Skip to main content
Springer Nature Link
Log in

Balancing the Risks and Benefits of the Use of Over-the-Counter Pain Medications in Children

  • Review Article
  • Published:
Drug Safety Aims and scope Submit manuscript

Abstract

Paracetamol (acetaminophen) and ibuprofen are the most frequently purchased over-the-counter (OTC) medicines for children. Parents purchase these medicines for the treatment of fever and pain. In some countries other NSAIDs such as aspirin (acetylsalicylic acid) and dipyrone are available.

We aimed to perform a narrative review of the efficacy and toxicity of OTC analgesic medicines for children in order to give guidance to health professionals and parents regarding the treatment of pain in a child.

Neither aspirin nor dipyrone are recommended for OTC use because of the association with Reye’s syndrome for the former and the risk of agranulocytosis for the latter. Both paracetamol and ibuprofen are effective for the treatment of mild pain in children. Adverse effects with both medicines are infrequent. Ibuprofen is an NSAID and therefore there is a greater risk of gastrointestinal adverse effects and hypersensitivity.

Aspirin and dipyrone should be avoided. Paracetamol is the drug of first choice for mild pain in children because of its favourable safety profile. For the treatment of significant musculoskeletal pain, ibuprofen is the drug of first choice.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Subscribe and save

Springer+ Basic
$34.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or eBook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Price includes VAT (Canada)

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Nydert P, Kimland E, Kull I. Over-the-counter drug use: estimations within the Swedish paediatric population. Eur J Pediatr 2011; 170: 583–8

    Article  PubMed  Google Scholar 

  2. Trajanovska M, Manias E, Cranswick N, et al. Use of over-the-counter medicines for young children in Australia. J Paediatr Child Health 2010; 46: 5–9

    Article  PubMed  Google Scholar 

  3. Duncan P, Aref-Adib G, Venn A, et al. Use and misuse of aspirin in rural Ethiopia. East Afr Med J 2006; 83: 31–6

    PubMed  CAS  Google Scholar 

  4. Donald K, Hall S, Seaton C, et al. Is non-therapeutic aspirin use in children a problem in South Africa? South Afr Med J 2011; 101: 823–8

    CAS  Google Scholar 

  5. McIntyre J, Conroy S, Collier J, et al. Use of over-the-counter medicines in children. Int J Pharm Pract 2003; 11: 209–15

    Article  Google Scholar 

  6. McIntyre J. Management of fever in children. Arch Dis Child 2011; 96: 1173–4

    Article  PubMed  Google Scholar 

  7. Purssell E. Systematic review of studies comparing combined treatment with paracetamol and ibuprofen, with either drug alone. Arch Dis Child 2011; 96: 1175–9

    Article  PubMed  Google Scholar 

  8. Rosefsky JB. Ibuprofen safety. Pediatrics 1992; 89: 166–7

    PubMed  CAS  Google Scholar 

  9. Kokki H, Hendolin H, Maunuksela E, et al. Ibuprofen in the treatment of postoperative pain in small children: a randomized double-blind-placebo controlled parallel group study. Acta Anaesthesiologica Scandinavica 1994; 38: 467–72

    Article  PubMed  CAS  Google Scholar 

  10. Perrott DA, Piira T, Goodenough B, et al. Efficacy and safety of acetaminophen vs ibuprofen for treating children’s pain or fever: a meta-analysis. Arch Pediatr Adolesc Med 2004; 158: 521–6

    Article  PubMed  Google Scholar 

  11. Clark E, Plint AC, Correll R, et al. A randomized, controlled trial of acetaminophen, ibuprofen and codeine for acute pain relief in children with musculoskeletal trauma. Pediatrics 2007; 119: 460–7

    Article  PubMed  Google Scholar 

  12. Bradley RL, Ellis PE, Thomas P, et al. A randomized clinical trial comparing the efficacy of ibuprofen and paracetamol in the control of orthodontic pain. Am J Orthod Dentofacial Orthop 2007; 132: 511–7

    Article  PubMed  Google Scholar 

  13. Chan TYK, Chan AWK. Aminopyrine-induced blood dyscrasias: still a problem in many parts of the world. Pharmacoepidemiol Drug Saf 1996; 5: 215–9

    Article  PubMed  CAS  Google Scholar 

  14. Nor Aripin KNB, Choonara I. The management of paracetamol poisoning. Paediatr Child Health 2009; 19: 492–7

    Article  Google Scholar 

  15. Shepherd M, Aickin R. Paracetamol versus ibuprofen: a randomized controlled trial of outpatient analgesia efficacy for paediatric acute limb fractures. Emerg Med Australas 2009; 21: 484–90

    Article  PubMed  Google Scholar 

  16. Sánchez-Borges M, Capriles-Behrens E, Caballero-Fonseca F. Hypersensitivity to non-steroidal anti-inflammatory drugs in childhood. Pediatr Allergy Immunol 2004; 15: 376–80

    Article  PubMed  Google Scholar 

  17. Kidon MI, Kang LW, Chin CW, et al. Nonsteroidal anti-inflammatory drug hypersensitivity in preschool children. Allergy Asthma Clin Immunol 2007; 3: 114–22

    PubMed Central  PubMed  Google Scholar 

  18. Grimaldi-Bensouda L, Abenhaim L, Michaud L, et al. Clinical features and risk factors for upper gastrointestinal bleeding in children: a case-crossover study. Eur J Clin Pharmacol 2010; 66: 831–7

    Article  PubMed  Google Scholar 

  19. Dowd JE, Cimaz R, Fink CW. Nonsteroidal anti-inflammatory drug-induced gastroduodenal injury in children. Arthritis Rheum 1995; 38: 1225–31

    Article  PubMed  CAS  Google Scholar 

  20. Schaller S, Kaplan BS. Acute nonoliguric failure in children associated with nonsteroidal anti-inflammatory agents. Pediatr Emerg Care 1998; 14: 416–8

    Article  PubMed  CAS  Google Scholar 

  21. Ulinksi T, Guigonis V, Dunan O, et al. Acute renal failure after treatment with non-steroidal anti-inflammatory drugs. Eur J Pediatr 2004; 163: 148–50

    Article  CAS  Google Scholar 

  22. Kidon MI, See Y. Adverse drug reactions in Singaporean children. Singapore Med J 2004; 45: 574

    PubMed  CAS  Google Scholar 

  23. Titchen T, Cranswick N, Beggs S. Adverse drug reactions to nonsteroidal anti-inflammatory drugs, COX-2 inhibitors and paracetamol in a paediatric hospital. Br J Clin Pharmacol 2005; 59: 718–23

    Article  PubMed Central  PubMed  CAS  Google Scholar 

  24. Autret-Leca E, Bensouda-Grimaldi L, Maurage C, et al. Upper gastrointestinal complications associated with NSAIDs in children. Therapie 2007; 62: 173–6

    Article  PubMed  Google Scholar 

  25. Clarkson A, Choonara I. Surveillance for fatal suspected adverse drug reactions in the UK. Arch Dis Child 2002; 87: 462–7

    Article  PubMed Central  PubMed  CAS  Google Scholar 

  26. Lesko SM, Mitchell AA. An assessment of the safety of pediatric ibuprofen: a practitioner-based randomized clinical trial. JAMA 1995; 273: 929–33

    Article  PubMed  CAS  Google Scholar 

  27. Hall AH, Smolinske SC, Conrad FL, et al. Ibuprofen overdose: 126 cases. Ann Emerg Med 1986; 15: 1308–13

    Article  PubMed  CAS  Google Scholar 

  28. Hall AH, Smolinske SC, Kulig KW, et al. Ibuprofen overdose: a prospective study. West J Med 1988; 148: 653–6

    PubMed Central  PubMed  CAS  Google Scholar 

  29. Linden CH, Townsend PL. Metabolic acidosis after acute ibuprofen overdosage. J Pediatr 1987; 111: 922–5

    Article  PubMed  CAS  Google Scholar 

  30. Zuckerman GB, Uy CC. Shock, metabolic acidosis, and coma following ibuprofen overdose in a child. Ann Pharmacother 1995; 29: 869–71

    PubMed  CAS  Google Scholar 

  31. Van Biljon G. Reversible renal failure associated with ibuprofen in a child. S Afr Med J 1989; 76: 34–5

    PubMed  Google Scholar 

  32. Kim J, Gazarian M, Verjee Z, et al. Acute renal insufficiency in ibuprofen overdose. Pediatr Emerg Care 1995; 11: 107–8

    Article  PubMed  CAS  Google Scholar 

  33. Giles HMcC. Encephalopathy and fatty degeneration of the viscera. Lancet 1965; I: 1075

    Article  Google Scholar 

  34. Starko KM, Ray CG, Dominguez LB, et al. Reye’s syndrome and salicylate use. Pediatrics 1980; 66: 859–64

    PubMed  CAS  Google Scholar 

  35. Belay ED, Bresee JS, Holman RC, et al. Reye’s syndrome in the United States from 1981 through 1997. N Engl J Med 1999; 340: 1377–82

    Article  PubMed  CAS  Google Scholar 

  36. Hedenmalm K, Spigset O. Agranulocytosis and other blood dyscrasias associated with dipyrone (metamizole). Eur J Clin Pharmacol 2002; 58: 265–74

    Article  PubMed  CAS  Google Scholar 

  37. Hamerschlak N, Maluf E, Biasi Cavalcanti A, et al. Incidence and risk factors for agranulocytosis in Latin American countries: the Latin study. Eur J Clin Pharmacol 2008; 64: 921–9

    Article  PubMed  Google Scholar 

  38. Bárzaga Arencibia Z, Novoa Sotomayer D, Caballero Mollinedo N, et al. Adverse drug reactions in children in Camagüey Province, Cuba. Arch Dis Child 2010; 95: 474–7

    Article  PubMed  Google Scholar 

  39. Rumack BH. Acetaminophen overdose in young children: treatment and effects of alcohol and other additional ingestants in 417 cases. Am J Dis Child 1984; 138: 428–33

    Article  PubMed  CAS  Google Scholar 

  40. Alander SW, Dowd MD, Bratton SL, et al. Pediatric acetaminophen overdose: risk factors associated with hepatocellular injury. Arch Pediatr Adolesc Med 2000; 154: 346–50

    Article  PubMed  CAS  Google Scholar 

  41. Rivera-Penera T, Gugig R, Davis J, et al. Outcome of acetaminophen overdose in pediatric patients and factors contributing to hepatotoxicity. J Pediatr 1997; 130: 300–4

    Article  PubMed  CAS  Google Scholar 

  42. Heubi JE, Barbacci MB, Zimmerman HJ. Therapeutic misadventures with acetaminophen: hepatotoxicity after multiple doses in children. J Pediatr 1998; 132: 22–7

    Article  PubMed  CAS  Google Scholar 

  43. Bailey B, Lalkin A, Kapur BM, et al. Is chronic poisoning with acetaminophen in children a frequent occurrence in Toronto? Can J Clin Pharmacol 2001; 8: 96–101

    PubMed  CAS  Google Scholar 

  44. Morton NS, Arana A. Paracetamol-induced fulminant hepatic failure in a child after 5 days of therapeutic doses. Paediatr Anaesth 1999; 9: 463–5

    Article  PubMed  CAS  Google Scholar 

  45. Mahadevan SBK, McKiernan PJ, Davies P, et al. Paracetamol induced hepatotoxicity. Arch Dis Child 2006; 91: 598–603

    Article  PubMed Central  PubMed  CAS  Google Scholar 

  46. McIntire SC, Rubenstein RC, Gartner Jr JC, et al. Acute flank pain and reversible renal dysfunction associated with nonsteroidal anti-inflammatory drug use. Pediatrics 1993; 92: 459–60

    PubMed  CAS  Google Scholar 

  47. Zaffanello M, Brugnara M, Angeli S, et al. Acute non-oliguric failure and cholestatic hepatitis induced by ibuprofen and acetaminophen: a case report. Acta Paediatrica 2009; 98: 903–5

    Article  PubMed  Google Scholar 

  48. Sánchez-Borges M, Caballero-Fonseca F, Capriles-Hulett A, et al. Hypersensitivity reactions to nonsteroidal anti-inflammatory drugs: an update. Pharmaceuticals 2010; 3: 10–8

    Article  CAS  PubMed Central  Google Scholar 

  49. Boussetta K, Ponvert C, Karila C, et al. Hypersensitivity reactions to paracetamol in children: a study of 25 cases. Allergy 2005; 60: 1174–7

    Article  PubMed  CAS  Google Scholar 

  50. Beasley R, Clayton T, Crane J, et al. Association between paracetamol use in infancy and childhood, and risk of asthma, rhinoconjunctivitis, and eczema in children aged 6–7 years: analysis from phase three of the ISAAC programme. Lancet 2008; 372: 1039–48

    Article  PubMed  CAS  Google Scholar 

  51. Etminan M, Sadatsafavi M, Jafari S, et al. Acetaminophen use and the risk of asthma in children and adults: a systematic review and metaanalysis. Chest 2009; 136: 1316–23

    Article  PubMed  Google Scholar 

  52. Wickens K, Beasley R, Town I, et al. The effects of early and late paracetamol exposure on asthma and atopy: a birth cohort. Clin Exp Allergy 2011; 41: 399–406

    Article  PubMed  CAS  Google Scholar 

  53. Foliaki S, Pearce N, Björkstén B, et al. Antibiotic use in infancy and symptoms of asthma, rhinoconjunctivitis, and eczema in children 6 and 7 years old. International Study of Asthma and Allegies in Childhood Phase III. J Allergy Clin Immunol 2009; 124: 982–9

    Article  PubMed  CAS  Google Scholar 

  54. Tapiainen T, Dunder T, Möttönen M, et al. Adolescents with asthma or atopic eczema have more febrile days in early childhood: a possible explanation for the connection between paracetamol and asthma? J Allergy Clin Immunol 2010; 125: 751–2

    Article  PubMed  CAS  Google Scholar 

  55. Schnabel E, Heinrich J, LISA Study Group. Respiratory tract infections and not paracetamol medication during infancy are associated with asthma development in childhood. J Allergy Clin Immunol 2010; 126: 1071–3

    Article  PubMed  Google Scholar 

  56. Oddy WH, de Klerk NH, Sly PD, et al. The effects of respiratory infections, atopy, and breastfeeding on childhood asthma. Eur Respir J 2002; 19: 899–905

    Article  PubMed  CAS  Google Scholar 

  57. Jackson DJ, Gangnon RE, Evans MD, et al. Wheezing rhinovirus illnesses in early life predict asthma developing in high-risk children. Am J Respir Crit Care Med 2008; 178: 667–72

    Article  PubMed Central  PubMed  Google Scholar 

  58. Lowe AJ, Carlin JB, Bennett CM, et al. Paracetamol use in early life and asthma: prospective birth cohort study. BMJ 2010; 341: c4616

    Article  PubMed Central  PubMed  CAS  Google Scholar 

  59. von Mutius E, Illi S, Hirsch T, et al. Frequency of infections and risk of asthma, atopy and airway hyperresponsiveness in children. Eur Respir J 1999; 14: 4–11

    Article  Google Scholar 

  60. Celedón JC, Fuhlbrigge A, Rifas-Shiman S, et al. Antibiotic use in the first year of life and asthma in early childhood. Clin Exp Allergy 2004; 34: 1011–6

    Article  PubMed  Google Scholar 

  61. Farquhar H, Crane J, Mitchell EA, et al. The acetaminophen and asthma hypothesis 10 years on: a case to answer. J Allergy Clin Immunol 2009; 124: 649–51

    Article  PubMed  Google Scholar 

Download references

Acknowledgements

No sources of funding were used to prepare this review. The authors have no conflicts of interest that are directly relevant to the content of this review.

Author information

Authors and Affiliations

  1. Children’s Hospital “Eduardo Agramonte Piña”, Camagüey Province, Cuba

    Zeina Bárzaga Arencibia

  2. Academic Division of Child Health, The Medical School, University of Nottingham, Derbyshire Children’s Hospital, Uttoxeter Road, Derby, DE22 3DT, UK

    Imti Choonara (Professor in Child Health)

Authors
  1. Zeina Bárzaga Arencibia
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Imti Choonara
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Imti Choonara.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Arencibia, Z.B., Choonara, I. Balancing the Risks and Benefits of the Use of Over-the-Counter Pain Medications in Children. Drug Saf 35, 1119–1125 (2012). https://doi.org/10.1007/BF03261998

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/BF03261998

Keywords

Search

Navigation