The incidence of drug-related adverse reactions in patients during 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%, pruritus 0.5%, rash 0.3%, abdominal pain 0.3%, genital moniliasis 0.3%, dizziness 0.3%, dyspepsia 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 disorder 0.1%, tremor 0.1%, urticaria 0.1%.
In clinical trials, the most frequently reported adverse events occuring 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 occured in 1 to 3% of 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%, pruritus 1.6%, pain 1.4 %, chest pain 1.1%, back pain 1.0%. The following adverse events occured in clinical trials at a rate of 0.5 to less than 1% regardless of drug relationship: agitation, anorexia, anxiety, arthralgia, dry mouth, dyspnea, edema, fatigue, fever, genital pruritus, 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 infarction, 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 reaction, anemia, angina pectoris, Acute Respiratory Distress Syndrome (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, gastrointestinal hemorrhage, granulocytopenia, hallucination, heart block, hepatic coma, hypoglycemia, hypotension, impaired concentration, increased Lactate Dehydrogenase (LDH), jaundice, leukocytosis, leukopenia, lymphadenopathy, manic reaction, mental deficiency, muscle weakness, pancreatitis, paralysis, paranoaia, postural hypertension, pseudomembranous colitis, rhabdomyolisis, sleep disorder, stupor, syncope, tachycardia, tendonitis, thrombocytopenia, vertigo, weight decrease, White Blood Cell (WBC) abnormal not otherwise specified.
In clinical trials using multiple-dose therapy, opthalmologic abnormalities, including cataracts and multiple punctate 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 clyndruria 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, decreased lymphocytes.
Post-Marketing Adverse Reactions:
Additional serious adverse reactions reported from the marketing experience with levofloxacin outside of the United States regardless of drug relationship include: allergic pneumonitis, anaphylactic shock, anaphylactoid reaction, dysphonia, abnormal EEG, encephalopathy, eosinophilia, erythema multiforme, haemolytic anaemia, multi-system organ failure, palpitation, paresthesia, Stevens-Johnson syndrome, tendon rupture and vasodilation.