Last update June 18, 2022


Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

It is a tricyclic antidepressant with actions and uses similar to those of amitriptyline. It has marked antimuscarinic and sedative properties. It is used in the treatment of depression and obsessive-compulsive disorder. Oral administration in one or two daily doses.

Excreted into breast milk in a clinically non-significant amount (Khachman 2009, Yoshida 1997, Schimmell 1991) with no problems observed in breastfed infants from treated mothers. (Khachman 2009, Nulman 2002, Birnbaum 1999, Yoshida 1997, Wisner 1995, Schimmell 1991, Misri 1991)

Levels found in the plasma of those infants were very low or undetectable. (Khachman 2009, Birnbaum 1999, Yoshida 1997, Wisner 1995, Schimmell 1991)

Because of a tiny excretion into the milk, symptoms due to deprivation syndrome would not be avoided by breastfeeding the infants whose mothers were taking this medication during pregnancy. (ter Horst 2012, Khachman 2009)

Galactorrhea and increased plasma prolactin levels have been reported. (Cordes 2011, Egberts 1997, Fowlie 1987)

Known safer alternatives may be preferable, especially during the neonatal period and in the event of prematurity. (Sriraman 2015, Gentile 2014, Davanzo 2011, Weissman 2004, Gjerdingen 2003)

List of WHO essential medicines: compatible with breastfeeding. (WHO-UNICEF 2002)

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, Venkatesh 2017, Gorman 2012)

See below the information of this related product:

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


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.


Main tradenames from several countries containing N06AA04 in its composition:


Variable Value Unit
Oral Bioavail. 50 %
Molecular weight 351 daltons
Protein Binding 98 %
VD 12 - 17 l/Kg
Tmax 2 - 6 hours
21 (12 - 36) hours
M/P ratio 0.8 - 1.6 -
Theoretical Dose 0.05 mg/Kg/d
Relative Dose 1.3 - 3 %
Ped.Relat.Dose 1 - 3 %


  1. 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)
  2. 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
  3. 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
  4. 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)
  5. 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
  6. Gentile S. Tricyclic antidepressants in pregnancy and puerperium. Expert Opin Drug Saf. 2014 Abstract
  7. Gorman JR, Kao K, Chambers CD. Breastfeeding among women exposed to antidepressants during pregnancy. J Hum Lact. 2012 Abstract
  8. ter Horst PG, van der Linde S, Smit JP, den Boon J, van Lingen RA, Jansman FG, De Jong-van den Berg LT, Wilffert B. Clomipramine concentration and withdrawal symptoms in 10 neonates. Br J Clin Pharmacol. 2012 Abstract Full text (link to original source) Full text (in our servers)
  9. Cordes J, Kahl KG, Werner C, Henning U, Regenbrecht G, Larisch R, Schmidt-Kraepelin C, Thünker J, Agelink MW, Löffler S, Hohlfeld T, Gaebel W, Klimke A. Clomipramine-induced serum prolactin as a marker for serotonin and dopamine turnover: results of an open label study. Eur Arch Psychiatry Clin Neurosci. 2011 Dec;261(8):567-73. Abstract
  10. Davanzo R, Copertino M, De Cunto A, Minen F, Amaddeo A. Antidepressant drugs and breastfeeding: a review of the literature. Breastfeed Med. 2011 Abstract
  11. Khachman D, Gandia P, Gaillard M-A, Seraissol P, Mendousse P, Assouline C, Houin G. Clomipramine in breast milk: a case study. Journal de Pharmacie Clinique. 2009;28(1):33-38. Abstract Full text (in our servers)
  12. Novartis. Clomipramine. Drug Summary. 2005 Full text (in our servers)
  13. Sigma. Clomipramina. Ficha técnica. 2005 Full text (in our servers)
  14. Yoshida K, Yamashita H. [Treatment strategy for women with puerperal psychiatric disorders--psychopharmaco-therapy and its impact on fetus and breast-fed infants]. Seishin Shinkeigaku Zasshi. 2003 Abstract
  15. 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)
  16. 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
  17. WHO / UNICEF. BREASTFEEDING AND MATERNAL MEDICATION Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. Department of Child and Adolescent Health and Development (WHO/UNICEF) 2002 Abstract Full text (link to original source) Full text (in our servers)
  18. 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)
  19. Yoshida K, Smith B, Craggs M, Kumar RC. Investigation of pharmacokinetics and of possible adverse effects in infants exposed to tricyclic antidepressants in breast-milk. J Affect Disord. 1997 Abstract
  20. 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)
  21. Wisner KL, Perel JM, Findling RL. Antidepressant treatment during breast-feeding. Am J Psychiatry. 1996 Sep;153(9):1132-7. Review. Abstract
  22. Misri S, Sivertz K. Tricyclic drugs in pregnancy and lactation: a preliminary report. Int J Psychiatry Med. 1991 Abstract
  23. Schimmell MS, Katz EZ, Shaag Y, Pastuszak A, Koren G. Toxic neonatal effects following maternal clomipramine therapy. J Toxicol Clin Toxicol. 1991 Abstract
  24. Fowlie S, Burton J. Hyperprolactinaemia and nonpuerperal lactation associated with clomipramine. Scott Med J. 1987 Abstract

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