Avelox Adverse Reactions



Bayer HealthCare Pharma


Full Prescribing Info
Adverse Reactions
Adverse drug reactions (ADRs) based on all clinical studies with moxifloxacin 400 mg (oral and sequential therapy) sorted by CIOMS III categories of frequency (overall n=12,984, including n=2535 for sequential therapy studies; status: December 2005) are as follows. ADRs listed under "common" were observed with a frequency below 3% with the exception of nausea and diarrhoea.
ADRs derived from post-marketing reports (status: September 2006) are marked with (*).
Frequencies are defined by the following conventions: Common (≥1% to <10%); uncommon (≥0.1% to <1%); rare (≥0.01% to <0.1%); very rare (<0.01%).
Infections and Infestations: Antibiotic-Induced Superinfections: Common: Mycotic superinfections.
Blood and Lymphatic System Disorders: Changes In Blood Cell Counts: Uncommon: Anemia, leucopenia, neutropenia, thrombocytopenia, thrombocythemia. Changes in Coagulation: Uncommon: Prolonged prothrombin time/increased INR. Rare: Abnormal thromboplastin level. Very Rare: Increased prothrombin level/decreased INR, abnormal prothrombin level/INR.
Immune System Disorders: Acute Hypersensitivity Reactions: Uncommon: Allergic reaction, pruritus, rash, urticaria, blood eosinophilia. Rare: Anaphylactic/anaphylactoid reaction, allergic edema/angioedema (including potentially life-threatening laryngeal edema). Very Rare: Anaphylactic/anaphylactoid shock (potentially life-threatening).
Metabolism and Nutritional Disorders: Changes in Laboratory Parameters: Uncommon: Hyperlipidemia. Rare: Hyperglycemia, hyperuricemia.
Psychiatric Disorders: Behavioural Disturbances: Uncommon: Anxiety reactions, psychomotor hyperactivity/agitation. Rare: Emotional lability, depression (in very rare cases, potentially culminating in self-endangering behaviour*), hallucinations. Very Rare: Depersonalization, psychotic reactions (potentially culminating in self-endangering behaviour*).
Nervous System Disorders: Unspecific Altered Peripheral Perception: Uncommon: Paresthesia, dysesthesia. Rare: Hypoesthesia. Very Rare: Hyperesthesia.
Smell and Taste Disorders: Uncommon: Taste disorder (including ageusia in very rare cases). Rare: Smell disorders (including anosmia).
Increased Neurological Activities: Common: Headache, dizziness. Uncommon: Confusion and disorientation, sleep disorder, tremor, vertigo. Rare: Abnormal dreams, disturbed coordination (including gait disturbances especially due to dizziness or vertigo; in very rare cases leading to fall with injuries especially in the elderly*), seizures of various clinical manifestations (including grand mal convulsions).
Decreased Neurological Activities: Uncommon: Somnolence. Rare: Disturbed attention, speech disorders, amnesia.
Eye Disorders: Uncommon: Visual disturbances (especially in the course of CNS reactions).
Ear and Labyrinth Disorders: Rare: Tinnitus.
Cardiovascular System Disorders: Repolarisation Disorders: Common: QT prolongation in patients with hypokalemia. Uncommon: QT prolongation.
Unspecific Arrhythmias: Uncommon: Palpitations, tachycardia. Very Rare: Unspecified arrhythmias.
Ventricular Arrhythmias: Rare: Ventricular tachyarrhythmias. Very Rare: Torsade de pointes*; cardiac arrest especially in patients with severe underlying proarrhythmic conditions eg, clinically significant bradycardia, acute myocardial ischemia*.
Unspecified Cardiovascular Symptoms: Uncommon: Vasodilatation. Rare: Syncope, hypertension, hypotension.
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Dyspnea (including asthmatic conditions).
Gastrointestinal Disorders: Gastrointestinal Symptoms: Common: Nausea, vomiting, gastrointestinal and abdominal pains. Uncommon: Anorexia, constipation, dyspepsia, flatulence, gastroenteritis (excluding erosive gastroenteritis), increased amylase. Rare: Dysphagia, stomatitis.
Antibiotic-Induced Diarrheal Disorders: Common: Diarrhea. Rare: Pseudomembranous colitis (in very rare cases associated with life-threatening complications).
Hepatobiliary Disorders: Mild to Moderate Hepatic Reactions: Common: Increased transaminases. Uncommon: Hepatic impairment (including increased LDH), increased bilirubin, increased γ-glutamyl transferase, increased blood alkaline phosphatase.
Severe Hepatic Reactions: Rare: Jaundice, hepatitis (predominantly cholestatic). Very Rare: Fulminant hepatitis (potentially leading to life-threatening liver failure*.
Skin and Subcutaneous Tissue Disorders: Bullous Skin Reactions: Very Rare: Bullous skin reactions eg, Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening)*.
Musculoskeletal and Connective Tissue Disorders: Tendon Disorders:
Rare: Tendonitis. Very Rare: Tendon rupture.
Unspecific Joint and Muscular Disorders: Uncommon: Arthralgia, myalgia. Rare: Increased muscle tone and cramping. Very Rare: Arthritis, gait disturbance (caused by muscular, tendon or joint symptoms)*.
Renal and Urinary Disorders: Renal Impairment: Uncommon: Dehydration (caused by diarrhea or reduced fluid intake). Rare: Renal impairment, renal failure (due to dehydration especially in elderly with preexisting renal disorders).
General Disorders and Administration Site Conditions: General Feeling of Illness: Uncommon: Feeling unwell, unspecific pain, sweating.
Infusion Site Reactions: Common: Injection and infusion site reactions. Uncommon: Infusion site thrombophlebitis.
General Disorders: Rare: Edema.
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