Last update: Aug. 21, 2021

Fluoxetine Hydrochloride

Low Risk for breastfeeding


Moderately safe. Probably compatible.
Mild risk possible. Follow up recommended.
Read the Comment.

SSRI antidepressant.
Oral administration once a day.

It is excreted in breast milk in a small amount (Lopes 2018, Weisskopf 2017, Salazar 2016, Berle 2004, Heikkinen 2003, Suri 2002, Hendrick 2001, Kristensen 1999, Yoshida 1998, Burch 1992, Isenberg 1990), although greater than that of other antidepressants of the same SSRI group with relative dose > 10 % (Pogliani 2019, Sriraman 2015, Sachs 2013, Taddio 1996, Nordeng 2001).

Plasma levels of infants whose mothers took fluoxetine were undetectable or at low therapeutic limits (Weissman 2004, Epperson 2003, Hendrick 2001, Birnbaum 1999, Brent 1998, Yoshida 1998).

Few cases of colicky pain, irritability, insomnia, anorexia and slow weight gain have been described (Kristensen 1999, Chambers 1999, Lester 1993), but most reported cases have failed to show harm effect outside the newborn period (Taddio 1996). Large experience with the use of Fluoxatine did not find harm effect on weight gain and neurological development of infants either at short or long term (Pogliani 2019, Gashlin 2016, Epperson 2003, Heikkinen 2003, Hendrick 2003, Nulman 2002, Hendrick 2001, Birnbaum 1999, Yoshida1998).

Transient troubles in the early neonatal period (poor adaptation or hyperstimulation of serotonin) among newborn or premature infants with high serum levels as a result of treatment with fluoxetine to the mother during pregnancy have been observed (Kieviet 2015, Morris 2015, Hale 2010, Nordeng 2001).

Fluoxetine, like other antidepressants, can cause galactorrhea problems and or hyperprolactinaemia (Suthar 2018, Kaba 2017, Trenque 2011, Papakostas 2006, Peterson 2001, Egberts 1997, Arya 1995).

Several medical societies, experts and expert consensus, consider the use of this medication safe or probably safe during breastfeeding (Hale, Lactmed, Uguz 2021, Amir 2011, Berle 2011, Lanza 2009, ABM 2008, Pomp 2001).

Safer known alternatives may be preferable, especially during the neonatal period and in cases of prematurity (Davanzo 2011, Patil 2011, Gentile 2005, Rubin 2004, Weissman 2004, Gjerdingen 2003, Wisner 2002, Nordeng 2001, Wisner 1996).

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).

Alternatives

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

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

Fluoxetine Hydrochloride in other languages or writings:

Group

Fluoxetine Hydrochloride belongs to this group or family:

Tradenames

Main tradenames from several countries containing Fluoxetine Hydrochloride in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 100 %
Molecular weight 346 daltons
Protein Binding 94,5 %
VD 2,6 l/Kg
Tmax 6 - 8 hours
T1/2 144 hours
M/P ratio 0,3 - 0,9 -
Theoretical Dose 0,01 - 0,06 mg/Kg/d
Relative Dose 3 - 20,0 %

References

  1. 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
  2. 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
  3. Lopes BR, Cassiano NM, Carvalho DM, Moisés ECD, Cass QB. Simultaneous quantification of fluoxetine and norfluoxetine in colostrum and mature human milk using a 2-dimensional liquid chromatography-tandem mass spectrometry system. J Pharm Biomed Anal. 2018 Feb 20;150:362-367. Abstract
  4. Suthar N, Pareek V, Nebhinani N, Suman DK. Galactorrhea with antidepressants: A case series. Indian J Psychiatry. 2018 Jan-Mar;60(1):145-146. Abstract
  5. 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
  6. 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
  7. 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
  8. Kaba D, Öner Ö. Galactorrhea After Selective Serotonin Reuptake Inhibitor Use in an Adolescent Girl: A Case Report. J Clin Psychopharmacol. 2017 Jun;37(3):374-376. Abstract
  9. 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
  10. Gashlin LZ, Sullo D, Lawrence RA, Rosen-Carole C. Treatment of Narcolepsy with Sodium Oxybate While Breastfeeding: A Case Report. Breastfeed Med. 2016 Jun;11:261-3. Abstract
  11. 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
  12. Kieviet N, Hoppenbrouwers C, Dolman KM, Berkhof J, Wennink H, Honig A. Risk factors for poor neonatal adaptation after exposure to antidepressants in utero. Acta Paediatr. 2015 Apr;104(4):384-91. Abstract
  13. 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)
  14. Morris R, Matthes J. Serotonin syndrome in a breast-fed neonate. BMJ Case Rep. 2015 May 6;2015. pii: bcr2015209418. Abstract
  15. Sachs HC; Committee On Drugs. The transfer of drugs and therapeutics into human breast milk: an update on selected topics. Pediatrics. 2013 Sep;132(3):e796-809. Abstract Full text (link to original source) Full text (in our servers)
  16. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  17. Gorman JR, Kao K, Chambers CD. Breastfeeding among women exposed to antidepressants during pregnancy. J Hum Lact. 2012 Abstract
  18. 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
  19. 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)
  20. Patil AS, Kuller JA, Rhee EH. Antidepressants in pregnancy: a review of commonly prescribed medications. Obstet Gynecol Surv. 2011 Abstract
  21. Davanzo R, Copertino M, De Cunto A, Minen F, Amaddeo A. Antidepressant drugs and breastfeeding: a review of the literature. Breastfeed Med. 2011 Abstract
  22. 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)
  23. 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
  24. 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)
  25. 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)
  26. Papakostas GI, Miller KK, Petersen T, Sklarsky KG, Hilliker SE, Klibanski A, Fava M. Serum prolactin levels among outpatients with major depressive disorder during the acute phase of treatment with fluoxetine. J Clin Psychiatry. 2006 Abstract
  27. Gentile S. The safety of newer antidepressants in pregnancy and breastfeeding. Drug Saf. 2005 Abstract
  28. 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)
  29. 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
  30. 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
  31. Heikkinen T, Ekblad U, Palo P, Laine K. Pharmacokinetics of fluoxetine and norfluoxetine in pregnancy and lactation. Clin Pharmacol Ther. 2003 Abstract
  32. 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
  33. Epperson CN, Jatlow PI, Czarkowski K, Anderson GM. Maternal fluoxetine treatment in the postpartum period: effects on platelet serotonin and plasma drug levels in breastfeeding mother-infant pairs. Pediatrics. 2003 Abstract Full text (in our servers)
  34. 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)
  35. Suri R, Stowe ZN, Hendrick V, Hostetter A, Widawski M, Altshuler LL. Estimates of nursing infant daily dose of fluoxetine through breast milk. Biol Psychiatry. 2002 Abstract
  36. Nulman I, Rovet J, Stewart DE, Wolpin J, Pace-Asciak P, Shuhaiber S, Koren G. Child development following exposure to tricyclic antidepressants or fluoxetine throughout fetal life: a prospective, controlled study. Am J Psychiatry. 2002 Abstract
  37. Wisner KL, Parry BL, Piontek CM. Clinical practice. Postpartum depression. N Engl J Med. 2002 Abstract
  38. Peterson MC. Reversible galactorrhea and prolactin elevation related to fluoxetine use. Mayo Clin Proc. 2001 Abstract Full text (in our servers)
  39. Pomp EF, Gedde-Dahl A. Fluoksetin – trygt under graviditet og amming. \ [Fluoxetine--safe during pregnancy and breast feeding]. Tidsskr Nor Laegeforen. 2001 Abstract Full text (in our servers)
  40. Hendrick V, Stowe ZN, Altshuler LL, Mintz J, Hwang S, Hostetter A, Suri R, Leight K, Fukuchi A. Fluoxetine and norfluoxetine concentrations in nursing infants and breast milk. Biol Psychiatry. 2001 Abstract
  41. 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)
  42. Nordeng H, Lindemann R, Perminov KV, Reikvam A. Neonatal withdrawal syndrome after in utero exposure to selective serotonin reuptake inhibitors. Acta Paediatr. 2001 Abstract
  43. 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) Full text (in our servers)
  44. Chambers CD, Anderson PO, Thomas RG, Dick LM, Felix RJ, Johnson KA, Jones KL. Weight gain in infants breastfed by mothers who take fluoxetine. Pediatrics. 1999 Abstract Full text (in our servers)
  45. Kristensen JH, Ilett KF, Hackett LP, Yapp P, Paech M, Begg EJ. Distribution and excretion of fluoxetine and norfluoxetine in human milk. Br J Clin Pharmacol. 1999 Abstract Full text (in our servers)
  46. Brent NB, Wisner KL. Fluoxetine and carbamazepine concentrations in a nursing mother/infant pair. Clin Pediatr (Phila). 1998 Abstract
  47. Yoshida K, Smith B, Craggs M, Kumar RC. Fluoxetine in breast-milk and developmental outcome of breast-fed infants. Br J Psychiatry. 1998 Abstract
  48. 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)
  49. Wisner KL, Perel JM, Findling RL. Antidepressant treatment during breast-feeding. Am J Psychiatry. 1996 Sep;153(9):1132-7. Review. Abstract
  50. Taddio A, Ito S, Koren G. Excretion of fluoxetine and its metabolite, norfluoxetine, in human breast milk. J Clin Pharmacol. 1996 Abstract
  51. Arya DK, Taylor WS. Lactation associated with fluoxetine treatment. Aust N Z J Psychiatry. 1995 Abstract
  52. Lester BM, Cucca J, Andreozzi L, Flanagan P, Oh W. Possible association between fluoxetine hydrochloride and colic in an infant. J Am Acad Child Adolesc Psychiatry. 1993 Abstract
  53. Burch KJ, Wells BG. Fluoxetine/norfluoxetine concentrations in human milk. Pediatrics. 1992 Apr;89(4 Pt 1):676-7. No abstract available. Abstract
  54. [No authors listed] Can a woman breastfeed while taking Prozac? J Hum Lact. 1991 Abstract
  55. Isenberg KE. Excretion of fluoxetine in human breast milk. J Clin Psychiatry. 1990 Abstract
  56. Hale TW. Hale's Medications & Mothers' Milk. [Internet]. Springer Publishing Company; 1991-. Available from: https://www.halesmeds.com None
  57. 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/ None Full text (link to original source)

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