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Acetaminophen use while Breastfeeding

Drugs containing Acetaminophen: Norco, Percocet, Tylenol, Vicodin, Paracetamol, Fioricet, Tylenol with Codeine #3, Lortab, Percocet 5/325, Percocet 10/325, Show all 963 »Ultracet, Midrin, Endocet, Tylenol with Codeine #4, Panadol, Excedrin, Tylenol with Codeine, Roxicet, Darvocet-N 100, Tylenol Extra Strength, Percocet 7.5/325, Mapap, Excedrin Migraine, Tylox, Darvocet-N 50, Tylenol PM, Fioricet with Codeine, Hycet, Lorcet, Esgic, Vicodin ES, Panadol Osteo, Alka-Seltzer Plus Cold, Tylenol Arthritis Pain, Perfalgan, Trezix, Q-Pap, Midol PMS, Dologesic, Severe Allergy and Sinus Headache, Anexsia, Midol Maximum Strength Menstrual, Bupap, Ofirmev, Vicks Dayquil Daytime Cold/Flu, Excedrin Extra Strength, Floricet with Codeine, Lorcet 10/650, Percocet 10/650, Tencon, Excedrin Tension Headache, Cough & Cold Relief, Percogesic, Xartemis XR, Darvocet A500, Children's Tylenol, Panadol ActiFast, Coricidin HBP Cold & Flu, Aceta, Dafalgan, Doliprane, Infant's Tylenol, Dologen, Sudafed PE Pressure + 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Children 5-12 Years, Chemists Own Chiildrens Paracetamol 5-12 Years, Pharmacy Health Colour Free Childrens Paracetamol, Gold Cross Paracetamol, Doliprane Sans Sucre, Genapap Extra Strength, Dolitabs, Home Brand Paracetamol, Dolko, Coles Paracetamol, Doliprane Adultes, Claradol, Anacin Aspirin Free, Conacetol, Dolono, ICN Paracetamol, Redutemp, Expandox, Dolono Infant, Geluprane, Paracetamol Arrow, Silapap Childrens, Efferalganodis, Dolko Enfants, Dolotec, Vicks Formula 44 Custom Care Body Aches, James Dean Pharmacy Paracetamol, Q-Nol, Herron Paracetamol Handy Pack, Topcare Arthritis Pain Relief, Accidental First Aid Supplies Paracetamol, Panadol Jr, Flu Strength Hot Lemon Powders, Rex Paracetamol, Guardian Paracetamol Tabsules, Tylenol Cold Sore Throat, Alpha First Aid Supplies Paracetamol, Guardian Childrens Paracetamol 5-12 Years, Guardian Paracetamol, Paineze Paracetamol, Health Care Chemist Paracetamol Infant Drops Colour Free, Herron Paracetamol Capseals, Tempra 3, Herron Paracetamol Capseals Handy Pack, Pharbetol, Tempra 2, Herron Paracetamol, Genebs, Herron Gold Paracetamol Tabsules, Tylenol Regular Strength, Panamol, Pharmacist Paracetamol, Terry White Chemists Colour Free Paracetamol Infant Drops, Panadol Gel Caps, Gelpirin-CCF, Priceline Paracetamol, Conney Aspirin-Free, Contac Cold + Flu (Night Formula), Triaminic Flu, Cough & Fever, Alka-Seltzer Plus-D, Contac Cold and Flu Maximum Strength, Theraflu Flu & Cough, Allpanto-S, Co-Apap, ConRx Allergy Sinus, Allergy Pain Relief, GNP Cold Relief Plus, Gendecon, Tylenol Sinus Congestion & Pain Nighttime, Comtrex Severe Cold & Sinus, Onset Forte, Relief-PE, Allergy Sinus PE Pain Relief, Allergy Multi-Symptom, Pyrroxate, Robitussin Peak Cold Nighttime Nasal Relief, Childrens Tylenol Cold Plus Cough, Genacol Maximum Strength, Dimetapp Children's Multi-Symptom Cold & Flu, Comtrex Nighttime Cold & Cough, XL-3 Xtra Cold and Cough, Cold Multi-Symptom (Nighttime), Multi Symptom Cold (Night Formula), Tylenol Cold Head Congestion Day and Night, Theraflu Nighttime Severe Cold & Cough Caplets, PediaCare Flu Plus Acetaminophen, Tylenol Cold Multi-Symptom Nighttime, Tylenol Cold Head Congestion Nighttime, Comtrex Cold & Cough Day Night, Multi Symptom Cold Relief, Alka-Seltzer Plus Flu Formula, Comtrex Day and Night, Cough Formula M Multi-Symptom, Comtrex Cold and Flu Maximum Strength Tablet, Comtrex Cold and Flu Maximum Strength Liquid, Pharmore Paracetamol, Contac Severe Cold and Flu Maximum Stength, Dimetapp Children's Nighttime Flu, Theraflu Warming Relief Nighttime Multi-Symptom Cold Caplets, Comtrex Cold and Flu Maximum Strength, Comtrex Maximum Strength Cold Relief, Comtrex Flu Therapy, Tylenol Plus Children's Cold, Phenaphen with Codeine, EZ III, Aceta w/ Codeine, Cocet Plus, Phenflu CDX, Terry White Chemists Paracetamol, Tavist Allergy/Sinus/Headache, Triaminicin, Sinutab Maximum Strength Caplets, Bristol Pharma Paracetamol, Actifed Cold & Sinus, Phenflu CD, Maxiflu CD, Drixoral Cold and Flu, Drixoral Sinus, Hexaflu, PediaCare Cough & Sore Throat Plus Acetaminophen, Drixoral Allergy Sinus, Sinadrin Plus, Maxiflu CDX, Dologen 325, Drixoral Cold/Flu, Complete Sinus Relief, Allerest Headache Strength, Comtrex Allergy Sinus Night and Day, Covangesic, Rhinogesic, Tylenol Childrens Paracetamol, Alumadrine, Dryphen, HEB Allergy, XL-3 Cold Medicine, Sine-Off Sinus/Cold, Tylenol Sinus Congestion and Pain Cool Burst Day Night, Alka-Seltzer Plus Cold & Flu, Duadacin, Terry White Chemists Paracetamol Colourfree Children 5-12 Years, Kolephrin, Allerest Sinus, Tylenol Allergy Sinus, Comtrex Allergy Sinus Maximum Strength, Codimal, Comtrex Allergy Sinus, Pharmacist Advice Paracetamol, Comtrex Sinus and Nasal, Comtrex Nighttime Flu Therapy, Simplet, Alka-Seltzer Plus Cold & Cough Formula Liquid, PediaCare Multi-Symptom Cold Plus Acetaminophen, Prominol, Marten-Tab, Promacet, Axocet, Black And Gold Paraceatmol, Dolgic, Sedapap, Pharmacist Advice Paracetamol Infant Drops, Triaprin, Phrenilin Forte, Bucet, Healthsense Pain Relief Drops Children 1 Month to 2 Years, Biochemie Paracetamol, Two-Dyne, Tenake, Anolor 300, Femcet, Anoquan, Pharmagesic, Pharmaction Paracetamol, Pain-Eze Paracetamol Infant Drops Colour Free, Alagesic LQ, Isocet, Black and Gold Paracetamol, Dristan Cold Maximum Strength, Arthriten, Excedrin Menstrual Complete, ConRx Pain Reliever, Uricalm Intensive, Genace, Bayer Migraine Formula, Hexal Comfarol, Goody's Body Pain, Vitapap, Paracetamol Soluble, Blooms the Chemist Paracetamol, Supac, PainAid Extra-Strength Formula, Excedrin PM Headache, Rhinocaps, Staflex, Comtrex Acute Head Cold, Excedrin PM Triple Action, Exaprin, CVS Extra Strength Headache Relief, Medique Pain-Off, Extra Pain Relief, Saleto, Tencet, Fiorpap, Genapap, Cafgesic, Rid-A-Pain Compound, Ninjacof-A, Basics Paracetamol, Flextra Plus, Sigma Pain Relief, Emagrin Forte (old formulation), MigraTen, Durabac Forte, Saleto-D, Cotabflu, Colrex Compound, Tylenol Plus Children's Cough & Runny Nose, Tylenol Plus Children's Multi-Symptom Cold, Tylenol Plus Children's Flu, Alka-Seltzer Plus Cold & Cough Formula Liquid Gels, Coricidin HBP Multi-Symptom Cold (Night), Flu Relief BP, Colrex, Coricidin HBP Maximum Strength Flu, Mapap Cough & Sinus Formula, Vicks Formula 44 Custom Care Cough & Cold PM, DHC Plus, Panlor SS, Dolgic Plus, Dolgic LQ, Capacet, Orbivan, Alagesic, Pacaps, Endolor, Ide-cet, G-1, Medigesic, Bi-Lo Paracetamol, Pharmacist Paracetamol Infant Drops Colour Free, Hycomine Compound, Sinapils, Paraspen Drops, Panlor DC, Excedrin Quick Tab, Valorin Extra, Phrenilin with Caffeine and Codeine, Pharmacist Paracetamol Infant Drops, Panadol Colourfree Drops, Excedrin Mild Headache, Drixoral Cough/Sore Throat

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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