Table 4.
List of ADRs for psychiatric disorders, nervous system disorders, eye disorders, ear and labyrinth disorders, cardiac disorders, vascular disorders.
| Types of ADRs | Number (%) |
|---|---|
| Psychiatric disorders | 149 (3.96) |
| Anger | 1 (0.03) |
| Anxiety | 1 (0.03) |
| Completed suicide | 1 (0.03) |
| Delirium | 5 (0.13) |
| Depression | 4 (0.11) |
| Hallucination | 7 (0.19) |
| Hallucination, auditory | 1 (0.03) |
| Hallucination, visual | 1 (0.03) |
| Initial insomnia | 1 (0.03) |
| Insomnia | 127 (3.38) |
| Irritability | 4 (0.11) |
| Listless | 1 (0.03) |
| Logorrhea | 1 (0.03) |
| Middle insomnia | 1 (0.03) |
| Restlessness | 5 (0.13) |
| Anxiety disorder | 1 (0.03) |
| Nervous system disorders | 91 (2.42) |
| Altered state of consciousness | 2 (0.05) |
| Amnesia | 1 (0.03) |
| Cerebral hemorrhage | 1 (0.03) |
| Cerebral infarction | 6 (0.16) |
| Cerebral thrombosis | 1 (0.03) |
| Dementia | 2 (0.05) |
| Dementia Alzheimer’s type | 3 (0.08) |
| Dizziness | 23 (0.61) |
| Dizziness postural | 1 (0.03) |
| Dysarthria | 2 (0.05) |
| Dysgeusia | 2 (0.05) |
| Dyskinesia | 1 (0.03) |
| Headache | 3 (0.08) |
| Hypoesthesia | 3 (0.08) |
| Memory impairment | 1 (0.03) |
| Neuralgia | 1 (0.03) |
| Neuropathy peripheral | 2 (0.05) |
| Somnolence | 32 (0.85) |
| Syncope | 1 (0.03) |
| Tremor | 2 (0.05) |
| Cognitive disorder | 1 (0.03) |
| Restless legs syndrome | 6 (0.16) |
| Thalamus hemorrhage | 1 (0.03) |
| Hypoglycemic unconsciousness | 1 (0.03) |
| Eye disorders | 6 (0.16) |
| Blepharitis | 1 (0.03) |
| Cataract | 2 (0.05) |
| Conjunctivitis allergic | 1 (0.03) |
| Diplopia | 1 (0.03) |
| Eyelid edema | 1 (0.03) |
| Ear and labyrinth disorders | 6 (0.16) |
| Tinnitus | 2 (0.05) |
| Vertigo | 3 (0.08) |
| Sudden hearing loss | 1 (0.03) |
| Cardiac disorders | 17 (0.45) |
| Acute myocardial infarction | 2 (0.05) |
| Angina pectoris | 2 (0.05) |
| Arrhythmia | 1 (0.03) |
| Atrial flutter | 1 (0.03) |
| Cardiac failure | 1 (0.03) |
| Cardiac failure acute | 1 (0.03) |
| Cardiac failure congestive | 1 (0.03) |
| Cardiorespiratory arrest | 1 (0.03) |
| Myocardial infarction | 2 (0.05) |
| Palpitations | 4 (0.11) |
| Prinzmetal angina | 1 (0.03) |
| Vascular disorders | 7 (0.19) |
| Hypertension | 4 (0.11) |
| Orthostatic hypotension | 1 (0.03) |
| Peripheral arterial occlusive disease | 2 (0.05) |
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.