Avelox Side Effects

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.

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Avelox:

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

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Avelox Tablets:

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

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Avelox Side Effects - for the Professional

Avelox

Serious and Otherwise Important Adverse Reactions

The following serious and otherwise important adverse reactions are discussed in greater detail in the warnings and precautions section of the label:

• Tendinopathy and Tendon Rupture [see Warnings and Precautions (5.1)]
• QT Prolongation [see Warnings and Precautions (5.3)]
• Hypersensitivity Reactions [see Warnings and Precautions (5.4)]
• Other Serious and Sometimes Fatal Reactions [see Warnings and Precautions (5.5)]
• Central Nervous System Effects [see Warnings and Precautions (5.6)]
• Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.7)]
• Peripheral Neuropathy [see Warnings and Precautions (5.8)]
• Photosensitivity/Phototoxicity [see Warnings and Precautions (5.10)]
• Development of Drug Resistant Bacteria [see Warnings and Precautions (5.11)]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to Avelox in 14981 patients in 71 active controlled Phase II- IV clinical trials in different indications [see Indications and Usage (1)]. The population studied had a mean age of 50 years (approximately 73% of the population was <65 years of age), 50% were male, 63% were Caucasian, 12% were Asian and 9% were Black. Patients received Avelox 400 mg once daily PO, IV, or sequentially (IV followed by PO). Treatment duration was usually 6-10 days, and the mean number of days on therapy was 9 days.

Discontinuation of Avelox due to adverse events occurred in 5.0% of patients overall, 4.1% of patients treated with 400 mg PO, 3.9% with 400 mg IV and 8.2% with sequential therapy 400 mg PO/IV. The most common adverse events leading to discontinuation with the 400 mg PO doses were nausea (0.8%), diarrhea (0.5%), dizziness (0.5%), and vomiting (0.4%). The most common adverse event leading to discontinuation with the 400 mg IV dose was rash (0.5%). The most common adverse events leading to discontinuation with the 400 mg IV/PO sequential dose were diarrhea (0.5%), pyrexia (0.4%).

Adverse reactions occurring in ≥1% of Avelox-treated patients and less common adverse reactions, occurring in 0.1 to <1% of Avelox-treated patients, are shown in Tables 2 and Table 3, respectively. The most common adverse drug reactions (≥3%) are nausea, diarrhea, headache, and dizziness.

Table 2: Common (≥ 1.0%) Adverse Reactions Reported in Active-Controlled Clinical Trials with Avelox

* MedDRA Version 12.0
System Organ Class	Adverse Reactions*	% (N=14,981)
Blood and Lymphatic System Disorders	Anemia	1.1
Gastrointestinal Disorders	Nausea	6.9
	Diarrhea	6.0
	Vomiting	2.4
	Constipation	1.9
	Abdominal pain	1.5
	Abdominal pain upper	1.1
	Dyspepsia	1.0
General Disorders and Administration Site Conditions	Pyrexia	1.1
Investigations	Alanine aminotransferase increased	1.1
Metabolism and Nutritional Disorder	Hypokalemia	1
Nervous System Disorders	Headache	4.2
	Dizziness	3.0
Psychiatric Disorders	Insomnia	1.9

 

Table 3: Less Common (0.1 to <1.0%) Adverse Reactions Reported in Active-Controlled Clinical Trials with Avelox (N=14,981)

* MedDRA Version 12.0
System Organ Class	Adverse Reactions*
Blood and Lymphatic System Disorders	Thrombocythemia
	Eosinophilia
	Neutropenia
	Thrombocytopenia
	Leukopenia
	Leukocytosis
Cardiac Disorders	Atrial fibrillation
	Palpitations
	Tachycardia
	Cardiac failure congestive
	Angina pectoris
	Cardiac failure
	Cardiac arrest
	Bradycardia
Ear and Labyrinth Disorders	Vertigo
	Tinnitus
Eye Disorders	Vision blurred
Gastrointestinal Disorders	Dry mouth
	Abdominal discomfort
	Flatulence
	Abdominal distention
	Gastritis
	Gastroesophageal reflux disease
General Disorders and Administration Site Conditions	Fatigue
	Chest pain
	Asthenia
	Edema peripheral
	Pain
	Malaise
	Infusion site extravasation
	Edema
	Chills
	Chest discomfort
	Facial pain
Hepatobiliary disorders	Hepatic function abnormal
Infections and Infestations	Vulvovaginal candidiasis
	Oral candidiasis
	Vulvovaginal mycotic infection
	Candidiasis
	Vaginal infection
	Oral fungal infection
	Fungal infection
	Gastroenteritis
Investigations	Aspartate aminotransferase increased
	Gamma-glutamyltransferase increased
	Blood alkaline phosphatase increased
	Hepatic enzyme increased
	Electrocardiogram QT prolonged
	Blood lactate dehydrogenase increased
	Platelet count increased
	Blood amylase increased
	Blood glucose increased
	Lipase increased
	Hemoglobin decreased
	Blood creatinine increased
	Transaminases increased
	White blood cell count increased
	Blood urea increased
	Liver function test abnormal
	Hematocrit decreased
	Prothrombin time prolonged
	Eosinophil count increased
	Activated partial thromboplastin time prolonged
	Blood bilirubin increased
	Blood triglycerides increased
	Blood uric acid increased
	Blood pressure increased
Metabolism and Nutrition Disorders	Hyperglycemia
	Anorexia
	Hypoglycemia
	Hyperlipidemia
	Decreased appetite
	Dehydration
Musculoskeletal and Connective Tissue Disorders	Back pain
	Pain in extremity
	Arthralgia
	Myalgia
	Muscle spasms
	Musculoskeletal chest pain
	Musculoskeletal pain
Nervous System Disorders	Dysgeusia
	Somnolence
	Tremor
	Lethargy
	Paresthesia
	Tension headache
	Hypoesthesia
	Syncope
Psychiatric Disorders	Anxiety
	Confusional state
	Agitation
	Depression
	Nervousness
	Restlessness
	Hallucination
	Disorientation
Renal and Urinary Disorders	Renal failure
	Dysuria
	Renal failure acute
Reproductive System and Breast Disorders	Vulvovaginal pruritus
Respiratory, Thoracic, and Mediastinal Disorders	Dyspnea
	Asthma
	Wheezing
	Bronchospasm
Skin and Subcutaneous Tissue Disorders	Rash
	Pruritus
	Hyperhidrosis
	Erythema
	Urticaria
	Dermatitis allergic
	Night sweats
Vascular Disorders	Hypertension
	Hypotension
	Phlebitis

 6.3 Laboratory Changes

Changes in laboratory parameters, without regard to drug relationship, which are not listed above and which occurred in ≥ 2% of patients and at an incidence greater than in controls included: increases in MCH, neutrophils, WBCs, PT ratio, ionized calcium, chloride, albumin, globulin, bilirubin; decreases in hemoglobin, RBCs, neutrophils, eosinophils, basophils, PT ratio, glucose, pO2, bilirubin, and amylase. It cannot be determined if any of the above laboratory abnormalities were caused by the drug or the underlying condition being treated.

Postmarketing Experience

Table 4 lists adverse reactions that have been identified during post-approval use of Avelox. 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.

Table 4: Postmarketing Reports of Adverse Drug Reactions

System/Organ Class	Adverse Reaction
Blood and Lymphatic System Disorders	Agranulocytosis Pancytopenia [see Warnings and Precautions (5.5)
Cardiac Disorders	Ventricular tachyarrhythmias (including in very rare cases cardiac arrest and torsade de pointes, and usually in patients with concurrent severe underlying proarrhythmic conditions)
Hepatobiliary Disorders	Hepatitis (predominantly cholestatic) Hepatic failure (including fatal cases) Jaundice Acute hepatic necrosis [see Warnings and Precautions (5.5)]
Immune System Disorders	Anaphylactic reaction Anaphylactic shock Angioedema (including laryngeal edema) [see Warnings and Precautions (5.4, 5.5)]
Musculoskeletal and Connective Tissue Disorders	Tendon rupture [see Warnings and Precautions (5.1)]
Nervous System Disorders	Altered coordination Abnormal gait [see Warnings and Precautions (5.8)] Myasthenia gravis (exacerbation of) [see Warnings and Precautions (5.2)]
Psychiatric Disorders	Psychotic reaction (very rarely culminating in self-endangering behavior)
Renal and Urinary Disorders	Renal dysfunction Interstitial nephritis [see Warnings and Precautions (5.5)]
Respiratory, Thoracic and Mediastinal Disorders	Allergic pneumonitis [see Warnings and Precautions (5.5)]
Skin and Subcutaneous Tissue Disorders	Photosensitivity/phototoxicity reaction [see Warnings and Precautions (5.10)] Stevens-Johnson syndrome Toxic epidermal necrolysis [see Warnings and Precautions (5.5)]

 

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Side Effects by Body System - for Healthcare Professionals

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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