Levofloxacin

Levofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology ( 12.4)].

• & USAGE Levofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated (1, 12.4). • Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3) • Skin and Skin Structure Infections (SSSI): Complicated (1.4) and Uncomplicated (1.5) • Chronic bacterial prostatitis (1.6) • Inhalational Anthrax, Post-Exposure in adult and pediatric patients (1.7) • Plague in adult and pediatric patients (1.8) • Urinary Tract Infections (UTI): Complicated (1.9, 1.10) and Uncomplicated (1.12) • Acute Pyelonephritis (1.11) • Acute Bacterial Exacerbation of Chronic Bronchitis (1.13) • Acute Bacterial Sinusitis (1.14) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.15).ICD-10: J18.9, J20.9, J32.9, N39.0

• Levofloxacin tablets are contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see Warnings and Precautions ( 5.3 )].contraindicated

DOSAGE & ADMINISTRATION • Administer Levofloxacin Tablets to pediatric patients weighing 30 kg and greater only (2.1, 2.2). • Levofloxacin Tablets cannot be administered to pediatric patients who weigh less than 30 kg because of the limitations of the available strengths. Alternative formulations of levofloxacin may be considered for pediatric patients who weigh less than 30 kg (2.2). Dosage in Adult and Pediatric Patients with Creatinine Clearance greater than or equal to 50 mL/minute (2.1. 2.2) Type of Infection Dose Every 24 hours Duration (days) Nosocomial Pneumonia (1.1) 750 mg 7 to 14 Community Acquired Pneumonia (1.2) 500 mg 7 to 14 Community Acquired Pneumonia (1.3) 750 mg 5 Complicated SSSI (1.4) 750 mg 7 to 14 Uncomplicated SSSI (1.5) 500 mg 7 to 10 Chronic Bacterial Prostatitis (1.6) 500 mg 28 Inhalational Anthrax (Post-Exposure) (1.7) Adults and Pediatric Patients 50 kg or greater Pediatric Patients 30 kg to less than 50 kg (2.2) 500 mg 250 mg every 12 hours 60 60 Plague (1.8) Adults and Pediatric Patients 50 kg or greater Pediatric Patients 30 kg to less than 50 kg (2.2) 500 mg 250 mg every 12 hours 10 to 14 10 to 14 Complicated UTI (1.9) or Acute Pyelonephritis (1.11) 750 mg 5 Complicated UTI (1.10) or Acute Pyelonephritis (1.11) 250 mg 10 Uncomplicated UTI (1.12) 250 mg 3 Acute Bacterial Exacerbation of Chronic Bronchitis (1.13) 500 mg 7 Acute Bacterial Sinusitis (1.14) 750 mg 5 500 mg 10 to 14 • Adjust dose for creatinine clearance less than 50 mL/minute (2.3, 8.6, 12.3) 2.1 Dosage of Levofloxacin Tablets in Adult Patients with Creatinine Clearance ≥ 50 mL/m…

Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose ( 4 , 5.7 ) Hematologic (including agranulocytosis, thrombocytopenia), and renal toxicities may occur after multiple doses ( 5.6 ) Hepatotoxicity: Severe, and sometimes fatal, hepatoxicity has been reported. Discontinue immediately if signs and symptoms of hepatitis occur ( 5.8 ) Clostridium difficile -associated colitis: evaluate if diarrhea occurs ( 5.10 ) Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval ( 5.11 , 8.5 ) 5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects Fluoroquinolones, including levofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting levofloxacin. Patients of any age or without pre-existing risk factors have experienced these adverse reactions [see Warnings and Precautions (5.2 , 5.3 , 5.4 )].

The most common reactions (≥3%) were nausea, headache, diarrhea, insomnia, constipation and dizziness ( 6.2 ). To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Serious and Otherwise Important Adverse Reactions The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: • Disabling and Potentially Irreversible Serious Adverse Reactions [ see Warnings and Precautions (5.1)] • Tendinitis and Tendon Rupture [see Warnings and Precautions ( 5.2)] • Peripheral Neuropathy [see Warnings and Precautions (5.3)] • Central Nervous System Effects [see Warnings and Precautions ( 5.4)] • Exacerbation of Myasthenia Gravis [see Warnings and Precautions ( 5.5)] • Other Serious and Sometimes Fatal Reactions [see Warnings and Precautions ( 5.6)] • Hypersensitivity Reactions [see Warnings and Precautions (5.7)] • Hepatotoxicity [see Warnings and Precautions ( 5.8)] • Risk of Aortic Aneurysm and Dissection [see Warnings and Precautions ( 5.9 )] • Clostridium difficile-Associated Diarrhea [see Warnings and Precautions ( 5.10 )] • Prolongation of the QT Interval [see Warnings and Precautions ( 5.11 )] • Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions ( 5.12 )] • Blood Glucose Disturbances [see Warnings and Precautions ( 5.13 )] • Photosensitivity/Phototoxicity [see Warnings and Precautions ( 5.14 )] • Development of Drug Resistant Bacteria [see Warnings and Precautions ( 5.15 )] Crystalluria and cylindruria h…

• Geriatrics: Severe hepatotoxicity has been reported. The majority of reports describe patients 65 years of age or older (5.8, 8.5, 17). May have increased risk of tendinopathy (including rupture), especially with concomitant corticosteroid use (5.2, 8.5, 17). May be more susceptible to prolongation of the QT interval. (5.11, 8.5, 17). • Pediatrics: Musculoskeletal disorders (arthralgia, arthritis, tendinopathy, and gait abnormality) seen in more levofloxacin-treated patients than in comparator. Shown to cause arthropathy and osteochondrosis in juvenile animals (5.12, 8.4, 13.2). Safety in pediatric patients treated for more than 14 days has not been studied. Risk-benefit appropriate only for the treatment of inhalational anthrax (post-exposure) (1.7, 2.2, 8.4, 14.9) and plague (1.8, 2.2, 8.4, 14.10) 8.1 Pregnancy Pregnancy Category C. Levofloxacin was not teratogenic in rats at doses as high as 810 mg/kg/day which corresponds to 9.4 times the highest recommended oral human dose based upon relative body surface area. The oral dose of 810 mg/kg/day to rats caused decreased fetal body weight and increased fetal mortality. No teratogenicity was observed when rabbits were dosed orally as high as 50 mg/kg/day which corresponds to 1.1 times the highest recommended oral human dose based upon relative body surface area.

Metabolism

The mean ± SD pharmacokinetic parameters of levofloxacin determined under single and steady-state conditions following administration of the oral tablets, are summarized in Table 8. Table 8: Mean ± SD Levofloxacin PK Parameters Regimen C max (mcg/mL) T max (h) AUC (mcg•h/mL) CL/F 1 (mL/min) Vd/F 2 (L) t 1/2 (h) CL R (mL/min) Single dose 250 mg oral tablet 3 2.8 ± 0.4 1.6 ± 1 27.2 ± 3.9 156 ± 20 ND 7.3 ± 0.9 142 ± 21 500 mg oral tablet 3 * 5.1 ± 0.8 1.3 ± 0.6 47.9 ± 6.8 178 ± 28 ND 6.3 ± 0.6 103 ± 30 750 mg oral tablet 4 * 9.3 ± 1.6 1.6 ± 0.8 101 ± 20 129 ± 24 83 ± 17 7.5 ± 0.9 ND Multiple dose…

In the event of an acute overdosage, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis. Levofloxacin exhibits a low potential for acute toxicity. Mice, rats, dogs and monkeys exhibited the following clinical signs after receiving a single high dose of levofloxacin: ataxia, ptosis, decreased locomotor activity, dyspnea, prostration, tremors, and convulsions. Doses in excess of 1500 mg/kg orally and 250 mg/kg IV produced significant mortality in rodents.

• Dec 20, 2010ANDAANDA078282Rubicon Research
• Jun 20, 2011ANDAANDA076710Dr Reddys Labs Inc
• Jun 20, 2011ANDAANDA201043Aurobindo Pharma Ltd
• Jun 20, 2011ANDAANDA078424Lupin
• Jun 20, 2011ANDAANDA091678Novitium Pharma
• Jul 7, 2011ANDAANDA090343Inforlife
• Sep 16, 2011ANDAANDA091375Hikma Farmaceutica
• Mar 22, 2012ANDAANDA200839Macleods Pharms Ltd

1. 1Off Label Use3,2095.4%
2. 2Drug Ineffective3,0305.1%
3. 3Dyspnoea3,0095.1%
4. 4Pneumonia2,9064.9%
5. 5Nausea2,8504.8%
6. 6Pyrexia2,7594.7%
7. 7Fatigue2,7134.6%
8. 8Acute Kidney Injury2,6104.4%
9. 9Diarrhoea2,5184.3%
10. 10Pain2,4504.1%
11. 11Chronic Kidney Disease2,2883.9%
12. 12Arthralgia2,2713.8%
13. 13Pain In Extremity1,9333.3%
14. 14Vomiting1,9113.2%
15. 15Death1,8093.1%

Recent PubMed references pinned to Levofloxacin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Ratiometric Fluorescence and Smartphone-Assisted Visual Assay of Tetracycline and Levofloxacin Based on Dual-Emission Carbon Dots.
  Luminescence : the journal of biological and chemical luminescence · 2026 · Guo B, Wu M, Wang D, et al.
  PMID 42270436DOI 10.1002/bio.70538
• Levofloxacin versus moxifloxacin in nitazoxanide-based quadruple therapy as a first-line treatment for Helicobacter pylori infection: NILE, a randomized, comparative, multicenter study.
  Scientific reports · 2026 · El-Azab G, Salam SA, Moustafa E, et al.
  PMID 42151286DOI 10.1038/s41598-026-51062-4
• Gut microbiome and metabolic responses of adult zebrafish (Danio rerio) to the co-exposure of polyethylene microplastics and levofloxacin.
  Environmental pollution (Barking, Essex : 1987) · 2026 · Li M, Liu T, Yuan Y, et al.
  PMID 42142727DOI 10.1016/j.envpol.2026.128358
• Multi-compartmental Ni-MOF@C microcapsules for enhanced electrochemical detection of paracetamol and levofloxacin.
  Analytica chimica acta · 2026 · Hao R, Xie W, Tian D, et al.
  PMID 42128565DOI 10.1016/j.aca.2026.345576
• In vitro effects of pH variation and immune-induced copper accumulation on the antibacterial and cytotoxic activity of levofloxacin during Streptococcus pneumoniae infection.
  Bioorganic chemistry · 2026 · Labović M, Milenković MR, Bajuk-Bogdanović D, et al.
  PMID 42127742DOI 10.1016/j.bioorg.2026.109947
• Antenna effect of luminescent levofloxacin-lanthanide complexes in biological medium.
  Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy · 2026 · Pestaña-Ocaña ME, Guerrero-García P, Quesada-Moreno MM, et al.
  PMID 42068740DOI 10.1016/j.saa.2026.127963
• Determination of frequency of spontaneous resistance for gepotidacin and levofloxacin against a collection of gram-positive and gram-negative organisms.
  Antimicrobial agents and chemotherapy · 2026 · Morgan GM, Kimbrough JH, Karr MH, et al.
  PMID 42059811DOI 10.1128/aac.01832-25
• An eye drop combination for treating Staphylococcus aureus-induced keratitis in rats: repurposing ibuprofen.
  Scientific reports · 2026 · Seiffein NL, Kamel MA, Ali GH, et al.
  PMID 42031955DOI 10.1038/s41598-026-48096-z

The 10 most recently updated of 459 ClinicalTrials.gov registrations naming Levofloxacin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Evaluation of Efficacy and Safety Parameters of Different Antibiotics Regimens for Management of Empyema
  Completed · Interventional · 80 enrolled · Fayoum University
  NCT06787885updated 2026-06-05
• Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB
  Recruiting · Phase 2 · Phase 3 · Interventional · 2,530 enrolled · Johns Hopkins University
  NCT06568484updated 2026-06-03
• Vonoprazan High-Dose Dual VS Levofloxacin Concomitant
  Not yet recruiting · Phase 4 · Interventional · 150 enrolled · Damascus Hospital
  NCT07624422updated 2026-06-03
• STeroids and Enhanced Spectrum Antibiotics for the Treatment of Patients in Africa With Refractory Sepsis
  Not yet recruiting · Phase 3 · Interventional · 344 enrolled · University of Virginia
  NCT07332325updated 2026-06-01
• Early Discontinuation of Antibiotics in Paediatric High-risk Febrile Neutropenia
  Not yet recruiting · Phase 4 · Interventional · 136 enrolled · Hospital Universitari Vall d'Hebron Research Institute
  NCT07590648updated 2026-05-15
• Enhanced Treatment Strategy for Disseminated MAC Infection in HIV Patients: A Randomized Controlled Trial
  Not yet recruiting · Interventional · 124 enrolled · Shanghai Public Health Clinical Center
  NCT07585461updated 2026-05-13
• Shorter and Safer Treatment Regimens for Latent TB
  Recruiting · Phase 2 · Phase 3 · Interventional · 1,800 enrolled · McGill University Health Centre/Research Institute of the McGill University Health Centre
  NCT06498414updated 2026-05-11
• Levofloxacin-Based Sequential Therapy Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication
  Not yet recruiting · Interventional · 90 enrolled · University of Health Sciences Lahore
  NCT07574983updated 2026-05-08
• Postoperative Antibiotic Management Duration Following Surgery for Intravenous Drug Abuse (IVDA) Endocarditis (OPTIMAL)
  Terminated · Phase 4 · Interventional · 5 enrolled · West Virginia University
  NCT05156437updated 2026-05-05
• Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
  Recruiting · Observational · 1,600 enrolled · Duke University
  NCT03511118updated 2026-04-24

Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

• CiprofloxacinFluoroquinolone Antibacterial82%

Frequently asked questions

How does Levofloxacin work?

Levofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology ( 12.4)].

What is Levofloxacin used for?

According to FDA labeling, Levofloxacin carries indications including: & USAGE Levofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated (1, 12.4). • Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3) • Skin and Skin Structure Infections (SSSI): Complicated (1.4) and Uncomplicated (1.5) • Chronic bacterial prostatitis (1.6) • Inhalational Anthrax, Post-Exposure in adult and pediatric patients (1.7) • Plague in adult and pediatric patients (1.8) • Urinary Tract Infections (UTI): Complicated (1.9, 1.10) and Uncomplicated (1.12) • Acute Pyelonephritis (1.11) • Acute Bacterial Exacerbation of Chronic Bronchitis (1.13) • Acute Bacterial Sinusitis (1.14) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.15).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Levofloxacin?

Levofloxacin is classified as Fluoroquinolones, Fluoroquinolone Antibacterial, DNA Gyrase Inhibitors, Topoisomerase 4 Inhibitors, Decreased DNA Integrity, Decreased DNA Replication, Decreased Protein Synthesis, Decreased Transcription to RNA, Increased Protein Breakdown.

What are the brand names for Levofloxacin?

Levofloxacin is marketed under brand names including Levaquin.

What are the contraindications for Levofloxacin?

Levofloxacin labeling lists contraindications including: Levofloxacin tablets are contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see Warnings and Precautions ( 5.3 )].. Always consult the full prescribing information and a clinician.