Latest industry information on the safety profile of levofloxacin in Japan

Related Experiment Video

Updated: Oct 4, 2026

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
11:17

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses

Published on: August 30, 2018

K Yagawa1

  • 1Drug Safety Administration Department, Daiichi Pharmaceutical Co., Ltd., Tokyo, Japan.

Chemotherapy
|September 11, 2001
PubMed

Insights

Levofloxacin demonstrates a low incidence of serious adverse drug reactions (ADRs), including convulsions, phototoxicity, cardiac effects, and hepatotoxicity. This safety profile is supported by pre-clinical and post-marketing surveillance data.

Area of Science:

  • Pharmacovigilance
  • Drug Safety
  • Clinical Pharmacology

Background:

  • Fluoroquinolones are associated with several major adverse drug reactions (ADRs).
  • Central nervous system (CNS) events like convulsions are a concern, particularly with co-administration of NSAIDs.
  • Other potential ADRs include phototoxicity, cardiac effects, and hepatotoxicity.

Purpose of the Study:

  • To evaluate the incidence and risk of major adverse drug reactions (ADRs) associated with levofloxacin.
  • To compare the safety profile of levofloxacin regarding convulsions, phototoxicity, cardiac effects, and hepatotoxicity with other fluoroquinolones.

Main Methods:

  • Analysis of post-marketing surveillance (PMS) data for levofloxacin.
  • Review of pre-clinical animal studies.
  • Examination of reported cases of adverse events, including convulsions, phototoxicity, cardiac effects, and hepatotoxicity.
  • Prospective study to confirm ADR incidence rates.

Main Results:

  • Levofloxacin shows a low rate of serious convulsions (1/260,000 without NSAIDs, 1/65,000 with NSAIDs).
  • Phototoxicity potential is very low (1 in 1.8 million cases).
  • Levofloxacin has no observed effect on myocardial conduction compared to other fluoroquinolones.
  • Incidence of hepatotoxicity is low (1/100,000).
  • Overall ADR incidence in a prospective study was 1.3%.

Conclusions:

  • Levofloxacin exhibits a favorable safety profile with a low incidence of major adverse drug reactions.
  • The drug is significantly less phototoxic than sparfloxacin and has no cardiac effects compared to sparfloxacin and grepafloxacin.
  • Post-marketing surveillance and prospective studies confirm the low risk of serious adverse events associated with levofloxacin.

More Related Videos

Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products09:24

Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products

Published on: August 22, 2017

Related Concept Videos

Inhibitors of Bacterial DNA Synthesis01:28

Inhibitors of Bacterial DNA Synthesis

Bacterial pathogens depend on precise and efficient DNA replication to sustain infection. Two type II topoisomerases—DNA gyrase and topoisomerase IV—are critical to this process, as they resolve DNA supercoiling and unlink chromosomes during replication. Fluoroquinolones, synthetic derivatives of quinolones, exploit this mechanism by stabilizing the transient DNA–enzyme cleavage complex, preventing strand religation, and causing lethal double-strand breaks. These antibiotics are selectively...
Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Pharmacokinetics in Pediatric Patients: Drug Excretion01:26

Pharmacokinetics in Pediatric Patients: Drug Excretion

In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
Drug Toxicity: Risk factors01:24

Drug Toxicity: Risk factors

Adverse Drug Reactions (ADRs) are potential complications that arise during pharmacotherapy, influenced by multiple risk factors. Age plays a significant role; both neonates and the elderly are at heightened risk due to their respective immature and diminished metabolic and elimination processes. Gender also impacts ADRs, with females experiencing a 1.5 to 1.7-fold greater risk than males, which may be linked to pharmacokinetic, pharmacodynamic, and hormonal differences. Notably, neonates, the...