The incidence of drug-related adverse reactions in patients phase 2 and 3 clinical trials conducted in North America was 6.2%. Among patients receiving multiple-dose therapy 3.7% discontinued therapy with levofloxacin due to adverse experience. In clinical trials, the following events were considered likely to be drug-related in patients receiving multiple doses of levofloxacin; diarrhea 1.2%, nausea 1.2%, vaginitis 0.8%, flatulence 0.5%, pruritis 0.5%, rash 0.3%, abdominal pain 0.3%, insomnia 0.3%, taste perversion 0.2%, vomiting 0.2% , anorexia 0.1%, anxiety 0.1%, constipation 0.1%, edema 0.1%, fatigue 0.1%, headache 0.1%, increased sweating 0.1%, leukorrhea 0.1%, malaise 0.1%, nervousness 0.1%, sleep disorders 0.1%, tremor 0.1%, urticaria 0.1%. In clinical trials, the most frequently reported adverse events occurring in >3% of the study population regardless of drug relationship were: nausea 6.6%, diarrhea 5.4%, headache 5.4%, constipation 3.1%. In clinical trials, the following events occurred in 1 to 3 patients regardless of drug relationship: insomnia 2.9%, dizziness 2.5%, vomiting 2.1%, abdominal pain 2.0%, dyspepsia 2.0%, rash 1.7%, vaginitis 1.8%, flatulence 1.6%, pruritis 1.6%, pain 1.4%, chest pain 1.1%, back pain 1.0%. The following adverse events occurred in clinical trials at rate of 0.5 to less than 1% regardless of drug relationship: agitation, anorexia, anxiety, arthralgia, dry mouth, dyspnea, edema, fatigue, fever, genital pruritis, increased sweating, nervousness, pharyngitis, rhinitis, skin disorder, somnolence, taste perversion.
Additional adverse events occurring in clinical trials at a rate of 0.3 to less than 0.5% regardless of drug relationship include: cardiac failure, hypertension, leukorrhea, myocardial infarctions, myalgia, purpura, tinnitus, tremor, urticaria.
Events occurring at a frequency lower than 0.3% regardless of drug relationship but considered medically important include: abnormal coordination, abnormal dreaming, abnormal hepatic function, abnormal platelets, abnormal renal function, abnormal vision, acute renal failure, aggravated diabetes mellitus, aggressive reactions, anemia angina pectoris, ARDS, arrhythmia, arthritis, asthma, bradycardia, cardiac arrest, cerebrovascular disorder, circulatory failure, coma, confusion, convulsions (seizures), coronary thrombosis, delirium, depression, diplopia, embolism blood clot, emotional lability, erythema nodosum, G.I. hemorrhage, granulocytopenia, hallucination, heart block, hepatic coma, hypoglycemia, hypotension, impaired concentration, increase LDH, jaundice, leukocytosis, leukopenia, lymphadenopathy, manic reactions, mental deficiency, muscle weakness, pancreatitis, paralysis, paranoia, postural hypertension, pseudomembranous colitis, rhabdomyolysis, sleep disorder, stupor, syncope, tachycardia, tendinitis, thrombocytopenia, vertigo, weight decrease, WBC abnormal not otherwise specified. In clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctuate lenticular opacities, have been noted in patients undergoing treatment with other quinolones. The relationship of the drugs to these events is not presently established. Crystalluria and cylindruria have been reported with other quinolones. The following laboratory abnormalities appeared in 1.9% of patients receiving multiple doses of levofloxacin. It is not known whether these abnormalities were caused by the drug or the underlying condition being treated. Blood chemistry: decreased glucose, lymphocytes.
Post-Marketing Adverse Reactions:
Additional serious adverse reactions reported from the marketing experience of levofloxacin outside of the United States regardless of drug relationship include: allergic pneumonitis, anaphylactic shock, anaphylactoid reaction, dysphonia, abnormal EEG, encephalopathy, eosinophilia, erythema multiforme, hemolytic anemia, multi-system organ failure, palpitation, paresthesia, Stevens-Johnsons Syndrome, tendon rupture, vasodilation.