Last update Dec. 2, 2022



Safe substance and/or breastfeeding is the best option.

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 amount (Gesseck 2021, 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). Plasma levels of tramadol in a newborn on the third day of life whose mother took 300 mg daily of tramadol since pregnancy were 100 times lower than the therapeutic levels used in newborns and infants. According to their doctors, breastfeeding could have attenuated withdrawal symptoms. (Hartenstein 2010)

Its use is authorized in pediatrics, even in newborns, in many countries. (Palmer 2018, Alencar 2012)

An 8-month-old breastfed infant girl suffered from fatal poisoning. Mother and father were addicted to tramadol. It could not be established that the cause of death was exposure to tramadol through breast milk. (Hussien 2017)

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 considers this contraindication of the FDA inappropriate. (Palmer 2018)

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.


  • Ibuprofen (Safe substance and/or breastfeeding is the best option.)
  • Paracetamol (Safe substance and/or breastfeeding is the best option.)

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

Tramadol is also known as

Tramadol in other languages or writings:


Tramadol belongs to this group or family:


Main tradenames from several countries containing Tramadol in its composition:


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
6 - 7 hours
M/P ratio 2.4 - 3 -
Theoretical Dose 0.11 mg/Kg/d
Relative Dose 2.3 %
Ped.Relat.Dose 2.6 %


  1. Gesseck AM, Nanco CR, Hendricks-Muñoz KD, Xu J, Wolf CE, Poklis JL, Peace MR. Neonatal Exposure to Tramadol through Mother's Breast Milk. J Anal Toxicol. 2021 May 26. pii: bkab055. Abstract
  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. AEMPS. Tramadol. Ficha técnica. 2018 Full text (in our servers)
  4. Hussien R. Tramadol intoxication in an 8-months-old infant through breastfeeding: A case report. J Clin Toxicol. 2017;7:335. Full text (link to original source) Full text (in our servers)
  5. 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. Breastfeed Med. 2017 Nov;12(9):500-506. Full text (link to original source) Full text (in our servers)
  6. 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 Jul 3;10:1521-1527. Abstract Full text (link to original source) Full text (in our servers)
  7. Actavis (UK). Tramadol. Drug summary. 2017 Full text (in our servers)
  8. 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)
  9. Hale TW, Rowe HE. Medications & Mothers' Milk. A Manual of Lactation Pharmacology. Springer Publishing Company. 2017
  10. Vallersnes OM, Dines AM, Wood DM, Yates C, Heyerdahl F, Hovda KE, Giraudon I; Euro-DEN Research Group., Dargan PI. Psychosis associated with acute recreational drug toxicity: a European case series. BMC Psychiatry. 2016 Aug 18;16:293. Abstract Full text (link to original source)
  11. Dalal PG, Bosak J, Berlin C. Safety of the breast-feeding infant after maternal anesthesia. Paediatr Anaesth. 2014 Abstract
  12. 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 Sep;40(5 Suppl 3):S1-S80. Review. Abstract Full text (in our servers)
  13. Carvalho FA, Tenório SB. Comparative study between doses of intrathecal morphine for analgesia after caesarean. Braz J Anesthesiol. 2013 Abstract
  14. 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)
  15. 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
  16. Bloor M, Paech MJ, Kaye R. Tramadol in pregnancy and lactation. Int J Obstet Anesth. 2012 Abstract
  17. Sammour RN, Ohel G, Cohen M, Gonen R. Oral naproxen versus oral tramadol for analgesia after cesarean delivery. Int J Gynaecol Obstet. 2011 Abstract
  18. 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)
  19. 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
  20. FDA. Tramadol. Drug Summary. 2010 Full text (link to original source) Full text (in our servers)
  21. Hartenstein S, Proquitté H, Bauer S, Bamberg C, Roehr CC. Neonatal abstinence syndrome (NAS) after intrauterine exposure to tramadol. J Perinat Med. 2010 Abstract
  22. 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)
  23. 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)
  24. 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)
  25. Kmetec V, Roskar R. HPLC determination of tramadol in human breast milk. J Pharm Biomed Anal. 2003 Abstract

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