Lomefloxacin Side Effects

Brand Names: Maxaquin

Please note - some side effects for Lomefloxacin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Lomefloxacin - for the Consumer

Lomefloxacin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lomefloxacin:

Diarrhea; dizziness; headache; nausea.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; bloody stools; burning sensations; confusion; convulsions; joint pain or swelling; pain, tingling, or numbness in the hands or feet; seizures; severe or continuing diarrhea; severe sunburn; skin burning, redness, swelling, blisters, or itching; stomach pain/cramps; tendon pain; tremors; vaginal irritation or discharge; weakness.

Side Effects by Body System

General

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.

Gastrointestinal

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.

Nervous system

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.

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.

Hypersensitivity

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.

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.

Dermatologic

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.

Hepatic

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.

Hematologic

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.

Musculoskeletal

Musculoskeletal side effects have included arthralgias, myalgias, and leg cramps in less than 1% of patients.

Cardiovascular

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.

Renal

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.

Respiratory

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.

Other

Other side effects have included earache, tinnitus, viral infection, moniliasis, and fungal infection in less than 1% of patients.

Genitourinary

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.

Metabolic

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.

Ocular

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.

Psychiatric

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.

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