|
Side Effects & Drug Interactions
ADVERSE REACTIONS
The incidence of drug-related adverse reactions in patients during Phase 3 clinical trials conducted in North America was 6.2%. Among patients receiving levofloxacin therapy, 4.3% discontinued levofloxacin therapy due to adverse experiences. The overall incidence, type and distribution of adverse events was similar in patients receiving levofloxacin doses of 750 mg once daily compared to patients receiving doses from 250 mg once daily to 500 mg twice daily. In clinical trials, the following events were considered likely to be drug-related in patients receiving levofloxacin: Text Continues Below
nausea 1.2%,
diarrhea 1.0%,
vaginitis 0.6%,
insomnia 0.4%,
abdominal pain 0.4%,
flatulence 0.3%,
pruritus 0.3%,
dizziness 0.3%,
rash 0.3%,
dyspepsia 0.2%,
genital moniliasis 0.2%,
moniliasis 0.2%,
taste perversion 0.2%,
vomiting 0.2%,
injection site pain 0.2%,
injection site reaction 0.2%,
injection site inflammation 0.1%,
constipation 0.1%, fungal infection 0.1%,
genital pruritis 0.1%,
headache 0.1%,
nervous-ness 0.1%,
rash erythematous 0.1%,
urticaria 0.1%,
anorexia 0.1%,
somnolence 0.1%,
agitation 0.1%,
rash maculo-papular 0.1%,
tremor 0.1%,
condition aggravated 0.1%,
allergic reaction 0.1%. In clinical trials, the following events occurred in >3% of patients, regardless of drug relationship: nausea 7.1%,
headache 6.2%,
diarrhea 5.5%,
insomnia 5.1%,
constipation 3.5%. In clinical trials, the following events occurred in 1 to 3% of patients, regardless of drug relationship:
abdominal pain 2.7%,
dizziness 2.5%,
vomiting 2.5%,
dyspepsia 2.3%,
vaginitis 1.7%,
rash 1.6%,
chest pain 1.4%,
pruritus 1.3%,
sinusitis 1.3%,
dyspnea 1.4%,
fatigue 1.4%,
flatulence 1.2%,
pain 1.6%,
back pain 1.2%,
rhinitis 1.2%,
anxiety 1.2%,
pharyngitis 1.2%. In clinical trials, the following events, of potential medical importance, occurred at a rate of 0.1% to 0.9%, regardless of drug relationship: Page: 1 | 2 | 3 | 4 | Next >>
|
