Paroxetine (Page 10 of 17)

Commonly Observed Adverse Events:

Major Depressive Disorder:

The most commonly observed adverse events associated with the use of paroxetine (incidence of 5% or greater and incidence for paroxetine tablets at least twice that for placebo, derived from Table 2) were: Asthenia, sweating, nausea, decreased appetite, somnolence, dizziness, insomnia, tremor, nervousness, ejaculatory disturbance, and other male genital disorders.

Obsessive Compulsive Disorder:

The most commonly observed adverse events associated with the use of paroxetine (incidence of 5% or greater and incidence for paroxetine tablets at least twice that of placebo, derived from Table 3) were: Nausea, dry mouth, decreased appetite, constipation, dizziness, somnolence, tremor, sweating, impotence, and abnormal ejaculation.

Panic Disorder:

The most commonly observed adverse events associated with the use of paroxetine (incidence of 5% or greater and incidence for paroxetine tablets at least twice that for placebo, derived from Table 3) were: Asthenia, sweating, decreased appetite, libido decreased, tremor, abnormal ejaculation, female genital disorders, and impotence.

Social Anxiety Disorder:

The most commonly observed adverse events associated with the use of paroxetine (incidence of 5% or greater and incidence for paroxetine tablets at least twice that for placebo, derived from Table 3) were: Sweating, nausea, dry mouth, constipation, decreased appetite, somnolence, tremor, libido decreased, yawn, abnormal ejaculation, female genital disorders, and impotence.

Generalized Anxiety Disorder:

The most commonly observed adverse events associated with the use of paroxetine (incidence of 5% or greater and incidence for paroxetine tablets at least twice that for placebo, derived from Table 4) were: Asthenia, infection, constipation, decreased appetite, dry mouth, nausea, libido decreased, somnolence, tremor, sweating, and abnormal ejaculation.

Posttraumatic Stress Disorder:

The most commonly observed adverse events associated with the use of paroxetine (incidence of 5% or greater and incidence for paroxetine tablets at least twice that for placebo, derived from Table 4) were: Asthenia, sweating, nausea, dry mouth, diarrhea, decreased appetite, somnolence, libido decreased, abnormal ejaculation, female genital disorders, and impotence.

Incidence in Controlled Clinical Trials:

The prescriber should be aware that the figures in the tables following cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the populations studied.

Major Depressive Disorder:

Table 2 enumerates adverse events that occurred at an incidence of 1% or more among paroxetine-treated patients who participated in short-term (6-week) placebo-controlled trials in which patients were dosed in a range of 20 mg to 50 mg/day. Reported adverse events were classified using a standard COSTART-based Dictionary terminology.

Table 2 Treatment-Emergent Adverse Experience Incidence in Placebo-Controlled Clinical Trials for Major Depressive Disorder *

* Events reported by at least 1% of patients treated with paroxetine tablets are included, except the following events which had an incidence on placebo ≥ paroxetine tablets: Abdominal pain, agitation, back pain, chest pain, CNS stimulation, fever, increased appetite, myoclonus, pharyngitis, postural hypotension, respiratory disorder (includes mostly “cold symptoms” or “URI”), trauma, and vomiting.

Includes mostly “lump in throat” and “tightness in throat.”

Percentage corrected for gender.

§ Mostly “ejaculatory delay.”

Includes “anorgasmia,” “erectile difficulties,” “delayed ejaculation/orgasm,” and “sexual dysfunction,” and “impotence.”

# Includes mostly “difficulty with micturition” and “urinary hesitancy.”

Þ Includes mostly “anorgasmia” and “difficulty reaching climax/orgasm.”

Body System Preferred Term Paroxetine Tablets Placebo
(n = 421) (n = 421)
Body as a Whole Headache 18% 17%
Asthenia 15% 6%
Cardiovascular Palpitation 3% 1%
Vasodilation 3% 1%
Dermatologic Sweating 11% 2%
Rash 2% 1%
Gastrointestinal Nausea 26% 9%
Dry Mouth 18% 12%
Constipation 14% 9%
Diarrhea 12% 8%
Decreased Appetite 6% 2%
Flatulence 4% 2%
Oropharynx Disorder 2% 0%
Dyspepsia 2% 1%
Musculoskeletal Myopathy 2% 1%
Myalgia 2% 1%
Myasthenia 1% 0%
Nervous System Somnolence 23% 9%
Dizziness 13% 6%
Insomnia 13% 6%
Tremor 8% 2%
Nervousness 5% 3%
Anxiety 5% 3%
Paresthesia 4% 2%
Libido Decreased 3% 0%
Drugged Feeling 2% 1%
Confusion 1% 0%
Respiration Yawn 4% 0%
Special Senses Blurred Vision 4% 1%
Taste Perversion 2% 0%
Urogenital System Ejaculatory Disturbance ‡,§ 13% 0%
Other Male Genital Disorders ‡,¶ 10% 0%
Urinary Frequency 3% 1%
Urination Disorder # 3% 0%
Female Genital Disorders ‡,Þ 2% 0%

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