Last update: Nov. 3, 2018

Labetalol Hydrochloride

Very Low Risk for breastfeeding

Safe. Compatible.
Minimal risk for breastfeeding and infant.

Labetalol is a non-cardioselective beta-blocker used in the treatment of hypertension, stable chronic angina pectoris, sympathetic overactivity syndrome associated with severe tetanus, the control of blood pressure in patients with pheochromocytoma, in pregnant women with preeclampsia and to produce controlled hypotension during anesthesia in order to reduce bleeding resulting from surgical procedures.
Administration is carried out orally in 2 daily doses or intravenously for the emergency treatment of hypertension.

Despite not having high protein binding (Riant 1986), other pharmacokinetic properties (moderate liposolubility and high volume of distribution) probably explain why labetalol is excreted in breastmilk in clinically insignificant amounts (Hale 2019, Anderson 2018, FDA 2010, Atkinson 1990 and 1988, Lunell 1985, Michael 1979).

In addition, its low oral bioavailability hinders its transfer to infant plasma from breastmilk, except in premature babies and the immediate neonatal period when there may be increased intestinal permeability.

No problems have been observed in term infants whose mothers were prescribed labetalol during breastfeeding (Briggs 2017, AEMPS 2001, Michael 1979). Plasma levels of breastfed babies whose mothers took labetalol were very low (Lunell 1985, Michael 1979).

A poorly documented case of asymptomatic bradycardia has been recorded (poster) in an extremely premature baby of 26 weeks of gestation with 640g birth weight, whose mother took 600 mg of labetalol per day. Through breastmilk, the baby received 0.1 mg/kg /day of labetalol, which is 1% of the maternal dose and 0.8% of the pediatric dose (Mirpuri 2008).

Oral labetalol does not affect the secretion of prolactin (Barbieri 1982). Labetalol has been associated with neonatal hypoglycemia during pregnancy or delivery, but not during breastfeeding. (Munshi 1992).
The use of labetalol for the treatment of hypertension during pregnancy has been associated with Raynaud's phenomenon and nipple pain during breastfeeding. Discontinuing labetalol eliminated the pain (McGuinness 2013).

Some authors do not consider beta-blockers to be drugs of choice for the treatment of hypertension, unless there is another indication simultaneously, such as migraine or the prophylaxis of angina (Anderson 2018).

Several medical associations, experts and expert consensus believe its use to be safe or probably safe during breastfeeding (Hale 2019 p 418, Briggs 2017, Serrano 2014, Davanzo 2014, Rowe 2013, Podymow 2011, Ghanem 2008). The American Academy of Pediatrics considers labetalol to be generally compatible with breastfeeding (AAP 2001).


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

Labetalol Hydrochloride is also known as

Labetalol Hydrochloride in other languages or writings:


Labetalol Hydrochloride belongs to this group or family:


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


Variable Value Unit
Oral Bioavail. 25 - 40 %
Molecular weight 365 daltons
Protein Binding 50 %
VD 5,1 - 9,4 l/Kg
pKa 8,05 -
Tmax 1 - 2 hours
T1/2 6 - 8 hours
M/P ratio 1 - 2,6 -
Theoretical Dose 0,006 - 0,09 mg/Kg/d
Relative Dose 0,05 - 0,45 %
Ped.Relat.Dose 0,05 - 0,75 %


  1. Ghelfi AM, Ferretti MV, Staffieri GJ. Tratamiento farmacológico de la hipertensión arterial no severa durante el embarazo, el posparto y la lactancia. [Pharmacological treatment of non-severe hypertension during pregnancy, postpartum and breastfeeding]. Hipertens Riesgo Vasc. 2021 Feb 22. pii: S1889-1837(21)00013-1. Abstract
  2. Park S, Choi NK. Breastfeeding and Maternal Hypertension. Am J Hypertens. 2018 Abstract
  3. Anderson PO. Treating Hypertension During Breastfeeding. Breastfeed Med. 2018 Abstract
  4. Serrano Aguayo P, García de Quirós Muñoz JM, Bretón Lesmes I, Cózar León MV. Tratamiento de enfermedades endocrinológicas durante la lactancia. [Endocrinologic diseases management during breastfeeding.] Med Clin (Barc). 2015 Jan 20;144(2):73-9. Abstract
  5. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. Tenth edition (acces on line) 2015
  6. McGuinness N, Cording V. Raynaud's phenomenon of the nipple associated with labetalol use. J Hum Lact. 2013 Abstract Full text (link to original source)
  7. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  8. Podymow T, August P. Antihypertensive drugs in pregnancy. Semin Nephrol. 2011 Abstract
  9. Tamargo Menéndez J, Delpón Mosquera E. Farmacología de los bloqueantes de los receptores β-adrenérgicos. Curso βeta 2011 de Actualización en Betabloqueantes. 2011 Full text (in our servers)
  10. FDA-Prometheus. Labetalol. Drug Summary. 2010 Full text (in our servers)
  11. Ghanem FA, Movahed A. Use of antihypertensive drugs during pregnancy and lactation. Cardiovasc Ther. 2008 Abstract Full text (link to original source) Full text (in our servers)
  12. Mirpuri J, Patel H, Rhee D, Crowley K. What's mom on? A case of bradycardia in a premature infant on breast milk. J Invest Med. 2008;56:409. Poster 203. 2008
  13. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Abstract Full text (link to original source) Full text (in our servers)
  14. AEMPS-Kern. Labetalol. Ficha técnica. 2001 Full text (in our servers)
  15. Kirsten R, Nelson K, Kirsten D, Heintz B. Clinical pharmacokinetics of vasodilators. Part II. Clin Pharmacokinet. 1998 Abstract
  16. Munshi UK, Deorari AK, Paul VK, Singh M. Effects of maternal labetalol on the newborn infant. Indian Pediatr. 1992 Abstract
  17. Atkinson H, Begg EJ. Concentrations of beta-blocking drugs in human milk. J Pediatr. 1990 Abstract
  18. Atkinson HC, Begg EJ, Darlow BA. Drugs in human milk. Clinical pharmacokinetic considerations. Clin Pharmacokinet. 1988 Abstract
  19. Riant P, Urien S, Albengres E, Duche JC, Tillement JP. High plasma protein binding as a parameter in the selection of betablockers for lactating women. Biochem Pharmacol. 1986 Abstract
  20. Lunell NO, Kulas J, Rane A. Transfer of labetalol into amniotic fluid and breast milk in lactating women. Eur J Clin Pharmacol. 1985 Abstract
  21. Barbieri C, Larovere MT, Mariotti G, Ferrari C, Caldara R. Prolactin stimulation by intravenous labetalol is mediated inside the central nervous system. Clin Endocrinol (Oxf). 1982 Abstract
  22. Hale TW. Hale's Medications & Mothers' Milk. [Internet]. Springer Publishing Company; 1991-. Available from: None

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