Options: Hide MedDRA Preferred Terms
| MedDRA Preferred Term | Side effect | Data for drug | Placebo | Labels | ||
|---|---|---|---|---|---|---|
| 1 | 2 | 3 | ||||
| Dizziness | Dizziness | 0.5% - 5% | 3% | x | x | x |
| Headache | Headache | 0.3% - 7% | 7% | x | x | x |
| Asthenia | Fatigue | 0.3% - 4% | 2% | x | x | x |
| Fatigue | Fatigue | 0.3% - 4% | 2% | x | x | x |
| Nausea | Nausea | 0.3% - 3% | 2% | x | x | x |
| Upper respiratory tract infection | Upper respiratory tract infection | 3% | 2% | x | ||
| Insomnia | Insomnia exacerbated | 3% | 2% | x | x | x |
| Insomnia | 0.3% | x | ||||
| Chronic insomnia | x | x | ||||
| Somnolence | Somnolence | 0.8% - 5% | 2% - 3% | x | x | x |
| Arthralgia | Arthralgia | 2% | 1% | x | ||
| Musculoskeletal discomfort | Arthralgia | 2% | 1% | x | ||
| Myalgia | 2% | 1% | x | |||
| Depression | Depression | 2% | 1% | x | ||
| Diarrhoea | Diarrhoea | 2% | 2% | x | ||
| Dysgeusia | Dysgeusia | 2% | 1% | x | ||
| Myalgia | Myalgia | 2% | 1% | x | ||
| Influenza | Influenza | 1% | 0% | x | ||
| Blood cortisol decreased | Blood cortisol decreased | 1% | 0% | x | ||
| Thinking abnormal | Thinking abnormal | x | x | |||
| Mental disability | Thinking abnormal | x | x | |||
| Anaphylactic shock | Anaphylactoid reaction | x | x | |||
| Anaphylactoid reaction | Anaphylactoid reaction | x | x | |||
Information about indications was extracted from the indications and usage sections of the labels.
| Indication | Labels | |||||
|---|---|---|---|---|---|---|
| Insomnia | x | x | ||||
standard – alternative
| 100% | ||
| 75% | ||
| 50% | ||
| 10% | ||
| frequent (1% to 100%) | ||
| infrequent (0.1% to 1%) | ||
| rare (<0.1%) | ||
| postmarketing | ||
| 0% | ||
| no frequency information | ||
| not found on label |