acetaminophen (Tylenol, Paracematol, Panadol, Tempra, Datril, APAP, non-Aspirin)

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Introduction

Tradenames: Tylenol, Paracematol, Panadol, Tempra, Datril.

Indications

Contraindications

Caution: in patients with G6PD deficiency

pregnancy category = a

safety in lactation = +

Benefit/risk

  • no benefit or harm in critically ill patients with fever[21]
  • may be of no benefit in patients with influenza[22]

Dosage

Pediatrics: 15 mg/kg/dose (max 80 mg/kg/day)

* intravenous acetaminophen 1000 mg with comparable analgesic efficacy as 0.5 mg of hydromorphone in elderly (>= 65 years)[30] .

Tabs: 160, 325, 500 mg.

Tabs: 500 mg tablets may be withdrawn from US market[12]

Tabs: (chewable): 80 mg.

Suppositories: 120, 325, 650 mg.

Elixir: 160 mg/5 mL.

Drops: 80 mg/0.8 mL dropperful.

Dosage adjustment in renal failure

Table

eGFR* dosage
10-50 (mL/min) every 6 hours
< 10 (mL/min) every 8 hours (metabolites may accumulate)

* estimated glomerular filtration rate (eGFER)

Pharmacokinetics

elimination via liver

elimination via kidney

1/2life = 1-4 hours

protein binding = 20-50 %

elimination by hemodialysis = +

elimination by peritoneal dialysis = -

Adverse effects

Overdose: (also see acetaminophen poisoning)

Drug interactions

Laboratory

Mechanism of action

Notes

  • FDA working group makes new recommendations for acetaminophen to reduce hepatic toxicity, May 2009[9]. These include:
    • using stronger warnings on the drug's label;
    • limiting the single adult dose to a maximum of 650 mg;
    • lowering the maximum daily dose for adults from 4000 mg to no greater than 3250 mg (less than that for chronic alcohol users);
    • limiting immediate-release tablet formulations for adults to 325 mg;
    • restricting pediatric liquid formulations to a single mid-strength concentration;
    • eliminating acetaminophen from combination products

More general terms

Additional terms

Component of

References

  1. ↑ The Pharmacological Basis of Therapeutics, 9th ed. Gilman et al, eds. Permagon Press/McGraw Hill, 1996
  2. ↑ Saunders Manual of Medical Practice, Rakel (ed), WB Saunders, Philadelphia, 1996, pg 1160-63
  3. ↑ Drug Information & Medication Formulary, Veterans Affairs, Central California Health Care System, 1st ed., Ravnan et al eds, 1998
  4. ↑ Prescriber's Letter 8(4):23 2001
  5. ↑ 5.0 5.1 Journal Watch 24(17):134, 2004 Curhan GC, Knight EL, Rosner B, Hankinson SE, Stampfer MJ. Lifetime nonnarcotic analgesic use and decline in renal function in women. Arch Intern Med. 2004 Jul 26;164(14):1519-24. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15277282
  6. ↑ 6.0 6.1 Prescriber's Letter 12(9): 2005 Non-narcotic Analgesics and the Risk of Hypertension in Women Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=210915&pb=PRL (subscription needed) http://www.prescribersletter.com
  7. ↑ Prescriber's Letter 13(7): 2006 Safe Use of Acetaminophen (Tylenol) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=220714&pb=PRL (subscription needed) http://www.prescribersletter.com
  8. ↑ 8.0 8.1 Forman JP et al, Frequency of analgesic use and risk of hypertension among men. Arch Intern Med 2007, 167:394 PMID: https://www.ncbi.nlm.nih.gov/pubmed/17325302
  9. ↑ 9.0 9.1 Memorandum from Department of Health and Human Services, Food and Drugs Administration, Center For Drug Evaluation and Research dated May 22, 2009 regarding Report dated February 26, 2008 for meeting on June 29-30, 2009 Report is by: The Acetaminophen Hepatotoxicity Working Group Center for Drug Evaluation and Research Food and Drug Administration Department of Health and Human Services Recommendations for FDA Interventions to Decrease the Occurrence of Acetaminophen Hepatotoxicity http://www.fda.gov/ohrms/dockets/ac/09/briefing/2009-4429b1-01-FDA.pdf
  10. ↑ Prescriber's Letter 16(7): 2009 New Warnings and Proposed Changes to Acetaminophen Products Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=250701&pb=PRL (subscription needed) http://www.prescribersletter.com
  11. ↑ 11.0 11.1 11.2 Beasley RW et al Acetaminophen Use and Risk of Asthma, Rhinoconjunctivitis and Eczema in Adolescents: ISAAC Phase Three. Am J Respir Crit Care Med. 2010 Aug 13. PMID: https://www.ncbi.nlm.nih.gov/pubmed/20709817
    McBride JT. The association of acetaminophen and asthma prevalence and severity. Pediatrics 2011 Dec; 128:1181 PMID: https://www.ncbi.nlm.nih.gov/pubmed/22065272
    Cheelo M et al Paracetamol exposure in pregnancy and early childhood and development of childhood asthma: a systematic review and meta-analysis. Arch Dis Child. 26 November 2014 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25429049 <Internet> http://adc.bmj.com/content/early/2014/11/07/archdischild-2012-303043
  12. ↑ 12.0 12.1 FDA MedWatch, 01/13/11 Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug Safety Communication http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239955.htm
  13. ↑ 13.0 13.1 13.2 Johnson & Johnson McNeil Consumer Healthcare Announces Plans For New Dosing Instructions For Tylenol Products http://www.jnj.com/connect/news/all/mcneil-consumer-healthcare-announces-plans-for-new-dosing-instructions-for-tylenol-products
  14. ↑ Prescriber's Letter 18(9): 2011 COMMENTARY: Changes to Acetaminophen Labeling PATIENT HANDOUT: Safe Use of Acetaminophen (Tylenol) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=270910&pb=PRL (subscription needed) http://www.prescribersletter.com
  15. ↑ 15.0 15.1 Randles D et al. The common pain of surrealism and death: Acetaminophen reduces compensatory affirmation following meaning threats. Psychol Sci 2013 Apr 11 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/23579320 <Internet> http://pss.sagepub.com/content/early/2013/04/23/0956797612464786
  16. ↑ 16.0 16.1 FDA MedWatch. August 1, 2013. Acetaminophen: Drug Safety Communication - Association with Risk of Serious Skin Reactions. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm363519.htm
  17. ↑ FDA MedWatch. Jan 14, 2014 FDA MedWatch - Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement - Recommendation to Discontinue Prescribing and Dispensing. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm381650.htm
  18. ↑ 18.0 18.1 Liew Z, Ritz B, Rebordosa C et al Acetaminophen Use During Pregnancy, Behavioral Problems, and Hyperkinetic Disorders. JAMA Pediatr. February 24, 2014 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24566677 <Internet> http://archpedi.jamanetwork.com/article.aspx?articleid=1833486
    Cooper M, Langley K, Thapar A Antenatal Acetaminophen Use and Attention-Deficit/Hyperactivity Disorder. An Interesting Observed Association But Too Early to Infer Causality. JAMA Pediatr. February 24, 2014 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24566519 <Internet> http://archpedi.jamanetwork.com/article.aspx?articleid=1833483
  19. ↑ 19.0 19.1 FDA Drug Safety. April 2014. FDA reminds health care professionals to stop dispensing prescription combination drug products with more than 325 mg of acetaminophen. http://www.fda.gov/Drugs/DrugSafety/ucm394916.htm
  20. ↑ 20.0 20.1 Roberts E et al. Paracetamol: Not as safe as we thought? A systematic review of observational studies. Ann Rheum Dis 2015 Mar 2; <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25732175 <Internet> http://ard.bmj.com/content/early/2015/02/09/annrheumdis-2014-206914
  21. ↑ 21.0 21.1 Young P et al. Acetaminophen for fever in critically ill patients with suspected infection. N Engl J Med 2015 Oct 5 PMID: https://www.ncbi.nlm.nih.gov/pubmed/26436473
  22. ↑ 22.0 22.1 Jefferies S et al Randomized controlled trial of the effect of regular paracetamol on influenza infection. Respirology. Dec 6, 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26638130 <Internet> http://onlinelibrary.wiley.com/doi/10.1111/resp.12685/full
  23. ↑ 23.0 23.1 Stergiakouli E, Thapar A, Smith GD Association of Acetaminophen Use During Pregnancy With Behavioral Problems in Childhood. Evidence Against Confounding. JAMA Pediatr. Published online August 15, 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27533796 <Internet> http://archpedi.jamanetwork.com/article.aspx?articleid=2543281
  24. ↑ 24.0 24.1 Sheehan WJ et al Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma. N Engl J Med 2016; 375:619-630. August 18, 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27532828 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1515990?query=pfw&jwd=000000793830&jspc=FPG
    Litonjua AA. Acetaminophen and asthma - a small sigh of relief? N Engl J Med 2016 Aug 18; 375:684. PMID: https://www.ncbi.nlm.nih.gov/pubmed/27532835
  25. ↑ 25.0 25.1 Lin B, Curhan SG, Wang M et al Duration of Analgesic Use and Risk of Hearing Loss in Women. Am J Epidemiol (2016) 1-8. Published 14 December 2016 PMID: https://www.ncbi.nlm.nih.gov/pubmed/27974293 https://academic.oup.com/aje/article/doi/10.1093/aje/kww154/2661733/Duration-of-Analgesic-Use-and-Risk-of-Hearing-Loss
  26. ↑ 26.0 26.1 Medical Knowledge Self Assessment Program (MKSAP) 18, American College of Physicians, Philadelphia 2018
  27. ↑ Fenves AZ, Kirkpatrick HM 3rd, Patel VV, Sweetman L, Emmett M. Increased anion gap metabolic acidosis as a result of 5-oxoproline (pyroglutamic acid): a role for acetaminophen. Clin J Am Soc Nephrol. 2006 May;1(3):441-7. Review. PMID: https://www.ncbi.nlm.nih.gov/pubmed/17699243 Free Article
  28. ↑ 28.0 28.1 Louvet A, Ntandja Wandji LC, Lemaitre E et al. Acute liver injury with therapeutic doses of acetaminophen: A prospective study. Hepatology 2021 May; 73:1945 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33306215 https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31678
  29. ↑ 29.0 29.1 29.2 29.3 29.4 29.5 Windle ML Fast Five Quiz: Acetaminophen Medscape. July 22, 2021 https://reference.medscape.com/viewarticle/954960_2
  30. ↑ 30.0 30.1 Kolli S et al. A randomized study of intravenous hydromorphone versus intravenous acetaminophen for older adult patients with acute severe pain. Ann Emerg Med 2022 Nov; 80:432. PMID: https://www.ncbi.nlm.nih.gov/pubmed/35965162 PMCID: PMC9588558 (available on 2023-11-01) https://www.annemergmed.com/article/S0196-0644(22)00443-7/fulltext

Patient information

acetaminophen patient information

Database

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