Paroxetine: Side Effects, Uses & Monitoring
INDICATIONS AND USAGE Major Depressive DisorderPAXIL CR is indicated for the treatment of major depressive disorder.
- Data source
- FDA labeling via NIH DailyMed (label 4f4a52b2…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| 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 reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
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…
Conditions associated with Paroxetine in labeling
Anxiety and Panic
Persistent anxiety and panic symptoms that affect daily function and well-being....
Depression
A common but serious mood disorder causing persistent sadness, loss of interest, and changes in sleep, appetit...
Insomnia
Difficulty falling asleep, staying asleep, or getting restful sleep despite adequate opportunity, affecting da...
Panic Attacks
Sudden episodes of intense fear with physical symptoms such as palpitations, sweating, and breathlessness....
Panic Disorder
A condition marked by recurrent, unexpected panic attacks with intense fear and physical symptoms such as palp...
Frequently Asked Questions
What is Paroxetine used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Paroxetine?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Paroxetine. Individual risk varies.
Does Paroxetine require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Paroxetine.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.