Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS 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 have been reported with quinolones, including levofloxacin.
Therefore, adequate hydration of patients receiving levofloxacin should be maintained to prevent the formation of a highly concentrated urine [see Dosage and Administration ( 2.5 )].
6.2 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to levofloxacin in 7537 patients in 29 pooled Phase 3 clinical trials.
The population studied had a mean age of 50 years (approximately 74% of the population was < 65 years of age), 50% were male, 71% were Caucasian, 19% were Black.
Patients were treated with levofloxacin for a wide variety of infectious diseases [see Indications and Usage (1)].
Patients received levofloxacin doses of 750 mg once daily, 250 mg once daily, or 500 mg once or twice daily.
Treatment duration was usually 3 to 14 days, and the mean number of days on therapy was 10 days.
5 WARNINGS AND PRECAUTIONS 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.
Like all medications, Levofloxacin can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: