Paracetamol
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.
Despite unfavorable pharmacokinetic data, 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).
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, Bannwarth 2003, Bar-Oz 2003, Janssen 2000, Nice 2000, Spigset 2000, Mitchell 1999, Bodley 1997, Lee 1993, Bitzen 1981, Berlin 1980).
Alternatives
We do not have alternatives for Paracetamol since it is relatively safe.
Very Low Risk
Compatible. Not risky for breastfeeding or infant.
Low Risk
Moderately safe. Mild risk possible. Follow up recommended. Read the Comment.
High Risk
Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.
Very High Risk
Not recommended. Cessation of breastfeeding or alternative.
Synonyms
- Acetaminophen
- N-Acetyl-P-Aminophenol
Writings
- Παρακεταμόλη (Greek)
- باراسيتامول (Arabic)
- Парацетамол (Cyrillic)
- 对乙酰氨基酚 (Chinese)
- アセトアミノフェン (Japanese)
- Paracétamol (French)
- C8 H9 NO2 (Molecular formula)
- 4′-Hydroxyacetanilide; N-(4-Hydroxyphenyl)acetamide (Chemical name)
- N02BE01 (ATC Code/s)
Drug trade names
- Acecat™
- Acetofen™
- Acetolit™
- Actifed™ (France)
- Actron Compuesto™ (Spain)
- Actron™ (France)
- Adalgur N™
- Adalgur™
- Adol™
- Ai Er Xing (爱尔星)™
- Ai Sen (爱森)™
- Alador™
- Algidol™ (Spain)
- Algifene™ (Portugal)
- Algiseda™
- Algocit™
- Algodol™
- Algofetin (Альгофетин)™
- Algostase Mono™
- Anadin™
- Analgilasa™
- Anatyl™
- Anticatarral ™
- Antidol™
- Antigrippine™ (Portugal)
- AnYi (安怡)™
- Apap (Апап)™
- Apiredol™
- Apiretal™
- Apogrip™
- Apotel™
- Apracur Antifebril™
- Back-Aid™
- Basoplex™
- Becetamol™
- Bei Le Xin (倍乐信)™
- Ben-u-ron (悦诺清)™
- Ben-u-ron™
- Beseroldos™
- Bio Grip-T™
- Biocetamol™
- Brevex™
- Bufferin (百服宁)™
- Buscapina Compositum NF™
- Buscapina Compositum N™
- Calgayan™
- Calmador Plus™
- Calpol (Калпол)™
- Captin™
- Carbafen™
- Causalon™
- Cefabrina™
- Cefecon D (Цефекон Д)™
- Claradol™
- Cloq Plus™
- Codalgin™
- Coricidin™ (United States of America, Venezuela)
- Cupanol™
- Curpol™
- Dafalganhop™
- Dafalgan™
- Daleron (Далерон)™
- Day & Night™
- DayQuil D™
- Diliban™
- Dirox™
- Dolanet™
- Dolex Forte™ (Colombia)
- Dolex Gripa™ (Colombia)
- Dolex™ (Colombia, Uruguay)
- Dolipranelib™
- Dolipraneoro™
- Doliprane™
- Dolko™
- Dolocatil™
- Dolol-Instant™
- Dolomol (Доломол)™
- Dolostop™
- Dolprone™
- Dristan Descongestivo™
- Dristan Max™
- Dristan™ (Canada, Turkey)
- Duaneo™
- Dymadon™
- Efetamol™
- Efferalgan (Эффералган)™
- Efferalgan™
- Enelfa™
- Er He Yi (尔合依)™
- Er Re An (而热安)™
- Fan Nuo (凡诺)™
- Febrectal™
- Fensum™
- Fiebrolito™
- Fiebrol™
- Fiorinal™ (Australia)
- Flash™
- Flodigrip C™
- Flodigrip Descongestivo™
- Flodigrip-NF™
- Flutabs (Флютабс)™
- Forsodol (Форсодол)™
- Fortolin (保达琳)™
- Frenadol Complex™
- Frenadol PS™
- Frenadol™
- Gelocatil™
- Gewamol™
- Grippostad™
- Hemicraneal™
- Infulgan (Инфулган)™
- Invernosan™
- Itedal™
- Kang Yu Deng Tong (康裕登通)™
- Kofan (Кофан)™
- Kratofin simplex™
- Lemsip™
- Livzon Ganle (丽珠感乐)™
- Mejoral Cafeina™
- Mejoral™ (Argentina, Mexico)
- Melabon Infantil™ (Spain)
- Melabon K™ (Germany)
- Melabon™ (Austria, Spain)
- Mexalen™
- Midol Menstrual Complete™
- Midrin™
- Momentum™
- Neo Optalidon™ (Italy)
- Nodipir™
- Nodolex™
- Norflex Plus™
- Norgesic™
- Novalgin (Новалгин)™
- Novo Asat™
- Nupeldol™
- NyQuil Hot Therapy™
- NyQuil Nighttime Cold/Flu™
- Pa La Xin (帕拉辛)™
- Paedialgon™
- Pamol™
- Panadeine™
- Panadol (Панадол)™
- Panadol (必理通)™
- Panadol Antigripal™
- Panadol Extra™
- Panadol Plus™
- Panadol Ultra™
- Panadol™
- Panamax™
- Panodil™
- Para Z Mol™
- Paraflex Plus™
- Parafludeten™
- Parafon Forte™
- Parageniol™
- Parahexal™
- Parakapton™
- Paralgin™
- Parapaed™
- Paraspeed™
- Paratral™
- PCM™
- Peinfort™
- Perdolan™
- Perfalgan (Перфалган)™
- Perfalgan™
- Perfusalgan™
- Pharmagrip Duo™
- Plovacal™
- Pontalsic™
- Predualito™
- Pu Le Er (普乐尔)™
- Rapidol (Рапидол)™
- Refrianex Compuesto™
- Relaxophen™
- Resolvebohm™
- Robaxacet™
- Robaxifen™
- Robaxisal Compuesto™ (Spain)
- Sanalgin N™
- Saridon N™ (Portugal)
- Saridon™
- Setamol™
- Shi Ning (施宁)™
- Sinpro N™
- Sinutab Extra™ (Mexico)
- Sinutab II™ (Portugal)
- Sinutab NT™ (Canada)
- Sinutab™ (Argentina, Belgium, Ireland)
- Snaplets-FR (斯耐普)™
- Strimol (Стримол)™
- Su Ting (素廷)™
- Tafirol Flex™
- Tafirol™
- Takipirina™
- Talgo™
- Termalgin™
- Termofren™
- Tetradox™
- Togal™
- Tramacet™
- Tylenol (泰诺林)™
- Tylenol Back Pain™
- Tylenol n1-n2-n3™
- Tylenol n4™
- Tylenol™
- Tylex CD™ (Mexico, Venezuela)
- Tylex Flu™ (Mexico)
- Tylex™ (Brazil, Ireland, United Kingdom)
- Tylex™ (Mexico, Venezuela)
- Ultracet (及通安)™
- Ultracet™
- Unebril™
- Vicks DayQuil Multi-Symptom Cold/Flu Relief™
- Vicks NyQuil Multi-Symptom Cold Flu Relief™
- Vicks Sinex™ (United Kingdom)
- Viclor™
- Xing Le Ning (兴乐宁)™
- Xumadol™
- Yi Di Qing (一滴清)™
- Yi Li Miao (宜利妙)™
- Yi Shang (易尚)™
- Zaldiar (Залдіар)™
- Zaldiar™
- АНАПІРОН
- БЛІМОЛ
- ГРИППОСТАД® ГАРЯЧИЙ НАПІЙ
- ЕЛГАН
- ЕФЕРАЛГАН
- ІНФУЛГАН
- ПАНАДОЛ®
- ПАНАДОЛ® БЕБІ
- ПАНАДОЛ® ЕДВАНС
- ПАНАДОЛ® СОЛЮБЛ
- ПАРАЦЕТАМОЛ
- ПАРАЦЕТАМОЛ (АРС 154)
- ПАРАЦЕТАМОЛ DC 90 %
- ПАРАЦЕТАМОЛ Б. БРАУН 10 МГ/МЛ
- ПАРАЦЕТАМОЛ БЕБІ
- ПАРАЦЕТАМОЛ ДЛЯ ДІТЕЙ
- ПАРАЦЕТАМОЛ ЄВРО
- ПАРАЦЕТАМОЛ СОЛЮБЛ
- ПАРАЦЕТАМОЛ-ВІШФА
- ПАРАЦЕТАМОЛ-ДАРНИЦЯ
- ПІАРОН
- РОДАПАП DC 90 HSP
References
- Reece-Stremtan Sarah, Campos Matilde, Kokajko Lauren, and The Academy of Breastfeeding Medicine. Breastfeeding Medicine. ABM Clinical Protocol #15: Analgesia and Anesthesia for the Breastfeeding Mother, Revised 2017. Breastfeeding Medicine. 2017 Full text (link to original source) Full text (in our servers)
- AEMPS. Paracetamol. Ficha técnica. 2017 Full text (in our servers)
- GSK. Paracetamol (Panadol). Drug Summary. 2015 Full text (in our servers)
- Davanzo R, Bua J, Paloni G, Facchina G. Breastfeeding and migraine drugs. Eur J Clin Pharmacol. 2014Abstract
- Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. 2013Abstract
- Athavale MA, Maitra A, Patel S, Bhate VR, Toddywalla VS. Development of an in vitro cell culture model to study milk to plasma ratios of therapeutic drugs. Indian J Pharmacol. 2013Abstract Full text (link to original source) Full text (in our servers)
- Worthington I, Pringsheim T, Gawel MJ, Gladstone J, Cooper P, Dilli E, Aube M, Leroux E, Becker WJ; Canadian Headache Society Acute Migraine Treatment Guideline Development Group. Canadian Headache Society Guideline: acute drug therapy for migraine headache. Can J Neurol Sci. 2013Abstract Full text (in our servers)
- Sachs HC; Committee On Drugs. The transfer of drugs and therapeutics into human breast milk: an update on selected topics. Pediatrics. 2013Abstract Full text (link to original source) Full text (in our servers)
- Amir LH, Pirotta MV, Raval M. Breastfeeding--evidence based guidelines for the use of medicines. Aust Fam Physician. 2011Abstract Full text (link to original source) Full text (in our servers)
- Zrour-Hassen S, Jguirim M, Aouam K, Korbaa W, Younes M, Bejia I, Touzi M, Bergaoui N. [Safety of rheumatic disease drugs at childbearing age]. Therapie. 2010Abstract
- Zrour-Hassen S, Jguirim M, Aouam K, Korbaa W, Younes M, Bejia I, Touzi M, Bergaoui N. [Safety of rheumatic disease drugs at childbearing age]. Therapie. 2010Abstract
- Chen LH, Zeind C, Mackell S, LaPointe T, Mutsch M, Wilson ME. Breastfeeding travelers: precautions and recommendations. J Travel Med. 2010Abstract Full text (link to original source) Full text (in our servers)
- Østensen M, Motta M. Therapy insight: the use of antirheumatic drugs during nursing. Nat Clin Pract Rheumatol. 2007Abstract
- Bar-Oz B, Bulkowstein M, Benyamini L, Greenberg R, Soriano I, Zimmerman D, Bortnik O, Berkovitch M. Use of antibiotic and analgesic drugs during lactation. Drug Saf. 2003Abstract
- Bannwarth B, Péhourcq F. [Pharmacologic basis for using paracetamol: pharmacokinetic and pharmacodynamic issues]. Drugs. 2003Abstract
- WHO / UNICEF. BREASTFEEDING AND MATERNAL MEDICATION Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. Department of Child and Adolescent Health and Development (WHO/UNICEF) 2002 Full text (link to original source) Full text (in our servers)
- AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001Abstract Full text (link to original source) Full text (in our servers)
- Janssen NM, Genta MS. The effects of immunosuppressive and anti-inflammatory medications on fertility, pregnancy, and lactation. Arch Intern Med. 2000Abstract Full text (link to original source) Full text (in our servers)
- Spigset O, Hägg S. Analgesics and breast-feeding: safety considerations. Paediatr Drugs. 2000Abstract
- Nice FJ, Snyder JL, Kotansky BC. Breastfeeding and over-the-counter medications. J Hum Lact. 2000Abstract
- Mitchell JL. Use of cough and cold preparations during breastfeeding. J Hum Lact. 1999Abstract
- Bodley V, Powers D. Long-term treatment of a breastfeeding mother with fluconazole-resolved nipple pain caused by yeast: a case study. J Hum Lact. 1997Abstract
- Lee JJ, Rubin AP. Breast feeding and anaesthesia. Anaesthesia. 1993Abstract Full text (link to original source) Full text (in our servers)
- Ito S, Blajchman A, Stephenson M, Eliopoulos C, Koren G. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993Abstract
- Notarianni LJ, Oldham HG, Bennett PN. Passage of paracetamol into breast milk and its subsequent metabolism by the neonate. Br J Clin Pharmacol. 1987Abstract Full text (link to original source)
- Matheson I, Lunde PK, Notarianni L. Infant rash caused by paracetamol in breast milk? Pediatrics. 1985Abstract
- Bitzén PO, Gustafsson B, Jostell KG, Melander A, Wåhlin-Boll E. Excretion of paracetamol in human breast milk. Eur J Clin Pharmacol. 1981Abstract
- Findlay JW, DeAngelis RL, Kearney MF, Welch RM, Findlay JM. Analgesic drugs in breast milk and plasma. Clin Pharmacol Ther. 1981Abstract
- Berlin CM Jr, Yaffe SJ, Ragni M. Disposition of acetaminophen in milk, saliva, and plasma of lactating women. Pediatr Pharmacol (New York). 1980Abstract
- Hurden E L, Harvey D R, Lewis P J. Excretion of paracetamol in human breast milk. In: Neonatal Society Meeting held on 4 July 1980 in Southampton. Arch Dis Child. 1980Abstract Full text (link to original source) Full text (in our servers)