Alprazolam (Page 5 of 10)
Treatment-Emergent Adverse Events Reported in Placebo-Controlled Trials of Anxiety Disorders
| Treatment Emergent Symptom Incidence * | Incidence of Intervention Because of Symptom | ||
|---|---|---|---|
| Alprazolam Tablets | Placebo | Alprazolam Tablets | |
| Number of Patients | 565 | 505 | 565 |
| % of Patients Reporting: | |||
| Central Nervous System | |||
| Drowsiness | 41.0 | 21.6 | 15.1 |
| Light-headedness | 20.8 | 19.3 | 1.2 |
| Depression | 13.9 | 18.1 | 2.4 |
| Headache | 12.9 | 19.6 | 1.1 |
| Confusion | 9.9 | 10.0 | 0.9 |
| Insomnia | 8.9 | 18.4 | 1.3 |
| Nervousness | 4.1 | 10.3 | 1.1 |
| Syncope | 3.1 | 4.0 | † |
| Dizziness | 1.8 | 0.8 | 2.5 |
| Akathisia | 1.6 | 1.2 | † |
| Tiredness/Sleepiness | † | † | 1.8 |
| Gastrointestinal | |||
| Dry Mouth | 14.7 | 13.3 | 0.7 |
| Constipation | 10.4 | 11.4 | 0.9 |
| Diarrhea | 10.1 | 10.3 | 1.2 |
| Nausea/Vomiting | 9.6 | 12.8 | 1.7 |
| Increased Salivation | 4.2 | 2.4 | † |
| Cardiovascular | |||
| Tachycardia/Palpitations | 7.7 | 15.6 | 0.4 |
| Hypotension | 4.7 | 2.2 | † |
| Sensory | |||
| Blurred Vision | 6.2 | 6.2 | 0.4 |
| Musculoskeletal | |||
| Rigidity | 4.2 | 5.3 | † |
| Tremor | 4.0 | 8.8 | 0.4 |
| Cutaneous | |||
| Dermatitis/Allergy | 3.8 | 3.1 | 0.6 |
| Other | |||
| Nasal Congestion | 7.3 | 9.3 | † |
| Weight Gain | 2.7 | 2.7 | † |
| Weight Loss | 2.3 | 3.0 | † |
In addition to the relatively common (ie, greater than 1%) untoward events enumerated in the table above, the following adverse events have been reported in association with the use of benzodiazepines: dystonia, irritability, concentration difficulties, anorexia, transient amnesia or memory impairment, loss of coordination, fatigue, seizures, sedation, slurred speech, jaundice, musculoskeletal weakness, pruritus, diplopia, dysarthria, changes in libido, menstrual irregularities, incontinence and urinary retention.
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