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.