Data on the side effects of moxifloxacin at a dosage of 400 mg (for oral administration and stepwise therapy) are obtained from clinical studies and post-marketing reports.
Classification of WHO frequency of development of side effects:
very often - ≥ 1/10 of appointments (> 10%)
often from ≥1 / 100 to <1/10 of appointments (> 1% and <10%)
infrequently - from ≥ 1/1000 to <1/100 of prescriptions (> 0.1% and <1%)
rarely from ≥ 1/10000 to <1/1000 appointments (> 0.01% and <0.1%)
very rarely - from <1/10000 appointments (<0.01%), including individual messages.
Allergic reactions
Infrequent - hives, itching, rash, eosinophilia; rarely anaphylactic / anaphylactoid reactions, angioedema, including laryngeal edema (potentially life-threatening); very rarely - anaphylactic shock (including life-threatening).
Disorders of the psyche
Infrequently - a sense of anxiety, psychomotor activity, agitation; rarely - emotional lability, depression (in very rare cases, behavior with a tendency to self-injury,such as suicidal thoughts or suicidal attempts), hallucinations; very rarely - depersonalization, psychotic reactions (potentially manifested in behavior with a tendency to self-harm, such as suicidal thoughts or suicidal attempts).
Disturbances from the nervous system
Often - dizziness, headache; rarely - peripheral sensory or sensorimotor neuropathy; infrequently - confusion, disorientation, vertigo, drowsiness, tremor, paresthesia / dysesthesia, sleep disorders, taste disorders; rarely - hypodesis, pathological dreams, impaired coordination (including gait disturbance due to dizziness, very rarely leading to trauma from falling, especially in elderly patients), seizures with various clinical manifestations (including "grand mal" seizures), disorders attention, speech disorder, amnesia, impaired sense of smell, including anosmia; very rarely - hyperesthesia, loss of taste sensitivity.
Disturbances on the part of the organ of sight
Infrequent - vision disorders - blurred vision, decreased visual acuity, diplopia, especially in combination with dizziness and confusion; very rarely - transient loss of vision (especially against the background of reactions from the central nervous system).
Hearing disorders and labyrinthine disorders
Rarely, noise in the ears, hearing impairment up to deafness (usually reversible).
Heart Disease
Elongation of the QT interval (often in patients with concomitant hypokalemia, infrequently in the remaining patients); infrequent - a feeling of palpitation, tachycardia, vasodilation; rarely - lowering blood pressure, increasing blood pressure, fainting, ventricular tachyarrhythmias; very rarely - nonspecific arrhythmias (polymorphic ventricular tachycardia (Torsade de Pointes), cardiac arrest (mainly in persons with predisposing to arrhythmias, such as clinically significant bradycardia, acute myocardial ischemia).
Disturbances from the respiratory system, chest and mediastinal organs
Infrequent - shortness of breath (including asthmatic condition).
Disorders from the gastrointestinal tract
Often - nausea, vomiting, abdominal pain, diarrhea, transient increase in transaminase activity; infrequently - anorexia, constipation, indigestion, flatulence, gastroenteritis (except erosive gastroenteritis); rarely - dysphagia, stomatitis, pseudomembranous colitis (in very rare cases associated with life-threatening complications).
Disturbances from the liver and bile ducts
Infrequent - increased concentrations of amylase, bilirubin, impaired liver function (including increased lactate dehydrogenase concentration), increased concentration of γ-glutamyltransferase and alkaline phosphatase; rarely - jaundice, hepatitis (mostly cholestatic); very rarely - fulminant hepatitis, potentially leading to life-threatening liver failure.
Disturbances from the skin and subcutaneous tissues
Very rarely - bullous skin reactions, for example, Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening).
Disturbances from musculoskeletal and connective tissue
Infrequent - arthralgia, myalgia; rarely - tendonitis, increased muscle tone and cramps, muscle weakness; very rarely - increased symptoms of myasthenia gravis, tendon ruptures, arthritis, gait disorders due to damage to the musculoskeletal system.
Disorders from the kidneys and urinary tract
Rarely, renal dysfunction, renal failure (as a result of dehydration, which can lead to kidney damage, especially in elderly patients with concomitant renal dysfunction).
Violations of the genitals and mammary gland
Often - candidal superinfection, vaginitis; infrequently - dehydration (caused by diarrhea or decreased fluid intake).
General disorders and disorders at the site of administration
Infrequent - general malaise (including symptoms of poor health, nonspecific pain and sweating); rarely - swelling.
Laboratory and instrumental data
Infrequent anemia, leukopenia (including neutropenia), thrombocytopenia, thrombocytosis, prolongation of prothrombin time and an increase in the international normalized ratio (INR); rarely - change in the concentration of thromboplastin; very rarely - an increase in the concentration of prothrombin and a decrease in INR, a change in the concentration of prothrombin, hyperlipidemia, hyperglycemia, hyperuricemia.