Data on adverse reactions recorded with the use of moxifloxacin 400 mg (by mouth, with stepwise therapy [intravenous administration of the drug followed by oral administration] and only intravenously) are obtained from clinical studies and post-registration reports (in italics). Adverse reactions listed in the "frequently" group occurred with a frequency below 3%, except for nausea and diarrhea.
In each frequency group, undesirable drug reactions are listed in order of decreasing significance. The frequency is defined as follows: often (from ≥ 1/100 to <1/10), infrequently (from ≥ 1/1000 to <1/100), rarely (from ≥ 1/10 000 to <1/1000), very rarely (<1/10 000).
Infectious and parasitic diseases: often - fungal superinfections.
On the part of the hematopoiesis system: infrequently - anemia, leukopenia, neutropenia, thrombocytopenia, thrombocytosis,lengthening of the prothrombin time / increase in the international normalized relationship (INR); rarely - changes in the concentration of thromboplastin; very rarely - an increase in the concentration of prothrombin / decrease INR.
From the immune system: infrequently - allergic reactions, itching, rashes, urticaria, eosinophilia; rarely anaphylactic / anaphylactoid reactions, angioedema, including laryngeal edema (potentially life-threatening); very rarely - anaphylactic / anaphylactoid shock (including potentially life-threatening).
From the side of metabolism: infrequently hyperlipidemia; rarely - hyperglycemia, hyperuricemia; very rarely - hypoglycemia.
Mental disorders: infrequent - anxiety, psychomotor hyperreactivity / agitation; rarely - emotional lability, depression (in very rare cases, behavior with a tendency to self-harm, such as suicidal thoughts or suicidal attempts) is possible, hallucinations; very rarely - depersonalization, psychotic reactions (potentially manifested in behavior with a tendency to self-harm, such as suicidal thoughts or suicidal attempts).
From the nervous system: often - headache, dizziness; infrequently - Paresthesia / dysesthesia, a violation of taste sensitivity (including very rare cases of agevia), confusion and disorientation, vertigo, drowsiness, tremor, sleep disturbances; rarely - hypoesthesia, impaired sense of smell (including anosmia), atypical dreams, impaired coordination (including gait disturbance due to dizziness or vertigo (in very rare cases leading to trauma from falling, especially in elderly patients), seizures with various clinical manifestations (including "grand mal" seizures), attention disorders, speech disorders, amnesia, peripheral neuropathy and polyneuropathy; very rarely hyperstasy.
From the side of the organ of vision: infrequently - visual impairment (especially with CNS reactions); very rarely - transient loss of vision (especially against the background of reactions from the central nervous system).
From the side of the hearing organ and labyrinthine disorders: rarely - noise in the ears, hearing impairment, including deafness (usually reversible).
From the side of the cardiovascular system: often - lengthening the interval QT in patients with concomitant hypokalemia; infrequent - lengthening of the interval QT, palpitation, tachycardia, vasodilation; rarely - ventricular tachyarrhythmias, fainting, increased blood pressure, decreased blood pressure; 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).
From the respiratory system, chest and mediastinum: infrequently - shortness of breath (including asthmatic condition).
From the gastrointestinal tract: often - nausea, vomiting, abdominal pain, diarrhea; infrequent - reduced appetite and reduced food intake, constipation, dyspepsia, flatulence, gastroenteritis (other than erosive gastroenteritis), increased amylase activity; rarely - dysphagia, stomatitis, pseudomembranous colitis (in very rare cases associated with life-threatening complications).
From the liver and bile ducts: often - increased activity "hepatic" transaminases; infrequently - a violation of liver function (including increased lactate dehydrogenase activity, rarely - jaundice, hepatitis (mostly cholestatic), very rarely - fulminant hepatitis, potentially leading to life-threatening liver failure (including fatal cases).
From the skin and soft tissues: very rarely - bullous skin reactions, for example, Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening).
From the musculoskeletal and connective tissue: infrequently arthralgia, myalgia; rarely - tendonitis, increased muscle tone and cramps, muscle weakness; rarely - ruptures of tendons, arthritis, violation of gait due to damage to the musculoskeletal system, increased symptoms of myasthenia gravis gravis.
From the side of the kidneys and urinary tract: infrequently - dehydration (caused by diarrhea or decreased fluid intake); rarely - renal dysfunction, renal failure due to dehydration, which can lead to kidney damage, especially in elderly patients with pre-existing impaired renal function.
General disorders and injuries at the injection site: often - local reactions; infrequently - general malaise, pain without a clear cause, sweating, phlebitis / thrombophlebitis at the site of administration; rarely - swelling.
The frequency of development of the following adverse reactions was higher in the group receiving stepwise therapy (intravenous administration of moxifloxacin followed by oral administration):
Often: increased activity of gamma-glutamyltransferase.
Infrequently: ventricular tachyarrhythmias, hypotension, edema, pseudomembranous colitis (in very rare cases associated with life-threatening complications), seizures with various clinical manifestations (incl. "grand mal" seizures), hallucinations, impaired renal function, renal failure (as a result of dehydration, which can lead to kidney damage, especially in older patients with pre-existing impaired renal function).