 (0.03) |
| Bronchitis chronic | 1 (0.03) |
| Cough | 1 (0.03) |
| Hemoptysis | 1 (0.03) |
| Interstitial lung disease | 1 (0.03) |
| Pleurisy | 1 (0.03) |
| Pneumonia aspiration | 2 (0.05) |
| Pulmonary edema | 2 (0.05) |
| Upper respiratory tract inflammation | 2 (0.05) |
| Laryngeal discomfort | 1 (0.03) |
| Gastrointestinal disorders | 75 (1.99) |
| Abdominal discomfort | 6 (0.16) |
| Abdominal distension | 1 (0.03) |
| Abdominal pain | 2 (0.05) |
| Chronic gastritis | 2 (0.05) |
| Constipation | 34 (0.90) |
| Diarrhea | 5 (0.13) |
| Dyspepsia | 1 (0.03) |
| Dysphagia | 1 (0.03) |
| Enterocolitis | 1 (0.03) |
| Gastric ulcer hemorrhage | 1 (0.03) |
| Gastritis | 3 (0.08) |
| Gastroesophageal reflux disease | 3 (0.08) |
| Ileus paralytic | 2 (0.05) |
| Intestinal obstruction | 1 (0.03) |
| Irritable bowel syndrome | 1 (0.03) |
| Lip swelling | 1 (0.03) |
| Melena | 1 (0.03) |
| Nausea | 13 (0.35) |
| Esophageal varices hemorrhage | 1 (0.03) |
| Pancreatitis acute | 1 (0.03) |
| Stomatitis | 2 (0.05) |
| Stress ulcer | 1 (0.03) |
| Vomiting | 5 (0.13) |
| Anal inflammation | 1 (0.03) |
| Large intestine polyp | 1 (0.03) |
| Hepatobiliary disorders | 6 (0.16) |
| Cholecystitis acute | 1 (0.03) |
| Hepatic function abnormal | 4 (0.11) |
| Liver disorder | 1 (0.03) |
| Skin and subcutaneous tissue disorders | 19 (0.51) |
| Dermatitis contact | 1 (0.03) |
| Dermatitis exfoliative | 1 (0.03) |
| Drug eruption | 1 (0.03) |
| Erythema | 1 (0.03) |
| Papule | 1 (0.03) |
| Pemphigoid | 1 (0.03) |
| Pruritus | 4 (0.11) |
| Rash | 7 (0.19) |
| Skin exfoliation | 2 (0.05) |
| Hangnail | 1 (0.03) |
| Musculoskeletal and connective tissue disorders | 9 (0.24) |
| Arthralgia | 2 (0.05) |
| Back pain | 4 (0.11) |
| Groin pain | 1 (0.03) |
| Joint swelling | 1 (0.03) |
| Muscle spasms | 1 (0.03) |
| Musculoskeletal pain | 3 (0.08) |
| Neck pain | 1 (0.03) |
| Pain in extremity | 1 (0.03) |
| Periarthritis | 1 (0.03) |
| Spinal column stenosis | 1 (0.03) |
| Reproductive system and breast disorders | 5 (0.13) |
| Gynecomastia | 4 (0.11) |
| Metrorrhagia | 1 (0.03) |
Notes: ADRs are coded with the preferred terms of MedDRA/J (version 18.1). The figure beside each category of disease shows the number (%) of patients with the type of ADR, while the number of each ADR shows the number of incidents (in parentheses, the number of incidents over the total number of patients researched).
Abbreviation: ADRs, adverse drug reactions.