Lomefloxacin Side Effects
Applies to lomefloxacin: oral tablet
Lomefloxacin therapy is generally well tolerated, and adverse effects are generally mild to moderate and transient in nature. Discontinuation of therapy due to adverse effects occurs in 2.2% of patients, primarily due to gastrointestinal (0.7%), skin (0.7%), or CNS (0.5%) side effects.[Ref]
Gastrointestinal side effects have included nausea (3.5%), diarrhea (1.4%), and abdominal pain (1.2%). Dyspepsia, vomiting, flatulence, constipation, gastrointestinal bleeding, dysphagia, stomatitis, tongue discoloration, and gastrointestinal inflammation have been reported in less than 1% of patients. Pseudomembranous colitis, painful oral mucosa and dysgeusia have been reported during postmarketing experience. Quinolone class antibiotics have been associated with intestinal perforation.[Ref]
Nervous system side effects have included headache (3.6%) and dizziness (2.1%). Tremor, vertigo, paresthesias, twitching, hypertonia, convulsions, hyperkinesia, coma, increased sweating, dry mouth, flushing, and syncope have been reported in less than 1% of patients. Quinolone class antibiotics have been associated with peripheral neuropathy, possible exacerbation of myasthenia gravis, and dysphasia.[Ref]
Spontaneous reporting of adverse effects to the FDA has revealed the rate of CNS toxicity related to lomefloxacin to generally be higher than that of other fluoroquinolones. These reports have included dizziness, tremors, anxiety, and seizures.
A 38-year-old male developed persistent (6 year duration) symptoms of peripheral neuropathy including twitching, numbness, "electrical" sensation, tingling, pain, hypesthesia, muscle/joint pain, fatigue, and multiple CNS symptoms.[Ref]
Hypersensitivity reactions resulting in rash and pruritus have been reported in up to 1% of patients treated with lomefloxacin. Photosensitivity can occur in up to 2.4% of treated patients. Photosensitivity reactions have occurred up to 3 weeks after drug ingestion. Anaphylaxis, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported during postmarketing experience. Quinolone class antibiotics have been associated with anaphylactoid reactions, shock, purpura, serum sickness, erythema multiforme, erythema nodosum, and vesiculobullous eruption.[Ref]
Moderate to severe phototoxic reactions have occurred in patients exposed to direct or indirect sunlight or to artificial light during or following lomefloxacin treatment. These reactions have also occurred in patients exposed to shaded or diffuse light, including exposure through glass. Rarely, phototoxic reactions have occurred several weeks after discontinuation of lomefloxacin. Exposure to sunlight should be avoided during lomefloxacin therapy, even when a sunscreen is used. Exposure should also be avoided for several days after lomefloxacin is discontinued. Patients should be advised to discontinue lomefloxacin use at the first sign of a phototoxic reaction.
A case of Henoch-Schonlein purpura has been reported in a patient treated with lomefloxacin.[Ref]
Dermatologic side effects have included photosensitivity (2.3%). Pruritus, rash, urticaria, skin exfoliation, bullous eruption, eczema, skin disorder, acne, skin discoloration, skin ulceration, angioedema have been reported in less than 1% of patients. Hyperpigmentation has been reported during postmarketing experience.[Ref]
Hepatic side effects have included abnormal liver function (<1%), and elevations of ALT (0.4%), AST (0.3%), bilirubin (0.1%), alkaline phosphatase (0.1%), and GGT (<0.1%). Quinolone class antibiotics have been associated with hepatic necrosis.[Ref]
Hematologic side effects have included purpura, lymphadenopathy, thrombocythemia, anemia, thrombocytopenia, and increased fibrinolysis in less than 1% of patients. Monocytosis (0.2%), eosinophilia (0.1%), leukopenia (0.1%), and leukocytosis (0.1%), prolonged prothrombin time (<0.1%), decreased hemoglobin (<0.1%), elevated ESR (<0.1%), macrocytosis (<0.1%), and hemolytic anemia have also been reported. Quinolone class antibiotics have been associated with agranulocytosis.[Ref]
Musculoskeletal side effects have included arthralgias, myalgias, and leg cramps in less than 1% of patients.[Ref]
Cardiovascular side effects have included tachycardia, hypertension, hypotension, bradycardia, myocardial infarction, angina pectoris, cardiac failure, arrhythmia, phlebitis, pulmonary embolism, extrasystoles, cerebrovascular disorder, cyanosis, and cardiomyopathy in less than 1% of patients. Cardiopulmonary arrest, cerebral thrombosis, torsade de pointes, and vasculitis have been reported during postmarketing experience.[Ref]
Renal side effects have included increased BUN (0.1%), decreased potassium (0.1%), and increased creatinine (0.1%). Interstitial nephritis, polyuria, renal failure, and urinary retention have been reported during postmarketing experience. Quinolone class antibiotics have been associated with renal calculi.[Ref]
Respiratory side effects have included respiratory infection, rhinitis, pharyngitis, dyspnea, cough, epistaxis, bronchospasm, respiratory disorder, increased sputum, stridor, and respiratory depression in less than 1% of patients. Laryngeal and pulmonary edema have been reported during postmarketing experience. Quinolone class antibiotics have been associated with hiccough.[Ref]
Genitourinary side effects have included vaginal moniliasis, vaginitis, leukorrhea, menstrual disorder, perineal pain, intermenstrual bleeding, epididymitis, orchitis, hematuria, micturition disorder, dysuria, strangury, and anuria in less than 1% of patients. Abnormal urine specific gravity and albuminuria have been reported in less than 0.1% of patients. Quinolone class antibiotics have been associated with albuminuria, candiduria, crystalluria, cylindruria, hematuria, and vaginal candidiasis.[Ref]
Metabolic side effects have included thirst, hyperglycemia, hypoglycemia, and gout in less than 1% of patients. Decreased total protein or albumin, increased albumin, and abnormal serum electrolytes have been reported in less than 0.1%. Quinolone class antibiotics have been associated with acidosis and elevations in serum triglycerides, serum cholesterol, blood glucose, and serum potassium.[Ref]
Ocular side effects have included abnormal vision, conjunctivitis, photophobia, eye pain, and abnormal lacrimation in less than 1% of patients. Diplopia has been reported during postmarketing experience. Quinolone class antibiotics have been associated with nystagmus.[Ref]
Psychiatric side effects have included insomnia, nervousness, somnolence, anorexia, depression, confusion, agitation, increased appetite, depersonalization, paranoid reaction, anxiety, paroniria, abnormal thinking, and concentration impairment in less than 1% of patients. Hallucinations and phobia have been reported during postmarketing experience. Quinolone class antibiotics have been associated with manic reactions.[Ref]
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Some side effects may not be reported. You may report them to the FDA.