Over 5000 patients have been treated with gatifloxacin in single- and multiple-dose clinical efficacy trials worldwide.
In gatifloxacin studies, the majority of adverse reactions were described as mild in nature. Gatifloxacin was discontinued for adverse events thought related to drug in 2.7% of patients.
Drug-related adverse events classified as possibly, probably, or definitely related with a frequency of >/=3% in patients receiving gatifloxacin in single- and multiple-dose clinical trials are as follows: nausea 8%, vaginitis 6%, diarrhea 4%, headache 3%, dizziness 3%.
In patients who were treated with either intravenous gatifloxacin or with intravenous followed by oral therapy, the incidence of adverse events was similar to those who received oral therapy alone. Local injection site reactions (redness at injection site) were noted in 5% of patients.
Additional drug-related adverse events (possibly, probably, or definitely related) considered clinically relevant that occurred in >/=0.1% to <3% of patients receiving gatifloxacin in single- and multiple-dose clinical trials are as follows:
Body as a Whole: allergic reaction, asthenia, back pain, chest pain, chills, face edema, fever
Cardiovascular System: hypertension, palpitation
Digestive System: abdominal pain, anorexia, constipation, dyspepsia, flatulence, gastritis, glossitis, mouth ulcer, oral moniliasis, stomatitis, vomiting
Metabolic/Nutritional System: hyperglycemia, peripheral edema, thirst
Musculoskeletal System: arthralgia, leg cramp
Nervous System: abnormal dream, agitation, anxiety, confusion, insomnia, nervousness, paresthesia, somnolence, tremor, vasodilatation, vertigo
Respiratory System: dyspnea, pharyngitis
Skin/Appendages: dry skin, pruritus, rash, sweating
Special Senses: abnormal vision, taste perversion, tinnitus
Urogenital System: dysuria
Additional drug-related adverse events considered clinically relevant that occurred in <0.1% (rare adverse events) of patients receiving gatifloxacin in single- and multiple-dose clinical trials are as follows: abnormal thinking, alcohol intolerance, arthritis, asthma (bronchospasm), ataxia, bone pain, bradycardia, breast pain, cheilitis, colitis, convulsion, cyanosis, depersonalization, depression, diabetes mellitus, dysphagia, ear pain, ecchymosis, edema, epistaxis, euphoria, eye pain, eye photosensitivity, gastrointestinal hemorrhage, generalized edema, gingivitis, halitosis, hallucination, hematemesis, hematuria, hostility, hyperesthesia, hypertonia, hyperventilation, hypoglycemia, lymphadenopathy, maculopapular rash, metrorrhagia, migraine, mouth edema, myalgia, myasthenia, neck pain, panic attack, paranoia, parosmia, photophobia, pseudomembranous colitis, psychosis, ptosis, rectal hemorrhage, stress, substernal chest pain, tachycardia, taste loss, tongue edema, vesiculobullous rash.
Clinically relevant changes in laboratory parameters, without regard to drug relationship, occurred in fewer than 1% of TEQUIN-treated patients. These included the following: neutropenia, increased ALT or AST levels, alkaline phosphatase, bilirubin, serum amylase, and electrolytes abnormalities. It is not known whether these abnormalities were caused by the drug or the underlying condition being treated.
POSTMARKETING ADVERSE EVENT REPORTS
The following events have been reported during post-approval use of TEQUIN (gatifloxacin). 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.
Abnormal renal function (including acute renal failure), acute allergic reaction including anaphylactic reaction and angioneurotic edema, hepatitis, hypotension, increased International Normalized Ratio (INR)/prothrombin time, pancreatitis, severe hyperglycemia (including hyperosmolar nonketotic hyperglycemia), severe hypoglycemia (including hypoglycemic coma), Stevens-Johnson syndrome, syncope, tendon rupture, thrombocytopenia, and torsades de pointes.