Acetaminophen use while Breastfeeding

Drugs containing Acetaminophen: Tylenol, Percocet, Norco, Vicodin, Fioricet, Paracetamol, Tylenol with Codeine #3, Lortab, Percocet 5/325, Percocet 10/325, Show all 965 »Ultracet, Endocet, Panadol, Excedrin, NyQuil, Midrin, Tylenol with Codeine #4, Tylenol with Codeine, Roxicet, Mapap, Darvocet-N 100, Excedrin Migraine, Percocet 7.5/325, Tylenol PM, Darvocet-N 50, Lorcet, Tylenol Extra Strength, Esgic, Alka-Seltzer Plus Cold, Fioricet with Codeine, Ofirmev, Vicodin ES, Hycet, Vicks Dayquil Daytime Cold/Flu, Coricidin HBP Cold & Flu, Dologesic, Q-Pap, Bupap, Xartemis XR, Percogesic Original Strength, Tylox, Nyquil Cold Medicine, Vicks Nyquil Cold & Flu Relief, Percocet 10/650, Cough & Cold Relief, Trezix, Midol PMS, Floricet with Codeine, Anexsia, Tylenol Arthritis Pain, Doliprane, Percogesic, Norel AD, Perfalgan, Children's Tylenol, Vanquish, Phrenilin, Lorcet Plus, Paracetamol Teva, Percocet 7.5/500, Tylenol Cold, Sinarest, Dologen, Panadol ActiFast, Coricidin D, Talacen, Robitussin 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Effervescent, Help I Have A Headache, Panlor DC, Hycomine Compound, Excedrin Quick Tab, Herron Paracetamol Tabsules, Excedrin Mild Headache, Valorin Extra, Vicks Formula 44 Custom Care Cough & Cold PM, Flu Relief BP, Cough Formula M Multi-Symptom, Comtrex Cold and Flu Maximum Strength Tablet, Comtrex Cold and Flu Maximum Strength Liquid, Genacol Maximum Strength, Chem Mart Chemadol, Leader 8 Hour Pain Reliever, Triaminic Multi-Symptom Fever & Cold, Comtrex Cold and Flu Maximum Strength, Comtrex Maximum Strength Cold Relief, Contac Severe Cold and Flu Maximum Stength, Childrens Tylenol Cold Plus Cough, Contac Cold and Flu Maximum Strength, Gelpirin-CCF, Chemworld Paracetamol Infant Colour Free, Chemworld Paracetamol, Chemworld Colourfree Childrens Paracetamol Junior 1-5 Years, Triaminic Flu, Cough & Fever, Alka-Seltzer Plus-D, Theraflu Flu & Cough, Allpanto-S, Co-Apap, Theraflu Warming Relief Nighttime Multi-Symptom Cold Caplets, Dimetapp Children's Nighttime Flu, Tylenol Plus Children's Flu, Alka-Seltzer Plus Cold & Cough Formula Liquid Gels, PediaCare Multi-Symptom Cold Plus Acetaminophen, Alka-Seltzer Plus Cold & Cough Formula Liquid, Tylenol Plus Children's Multi-Symptom Cold, Children's ElixSure, Coricidin HBP Multi-Symptom Cold (Night), Tylenol Plus Children's Cough & Runny Nose, Benylin Sore Throat, Mapap Rapid Release Gelcaps, PediaCare Flu Plus Acetaminophen, Codral Cold and Flu + Cough Day and Night, Cold Multi-Symptom (Nighttime), Multi Symptom Cold (Night Formula), Multi Symptom Cold Relief, Alka-Seltzer Plus Flu Formula, XL-3 Xtra Cold and Cough, Comtrex Nighttime Cold & Cough, Tylenol Cold Head Congestion Nighttime, Comtrex Cold & Cough Day Night, Theraflu Nighttime Severe Cold & Cough Caplets, Tylenol Cough & Sore Throat Nightime

Acetaminophen Levels and Effects while Breastfeeding

Summary of Use during Lactation

Acetaminophen is a good choice for analgesia, and fever reduction in nursing mothers. Amounts in milk are much less than doses usually given to infants. Adverse effects in breastfed infants appear to be rare.

Drug Levels

Maternal Levels. A single oral dose of 650 mg of acetaminophen was given to 12 nursing mothers who were 2 to 22 months postpartum. Peak milk levels of 10 to 15 mg/L occurred between 1 and 2 hours after the dose in all patients. Acetaminophen was undetectable (<0.5 mg/L) in all mothers 12 hours after the dose. The authors calculated that an infant who ingested 90 mL of breastmilk every 3 hours would receive an average of 0.88 mg of acetaminophen or 0.14% (range 0.04 to 0.23%) of the mother's absolute dosage.[1] Using data from this study, an infant would receive a maximum of about 2% of the maternal weight-adjusted dosage.

Three women took a single 500 mg dose of acetaminophen. Peak milk levels averaging 4.2 mg/L occurred within 2 hours after the dose.[2] Using data from this study, an infant would receive a maximum of about 3.6% of the maternal weight-adjusted dosage.

Four women who were 2 to 8 months postpartum were given a single 1 gram dose of acetaminophen. Peak milk levels occurred between 1 and 2.5 hours after the dose. The authors estimated that a breastfed infant would receive an average of 1.1% and a maximum of 1.8% of the maternal weight-adjusted dosage. This dose is about 0.5% of the lowest recommended infant dose of acetaminophen.[3]

Infant Levels. No acetaminophen was detected in the urine of 12 breastfed infants aged 2 to 22 months after maternal ingestion of 650 mg of acetaminophen.[1]

Urine was collected for 1 to 3.5 hours after nursing in 6 infants aged 2 to 6 days whose mothers received 1 to 2 grams of acetaminophen 2 to 4 hours before nursing their infant. Infants excreted an average of 401 mcg of acetaminophen and its metabolites in urine during the collection interval. These neonates excreted a greater percentage of drug as acetaminophen and much less as the sulfate metabolite than adults.[3]

Effects in Breastfed Infants

A maculopapular rash on the upper trunk and face of a 2-month-old infant was probably caused by acetaminophen in breastmilk. The rash occurred after 2 days of therapy in the mother at a dose of 1 gram at bedtime. It subsided when the drug was discontinued and recurred 2 weeks later after another acetaminophen dose of 1 gram was taken by the mother.[4]

Two papers report 14 women who breastfed after taking acetaminophen or its prodrug phenacetin with no adverse effects to their infants.[1][5]

In a telephone follow-up study, mothers reported no side effects among 43 infants exposed to acetaminophen in breastmilk.[6]

Two clinicians speculated that breastmilk exposure to acetaminophen during breastfeeding might be a risk factor for asthma and wheezing in the breastfed infants based on their personal observations.[7] However, these observations were uncontrolled and cannot be considered to be valid proof of an association.[8]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Ibuprofen

References

1. Berlin CM Jr, Yaffe SJ, Ragni M. Disposition of acetaminophen in milk, saliva and plasma of lactating women. Pediatr Pharmacol. 1980;1:135-41. PMID: 7202185

2. Bitzen PO, Gustafsson B, Jostell KG et al. Excretion of paracetamol in human breast milk. Eur J Clin Pharmacol. 1981;20:123-5. PMID: 7262173

3. Notarianni LJ, Oldham HG, Bennett PN. Passage of paracetamol into breast milk and its subsequent metabolism by the neonate. Br J Clin Pharmacol. 1987;24:63-7. PMID: 3620287

4. Matheson I, Lunde PKM, Notarianni L. Infant rash caused by paracetamol in breast milk? Pediatrics. 1985;76:651-2. Letter. PMID: 2931668

5. Findlay JWA, DeAngelis RL et al. Analgesic drugs in breast milk and plasma. Clin Pharmacol Ther. 1981;29:625-33. PMID: 6529531

6. Ito S, Blajchman A, Stephenson M et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168:1393-9. PMID: 8498418

7. Nadal-Amat J , Verd S. Paracetamol and asthma and lactation. Acta Paediatr. 2011;100:e2-3. PMID: 21244486

8. Bakkeheim E, Carlsen KH, Lodrup Carlsen KC. Paracetamol exposure during breastfeeding and risk of allergic disease. Acta Paediatr. 2011;100:e3. PMID: 21535130

Acetaminophen Identification

Substance Name

Acetaminophen

CAS Registry Number

103-90-2

Drug Class

Analgesics, Non-Narcotic

Administrative Information

LactMed Record Number

330

Last Revision Date

20150310

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