Paroxetine (Page 13 of 19)

Generalized Anxiety 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.

Table 4 Treatment-Emergent Adverse Experience Incidence in Placebo Controlled Clinical Trials for Generalized Anxiety Disorder *
Generalized Anxiety Disorder
Body System Preferred Term Paroxetine Tablets Placebo
( n = 735 ) ( n = 529 )
*
Events reported by at least 2% of GAD 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.
Percentage corrected for gender.
Body as a Whole Asthenia 14% 6%
Headache 17% 14%
Infection 6% 3%
Abdominal Pain
Trauma
Cardiovascular Vasodilation 3% 1%
Dermatologic Sweating 6% 2%
Gastrointestinal Nausea 20% 5%
Dry Mouth 11% 5%
Constipation 10% 2%
Diarrhea 9% 7%
Decreased Appetite 5% 1%
Vomiting 3% 2%
Dyspepsia
Nervous System Insomnia 11% 8%
Somnolence 15% 5%
Dizziness 6% 5%
Tremor 5% 1%
Nervousness 4% 3%
Libido Decreased 9% 2%
Abnormal Dreams
Respiratory System Respiratory Disorder 7% 5%
Sinusitis 4% 3%
Yawn 4%
Special Senses Abnormal Vision 2% 1%
Urogenital System Abnormal 25% 2%
Ejaculation
Female Genital 4% 1%
Disorder
Impotence 4% 3%

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