Paroxetine (Page 12 of 17)
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.
| * 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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