Alprazolam (Page 5 of 10)

Treatment-Emergent Adverse Events Reported in Placebo-Controlled Trials of Anxiety Disorders

ANXIETY DISORDERS
Treatment Emergent Symptom Incidence * Incidence of Intervention Because of Symptom
Alprazolam Tablets Placebo Alprazolam Tablets
*
Events reported by 1% or more of Alprazolam Tablets patients are included.
None reported
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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