Acetaminophen prophylaxis of adverse reactions following vaccination of infants with diphtheria-pertussis-tetanus toxoids-polio vaccine

Pediatr Infect Dis J. 1987 Aug;6(8):721-5. doi: 10.1097/00006454-198708000-00005.


The effect of acetaminophen on reducing the frequency and severity of adverse reactions following diphtheria-pertussis-tetanus toxoids-polio vaccine was studied in a randomized clinical trial involving 519 vaccinations in 383 infants 2 to 6 months of age and 70 infants 18 months of age. Significantly fewer local and systemic reactions were reported in acetaminophen-treated infants at 2 to 6 months of age. Acetaminophen also reduced the incidence of fever greater than 38.0 degrees C from 44% to 27%. Only 0.9% of acetaminophen-treated infants had overall behavioral changes rated as severe by parents compared to 13% of the placebo group. Infants vaccinated at 18 months of age had higher rates of systemic and local reactions than younger infants. Acetaminophen did not result in significant reductions in reaction rates after the booster at 18 months. We conclude that acetaminophen administered at the time of primary vaccination with diphtheria-pertussis-tetanus toxoids-polio can significantly reduce the frequency and severity of common adverse reactions.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetaminophen / therapeutic use*
  • Body Temperature
  • Clinical Trials as Topic
  • Diphtheria Toxoid / adverse effects*
  • Diphtheria-Tetanus-Pertussis Vaccine*
  • Double-Blind Method
  • Drug Combinations / adverse effects
  • Fever / prevention & control*
  • Humans
  • Immunization, Secondary
  • Infant
  • Pain / prevention & control
  • Pertussis Vaccine / adverse effects*
  • Poliovirus Vaccine, Inactivated / adverse effects*
  • Random Allocation
  • Tetanus Toxoid / adverse effects*
  • Vaccination
  • Vaccines, Combined


  • DTPP vaccine
  • Diphtheria Toxoid
  • Diphtheria-Tetanus-Pertussis Vaccine
  • Drug Combinations
  • Pertussis Vaccine
  • Poliovirus Vaccine, Inactivated
  • Tetanus Toxoid
  • Vaccines, Combined
  • Acetaminophen