Paroxetine: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Paroxetine. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| Ejaculatory disturbance | 27% |
| Abnormal ejaculation | 26% |
| Dry mouth | 15% |
| Dyspepsia | 13% |
| Decreased libido | 13% |
| Constipation | 10% |
| Female genital disorder | 10% |
| Orgasmic disturbance | 10% |
| Infection | 8% |
| Nervousness | 8% |
| Sinusitis | 8% |
| Abdominal pain | 7% |
| Libido decreased | 7% |
| Tremor | 7% |
| Female genital disorders | 7% |
| Nausea* | 6% |
| Flatulence | 6% |
| Sweating | 6% |
| Back pain | 5% |
| Trauma | 5% |
*Highest percentage across placebo-controlled trial tables summarized in current labeling.
Labeled uses
INDICATIONS AND USAGE Major Depressive DisorderPAXIL CR is indicated for the treatment of major depressive disorder. The efficacy of PAXIL CR in the treatment of a major depressive episode was established in two 12-week controlled trials of outpatients whose diagnoses corresponded to the DSM-IV category of major depressive disorder (see CLINICAL PHARMACOLOGY—Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least 5 of the following 9 symptoms during the same 2-week period: Depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. The antidepressant action of paroxetine in hospitalized depressed patients has not been adequately studied. PAXIL CR has not been systematically evaluat…
Medical disclaimer: Always consult a qualified healthcare professional about any medication.