Last update: July 6, 2018

Tramadol

Very Low Risk for breastfeeding


Safe. Compatible.
Not risky for breastfeeding or infant.

A centrally-acting analgesic which has a weak opioid effect (1/6 to 1/10 that of morphine) and noradrenergic and serotonergic properties (AEMPS 2017). Indicated in the treatment of moderate to intense pain.
Intravenous and oral administration every 4 to 6 hours.
It is metabolized to the active metabolite, O-desmethyltramadol (M1), through the hepatic enzyme CYP2D6 (Reece 2017), which is deficient in the first 3 months of life (Palmer 2018). Tramadol causes sedation and its metabolite M1 causes sedation and respiratory depression (Palmer 2018).

Tramadol and M1 are excreted in breastmilk in clinically insignificant amounts (AEMPS 2018, Actavis 2017, Reece 2017, FDA 2010, Hendrickson 2012, Hartenstein 2010, Ilett 2008, Kmetec 2003) even in cases of individuals with ultra-rapid metabolism (Salman 2011).
The dose received through breastmilk is much lower than the dose used in newborns and infants and no problems have been observed in infants whose mothers were taking it (Ilett 2008). The plasma levels of these infants were very low (Salman 2011).
Its use is authorized in pediatrics, even in newborns, in many countries (Palmer 2018, Alencar 2012).

With regard to sufentanil, tramadol increases prolactin levels and shortens the start time of breastfeeding (Chi 2017).

As with codeine (which is metabolized to morphine) there are ultra-fast metabolizers of tramadol that can accumulate a higher concentration of M1. For this reason, the FDA contraindicates codeine and also tramadol during breastfeeding (FDA 2017). But many experts consider tramadol safe or probably safe during breastfeeding (Palmer 2018, Reece 2017, Hale 2017 p 945, Bloor 2012, Salman 2011, Amir 2010, Ilett 2008), since:
- the metabolite of tramadol, M1, has a weak opioid effect, not like morphine, codeine metabolite.
- until two to three months of age the metabolism of tramadol to M1 is greatly diminished.
- Tramadol and M1 are excreted in very small amounts in breastmilk.
- no adverse effects have been reported in neonates or infants whose mothers were taking tramadol.

For these reasons, Palmer 2018 considers this contraindication of the FDA inappropriate.

A sufficient minimum dose should be used and signs of sedation or feeding difficulties should be monitored in the infant.

Postpartum pain, especially after an untreated caesarean section, makes it difficult to start breastfeeding (Carvalho 2013).
The use of non-steroidal anti-inflammatory drugs (NSAIDs) prescribed at fixed intervals can better control pain and have fewer side effects than tramadol (Worthington 2013, Sammour 2011).
The WHO’s guidelines for birth attendance should be followed, as well as decreasing the carrying out of caesarean sections and episiotomies, and therefore, the need to use analgesics in the first days.

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

Tramadol is also known as


Tramadol in other languages or writings:

Group

Tramadol belongs to this group or family:

Tradenames

Main tradenames from several countries containing Tramadol in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 60 - 75 %
Molecular weight 300 daltons
Protein Binding 20 %
VD 2,5 - 4 l/Kg
pKa 9,4 -
Tmax 2 hours
T1/2 6 - 7 hours
M/P ratio 2,4 - 3 -
Theoretical Dose 0,11 mg/Kg/d
Relative Dose 2,3 %
Relat.Ped.Dose 2,6 %

References

  1. AEMPS. Tramadol. Ficha técnica. 2018 Full text (in our servers)
  2. Palmer GM, Anderson BJ, Linscott DK, Paech MJ, Allegaert K. Tramadol, breast feeding and safety in the newborn. Arch Dis Child. 2018 Abstract
  3. FDA. FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women. Drug Safety Communications. 2017 Full text (link to original source) Full text (in our servers)
  4. Actavis (UK). Tramadol. Drug summary. 2017 Full text (in our servers)
  5. Chi X, Li M, Mei W, Liao M. Comparison of patient-controlled intravenous analgesia with sufentanil versus tramadol in post-cesarean section pain management and lactation after general anesthesia - a prospective, randomized, double-blind, controlled study. J Pain Res. 2017 Abstract Full text (link to original source) Full text (in our servers)
  6. Reece-Stremtan Sarah, Campos Matilde, Kokajko Lauren, and The Academy of Breastfeeding Medicine. Breastfeeding Medicine. ABM Clinical Protocol #15: Analgesia and Anesthesia for the Breastfeeding Mother, Revised 2017. Breastfeeding Medicine. 2017 Full text (link to original source) Full text (in our servers)
  7. Hale TW, Rowe HE. Medications & Mothers' Milk. A Manual of Lactation Pharmacology. Springer Publishing Company. 2017
  8. Carvalho FA, Tenório SB. Comparative study between doses of intrathecal morphine for analgesia after caesarean. Braz J Anesthesiol. 2013 Abstract
  9. Worthington I, Pringsheim T, Gawel MJ, Gladstone J, Cooper P, Dilli E, Aube M, Leroux E, Becker WJ; Canadian Headache Society Acute Migraine Treatment Guideline Development Group. Canadian Headache Society Guideline: acute drug therapy for migraine headache. Can J Neurol Sci. 2013 Abstract Full text (in our servers)
  10. Bloor M, Paech MJ, Kaye R. Tramadol in pregnancy and lactation. Int J Obstet Anesth. 2012 Abstract
  11. Hendrickson RG, McKeown NJ. Is maternal opioid use hazardous to breast-fed infants? Clin Toxicol (Phila). 2012 Abstract Full text (link to original source) Full text (in our servers)
  12. Alencar AJ, Sanudo A, Sampaio VM, Góis RP, Benevides FA, Guinsburg R. Efficacy of tramadol versus fentanyl for postoperative analgesia in neonates. Arch Dis Child Fetal Neonatal Ed. 2012 Abstract
  13. Salman S, Sy SK, Ilett KF, Page-Sharp M, Paech MJ. Population pharmacokinetic modeling of tramadol and its O-desmethyl metabolite in plasma and breast milk. Eur J Clin Pharmacol. 2011 Abstract
  14. Sammour RN, Ohel G, Cohen M, Gonen R. Oral naproxen versus oral tramadol for analgesia after cesarean delivery. Int J Gynaecol Obstet. 2011 Abstract
  15. Amir LH, Pirotta MV, Raval M. Breastfeeding--evidence based guidelines for the use of medicines. Aust Fam Physician. 2011 Abstract Full text (link to original source) Full text (in our servers)
  16. Hartenstein S, Proquitté H, Bauer S, Bamberg C, Roehr CC. Neonatal abstinence syndrome (NAS) after intrauterine exposure to tramadol. J Perinat Med. 2010 Abstract
  17. FDA. Tramadol. Drug Summary. 2010 Full text (link to original source) Full text (in our servers)
  18. Ilett KF, Paech MJ, Page-Sharp M, Sy SK, Kristensen JH, Goy R, Chua S, Christmas T, Scott KL. Use of a sparse sampling study design to assess transfer of tramadol and its O-desmethyl metabolite into transitional breast milk. Br J Clin Pharmacol. 2008 Abstract Full text (link to original source) Full text (in our servers)
  19. Kmetec V, Roskar R. HPLC determination of tramadol in human breast milk. J Pharm Biomed Anal. 2003 Abstract
  20. WHO Expert Committee on Drug Dependence. Critical review of psychoactive substances. WHO Technical Report Series. Thirty-third Report 2003 Full text (link to original source) Full text (in our servers)
  21. OMS. Comité de Expertos de la OMS en Farmacodependencia. Examen crítico de psicofármacos. OMS. Serie de informes técnicos, 33 informe. 2003 Full text (in our servers)

Total visits

188,249

Help us improve this entry

How to cite this entry

Do you need more information or did not found what you were looking for?

   Write to us at elactancia.org@gmail.com

e-lactancia is a resource recommended by Academy of Breastfeeding Medicine from United States of America

Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM