Last update July 5, 2022

C19 H20 FNO3

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

SSRI antidepressant with actions and uses similar to those of fluoxetine. Oral administration once a day.

It is excreted in breast milk in clinically insignificant amounts. (Pogliani 2019, Weisskopf 2017, Salazar 2016, Misri 2006 y 2000, Stowe 2000, Ohman 1999, Begg 1999, Spigset 1996).

Serum levels of breastfed infants whose mothers are on Paroxetine are usually undetectable or very low. (Berle 2004, Hendrick 2001, Misri 2000, Begg 1999, Birnbaum 1999)

No harm effect has been observed on health and short or long term development of infants. (Pogliani 2019, Uguz 2019 y 2016, Berle 2004, Merlob 2004, Hendrick 2003, Ohman 1999, Begg 1999)

Transient troubles in the early neonatal period like drug withdrawal syndrome among newborn or premature infants with high serum levels as a result of treatment with Paroxetine to the mother during pregnancy have been observed. (Hale 2010, Knoppert 2006, Costei 2002, Stiskal 2001, Nordeng 2001)

Paroxetine, like other antidepressants, can cause galactorrhea problems with or without hyperprolactinaemia. (Bhattacharjee 2021, Mishra 2019, Kumar 2018, Trenque 2011, Chakraborty 2010, Davenport 2002, Morrison 2001, González 2000, Bonin 1997, Egberts 1997)

Several medical societies, experts and expert consensus, consider the use of this medication safe or probably safe during breastfeeding. (Hale, Lactmed, Salazar 2016, Uguz 2021, 2019 y 2016, Orsolini 2015, Sriraman 2015, Rowe 2013, Amir 2011, Berle 2011, Patil 2011, Lanza 2009, ABM 2008, Field 2008, Gentile 2005, Weissman 2004, Rubin 2004, Gjerdingen 2003, Wisner 2002, Nordeng 2001)

Women suffering from depression during pregnancy need more breastfeeding support due to their increased risk of breastfeeding problems and early weaning. (Grzeskowiak 2018, Leggett 2017, Gorman 2012)


See below the information of this related product:

  • Maternal Depression (Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)

Alternatives

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

C19 H20 FNO3 is Paroxetine in Molecular formula.

Is written in other languages:

C19 H20 FNO3 is also known as

Tradenames

Main tradenames from several countries containing C19 H20 FNO3 in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 100 %
Molecular weight 366 daltons
Protein Binding 93 - 95 %
VD > 1 l/Kg
pKa 9.8 -
Tmax 6 - 10 hours
15 - 33 hours
M/P ratio 0.06 - 1.3 -
Theoretical Dose 0.02 mg/Kg/d
Relative Dose 2 - 5 %

References

  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on March 17, 2022 Full text (link to original source)
  2. LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2006 - Consulted on March 15, 2022 Full text (link to original source)
  3. Bhattacharjee S, Biswas R, Mandal N. Selective serotonin reuptake inhibitor-induced galactorrhea with hyperprolactinemia. Indian J Psychiatry. 2021 Nov-Dec;63(6):613-616. Abstract
  4. Uguz F. A New Safety Scoring System for the Use of Psychotropic Drugs During Lactation. Am J Ther. 2021 Jan-Feb 01;28(1):e118-e126. Abstract
  5. Rybakowski J, Cubała WJ, Gałecki P, Rymaszewska J, Samochowiec J, Szulc A, Dudek D. Recommendations of the Polish Psychiatric Association regarding the treatment of affective disorders in women of childbearing age. Part II: Bipolar disorder. Psychiatr Pol. 2019 Apr 30;53(2):263-276. Abstract Full text (link to original source)
  6. Uguz F. Short-Term Safety of Paroxetine Plus Low-Dose Mirtazapine During Lactation. Breastfeed Med. 2019 Mar;14(2):131-132. Abstract
  7. Mishra S, Nath S, Mishra BR, Pattnaik JI. Euprolactinemic Galactorrhea with Paroxetine: Exploring the Missing Link. Indian J Psychol Med. 2019 Jul-Aug;41(4):395-397. Abstract
  8. Pogliani L, Baldelli S, Cattaneo D, Pileri P, Clementi E, Cetin I, Zuccotti G. Selective serotonin reuptake inhibitors' passage into human milk of lactating women. J Matern Fetal Neonatal Med. 2019 Sep;32(18):3020-3025. Abstract
  9. Grzeskowiak LE, Leggett C, Costi L, Roberts CT, Amir LH. Impact of serotonin reuptake inhibitor use on breast milk supply in mothers of preterm infants: a retrospective cohort study. Br J Clin Pharmacol. 2018 Jun;84(6):1373-1379. Abstract Full text (link to original source)
  10. Kumar PNS, Gopalakrishnan A. Paroxetine induced galactorrhoea - A case report. Asian J Psychiatr. 2018 Apr;34:31-32. Abstract
  11. Leggett C, Costi L, Morrison JL, Clifton VL, Grzeskowiak LE. Antidepressant Use in Late Gestation and Breastfeeding Rates at Discharge from Hospital. J Hum Lact. 2017 Nov;33(4):701-709. Abstract
  12. Weisskopf E, Panchaud A, Nguyen KA, Grosjean D, Hascoët JM, Csajka C, Eap CB, Ansermot N; collaborators of the SSRI-Breast Milk study.. Simultaneous determination of selective serotonin reuptake inhibitors and their main metabolites in human breast milk by liquid chromatography-electrospray mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Jul 1;1057:101-109. Abstract
  13. Venkatesh KK, Castro VM, Perlis RH, Kaimal AJ. Impact of antidepressant treatment during pregnancy on obstetric outcomes among women previously treated for depression: an observational cohort study. J Perinatol. 2017 Sep;37(9):1003-1009. Abstract
  14. Salazar FR, D'Avila FB, de Oliveira MH, Ferreira PL, Bergold AM. Development and validation of a bioanalytical method for five antidepressants in human milk by LC-MS. J Pharm Biomed Anal. 2016 Sep 10;129:502-508. Abstract
  15. Uguz F, Arpaci N. Short-Term Safety of Paroxetine and Sertraline in Breastfed Infants: A Retrospective Cohort Study from a University Hospital. Breastfeed Med. 2016 Nov;11:487-489. Epub 2016 Aug 30. Abstract
  16. Larsen ER, Damkier P, Pedersen LH, Fenger-Gron J, Mikkelsen RL, Nielsen RE, Linde VJ, Knudsen HE, Skaarup L, Videbech P. Use of psychotropic drugs during pregnancy and breast-feeding. Acta Psychiatr Scand Suppl. 2015 Abstract
  17. Sriraman NK, Melvin K, Meltzer-Brody S. ABM Clinical Protocol #18: Use of Antidepressants in Breastfeeding Mothers. Breastfeed Med. 2015 Abstract Full text (link to original source) Full text (in our servers)
  18. Orsolini L, Bellantuono C. Serotonin reuptake inhibitors and breastfeeding: a systematic review. Hum Psychopharmacol. 2015 Jan;30(1):4-20. Abstract
  19. Davanzo R, Bua J, Paloni G, Facchina G. Breastfeeding and migraine drugs. Eur J Clin Pharmacol. 2014 Abstract
  20. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  21. Gorman JR, Kao K, Chambers CD. Breastfeeding among women exposed to antidepressants during pregnancy. J Hum Lact. 2012 Abstract
  22. Patil AS, Kuller JA, Rhee EH. Antidepressants in pregnancy: a review of commonly prescribed medications. Obstet Gynecol Surv. 2011 Abstract
  23. Davanzo R, Copertino M, De Cunto A, Minen F, Amaddeo A. Antidepressant drugs and breastfeeding: a review of the literature. Breastfeed Med. 2011 Abstract
  24. Amir LH, Pirotta MV, Raval M. Breastfeeding--evidence based guidelines for the use of medicines. Aust Fam Physician. 2011 Sep;40(9):684-90. Review. Abstract Full text (link to original source) Full text (in our servers)
  25. Berle JO, Spigset O. Antidepressant Use During Breastfeeding. Curr Womens Health Rev. 2011 Abstract Full text (link to original source) Full text (in our servers)
  26. Trenque T, Herlem E, Auriche P, Dramé M. Serotonin reuptake inhibitors and hyperprolactinaemia: a case/non-case study in the French pharmacovigilance database. Drug Saf. 2011 Abstract
  27. Chakraborty S, Sanyal D, Bhattacharyya R, Dutta S. A case of paroxetine-induced galactorrhoea with normal serum prolactin level. Indian J Pharmacol. 2010 Abstract Full text (in our servers)
  28. Hale TW, Kendall-Tackett K, Cong Z, Votta R, McCurdy F. Discontinuation syndrome in newborns whose mothers took antidepressants while pregnant or breastfeeding. Breastfeed Med. 2010 Abstract
  29. Lanza di Scalea T, Wisner KL. Antidepressant medication use during breastfeeding. Clin Obstet Gynecol. 2009 Abstract Full text (link to original source) Full text (in our servers)
  30. Academy of Breastfeeding Medicine Protocol Committee. ABM clinical protocol #18: use of antidepressants in nursing mothers. Breastfeed Med. 2008 Abstract Full text (link to original source) Full text (in our servers)
  31. Field T. Breastfeeding and antidepressants. Infant Behav Dev. 2008 Sep;31(3):481-7. Abstract
  32. Knoppert DC, Nimkar R, Principi T, Yuen D. Paroxetine toxicity in a newborn after in utero exposure: clinical symptoms correlate with serum levels. Ther Drug Monit. 2006 Abstract
  33. Misri S, Corral M, Wardrop AA, Kendrick K. Quetiapine augmentation in lactation: a series of case reports. J Clin Psychopharmacol. 2006 Oct;26(5):508-11. Abstract
  34. Gentile S. The safety of newer antidepressants in pregnancy and breastfeeding. Drug Saf. 2005 Abstract
  35. Merlob P, Stahl B, Sulkes J. Paroxetine during breast-feeding: infant weight gain and maternal adherence to counsel. Eur J Pediatr. 2004 Abstract
  36. Berle JØ, Steen VM, Aamo TO, Breilid H, Zahlsen K, Spigset O. Breastfeeding during maternal antidepressant treatment with serotonin reuptake inhibitors: infant exposure, clinical symptoms, and cytochrome p450 genotypes. J Clin Psychiatry. 2004 Abstract
  37. Weissman AM, Levy BT, Hartz AJ, Bentler S, Donohue M, Ellingrod VL, Wisner KL. Pooled analysis of antidepressant levels in lactating mothers, breast milk, and nursing infants. Am J Psychiatry. 2004 Abstract Full text (link to original source) Full text (in our servers)
  38. Rubin ET, Lee A, Ito S. When breastfeeding mothers need CNS-acting drugs. Can J Clin Pharmacol. 2004 Fall;11(2):e257-66. Epub 2004 Dec 8. Abstract
  39. Hendrick V, Smith LM, Hwang S, Altshuler LL, Haynes D. Weight gain in breastfed infants of mothers taking antidepressant medications. J Clin Psychiatry. 2003 Abstract
  40. Gjerdingen D. The effectiveness of various postpartum depression treatments and the impact of antidepressant drugs on nursing infants. J Am Board Fam Pract. 2003 Abstract Full text (link to original source) Full text (in our servers)
  41. Costei AM, Kozer E, Ho T, Ito S, Koren G. Perinatal outcome following third trimester exposure to paroxetine. Arch Pediatr Adolesc Med. 2002 Abstract Full text (in our servers)
  42. Davenport E, Velamoor R. A case of paroxetine-induced galactorrhea. Can J Psychiatry. 2002 Abstract
  43. Wisner KL, Parry BL, Piontek CM. Clinical practice. Postpartum depression. N Engl J Med. 2002 Abstract
  44. Stiskal JA, Kulin N, Koren G, Ho T, Ito S. Neonatal paroxetine withdrawal syndrome. Arch Dis Child Fetal Neonatal Ed. 2001 Mar;84(2):F134-5. Abstract
  45. Morrison J, Remick RA, Leung M, Wrixon KJ, Bebb RA. Galactorrhea induced by paroxetine. Can J Psychiatry. 2001 Abstract
  46. Nordeng H, Lindemann R, Perminov KV, Reikvam A. Neonatal withdrawal syndrome after in utero exposure to selective serotonin reuptake inhibitors. Acta Paediatr. 2001 Abstract
  47. Nordeng H, Bergsholm YK, Bøhler E, Spigset O. Overgang av selektive serotoninreopptakshemmere til morsmelk \ [The transfer of selective serotonin reuptake inhibitors to human milk]. Tidsskr Nor Laegeforen. 2001 Abstract Full text (link to original source) Full text (in our servers)
  48. Wisner KL, Findling RL, Perel JM. Paroxetine in breast milk. Am J Psychiatry. 2001 Abstract
  49. Hendrick V, Fukuchi A, Altshuler L, Widawski M, Wertheimer A, Brunhuber MV. Use of sertraline, paroxetine and fluvoxamine by nursing women. Br J Psychiatry. 2001 Abstract Full text (link to original source) Full text (in our servers)
  50. González E, Minguez L, Sanguino RM. Galactorrhea after paroxetine treatment. Pharmacopsychiatry. 2000 Abstract
  51. Stowe ZN, Cohen LS, Hostetter A, Ritchie JC, Owens MJ, Nemeroff CB. Paroxetine in human breast milk and nursing infants. Am J Psychiatry. 2000 Abstract Full text (in our servers)
  52. Misri S, Kim J, Riggs KW, Kostaras X. Paroxetine levels in postpartum depressed women, breast milk, and infant serum. J Clin Psychiatry. 2000 Abstract
  53. Hendrick V, Stowe ZN, Altshuler LL, Hostetter A, Fukuchi A. Paroxetine use during breast-feeding. J Clin Psychopharmacol. 2000 Abstract
  54. Ohman R, Hägg S, Carleborg L, Spigset O. Excretion of paroxetine into breast milk. J Clin Psychiatry. 1999 Abstract
  55. Begg EJ, Duffull SB, Saunders DA, Buttimore RC, Ilett KF, Hackett LP, Yapp P, Wilson DA. Paroxetine in human milk. Br J Clin Pharmacol. 1999 Abstract Full text (in our servers)
  56. Birnbaum CS, Cohen LS, Bailey JW, Grush LR, Robertson LM, Stowe ZN. Serum concentrations of antidepressants and benzodiazepines in nursing infants: A case series. Pediatrics. 1999 Abstract Full text (link to original source)
  57. Egberts AC, Meyboom RH, De Koning FH, Bakker A, Leufkens HG. Non-puerperal lactation associated with antidepressant drug use. Br J Clin Pharmacol. 1997 Abstract Full text (link to original source) Full text (in our servers)
  58. Bonin B, Vandel P, Sechter D, Bizouard P. Paroxetine and galactorrhea. Pharmacopsychiatry. 1997 Abstract
  59. Spigset O, Carleborg L, Norström A, Sandlund M. Paroxetine level in breast milk. J Clin Psychiatry. 1996 Abstract

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