Avelox Side Effects

Generic Name: moxifloxacin

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

Avelox

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 Avelox:

Diarrhea; dizziness; headache; nausea; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or tarry stools; burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet; chest pain; dark urine; decreased urination; fainting; fever, chills, or unusual cough; hallucinations; inability to move or bear weight on a joint or tendon area; irregular heartbeat; joint pain; moderate to severe sunburn; mood or mental changes (eg, new or worsening anxiety, agitation, confusion depression, nervousness, restlessness, sleeplessness); muscle pain or weakness; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; pale stools; persistent sore throat; pounding in the chest; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe or persistent dizziness; shortness of breath; stomach pain/cramps; suicidal thoughts or actions; tremor; unusual bruising or bleeding; unusual tiredness or weakness; vaginal yeast infection; vision changes; yellowing of the skin or eyes.

Avelox Tablets

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 Avelox Tablets:

Diarrhea; dizziness; headache; nausea; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or tarry stools; burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet; chest pain; dark urine; decreased urination; fainting; fever, chills, or unusual cough; hallucinations; inability to move or bear weight on a joint or tendon area; irregular heartbeat; joint pain; moderate to severe sunburn; mood or mental changes (eg, new or worsening anxiety, agitation, confusion depression, nervousness, restlessness, sleeplessness); muscle pain or weakness; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; pale stools; persistent sore throat; pounding in the chest; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe or persistent dizziness; shortness of breath; stomach pain/cramps; suicidal thoughts or actions; tremor; unusual bruising or bleeding; unusual tiredness or weakness; vaginal yeast infection; vision changes; yellowing of the skin or eyes.

Avelox Side Effects - for the Professional

Avelox

Clinical efficacy trials enrolled over 9,200 moxifloxacin orally and intravenously treated patients, of whom over 8,600 patients received the 400 mg dose. Most adverse events reported in moxifloxacin trials were described as mild to moderate in severity and required no treatment. Moxifloxacin was discontinued due to adverse reactions thought to be drug-related in 2.9% of orally treated patients and 6.3 % of sequentially (intravenous followed by oral) treated patients. The latter studies were conducted in community acquired pneumonia and complicated skin and skin structure infections and complicated intra-abdominal infections with, in general, a sicker patient population compared to the tablet studies.

Adverse reactions, judged by investigators to be at least possibly drug-related, occurring in greater than or equal to 2% of moxifloxacin treated patients were: nausea (6%), diarrhea (5%), dizziness (2%).

Additional clinically relevant uncommon events, judged by investigators to be at least possibly drug-related, that occurred in greater than or equal to 0.1% and less than 2% of moxifloxacin treated patients were:

BODY AS A WHOLE: abdominal pain, headache, asthenia, dehydration (secondary to diarrhea or reduced fluid intake), injection site reaction (including phlebitis), malaise, moniliasis, pain, allergic reaction

CARDIOVASCULAR: cardiac arrhythmia (not otherwise specified), tachycardia, palpitation, vasodilation, QT interval prolonged

DIGESTIVE: vomiting, abnormal liver function test, (increased transaminases, increased bilirubin), dyspepsia, dry mouth, flatulence, oral moniliasis, constipation, GGTP increased, anorexia, stomatitis, glossitis

HEMIC AND LYMPHATIC: leukopenia, eosinophilia, prothrombin decrease (prothrombin time prolonged/International Normalized Ratio (INR) increased), thrombocythemia

METABOLIC AND NUTRITIONAL: lactic dehydrogenase increased, amylase increased

MUSCULOSKELETAL: arthralgia, myalgia

NERVOUS SYSTEM: insomnia, nervousness, vertigo, somnolence, anxiety, tremor

SKIN/APPENDAGES: rash (maculopapular, purpuric, pustular), pruritus, sweating, urticaria

SPECIAL SENSES: taste perversion

UROGENITAL: vaginal moniliasis, vaginitis

Additional clinically relevant rare events, judged by investigators to be at least possibly drug-related, that occurred in less than 0.1% of moxifloxacin treated patients were:

abnormal dreams, abnormal vision, (visual disturbances temporally associated with CNS symptoms), agitation, amblyopia, amnesia, anemia, aphasia, arthritis, asthma, atrial fibrillation, back pain, chest pain, confusion, convulsions of various clinical manifestations (including grand mal convulsions), depersonalization, depression (potentially culminating in self-endangering behavior), dysphagia, dyspnea, ECG abnormal, emotional lability, face edema, gastritis, gastrointestinal disorder, hallucinations, hyperglycemia, hyperlipidemia, hypertension, hypertonia, hyperuricemia, hypesthesia, hypotension, incoordination, jaundice (predominantly cholestatic), kidney function abnormal, lab test abnormal (not specified), leg pain, paraesthesia, parosmia, pelvic pain, peripheral edema, photosensitivity/phototoxicity reactions, pseudomembranous colitis, prothrombin increase (prothrombin time decreased/International Normalized Ratio (INR) decreased), sleep disorders, speech disorders, supraventricular tachycardia, syncope, taste loss, tendon disorder, thinking abnormal, thrombocytopenia, thromboplastin decrease, tinnitus, tongue discoloration, ventricular tachycardia

Post-Marketing Adverse Event Reports:

Additional adverse events have been reported from worldwide post-marketing experience with moxifloxacin. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events, some of them life-threatening, include anaphylactic reaction, anaphylactic shock, angioedema (including laryngeal edema), hepatic failure, including fatal cases, hepatitis (predominantly cholestatic), photosensitivity/phototoxicity reaction, psychotic reaction (very rarely culminating in self-endangering behavior), renal dysfunction or renal failure, Stevens-Johnson syndrome, tendon rupture, toxic epidermal necrolysis, and ventricular tachyarrhythmias (including in very rare cases cardiac arrest and torsade de pointes, and usually in patients with concurrent severe underlying proarrhythmic conditions). Cases of altered coordination and abnormal gait have also been reported.

Side Effects by Body System

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 2.9% of patients receiving oral treatment and 4.6% of patients receiving intravenous followed by oral treatment.

Cardiovascular

Cardiovascular side effects have included cardiac arrhythmia (not otherwise specified), palpitation, tachycardia, vasodilation, and prolonged QT interval in 0.1% to less than 2% of patients. Abnormal ECG, arrhythmias, atrial fibrillation, atrial flutter, hypertension, hypotension, face edema, peripheral edema, ST-T wave changes, supraventricular tachycardia, syncope, ventricular extrasystoles, and ventricular tachycardia have been reported in less than 0.1% of patients. 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.

Musculoskeletal

Musculoskeletal side effects have included arthralgia and myalgia in 0.1% to less than 2% of patients, and arthritis, hypertonia, and tendon disorder in less than 0.1%. Tendon rupture and abnormal gait have been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects have included nausea (6%) and diarrhea (5%). Vomiting, abdominal pain, dyspepsia, dry mouth, constipation, oral moniliasis, anorexia, stomatitis, glossitis, and flatulence have been reported in 0.1% to less than 2% of patients. Gastritis, Clostridium difficile diarrhea, dysphagia, gastrointestinal disorder, pseudomembranous colitis, and tongue discoloration have been reported in less than 0.1% of patients.

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 dizziness (2%). Insomnia, headache, somnolence, tremor, and vertigo have been reported in 0.1% to less than 2% of patients. Agitation, amnesia, aphasia, confusion, convulsions of various clinical manifestations (including grand mal convulsions), hallucinations, hypesthesia, incoordination, paresthesia, parosmia, sleep disorders, speech disorders, and abnormal thinking have been reported in less than 0.1% of patients. Altered coordination has been reported during postmarketing experience. Quinolones have been associated with sensory and sensorimotor axonal polyneuropathy resulting in paresthesias, hypoesthesias, dysesthesias, and weakness.

Hypersensitivity

Hypersensitivity side effects have included allergic reaction (0.1% to less than 2%). Anaphylactic reaction, anaphylactic shock, angioedema (including laryngeal edema), toxic epidermal necrolysis, and Stevens-Johnson syndrome have been reported during postmarketing experience.

Hematologic

Hematologic side effects have included increased MCH, neutrophils, WBCs, and PT ratio, and decreased hemoglobin, RBCs, neutrophils, eosinophils, basophils, and PT ratio in greater than or equal to 2% of patients. Decreased prothrombin (prolonged prothrombin time, increased INR), thrombocythemia, eosinophilia, and leukopenia in have been reported in 0.1% to less than 2% of patients. Thrombocytopenia, anemia, increased prothrombin (decreased prothrombin time, decreased INR), and decreased thromboplastin have been reported in less than 0.1% of patients.

Hepatic

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.

Hepatic side effects have included increased and decreased bilirubin (greater than or equal to 2%). Abnormal liver function tests (increased transaminases, increased bilirubin) and increased GGTP have been reported in 0.1% to less than 2% of patients. Jaundice (primarily cholestatic; less than 0.1%) and acute fulminant hepatic failure have been reported. Hepatic failure (including fatal cases) and hepatitis (primarily cholestatic) have been reported during postmarketing experience.

Metabolic

Metabolic side effects have included increased ionized calcium, chloride, albumin, and globulin, and decreased glucose, pO2, and amylase in greater than or equal to 2% of patients. Increased amylase, increased lactic dehydrogenase, and dehydration (secondary to diarrhea or reduced fluid intake) have been reported in 0.1% to less than 2% of patients. Hyperglycemia, hyperlipidemia, and hyperuricemia have been reported in less than 0.1% of patients.

Dermatologic

Dermatologic side effects have included rash (maculopapular, purpuric, and pustular), pruritus, sweating, and urticaria in 0.1% to less than 2% of patients. Toxic epidermal necrolysis and photosensitivity/phototoxicity reactions have been reported in less than 0.1% of patients.

Other

Other side effects have included asthenia, moniliasis, pain, malaise, and taste perversion in 0.1% to less than 2% of patients. Pelvic pain, leg pain, back pain, chest pain, abnormal laboratory test (not specified), taste loss, tinnitus, and tongue discoloration have been reported in less than 0.1% of patients.

Genitourinary

Genitourinary side effects have included vaginal moniliasis and vaginitis (0.1% to less than 2%).

Local

Local side effects have included injection site reactions (including phlebitis) in 0.1% to less than 2% of patients.

Ocular

Ocular side effects have included amblyopia and abnormal vision (visual disturbances temporally associated with central nervous system symptoms) in less than 0.1% of patients.

Renal

Renal side effects have included abnormal kidney function (less than 0.1%). Renal dysfunction or renal failure has been reported during postmarketing experience.

Respiratory

Respiratory side effects have included dyspnea and asthma (less than 0.1%).

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