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Acetaminophen use while Breastfeeding

Drugs containing Acetaminophen: Norco, Percocet, Tylenol, Vicodin, Fioricet, Paracetamol, Tylenol with Codeine #3, Lortab, Percocet 5/325, Percocet 10/325, Show all 964 »Ultracet, Endocet, Midrin, Tylenol with Codeine #4, Panadol, Tylenol with Codeine, Excedrin, Percocet 7.5/325, Roxicet, Darvocet-N 100, Mapap, Excedrin Migraine, Tylenol Extra Strength, Darvocet-N 50, Tylenol PM, Lorcet, Fioricet with Codeine, Esgic, Hycet, Vicodin ES, Tylox, Ofirmev, Perfalgan, Q-Pap, Dologesic, Tylenol Arthritis Pain, Vicks Dayquil Daytime Cold/Flu, Panadol Osteo, Alka-Seltzer Plus Cold, Trezix, Percocet 10/650, Bupap, Midol PMS, Cough & Cold Relief, Coricidin HBP Cold & Flu, Xartemis XR, Norel AD, Dologen, Doliprane, Severe Allergy and Sinus Headache, Floricet with Codeine, Tencon, Aceta, Darvocet A500, Dolmar, Lorcet 10/650, Anexsia, Vicodin HP, Talacen, Tylenol Cold, Sudafed PE Pressure + Pain, Percogesic, Coricidin D, Excedrin Tension Headache, Vanquish, Midol Maximum Strength Menstrual, Balacet, 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Formula, CVS Extra Strength Headache Relief, Staflex, Comtrex Acute Head Cold, Sedapap, Dolgic, Marten-Tab, Prominol, Bucet, Phrenilin Forte, Dristan Cold Maximum Strength, Mapap Children's, Pharmacy Health Paracetamol Colour Free Infants and Childrens Drops 1 Month-4 Years, PediaCare Smooth Melts Acetaminophen Fever Reducer/Pain Reliever, Dolgic LQ, Bristol Pharma Paracetamol, Flu Relief BP, Vicks Formula 44 Custom Care Cough & Cold PM, Coricidin HBP Multi-Symptom Cold (Night), Tylenol Plus Children's Cough & Runny Nose, Tylenol Plus Children's Multi-Symptom Cold, Mapap Cough & Sinus Formula, Coricidin HBP Maximum Strength Flu, Colrex Compound, Colrex, Vicks NyQuil Cold & Flu Nighttime Relief (Alcohol Free), PediaCare Cough & Runny Nose Plus Acetaminophen, Tylenol Plus Children's Flu, Alka-Seltzer Plus Cold & Cough Formula Liquid Gels, Theraflu Nighttime Severe Cold & Cough Caplets, Comtrex Nighttime Cold & Cough, XL-3 Xtra Cold and Cough, Cold Multi-Symptom (Nighttime), Comtrex Cold & Cough Day Night, Tylenol Cold Head Congestion Nighttime, PediaCare Multi-Symptom Cold Plus Acetaminophen, Alka-Seltzer Plus Cold & Cough Formula Liquid, PediaCare Flu Plus Acetaminophen, Tylenol Cold Multi-Symptom Nighttime, Cotabflu, Pharmacist Advice Paracetamol Infant Drops, Hycomine Compound, Sinapils, Panadol Extend, Panlor DC, Excedrin Quick Tab, Valorin Extra, Vitapap, Phrenilin with Caffeine and Codeine, Paracetamol Soluble, Excedrin Mild Headache, DHC Plus, Emagrin Forte (old formulation), Hexal Comfarol, Black and Gold Paracetamol, Rid-A-Pain Compound, Ninjacof-A, Cafgesic, Flextra Plus, Blooms the Chemist Paracetamol, MigraTen, Durabac Forte, Saleto-D, Tylenol Cold & Cough Daytime

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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