Last update June 29, 2022

Nefazodone Hydrochloride

High Risk

Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.

It is an antidepressant structurally related to trazodone. Oral administration in two daily doses.

Its pharmacokinetic data (high percentage of protein binding, large volume of distribution and moderately high molecular weight) explain the negligible passage into breast milk observed. (Yapp 2000, Dodd 2000 & 1999)

However, a 9-week-old, 27-week-premature infant whose mother was taking nefazodone had drowsiness, lethargy, growth retardation, and hypothermia. (Gjerdingen 2003, Yapp 2000)

Until more published data is known about this drug in relation to breastfeeding, known safer alternatives are preferable (Davanzo 2011), especially during the neonatal period and in the event of prematurity.

Withdrawn from market in many countries because an increased risk of a rather rare but severe hepatotoxicity. (Choi 2003)

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

Nefazodone Hydrochloride in other languages or writings:

Groups

Nefazodone Hydrochloride belongs to these groups or families:

Tradenames

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

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 23 %
Molecular weight 507 daltons
Protein Binding 99 %
VD 0.2 - 0.9 l/Kg
pKa 7.09 -
Tmax 1 hours
2 - 4 hours
M/P ratio 0.1 - 0.3 -
Theoretical Dose 0.1 - 0.5 mg/Kg/d
Relative Dose 0.4 - 2.2 %

References

  1. Davanzo R, Copertino M, De Cunto A, Minen F, Amaddeo A. Antidepressant drugs and breastfeeding: a review of the literature. Breastfeed Med. 2011 Abstract
  2. 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)
  3. 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
  4. 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)
  5. Choi S. Nefazodone (Serzone) withdrawn because of hepatotoxicity. CMAJ. 2003 Nov 25;169(11):1187. No abstract available. Abstract
  6. Dodd S, Maguire KP, Burrows GD, Norman TR. Nefazodone in the breast milk of nursing mothers: a report of two patients. J Clin Psychopharmacol. 2000 Dec;20(6):717-8. No abstract available. Abstract
  7. Yapp P, Ilett KF, Kristensen JH, Hackett LP, Paech MJ, Rampono J. Drowsiness and poor feeding in a breast-fed infant: association with nefazodone and its metabolites. Ann Pharmacother. 2000 Nov;34(11):1269-72. Abstract
  8. Dodd S, Buist A, Burrows GD, Maguire KP, Norman TR. Determination of nefazodone and its pharmacologically active metabolites in human blood plasma and breast milk by high-performance liquid chromatography. J Chromatogr B Biomed Sci Appl. 1999 Jul 9;730(2):249-55. Abstract

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