Options: Show MedDRA Preferred Terms
| Side effect | Data for drug | Placebo | Labels | |
|---|---|---|---|---|
| 1 | 2 | |||
| Drowsiness | postmarketing, 32% | x | x | |
| Ataxia | postmarketing, 13% | x | x | |
| Dizziness | postmarketing, 7.6% | x | x | |
| Speech disorder | postmarketing, 2% | x | ||
| Digestion impaired | 1% | x | x | |
| Confusional state | postmarketing, 1% | x | x | |
| Headache | postmarketing, 1% | x | x | |
| Nausea | postmarketing, 1% | x | x | |
| Vomiting | postmarketing, 1% | x | x | |
| Sleep disorder | postmarketing, 1% | x | ||
| Aggression | postmarketing | x | x | |
| Anger | postmarketing | x | x | |
| Anorexia | postmarketing | x | ||
| Mental disorder | postmarketing | x | ||
| Connective tissue disorder | postmarketing | x | ||
| Delusion | postmarketing | x | x | |
| Diplopia | postmarketing | x | x | |
| Emotional disturbance NOS | postmarketing | x | ||
| Rash | postmarketing | x | x | |
| Eye disorder | postmarketing | x | ||
| Fatigue | postmarketing | x | x | |
| Fracture | postmarketing | x | x | |
| Gastrointestinal disorder | postmarketing | x | ||
| Hallucination | postmarketing | x | x | |
| Cardiac arrest | postmarketing | x | x | |
| Cardiac disorder | postmarketing | x | ||
| Cardiac failure | postmarketing | x | x | |
| Hypotension | postmarketing | x | x | |
| Incontinence | postmarketing | x | x | |
| Irritability | postmarketing | x | x | |
| Nervous system disorder | postmarketing | x | ||
| Nervousness | postmarketing | x | ||
| Nightmare | postmarketing | x | x | |
| Palpitations | postmarketing | x | x | |
| Pruritus | postmarketing | x | x | |
| Psychotic disorder | postmarketing | x | x | |
| Convulsion | postmarketing | x | x | |
| Muscle spasms | postmarketing | x | x | |
| Tachycardia | postmarketing | x | x | |
| Tremor | postmarketing | x | ||
| Dry mouth | postmarketing | x | x | |
| Agitation | postmarketing | x | ||
| Muscular weakness | postmarketing | x | x | |
| Haemoglobin decreased | postmarketing | x | x | |
| Malnutrition | postmarketing | x | x | |
| Unspecified disorder of skin and subcutaneous tissue | postmarketing | x | x | |
| Anterograde amnesia | postmarketing | x | x | |
| Respiratory depression | postmarketing | x | x | |
| Vision blurred | postmarketing | x | x | |
| Alertness decreased | postmarketing | x | x | |
| Anaphylactic shock | x | |||
| Hostility | x | |||
| Hypersensitivity | x | |||
| Emotional disorder | x | |||
| Euphoric mood | x | |||
| Excitability | x | |||
| Blood glucose decreased | x | |||
| White blood cell count decreased | x | |||
Information about indications was extracted from the indications and usage sections of the labels.
| Indication | Labels | |||
|---|---|---|---|---|
| Agitation | x | |||
| Anxiety | x | x | ||
| Anxiety disorder | x | |||
| Anxiety neurosis | x | |||
| Distress | x | |||
| Tension | 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 |