Ofloxacin-induced maculopapular rash in the infant


  • Amit S. Kamdi Department of Pharmacology, Pharmacology, Government Medical College, Chandrapur, Maharashtra, India
  • Pankaj N. Bohra Department of Pediatrics, Mayo SNEH Foundation, Chinchwad, Pune, Maharashtra, India
  • Suvarna M. Kalambe Department of Research & Development, Sanjeevani Multipurpose Society, Mul, Chandrapur, Maharashtra, India




Adverse drug reaction, Exanthema, Infant ofloxacin, Maculopapular, Rash


Adverse drug reactions (ADRs) are a major cause of morbidity and mortality in countries having limited healthcare resources. The ofloxacin is an antimicrobial used for treating several bacterial infections. The ofloxacin, belonging to quinolone group of drugs, is bactericidal and acts by inhibition of bacterial DNA gyrase. Among the adverse drug reaction of ofloxacin, skin rashes are rare. An ofloxacin-induced maculopapular rash is the unique rare condition in the infant. The present case report was assessing the causality in ofloxacin induced maculopapular rash in the infant. Naranjo Adverse Drug Reaction Probability Scale and World Health Organization and Uppsala Monitoring Centre (WHO-UMC) system for standardized case causality assessment were used for assessing the causality. According to the Naranjo and WHO-UMC, ofloxacin scaled as the probable/likely cause of this ADR in infant. So, authors can conclude that the ofloxacin should be used cautiously in the pediatric age group.


Aspden P, Wolcott JA, Bootman L, Cronenwelt LR. Institute of medicine, preventing medication errors, quality chasm series. 2007.

Impicciatore P, Choonara I, Clarkson A, Provasi D, Pandolfini C, Bonati M. Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol. 2001;52(1):77-83.

Bigby M. Rates of cutaneous reactions to drugs. Archives of dermatology. 2001 Jun 1;137(6):765-70.

Blondeau JM. Fluoroquinolones: mechanism of action, classification, and development of resistance. Survey Ophthalmol. 2004 Mar 1;49(2):73-8.

Sanders Jr WE, Morris JF, Alessi P, Makris AT, McCloskey RV, Trenholme GM, et al. Oral ofloxacin for the treatment of acute bacterial pneumonia: use of a nontraditional protocol to compare experimental therapy with “usual care” in a multicenter clinical trial. Am J Medi. 1991 Sep 1;91(3):261-6.

Akalin HE. Quinolones in the treatment of acute bacterial diarrhoeal diseases. Drugs. 1993 Jun 1;45(3):114-8.

Ketterl R, Beckurts T, Stübinger B, Claudi B. Use of ofloxacin in open fractures and in the treatment of post-traumatic osteomyelitis. J Antimicrobial Chemotherap. 1988 Jul 1;22(Supplement_C):159-66.

Kromann-Andersen B, Nielsen KK. Ofloxacin in urinary tract infections. Scand J Infect Dis Suppl. 1990 Jan 1;68:35-40.

Nouira S, Marghli S, Belghith M, Besbes L, Elatrous S, Abroug F. Once daily oral ofloxacin in chronic obstructive pulmonary disease exacerbation requiring mechanical ventilation: a randomised placebo-controlled trial. Lancet. 2001 Dec 15;358(9298):2020-5.

Vinh HA, Wain J, Vo TN, Cao NN, Mai TC, Bethell D, et al. Two or three days of ofloxacin treatment for uncomplicated multidrug-resistant typhoid fever in children. Antimicrobial Agents Chemotherap. 1996 Apr 1;40(4):958-61.

Dagan R. Fluoroquinolones in paediatrics-1995. Drugs. 1995;49(2):92-9.

Koverech A, Picari M, Granata F, Fostini R, Toniolo D, Recchia G. Safety profile of ofloxacin: the Italian data base. Infection. 1986 Jul 1;14(4):335-7.

Blomer R, Bruch K, Krauss H, Wacheck W. Safety of ofloxacin-adverse drug reactions reported during phase-II studies in europe and in Japan. Infection. 1986 Jul 1;14(4):332-4.

Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Therapeut. 1981 Aug 1;30(2):239-45.

The use of the WHO-UMC system for standardized case causality assessment. Uppsala Uppsala Monit Cent. 2005. Available at; http://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf.

Naveen KN, Pai VV, Rai V, Athanikar SB. Retrospective analysis of Steven Johnson syndrome and toxic epidermal necrolysis over a period of 5 years from northern Karnataka, India. Indian J Pharmacol. 2013 Jan;45(1):80.




How to Cite

Kamdi, A. S., Bohra, P. N., & Kalambe, S. M. (2018). Ofloxacin-induced maculopapular rash in the infant. International Journal of Basic & Clinical Pharmacology, 7(11), 2261–2263. https://doi.org/10.18203/2319-2003.ijbcp20184185



Case Reports