Prescription Drug Information: Paroxetine (Page 10 of 14)

Generalized Anxiety Disorderand and Posttraumatic Stress Disorder:

Table 4 enumerates adverse events that occurred at a frequency of 2% or more among GAD patients on paroxetine tablets who participated in placebo-controlled trials of 8-weeks duration in which patients were dosed in a range of 10 mg/day to 50 mg/day or among PTSD patients on paroxetine tablets who participated in placebo-controlled trials of 12-weeks duration in which patients were dosed in a range of 20 mg/day to 50 mg/day.

Table 4 Treatment-Emergent Adverse Experience Incidence in Placebo Controlled Clinical Trials for Generalized Anxiety Disorder and Posttraumatic Stress Disorder *

* Events reported by at least 2% of GAD and PTSD in patients treated with paroxetine tablets are included, except the following events which had an incidence on placebo ≥ paroxetine tablets [GAD]: Abdominal pain, back pain, trauma, dyspepsia, myalgia, and pharyngitis. [PTSD]: Back pain, headache, anxiety, depression, nervousness, respiratory disorder, pharyngitis, and sinusitis.

Percentage corrected for gender.

Generalized Anxiety Disorder Posttraumatic Stress Disorder
Body System Preferred Term Paroxetine Tablets Placebo Paroxetine Tablets Placebo
(n = 735) (n = 529) (n = 676) (n = 504)
Body as a Whole Asthenia 14% 6% 12% 4%
Headache 17% 14%
Infection 6% 3% 5% 4%
Abdominal Pain 4% 3%
Trauma 6% 5%
Cardiovascular Vasodilation 3% 1% 2% 1%
Dermatologic Sweating 6% 2% 5% 1%
Gastrointestinal Nausea 20% 5% 19% 8%
Dry Mouth 11% 5% 10% 5%
Constipation 10% 2% 5% 3%
Diarrhea 9% 7% 11% 5%
Decreased Appetite 5% 1% 6% 3%
Vomiting 3% 2% 3% 2%
Dyspepsia 5% 3%
Nervous System Insomnia 11% 8% 12% 11%
Somnolence 15% 5% 16% 5%
Dizziness 6% 5% 6% 5%
Tremor 5% 1% 4% 1%
Nervousness 4% 3%
Libido Decreased 9% 2% 5% 2%
Abnormal Dreams 3% 2%
Respiratory System Respiratory Disorder 7% 5%
Sinusitis 4% 3%
Yawn 4% 2% <1%
Special Senses Abnormal Vision 2% 1% 3% 1%
Urogenital System Abnormal 25% 2% 13% 2%
Ejaculation 5% 1%
Female Genital 4% 1% 9% 1%
Disorder
Impotence 4% 3%

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