Paroxetine (Page 11 of 17)
Obsessive Compulsive Disorder, Panic Disorder, and Social Anxiety Disorder:
Table 3 enumerates adverse events that occurred at a frequency of 2% or more among OCD 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 to 60 mg/day or among patients with panic disorder on paroxetine tablets who participated in placebo-controlled trials of 10- to 12-weeks duration in which patients were dosed in a range of 10 mg to 60 mg/day or among patients with social anxiety disorder on paroxetine tablets who participated in placebo-controlled trials of 12-weeks duration in which patients were dosed in a range of 20 mg to 50 mg/day.
| * Events reported by at least 2% of OCD, panic disorder, and social anxiety disorder in patients treated with paroxetine tablets are included, except the following events which had an incidence on placebo ≥ paroxetine tablets: [OCD]: Abdominal pain, agitation, anxiety, back pain, cough increased, depression, headache, hyperkinesia, infection, paresthesia, pharyngitis, respiratory disorder, rhinitis, and sinusitis. [panic disorder]: Abnormal dreams, abnormal vision, chest pain, cough increased, depersonalization, depression, dysmenorrhea, dyspepsia, flu syndrome, headache, infection, myalgia, nervousness, palpitation, paresthesia, pharyngitis, rash, respiratory disorder, sinusitis, taste perversion, trauma, urination impaired, and vasodilation. [social anxiety disorder]: Abdominal pain, depression, headache, infection, respiratory disorder, and sinusitis. | |||||||
| † Percentage corrected for gender. | |||||||
| Obsessive Compulsive Disorder | Panic Disorder | Social Anxiety Disorder | |||||
| Paroxetine Tablets | Placebo | Paroxetine Tablets | Placebo | Paroxetine Tablets | Placebo | ||
| Body System | Preferred Term | (n = 542) | (n = 265) | (n = 469) | (n = 324) | (n = 425) | (n = 339) |
| Body as a Whole | Asthenia | 22% | 14% | 14% | 5% | 22% | 14% |
| Abdominal Pain | — | — | 4% | 3% | — | — | |
| Chest Pain | 3% | 2% | — | — | — | — | |
| Back Pain | — | — | 3% | 2% | — | — | |
| Chills | 2% | 1% | 2% | 1% | — | — | |
| Trauma | — | — | — | — | 3% | 1% | |
| Cardiovascular | Vasodilation | 4% | 1% | — | — | — | — |
| Palpitation | 2% | 0% | — | — | — | — | |
| Dermatologic | Sweating | 9% | 3% | 14% | 6% | 9% | 2% |
| Rash | 3% | 2% | — | — | — | — | |
| Gastrointestinal | Nausea | 23% | 10% | 23% | 17% | 25% | 7% |
| Dry Mouth | 18% | 9% | 18% | 11% | 9% | 3% | |
| Constipation | 16% | 6% | 8% | 5% | 5% | 2% | |
| Diarrhea | 10% | 10% | 12% | 7% | 9% | 6% | |
| Decreased | |||||||
| Appetite | 9% | 3% | 7% | 3% | 8% | 2% | |
| Dyspepsia | — | — | — | — | 4% | 2% | |
| Flatulence | — | — | — | — | 4% | 2% | |
| Increased | |||||||
| Appetite | 4% | 3% | 2% | 1% | — | — | |
| Vomiting | — | — | — | — | 2% | 1% | |
| Musculoskeletal | Myalgia | — | — | — | — | 4% | 3% |
| Nervous System | Insomnia | 24% | 13% | 18% | 10% | 21% | 16% |
| Somnolence | 24% | 7% | 19% | 11% | 22% | 5% | |
| Dizziness | 12% | 6% | 14% | 10% | 11% | 7% | |
| Tremor | 11% | 1% | 9% | 1% | 9% | 1% | |
| Nervousness | 9% | 8% | — | — | 8% | 7% | |
| Libido Decreased | 7% | 4% | 9% | 1% | 12% | 1% | |
| Agitation | — | — | 5% | 4% | 3% | 1% | |
| Anxiety | — | — | 5% | 4% | 5% | 4% | |
| Abnormal | |||||||
| Dreams | 4% | 1% | — | — | — | — | |
| Concentration | |||||||
| Impaired | 3% | 2% | — | — | 4% | 1% | |
| Depersonalization | 3% | 0% | — | — | — | — | |
| Myoclonus | 3% | 0% | 3% | 2% | 2% | 1% | |
| Amnesia | 2% | 1% | — | — | — | — | |
| Respiratory System | Rhinitis | — | — | 3% | 0% | — | — |
| Pharyngitis | — | — | — | — | 4% | 2% | |
| Yawn | — | — | — | — | 5% | 1% | |
| Special Senses | Abnormal Vision | 4% | 2% | — | — | 4% | 1% |
| Taste Perversion | 2% | 0% | — | — | — | — | |
| Urogenital System | Abnormal | ||||||
| Ejaculation† | 23% | 1% | 21% | 1% | 28% | 1% | |
| Dysmenorrhea | — | — | — | — | 5% | 4% | |
| Female Genital | |||||||
| Disorder† | 3% | 0% | 9% | 1% | 9% | 1% | |
| Impotence† | 8% | 1% | 5% | 0% | 5% | 1% | |
| Urinary | |||||||
| Frequency | 3% | 1% | 2% | 0% | — | — | |
| Urination | |||||||
| Impaired | 3% | 0% | — | — | — | — | |
| Urinary Tract | |||||||
| Infection | 2% | 1% | 2% | 1% | — | — | |
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