Maxaquin Side Effects

Please note - some side effects for Maxaquin 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 Maxaquin - for the Consumer

Maxaquin

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 Maxaquin:

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.

Maxaquin Side Effects - for the Professional

Maxaquin

In clinical trials, most of the adverse events reported were mild to moderate in severity and transient in nature. During these clinical investigations, 5,623 patients received Maxaquin. In 2.2% of the patients, lomefloxacin was discontinued because of adverse events, primarily involving the gastrointestinal system (0.7%), skin (0.7%), or CNS (0.5%).

Adverse clinical events

The events with the highest incidence (≥ 1%) in patients, regardless of relationship to drug, were headache (3.6%), nausea (3.5%), photosensitivity (2.3%) [see Warnings], dizziness (2.1%), diarrhea (1.4%), and abdominal pain (1.2%).

Additional clinical events reported in < 1% of patients treated with Maxaquin, regardless of relationship to drug, are listed below:

Autonomic: increased sweating, dry mouth, flushing, syncope.

Body as a whole: fatigue, back pain, malaise, asthenia, chest pain, face edema, hot flashes, influenza-like symptoms, edema, chills, allergic reaction, anaphylactoid reaction, decreased heat tolerance.

Cardiovascular: tachycardia, hypertension, hypotension, myocardial infarction, angina pectoris, cardiac failure, bradycardia, arrhythmia, phlebitis, pulmonary embolism, extrasystoles, cerebrovascular disorder, cyanosis, cardiomyopathy.

Central and peripheral nervous system: tremor, vertigo, paresthesias, twitching, hypertonia, convulsions, hyperkinesia, coma.

Gastrointestinal: dyspepsia, vomiting, flatulence, constipation, gastrointestinal bleeding, dysphagia, stomatitis, tongue discoloration, gastrointestinal inflammation.

Hearing: earache, tinnitus.

Hematologic: purpura, lymphadenopathy, thrombocythemia, anemia, thrombocytopenia, increased fibrinolysis.

Hepatic: abnormal liver function.

Metabolic: thirst, hyperglycemia, hypoglycemia, gout.

Musculoskeletal: arthralgia, myalgia, leg cramps.

Ophthalmologic: abnormal vision, conjunctivitis, photophobia, eye pain, abnormal lacrimation.

Psychiatric: insomnia, nervousness, somnolence, anorexia, depression, confusion, agitation, increased appetite, depersonalization, paranoid reaction, anxiety, paroniria, abnormal thinking, concentration impairment.

Reproductive system: Female: vaginal moniliasis, vaginitis, leukorrhea, menstrual disorder, perineal pain, intermenstrual bleeding. Male: epididymitis, orchitis.

Resistance mechanism: viral infection, moniliasis, fungal infection.

Respiratory: respiratory infection, rhinitis, pharyngitis, dyspnea, cough, epistaxis, bronchospasm, respiratory disorder, increased sputum, stridor, respiratory depression.

Skin/Allergic: pruritus, rash, urticaria, skin exfoliation, bullous eruption, eczema, skin disorder, acne, skin discoloration, skin ulceration, angioedema.

Special senses: taste perversion.

Urinary: hematuria, micturition disorder, dysuria, strangury, anuria.

Adverse laboratory events

Changes in laboratory parameters, listed as adverse events, without regard to drug relationship include:

Hematologic: monocytosis (0.2%), eosinophilia (0.1%), leukopenia (0.1%), leukocytosis (0.1%).

Renal: elevated BUN (0.1%), decreased potassium (0.1%), increased creatinine (0.1%).

Hepatic: elevations of ALT (SGPT) (0.4%), AST (SGOT) (0.3%), bilirubin (0.1%), alkaline phosphatase (0.1%).

Additional laboratory changes occurring in < 0.1% in the clinical studies included: elevation of serum gamma glutamyl transferase, decrease in total protein or albumin, prolongation of prothrombin time, anemia, decrease in hemoglobin, thrombocythemia, thrombocytopenia, abnormalities of urine specific gravity or serum electrolytes, increased albumin, elevated ESR, albuminuria, macrocytosis.

Post-marketing adverse events

Adverse events reported from worldwide marketing experience with lomefloxacin are: anaphylaxis, cardiopulmonary arrest, laryngeal or pulmonary edema, ataxia, cerebral thrombosis, hallucinations, painful oral mucosa, pseudomembranous colitis, hemolytic anemia, hepatitis, tendinitis, diplopia, photophobia, phobia, exfoliative dermatitis, hyperpigmentation, Stevens-Johnson syndrome, toxic epidermal necrolysis, dysgeusia, interstitial nephritis, polyuria, renal failure, urinary retention, and vasculitis.

Quinolone-class adverse events

Additional quinolone-class adverse events include: peripheral neuropathy, torsades de pointes, erythema nodosum, hepatic necrosis, possible exacerbation of myasthenia gravis, dysphasia, nystagmus, intestinal perforation, manic reaction, renal calculi, acidosis and hiccough.

Laboratory adverse events include: agranulocytosis, elevation of serum triglycerides, elevation of serum cholesterol, elevation of blood glucose, elevation of serum potassium, albuminuria, candiduria, and crystalluria.

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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