Alprazolam (Page 6 of 10)
Treatment-Emergent Adverse Events Reported in Placebo-Controlled Trials of Panic Disorder
Treatment-Emergent Symptom Incidence * | ||
---|---|---|
Alprazolam Tablets | Placebo | |
| ||
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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