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 |