Last update Nov. 23, 2021
Very Low Risk
Analgesic and antipyretic. Indicated in the treatment of pain and fever. It has a weak anti-inflammatory effect. Oral, intravenous and rectal administration, every 4, 6 or 8 hours.
It is excreted in very small quantities in breast milk. (AEMPS 2017, GSK 2015, Notarianni 1987, Bitzén 1981, Findlay 1981, Berlin 1980, Hurden 1980) The amount that the infant can receive through breast milk is much lower than the usual pediatric dose.(Lee 1993)
No problems have been observed in infants whose mothers were taking it,(AEMPS 2017, Ito 1993) except for one case of mild dermatitis in an infant. (Matheson 1985)
No association has been observed between maternal paracetamol use and neurodevelopmental disorders in infants (autism spectrum disorder, ASD, attention deficit/hyperactivity disorder,ADHD).
The urinary levels of infants have been undetectable. (AEMPS 2017, Berlin 1980) Other authors have measured insignificant levels in urine, but only paracetamol, not their metabolites as in adults.(Notarianni 1987)
The hepatotoxicity of paracetamol is lower in newborns and small infants due to hepatic immaturity: the low levels of specific cytochrome P-450 enzymes hinder the conversion of the drug into its toxic metabolites. (Reece 2017, Sachs 2013)
Medication commonly used in Pediatrics, with authorized use in neonates, including premature infants.
American Academy of Pediatrics: medication usually compatible with breastfeeding. (AAP 2001)
List of essential medicines WHO: compatible with breastfeeding. (WHO / UNICEF, 2002)
The manufacturer (AEMPS 2017, GSK 2015) and expert authors and medical associations consider it compatible with breastfeeding. (Reece 2017, Davanzo 2014, Rowe 2013, Worthington 2013, Sachs 2013, Amir 2011, Zrour 2010, Chen 2010, Østensen 2007, Nice 2004, Bannwarth 2003, Bar-Oz 2003, Janssen 2000, Nice 2000, Spigset 2000, Mitchell 1999, Bodley 1997, Lee 1993, Bitzen 1981, Berlin 1980)
We do not have alternatives for 4′-Hydroxyacetanilide; N-(4-Hydroxyphenyl)acetamide; N-Acetyl-P-Aminophenol since it is relatively safe.
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.
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Thank you for helping to protect and promote breastfeeding.
e-lactancia is a resource recommended by Asociación Española de Bancos de Leche Humana of Spain
Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM