There are multiple possible causes for this observation and it is unknown to what extent fracture risk is directly attributable to SSRI treatment.The following adverse reactions are included in more detail in other sections of the prescribing information:Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. This medicine may be used to treat other conditions as determined by your … Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. In placebo-controlled clinical trials conducted with pediatric patients, the following adverse reactions were reported in at least 2% of pediatric patients treated with immediate-release paroxetine hydrochloride and at a rate at least twice that for pediatric patients receiving placebo: emotional lability (including self-harm, suicidal thoughts, attempted suicide, crying, and mood fluctuations), hostility, decreased appetite, tremor, sweating, hyperkinesia, and agitation.Adverse reactions upon discontinuation of treatment with immediate-release paroxetine hydrochloride in the pediatric clinical trials that included a taper phase regimen, which occurred in at least 2% of patients and at a rate at least twice that of placebo, were: emotional lability (including suicidal ideation, suicide attempt, mood changes, and tearfulness), nervousness, dizziness, nausea, and abdominal pain.SSRIs and SNRIs, including Paxil CR, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction In premarketing clinical trials with immediate‑release paroxetine hydrochloride, 17% of paroxetine treated patients (approximately 700) were 65 years or older. Because of the potential for serious adverse reactions in nursing infants from Paxil CR, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.The safety and effectiveness of Paxil CR in pediatric patients have not been established [see Three placebo-controlled trials in 752 pediatric patients with MDD have been conducted with immediate-release paroxetine, and effectiveness was not established in pediatric patients.
Adverse Reactions (≥5% of Patients Treated with Paxil CR and Greater than Placebo) in Pooled Studies PMDD (Studies 8, 9, 11), and in Study 10Table 5.
It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of CParoxetine hydrochloride is an odorless, off‑white powder, having a melting point range of 120° C to 138°C and a solubility of 5.4 mg/mL in water.Paxil CR tablets are intended for oral administration. 2500039-overview
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