Last reviewed 2026-04-20 · How we verify

Levaquin (levofloxacin)

Levofloxacin is a fluoroquinolone antibacterial agent.

Levofloxacin (Levaquin) is a respiratory fluoroquinolone approved in 1996, with enhanced pneumococcal coverage vs ciprofloxacin. Available generically. FDA black box warnings limit use to situations without alternatives.

At a glance

Mechanism of action

Levofloxacin belongs to the fluoroquinolone class of antibiotics. It works by inhibiting bacterial DNA replication and repair, though specific details are not provided in the text.

Approved indications

• Acute Moraxella catarrhalis bronchitis
• Acute bacterial bronchitis
• Acute bacterial sinusitis
• Acute exacerbation of chronic bronchitis
• Acute maxillary sinusitis
• Anthrax
• Bacterial Corneal Ulcer Infection
• Bacterial conjunctivitis
• Bacterial infection due to Klebsiella pneumoniae
• Bacterial pneumonia
• Bacterial urinary infection
• Chlamydial pneumonia
• Chronic Enterococcus faecalis Prostatitis
• Chronic Escherichia coli Prostatitis
• Chronic Staphylococcus epidermidis Prostatitis
• Complicated Skin and Skin Structure Enterococcus Faecalis Infection
• Complicated Skin and Skin Structure Infection
• Complicated Skin and Skin Structure Proteus Infection
• Complicated Skin and Skin Structure Staphylococcus Aureus Infection
• Complicated Skin and Skin Structure Streptococcus Pyogenes Infection

Boxed warnings

• BOXED WARNING SECTION WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS • Fluoroquinolones, including levofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions ( 5.1 )], including: o Tendinitis and tendon rupture [see Warnings and Precautions ( 5.2 )] o Peripheral neuropathy [see Warnings and Precautions ( 5.3)] o Central nervous system effects [see Warnings and Precautions (5.4)] Discontinue levofloxacin immediately and avoid the use of fluoroquinolones, including levofloxacin, in patients who experience any of these serious adverse reactions [see Warnings and Precautions (5.1)] • Fluoroquinolones, including levofloxacin, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid levofloxacin in patients with a known history of myasthenia gravis [see Warnings and Precautions ( 5.5)]. • Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.15 )], reserve levofloxacin for use in patients who have no alternative treatment options for the following indications: o Uncomplicated urinary tract infection [see Indications and Usage (1.12)] o Acute bacterial exacerbation of chronic bronchitis [see Indications and Usage ( 1.13)] o Acute bacterial sinusitis [see Indications and Usage ( 1.14)] WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS See full prescribing information for complete boxed warning . Fluoroquinolones, including levofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together ( 5.1 ), including: o Tendinitis and tendon rupture (5.2) o Peripheral neuropathy (5.3) o Central nervous system effects (5.4) Discontinue levofloxacin immediately and avoid the use of fluoroquinolones, including levofloxacin, in patients who experience any of these serious adverse reactions (5.1 ) Fluoroquinolones, including levofloxacin, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid levofloxacin in patients with a known history of myasthenia gravis [see Warnings and Precautions ( 5.5 )]. Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions ( 5.1 to 5.15 ), reserve levofloxacin for use in patients who have no alternative treatment options for the following indications: o Uncomplicated urinary tract infection (1.12 ) o Acute bacterial exacerbation of chronic bronchitis (1.13) o Acute bacterial sinusitis (1.14)

Common side effects

• moniliasis
• insomnia
• headache
• dizziness
• nausea
• diarrhea
• constipation
• abdominal pain
• vomiting
• dyspepsia
• rash
• pruritus

Key clinical trials

• Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia: Randomized-controlled Trial (NA)
• Risk of Acute Liver Injury in Users of Antimicrobials in the HealthCore Integrated Research Database Population (N/A)
• A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Kahook Dual Blade Surgery (Phase 3)
• Personalized Treatment for Refractory H Pylori Infection (NA)
• Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort (Phase 3)
• Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection - a Multi-center Randomized Controlled Trial (NA)
• A Randomized, Double-Blind, Comparative, Multi-Center Study of the Safety and Efficacy of TG-873870(Nemonoxacin) Versus Levofloxacin in Adult Patients With Community-Acquired Pneumonia (CAP) (Phase 3)
• A Randomized, Controlled Study to Investigate the Efficacy and Safety of a Topical Gentamicin-Collagen Sponge in Combination With Systemic Antibiotic Therapy in Diabetic Patients With a Moderate or Se (Phase 4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Levaquin CI brief — competitive landscape report
• Levaquin updates RSS · CI watch RSS
• Generic (originally Daiichi Sankyo/J&J) portfolio CI