Alprazolam (Page 6 of 10)

Treatment-Emergent Adverse Events Reported in Placebo-Controlled Trials of Panic Disorder

PANIC DISORDER
Treatment-Emergent Symptom Incidence *
Alprazolam Tablets Placebo
*
Events reported by 1% or more of Alprazolam Tablets patients are included.
Number of Patients % of Patients Reporting: 1388 1231
Central Nervous System
Drowsiness 76.8 42.7
Fatigue and Tiredness 48.6 42.3
Impaired Coordination 40.1 17.9
Irritability 33.1 30.1
Memory Impairment 33.1 22.1
Light-headedness/Dizziness 29.8 36.9
Insomnia 29.4 41.8
Headache 29.2 35.6
Cognitive Disorder 28.8 20.5
Dysarthria 23.3 6.3
Anxiety 16.6 24.9
Abnormal Involuntary Movement 14.8 21.0
Decreased Libido 14.4 8.0
Depression 13.8 14.0
Confusional State 10.4 8.2
Muscular Twitching 7.9 11.8
Increased Libido 7.7 4.1
Change in Libido (Not Specified) 7.1 5.6
Weakness 7.1 8.4
Muscle Tone Disorders 6.3 7.5
Syncope 3.8 4.8
Akathisia 3.0 4.3
Agitation 2.9 2.6
Disinhibition 2.7 1.5
Paresthesia 2.4 3.2
Talkativeness 2.2 1.0
Vasomotor Disturbances 2.0 2.6
Derealization 1.9 1.2
Dream Abnormalities 1.8 1.5
Fear 1.4 1.0
Feeling Warm 1.3 0.5
Gastrointestinal
Decreased Salivation 32.8 34.2
Constipation 26.2 15.4
Nausea/Vomiting 22.0 31.8
Diarrhea 20.6 22.8
Abdominal Distress 18.3 21.5
Increased Salivation 5.6 4.4
Cardio-Respiratory
Nasal Congestion 17.4 16.5
Tachycardia 15.4 26.8
Chest Pain 10.6 18.1
Hyperventilation 9.7 14.5
Upper Respiratory Infection 4.3 3.7
Sensory
Blurred Vision 21.0 21.4
Tinnitus 6.6 10.4
Musculoskeletal
Muscular Cramps 2.4 2.4
Muscle Stiffness 2.2 3.3
Cutaneous
Sweating 15.1 23.5
Rash 10.8 8.1
Other
Increased Appetite 32.7 22.8
Decreased Appetite 27.8 24.1
Weight Gain 27.2 17.9
Weight Loss 22.6 16.5
Micturition Difficulties 12.2 8.6
Menstrual Disorders 10.4 8.7
Sexual Dysfunction 7.4 3.7
Edema 4.9 5.6
Incontinence 1.5 0.6
Infection 1.3 1.7

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 Alprazolam Tablets: seizures, hallucinations, depersonalization, taste alterations, diplopia, elevated bilirubin, elevated hepatic enzymes, and jaundice.

Panic disorder has been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients (see PRECAUTIONS, General).

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