The Basics
What is Tramadol?
Used to help relieve moderate to moderately severe pain.
Brand names for Tramadol
Ultram
How Tramadol is classified
Analgesics – Opioid, Narcotics
Tramadol During Pregnancy
Tramadol pregnancy category
Category CNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Tramadol while pregnant
N/A
Taking Tramadol While Breastfeeding
What are recommendations for lactation if you're taking Tramadol?
The excretion of tramadol into milk is low and even lower amounts of the active metabolite, O-desmethyltramadol, are excreted. With usual maternal dosage, the amount excreted into breastmilk is much less than the dose that has been given to newborn infants for analgesia. A study of breastfeeding in breastfed newborn infants found no adverse effects attributable to tramadol. Although tramadol is unlikely to adversely affect nursing infant,[1] the U.S. Food and Drug Administration and the manufacturer recommend against the use of tramadol during breastfeeding.[2] If tramadol is used, monitor infants for increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties or limpness, and contact a physician immediately if any of these occur.
Maternal / infant drug levels
The excretion of tramadol into milk is low and even lower amounts of the active metabolite, O-desmethyltramadol, are excreted. With usual maternal dosage, the amount excreted into breastmilk is much less than the dose that has been given to newborn infants for analgesia. A study of breastfeeding in breastfed newborn infants found no adverse effects attributable to tramadol. Although tramadol is unlikely to adversely affect nursing infant,[1] the U.S. Food and Drug Administration and the manufacturer recommend against the use of tramadol during breastfeeding.[2] If tramadol is used, monitor infants for increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties or limpness, and contact a physician immediately if any of these occur.
Possible effects of Tramadol on milk supply
Tramadol can increase serum prolactin.[10] However, the prolactin level in a mother with established lactation may not affect her ability to breastfeed.
A randomized study compared tramadol and naproxen for post-cesarean section pain. Patients received the drugs either on a fixed schedule or as needed. No difference in breastfeeding rates were seen among the groups.[11]
In a study in China, women with a scheduled cesarean section were randomized to receive intravenous patient-controlled analgesia with either sufentanil or tramadol. Postpartum prolactin levels were higher in the tramadol group (348 mcg/L) than in the sufentanil group (314 mcg/L). The onset of lactation was sooner in the tramadol group (21.4 hours) than in the sufentanil group (25.1 hours). Both of these difference were statistically significant.[12] Injectable tramadol is not available in the United States.
Possible alternatives to Tramadol
Acetaminophen, Ibuprofen, Morphine.
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Palmer GM, Anderson BJ, Linscott DK et al. Tramadol, breast feeding and safety in the newborn. Arch Dis Child. 2018;103:1110-3. PMID: 29599166
2. United States Food and Drug Administration. FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women. 2017;April 20. https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm
3. Grond S, Sablotzki A. Clinical pharmacology of tramadol. Clin Pharmacokinet. 2004;43:879-923. PMID: 15509185
4. Lai J, Ma SW, Porreca F, Raffa RB. Tramadol, M1 metabolite and enantiomer affinities for cloned human opioid receptors expressed in transfected HN9.10 neuroblastoma cells. Eur J Pharmacol. 1996;316:369-72. PMID: 8982709
5. Allegaert K, Rochette A, Veyckemans F. Developmental pharmacology of tramadol during infancy: ontogeny, pharmacogenetics and elimination clearance. Paediatr Anaesth. 2011;21:266-73. PMID: 20723094
6. Kmetec V, Roskar R. HPLC determination of tramadol in human breast milk. J Pharm Biomed Anal. 2003;32:1061-6. PMID: 12899994
7. Hartenstein S, Proquitte H, Bauer S et al. Neonatal abstinence syndrome (NAS) after intrauterine exposure to tramadol. J Perinat Med. 2010;38:695-6. PMID: 20707626
8. Ilett KF, Paech MJ, Page-Sharp M et al. 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;65:661-6. PMID: 18294329
9. Salman S, Sy SK, Ilett KF et al. Population pharmacokinetic modeling of tramadol and its o-desmethyl metabolite in plasma and breast milk. Eur J Clin Pharmacol. 2011. PMID: 21394525
10. Seitz W, Kirchner E, Schaps D, Wagner T, Hesch RD. [Endocrine reaction pattern in the course of a one-phase tramadol-N2O combination anesthesia]. Anasth Intensivther Notfallmed. 1982;17:325-31. PMID: 6297329
11. Sammour RN, Ohel G, Cohen M, Gonen R. Oral naproxen versus oral tramadol for analgesia after cesarean delivery. Int J Gynaecol Obstet. 2011;113:144-7. PMID: 21435642
12. Chi X, Li M, Mei W et al. 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;10:1521-7. PMID: 28740418
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
