DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20184186

Systematic review of adverse drug reactions of ofloxacin

Amit S. Kamdi, Sarika D. Kokane, Pankaj N. Bohra, Suvarna M. Kalambe

Abstract


Adverse drug reactions (ADRs) are a major cause of morbidity and mortality in countries having limited healthcare resources. Of all the Adverse Drug Reactions, antimicrobials contribute 28% which is highest compared to the other drugs. Ofloxacin is an antimicrobial used for treating several bacterial infections. Incidence rate of adverse drug reactions (ADRs) to ofloxacin is 4.27%. Although these figures appear to be small, it is consumed for gastrointestinal infections along with ornidazole in India contributing significant burden of ADRs. However, there is no research done in past many years focusing on the adverse drug reactions of ofloxacin. This article bridges the gap of such a need. The objective of the present study was to review the adverse drug reactions related to ofloxacin in human and animal studies. Authors conducted Pubmed and Cochrane library search to review all the articles related to the adverse drug reaction of ofloxacin from 1980 to 2016. Authors got 84 articles pertaining to the adverse drug reactions of ofloxacin. Authors conclude that ofloxacin should be judiciously used as the side effect profile is increasing.

 


Keywords


Adverse drug reaction, Antibiotic, Human, Review, Side effects

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References


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 Jul;52(1):77-83.

Arulmani R, Rajendran SD, Suresh B. Adverse drug reaction monitoring in a secondary care hospital in South India. Br J Clin Pharmacol. 2008 Feb 1;65(2):210-6.

Center Watch. Floxin Tablets New FDA Drug. Available at: http://www.centerwatch.com/drug-information/fda-approved-drugs/drug/212/floxin-tablets-ofloxacin-tablets. Accessed on 2018 May 25.

Jüngst G, Mohr R. Side effects of ofloxacin in clinical trials and in post marketing surveillance. Drugs. 1987 Oct 1;34(1):144-9.

Guay DR, Opsahl JA, McMahon FG, Vargas R, Matzke GR, Flor S. Safety and pharmacokinetics of multiple doses of intravenous ofloxacin in healthy volunteers. Antimicrob Agents Chemotherap. 1992 Feb 1;36(2):308-12.

Gu YM, Chen XY, Wang YQ. Anaphylactic shock in a boy after taking oral ofloxacin. Chi J Pediatr. 2005 Aug;43(8):607.

Wilton LV, Pearce GL, Mann RD. A comparison of ciprofloxacin, norfloxacin, ofloxacin, azithromycin and cefixime examined by observational cohort studies. Br J Clin Pharmacol. 1996 Apr 1;41(4):277-84.

Dan M, Samra Z. Clostridium difficile colitis associated with ofloxacin therapy. Am J Med. 1989 Oct 1;87(4):479.

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):S332-4.

Upton C. Sleep disturbance in children treated with ofloxacin. BMJ. 1994;309(6966):1411.

Jüngst G, Mohr R. Overview of postmarketing experience with ofloxacin in Germany. J Antimicrob Chemotherap. 1988 Jul 1;22(Supplement_C):167-75.

Walton GD, Hon JK, Mulpur TG. Ofloxacin-induced seizure. Ann Pharmacotherap. 1997 Dec;31(12):1475-7.

Jeandel C, Laurain MC, Jouanny P, Penin F, Vespignani H. Status epilepticus induced by ofloxacin. Internal Medicine J. 1994 Mar;15(3):218-9.

Fennig S, Mauas L. Ofloxacin-induced delirium. J Clin Psychia. 1992; 53(4):137-8.

Getenet JC, Croisile B, Vighetto A, Grochowicki M, Goudable B, Aimard G, et al. Idiopathic intracranial hypertension after ofloxacin treatment. Acta Neurol Scand. 1993 Jun;87(6):503-4.

Thomas RJ, Reagan DR. Association of a tourette-like syndrome with ofloxacin. Ann Pharmacother. 1996;30(2):138-40.

Fredy IC, Krishnaveni YA, Lohith KB PP. Case report: ofloxacin induced - angioedema. World J Pharm Pharm Sci. 2015;5(1):1217-20.

Huminer D, Cohen JD, Majadla R, Dux S. Hypersensitivity vasculitis due to ofloxacin. BMJ. 1989 Jul 29;299(6694):303.

Tsuda S, Kato K, Karashima T, Inou Y, Sasai Y. Toxic pustuloderma induced by ofloxacin. Acta Dermato-venereol. 1993 Oct;73(5):382-4.

Kawada A, Himura M, Noguchi H, Banba K, Ishtbashi A, Banba H, et al. Fixed drug eruption induced by of ofoxacin. Contact Dermatitis. 1996 Jun;34(6):427-38.

Melde SL. Ofloxacin: a probable cause of toxic epidermal necrolysis. Ann Pharmacotherap. 2001 Nov;35(11):1388-90.

Nettis E, Giordano D, Pierluigi T, Ferrannini A, Tursi A. Erythema multiforme-like rash in a patient sensitive to ofloxacin. Acta Derm Venereol. 2002;82(5):395-6.

Dave S, Thappa DM, Nori AV, Jayanthi S. A rare variant of erythema nodosum leprosum: a case report. Dermatol Online J. 2003 Jan 1;9(5).

Sousa AL, Stefani MM, Pereira GA, Costa MB, Rebello PF, Gomes MK, et al. Mycobacterium leprae DNA associated with type 1 reactions in single lesion paucibacillary leprosy treated with single dose rifampin, ofloxacin, and minocycline. Am J Tropical Med Hygiene. 2007 Nov 1;77(5):829-33.

Özdemir D, Korkmaz U, Şahin İ, Şencan İ, Kavak A, Küçükbayrak A, et al. Ofloxacin induced Sweet's syndrome in a patient with Crohn's disease. J Infection. 2006 May 1;52(5):e155-7.

van der Linden PD, Sturkenboom MC, Herings RM, Leufkens HM, Rowlands S, Stricker BH. Increased risk of Achilles tendon rupture with quinolone antibacterial use, especially in elderly patients taking oral corticosteroids. Arch Internal Med. 2003 Aug 11;163(15):1801-7.

Schwald N, Debray-Meignan S. Suspected role of ofloxacin in a case of arthalgia, myalgia, and multiple tendinopathy. Rev Rheumatism. 1999;66(7-9):419-21.

Hsiao SH, Chang CM, Tsao CJ, Lee YY, Hsu MY, Wu TJ. Acute rhabdomyolysis associated with ofloxacin/levofloxacin therapy. Ann Pharmacotherap. 2005 Jan;39(1):146-9.

Ridzon R, Meador J, Maxwell R, Higgins K, Weismuller P, Onorato IM. Asymptomatic hepatitis in persons who received alternative preventive therapy with pyrazinamide and ofloxacin. Clin Infectious Dis. 1997 Jun 1;24(6):1264-5.

Jones SF, Smith RH. Quinolones may induce hepatitis. Br Med J. 1997 Mar 22;314(7084):869.

Carro PG, Huidobro ML, Zabala AP, Vicente EM. Fatal subfulminant hepatic failure with ofloxacin. Am J Gastroenterol. 2000 Jun;95(6):1606.

Blum A. Ofloxacin-induced acute severe hepatitis. South Med J. 199;84(9):1158.

Hautekeete ML, Kockx MM, Naegels S, Holvoet JK, Hubens H, Kloppel G. Cholestatic hepatitis related to quinolones: a report of two cases. J Hepatol. 1995;23(6):759-60.

Frothingham R. Rates of torsades de pointes associated with ciprofloxacin, ofloxacin, levofloxacin, gatifloxacin, and moxifloxacin. Pharmacotherapy. J Human Pharmacol Drug Therapy. 2001 Dec 1;21(12):1468-72.

Espiritu J, Walton T. Acute renal failure due to ofloxacin. West Virginia Med J. 1995 Jan;91(1):16.

Bharani A, Kumar H. Diabetes inspidus induced by ofloxacin. BMJ. 2001 Sep 8;323(7312):547.

Nepali N, Kalam A, Subish P, Khan GM. Hemoglobinurea due to ofloxacin in a 9 year old child-a case report. Pharmacol Online. 2007;1:1-5.

Tripathy S, Adhya A. Ofloxacin induced leucopenia in complicated falciparum malaria: a case report. Cases J. 2009 Dec;2(1):7097.

Dokianakis SN, Kornaros ME, Lyberatos G. On the effect of pharmaceuticals on bacterial nitrite oxidation. Water Sci Technol. 2004 Sep 1;50(5):341-6.