Acetaminophen / tramadol Pregnancy and Breastfeeding Warnings
Brand names: Tramapap, Ultracet
Medically reviewed by Drugs.com. Last updated on Mar 2, 2023.
Acetaminophen / tramadol Pregnancy Warnings
Use is not recommended unless the benefit outweighs the risk to the fetus
AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned
Comments: Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available.
Tramadol has been shown to cross the placental barrier, with an umbilical vein to maternal vein serum concentration ratio of 0.83. Animal studies have shown at very high doses, this drug has an effect on organ development, bone growth, and mortality rate. Prolonged maternal use of opioid analgesics during pregnancy may result in respiratory depression and physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. There have been postmarketing reports of neonatal seizures, neonatal withdrawal syndrome, fetal death, and still births with tramadol use. There are no adequate and well-controlled studies in pregnant women.
Chronic use of opioids may cause reduced fertility; it is unknown whether these effects are reversible.
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and
Acetaminophen / tramadol Breastfeeding Warnings
Maternal tramadol use may result in serious adverse reactions in breastfed infants including excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death. Newborns have limited capacity to metabolize the active 0-desmethyltramadol. Acetaminophen (paracetamol) is excreted in small amounts into breast milk and available published data have shown no ill effects when used in recommended doses. If this product is used, the infant should be monitored for increased sleepiness, difficulty breastfeeding, breathing difficulties or limpness.
Use is not recommended
Excreted into human milk: Yes (acetaminophen); yes (tramadol)
Comment: Breastfeeding is not recommended when taking codeine due to the risk of serious adverse reactions in breastfed infants.
See also
References for pregnancy information
- Product Information. Ultram (tramadol). McNeil Pharmaceutical. 2001;PROD.
- Product Information. Ultracet (acetaminophen-tramadol). Johnson and Johnson Medical Inc. 2001;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
References for breastfeeding information
- Product Information. Ultram (tramadol). McNeil Pharmaceutical. 2001;PROD.
- Product Information. Ultracet (acetaminophen-tramadol). Johnson and Johnson Medical Inc. 2001;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
- US Food and Drug Administration (FDA). 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. https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm 2017.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
