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Paxil side effects. Done in patients with panic disorder, 1 study was conducted in patients with social anxiety disorder, and 4 studies were done in female patients with PMDD. Two of the studies in major depressive disorder, which enrolled patients in the age range 18 to 65 years, are pooled. Information from a third study of major depressive disorder, which focused on elderly patients (60 to 88 years), is presented separately as is the information from the panic disorder studies and the information from the PMDD studies. Information on additional adverse events associated with PAXIL CR and the immediate-release formulation of paroxetine hydrochloride is included in a separate subsection (see Other Events). Adverse Findings Observed in Short-Term, Placebo-Controlled Trials With PAXIL CR Adverse Events Associated With Discontinuation of Treatment: Major Depressive Disorder: Ten percent (21 212) of patients treated with PAXIL CR discontinued treatment due to an adverse event in a pool of 2 studies of patien paxil side

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Ts with major depressive disorder. The most common events (& 179; 1%) associated with discontinuation and considered to be drug related (i.e., those events associated with dropout at a rate approximately twice or greater for PAXIL CR compared to placebo) included the following: PAXIL CR Placebo (n = 212) (n = 211) Nausea 3.7% 0.5% Asthenia 1.9% 0.5% Dizziness 1.4% 0.0% Somnolence 1.4% 0.0% In a placebo-controlled study of elderly patients with major depressive disorder, 13% (13 104) of patients treated with PAXIL CR discontinued due to an adverse event. Events meeting the above criteria included the following: PAXIL CR Placebo (n = 104) (n = 109) Nausea 2.9% 0.0% Headache 1.9% 0.9% Depression 1.9% 0.0% LFT’s abnormal 1.9% 0.0% Panic Disorder: Eleven percent (50 444) of patients treated with PAXIL CR in panic disorder studies discontinued treatment due to an adverse event. Events meeting the above criteria included the following: PAXIL CR Placebo (n = 444) (n = 445) Nausea 2.9% 0.4% Ins paxil side

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paxil side effects D adverse events were monitored in studies of both continuous and intermittent dosing of PAXIL CR in the treatment of PMDD. Generally paxil side effects, there were few differences in the adverse event profiles of the 2 dosing regimens. Thirteen percent (88 681) of patients treated with PAXIL CR in PMDD studies of continuous dosing discontinued treatment due to an adverse event. The most common events (& 179; 1%) associated with discontinuation in either group treated with PAXIL CR with an incidence rate that is at least twice that of placebo in PMDD trials that employed a continuous dosing regimen are shown in the following table. This table also shows those events that were paxil side effects.

paxil side effects Dose dependent (indicated with an asterisk) as defined as events having an incidence rate with 25 mg of PAXIL CR that was at least twice that with 12.5 mg of PAXIL CR (as well as the placebo group). PAXIL CR 25 mg (n = 348) PAXIL CR 12.5 mg (n = 333) Placebo (n = 349) TOTAL 15% 9.9% 6.3% Nausea* 6.0% 2.4% 0.9% Asthenia 4.9% 3.0% 1.4% Somnolence* 4.3% 1.8% 0.3% Insomnia 2.3% 1.5% 0.0% Concentration Impaired* 2.0% 0.6% 0.3% Dry mouth* 2.0% 0.6% 0.3% Dizziness* 1.7% 0.6% 0.6% Decreased Appetite* 1.4% 0.6% 0.0% Sweating* 1.4% 0.0% 0.3% Tremor* 1.4% 0.3% 0.0% Yawn* 1.1% 0.0% 0.0% Diarrhea 0.9% 1.2% 0.0% *Events considered to be dose dependent are defined as events having an incidence rate with 25 mg of PAXIL CR that was at least twice that with 12.5 mg of PAXIL CR (as well as the placebo group). Commonly Observed Adverse Events Major Depressive Disorder: The most commonly observed adverse events associated with the use of PAXIL CR in a pool of 2 trials (incidence of 5.0% or greater and incidence for PAXIL CR at least twice that for placebo paxil side effects, derived from Table 1) were: Abnormal ejaculation paxil side effects, abnormal vision paxil side effects, constipation paxil side effects, decreased libido paxil side effects, diarrhea paxil side effects, dizziness paxil side effects, female genital disorders paxil side effects, nausea paxil side effects, somnolence paxil side effects, sweating paxil side effects, trauma paxil side effects, tremor paxil side effects, and yawning. Using the same criteria paxil side effects, the adverse events associated with the use of PAXIL.

paxil side effects having an incidence rate with 25 mg of PAXIL CR that was at least twice that with 12.5 mg of PAXIL CR (as well as the placebo group). Commonly Observed Adverse Events Major Depressive Disorder: The most commonly observed adverse events associated with the use of PAXIL CR in a pool of 2 trials (incidence of 5.0% or greater and incidence for PAXIL CR at least twice that for placebo paxil side effects, derived from Table 1) were: Abnormal ejaculation paxil side effects, abnormal vision paxil side effects, constipation paxil side effects, decreased libido paxil side effects, diarrhea paxil side effects, dizziness paxil side effects, female genital disorders paxil side effects, nausea paxil side effects, somnolence paxil side effects, sweating paxil side effects, trauma paxil side effects, tremor paxil side effects, and yawning. Using the same criteria paxil side effects, the adverse events associated with the use of PAXIL .

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Ion or anxiety). They can add to sleepiness caused by paroxetine. & 149; Paroxetine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. What are the possible side effects of paroxetine? & 149; Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat. & 149; Contact your doctor promptly if you have any of the following side effects, especially if they are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania (mental and or physical hyperactivity), thoughts of suicide or hurting yourself. & 149; Call your doctor at once if you have any of these serious side effects: & 183; seizure (convulsions); & 183; tremors, shivering, muscle stiffness or twitching; & 183; problems with balance or coordination; or & 183; agitation, confusion, sweating, fast heartbeat. & 149; Other less serious side effects are more likely to occur, such as: & 183; feeling nervous, restless, or unable to sit still; & 183; drowsiness, dizziness, weakness; & 183; sleep problems (insomnia); & 183; nausea, constipation, loss of appetite; & 183; weight changes; & 183; decreased sex drive, impotence, or difficulty having an orgasm; or & 183; dry mouth, yawning, or ringing in your ears. & 149; Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems un
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