Options: Show MedDRA Preferred Terms
Side effect | Data for drug | Placebo | Labels | ||
---|---|---|---|---|---|
1 | 2 | 3 | |||
Dizziness | 0.5% - 5% | 3% | x | x | x |
Headache | 0.3% - 7% | 7% | x | x | x |
Fatigue | 0.3% - 4% | 2% | x | x | x |
Nausea | 0.3% - 3% | 2% | x | x | x |
Upper respiratory tract infection | 3% | 2% | x | ||
Insomnia exacerbated | 3% | 2% | x | x | x |
Somnolence | 0.8% - 5% | 2% - 3% | x | x | x |
Arthralgia | 2% | 1% | x | ||
Depression | 2% | 1% | x | ||
Diarrhoea | 2% | 2% | x | ||
Dysgeusia | 2% | 1% | x | ||
Myalgia | 2% | 1% | x | ||
Influenza | 1% | 0% | x | ||
Blood cortisol decreased | 1% | 0% | x | ||
Insomnia | 0.3% | x | |||
Thinking abnormal | x | x | |||
Anaphylactoid reaction | x | x | |||
Chronic insomnia | 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 |