Avelox ABC Pack Side Effects

Please note - some side effects for Avelox ABC Pack may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: intravenous solution; oral tablet

General

Moxifloxacin has been generally well tolerated with most adverse events reported as mild to moderate and requiring no treatment. Moxifloxacin was discontinued due to adverse reactions in 5% of patients overall, 4.1% of patients received 400 mg orally, 3.9% received 400 mg intravenously, and 8.2% received 400 mg intravenous/oral sequential treatment. The most common side effects leading to discontinuation with the oral dose were nausea (0.8%), diarrhea (0.5%), dizziness (0.5%), and vomiting (0.4%). The most common side effect leading to discontinuation with the intravenous dose was rash (0.5%). The most common side effects leading to discontinuation with the intravenous/oral sequential dose were diarrhea (0.5%) and pyrexia (0.4%).

Gastrointestinal

Gastrointestinal side effects have included nausea (6.9%), diarrhea (6%), vomiting (2.4%), constipation (1.9%), abdominal pain (1.5%), upper abdominal pain (1.1%), and dyspepsia (1%). Dry mouth, abdominal discomfort, abdominal distention, gastritis, gastroesophageal reflux disease, oral candidiasis, oral fungal infection, gastroenteritis, anorexia, and flatulence have been reported in 0.1% to less than 1% of patients. Clostridium difficile associated diarrhea, dysphagia, gastrointestinal disorder, pseudomembranous colitis, stomatitis, glossitis, and tongue discoloration have been reported.

The onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment. If diarrhea occurs and it is unresponsive to discontinuation of drug and/or standard therapy, pseudomembranous colitis should be considered.

Nervous system

Nervous system side effects have included headache (4.2%), dizziness (3%), and insomnia (1.9%). Somnolence, tremor, dysgeusia, lethargy, paresthesia, tension headache, hallucinations, hypoesthesia, syncope, tinnitus, and vertigo have been reported in 0.1% to less than 1% of patients. Amnesia, aphasia, confusion, convulsions of various clinical manifestations (including grand mal convulsions), incoordination, parosmia, sleep disorders, speech disorders, and abnormal thinking have been reported. Altered coordination, abnormal gait, and exacerbation of myasthenia gravis have been reported during postmarketing experience. Quinolones have been associated with sensory and sensorimotor axonal polyneuropathy resulting in paresthesias, hypoesthesias, dysesthesias, and weakness.

Cardiovascular

Cardiovascular side effects have included atrial fibrillation, palpitations, tachycardia, congestive cardiac failure, angina pectoris, cardiac failure, cardiac arrest, bradycardia, hypertension, hypotension, phlebitis, increased blood pressure, and prolonged electrocardiogram QT interval in 0.1% to less than 1% of patients. Abnormal ECG, arrhythmias, atrial flutter, ST-T wave changes, supraventricular tachycardia, cardiac arrhythmia (not otherwise specified), vasodilation, ventricular extrasystoles, and ventricular tachycardia have been reported. Elderly patients experienced more ECG abnormalities than younger patients. Ventricular tachyarrhythmias (including in very rare cases cardiac arrest and torsade de pointes, and usually in patients with concurrent severe underlying proarrhythmic conditions) have been reported during postmarketing experience.

The mean QTc interval prolongation in a study of 787 patients receiving moxifloxacin was 6 msec vs. 1 msec for a comparator group of patients receiving another antibiotic. There were 38 outliers in the moxifloxacin group (QTc interval greater than 450 msec for men or 470 msec for women) vs. 28 outliers in the comparator group.

In another study (n=48), there were greater increases in the QT and QTc interval with 800 mg moxifloxacin than with 1000 mg levofloxacin or 1500 mg ciprofloxacin.

Hematologic

Hematologic side effects have included anemia (1.1%). Prolonged prothrombin time, thrombocythemia, eosinophilia, neutropenia, thrombocytopenia, leukocytosis, leukopenia, increased platelet count, decreased hemoglobin, increased white blood cell count, decreased hematocrit, increased eosinophil count, and prolonged activated partial thromboplastin time have been reported in 0.1% to less than 1% of patients. Increased MCH, neutrophils, WBCs, albumin, and PT ratio, and decreased hemoglobin, RBCs, neutrophils, eosinophils, basophils, and PT ratio have been reported in greater than or equal to 2% of patients; however, it has not been determined if these laboratory abnormalities were due to the drug or the underlying condition being treated. Increased prothrombin (decreased prothrombin time, decreased INR), decreased thromboplastin, and decreased prothrombin (increased INR) have been reported. Agranulocytosis and pancytopenia have been reported during postmarketing experience.

Hepatic

Hepatic side effects have included increased alanine aminotransferase (1.1%). Abnormal liver function tests, abnormal hepatic function, and increased aspartate aminotransferase, transaminases, blood bilirubin, hepatic enzyme, and gamma-glutamyltransferase have been reported in 0.1% to less than 1% of patients. Increased and decreased bilirubin have been reported in greater than or equal to 2% of patients; however, it has not been determined if these laboratory abnormalities were due to the drug or the underlying condition being treated. Jaundice (primarily cholestatic) and acute fulminant hepatic failure have been reported. Hepatic failure (including fatal cases), jaundice, acute hepatic necrosis, and hepatitis (primarily cholestatic) have been reported during postmarketing experience.

A 69-year-old male developed jaundice, pruritus, weight loss, dark urine, elevated lever function tests (total bilirubin, 28.45 mg/dL; conjugated bilirubin, 20.6 mg/dL; alkaline phosphatase, 249 units/L; ALT, 58 units/L) 3 weeks after a 5-day course of oral moxifloxacin. A liver biopsy showed portal inflammatory infiltrates with lymphocytes and eosinophils and predominantly casts in canaliculi. Liver function tests normalized over 2 months.

A 23-year-old female developed acute fulminant hepatitis (transaminases up to 8500 units/L) with hepatocellular necrosis, toxic epidermal necrolysis, and encephalopathy after 3 days of moxifloxacin treatment. The condition culminated in multiple organ failure, acute respiratory distress syndrome, and death, despite a liver transplant.

Metabolic

Metabolic side effects have included hypokalemia (1%). Hyperglycemia, hypoglycemia, hyperlipidemia, decreased appetite, dehydration, and increased blood alkaline phosphatase, blood amylase, blood lactate dehydrogenase, blood glucose, lipase, blood triglycerides, and blood uric acid have been reported in 0.1% to less than 1% of patients. Increased ionized calcium, chloride, and globulin, and decreased glucose, pO2, and amylase have been reported in greater than or equal to 2% of patients; however, it has not been determined if these laboratory abnormalities were due to the drug or the underlying condition being treated. Dehydration (secondary to diarrhea or reduced fluid intake) and hyperuricemia have been reported.

Other

Other side effects have included pyrexia (1.1%). Fatigue, chest pain, asthenia, peripheral edema, pain, malaise, edema, chills, chest discomfort, candidiasis, fungal infection, and facial pain have been reported in 0.1% to less than 1% of patients. Pelvic pain, leg pain, back pain, abnormal laboratory test (not specified), taste loss, taste perversion, and tongue discoloration have been reported.

Musculoskeletal

Musculoskeletal side effects have included back pain, pain in extremity, arthralgia, myalgia, muscle spasms, musculoskeletal chest pain, and musculoskeletal pain in 0.1% to less than 1% of patients. Arthritis, hypertonia, and tendon disorder have been reported. Tendon rupture has been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have included allergic reaction and face edema. Anaphylactic reaction, anaphylactic shock, and angioedema (including laryngeal edema) have been reported during postmarketing experience.

Psychiatric

Psychiatric side effects have included nervousness, confusional state, agitation, depression, restlessness, disorientation, and anxiety in 0.1% to less than 1% of patients. Abnormal dreams, depersonalization, depression (potentially culminating in self-endangering behavior), and emotional lability have been reported. Psychotic reaction (very rarely culminating in self-endangering behavior) has been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included rash, pruritus, hyperhidrosis, erythema, allergic dermatitis, night sweats, and urticaria in 0.1% to less than 1% of patients. Maculopapular rash, purpuric rash, and pustular rash have been reported. Toxic epidermal necrolysis, photosensitivity/phototoxicity reactions, and Stevens-Johnson syndrome have been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included dysuria, vulvovaginal candidiasis, vulvovaginal mycotic infection, vaginal infection, and vulvovaginal pruritus in 0.1% to less than 1% of patients. Vaginitis has been reported.

Local

Local side effects have included infusion site extravasation (0.1% to less than 1%) and injection site reactions (including phlebitis).

Ocular

Ocular side effects have included blurred vision (0.1% to less than 1%), amblyopia, and abnormal vision (visual disturbances temporally associated with central nervous system symptoms).

Renal

Renal side effects have included increased blood creatinine, increased blood urea, renal failure, and acute renal failure in 0.1% to less than 1% of patients. Abnormal kidney function has been reported. Renal dysfunction and interstitial nephritis have been reported during postmarketing experience.

Respiratory

Respiratory side effects have included dyspnea, wheezing, bronchospasm, and asthma in 0.1% to less than 1% of patients. Allergic pneumonitis has been reported during postmarketing experience.

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