Paroxetine: Safety and tolerability issues

David M. Marks, Min Hyeon Park, Byung Joo Ham, Changsu Han, Ashwin A. Patkar, Prakash S. Masand, Chi Un Pae

Research output: Contribution to journalArticlepeer-review

49 Citations (Scopus)


Paroxetine is a selective serotonin re-uptake inhibitor (SSRI) available in immediate release and controlled release (CR) formulations. Paroxetine is the most potent inhibitor of serotonin re-uptake among the now available SSRIs. Paroxetine has been approved for the treatment of major depressive disorder (MDD), obsessive-compulsive disorder, panic disorder (PD), generalised anxiety disorder, post traumatic stress disorder (PTSD), and social anxiety disorder (SAD) in adults, whereas paroxetine CR is approved for the treatment of MDD, SAD, PD and premenstrual dysphoric disorder in adults. The overall efficacy of paroxetine seems to be comparable to other SSRIs in the treatment of approved indications, although paroxetine treatment induces more sedation, constipation, sexual dysfunction, discontinuation syndrome and weight gain than other SSRIs. Recent data suggest that paroxetine treatment leads to increased rates of congenital malformations, although this evidence is not conclusive. Paroxetine and paroxetine CR are not indicated for use in the paediatric population and are categorised as Pregnancy Class D. In conclusion, whether the tolerability profile of paroxetine differs substantially from other new antidepressants (including other SSRIs) needs to be determined in adequately powered well-designed randomised controlled comparative clinical trials.

Original languageEnglish
Pages (from-to)783-794
Number of pages12
JournalExpert Opinion on Drug Safety
Issue number6
Publication statusPublished - 2008 Nov
Externally publishedYes

Bibliographical note

Funding Information:
C Han has received research support from Korea Research Foundation Grant (MOEHRD) (KRF-2007-013-E00033) and from Korea University Neuropsychiatric Alumni Grant. AA Patkar is a consultant for Bristol-Myers Squibb, GlaxoSmithKline and Reckitt Benckiser; is on the speakers’ bureaus of Bristol-Myers Squibb, GlaxoSmithKline and Reckitt Benckiser; and has received research support from National Institutes of Health, AstraZeneca, Bristol-Myers Squibb, Forest, GlaxoSmithKline, Janssen, McNeil Consumer and Specialty Inc., Organon, Jazz Pharmaceuticals and Pfizer.


  • Newer antidepressants
  • Paroxetine
  • Paroxetine safety
  • Selective serotonin re-uptake inhibitor
  • Tolerability

ASJC Scopus subject areas

  • Pharmacology (medical)


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