Note: This document contains side effect information about gatifloxacin. Some dosage forms listed on this page may not apply to the brand name Tequin.

Applies to gatifloxacin: intravenous solution, oral tablet.

General

Gatifloxacin (the active ingredient contained in Tequin) has been generally well tolerated with most adverse events reported as mild to moderate. Gatifloxacin was discontinued due to adverse reactions in 2.7% of over 5,000 treated patients.^[Ref]

Gastrointestinal

The onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment.

An increased duration therapy may increase the risk of Clostridium difficile-associated diarrhea (CDAD). A long-term care facility reported that 14 of 47 patients developed CDAD after an average 13.5-day duration of gatifloxacin (the active ingredient contained in Tequin) therapy. In contrast, the mean duration of therapy was 6.9 days in patients who did not develop CDAD. In this facility, a formulary change from levofloxacin to gatifloxacin was associated with a significantly higher rate of CDAD than with levofloxacin, and the rate decreased after the formulary was changed back to levofloxacin.^[Ref]

Gastrointestinal side effects have included nausea (8%) and diarrhea (4%). Other gastrointestinal effects reported in 0.1% to 3% of patients include abdominal pain, anorexia, constipation, dyspepsia, flatulence, gastritis, glossitis, mouth ulcer, oral moniliasis, stomatitis, and vomiting. Additional side effects reported in less than 0.1% of patients have included colitis, dysphagia, gastrointestinal hemorrhage, gingivitis, halitosis, hematemesis, pseudomembranous colitis, rectal hemorrhage, pancreatitis, and taste loss. Quinolone class antibiotics have been associated with intestinal perforation.^[Ref]

Nervous system

Nervous system side effects have included dizziness (3%) and headache (3%). Insomnia, nervousness, paresthesia, somnolence, tremor, vasodilatation, and vertigo have been reported in 0.1% to 3% of patients. Additional nervous system side effects reported in less than 0.1% of patients include asthenia, ataxia, convulsion, hyperesthesia and migraine. Seizures and peripheral neuropathy have also been reported. Quinolone class antibiotics have been associated with possible exacerbation of myasthenia gravis and dysphasia.^[Ref]

Generalized seizures preceded by myoclonus was reported in an 87-year-old woman after a dose of intravenous gatifloxacin.^[Ref]

Dermatologic

Dermatologic side effects have included dry skin, rash, pruritus, and sweating in 0.1% to 3% of patients. Rarely reported side effects include maculopapular rash and vesiculobullous rash.^[Ref]

Hypersensitivity

Hypersensitivity side effects have included allergic reactions, anaphylactic reactions, Stevens-Johnson syndrome, and angioneurotic edema. Quinolone class antibiotics have been associated with anaphylactoid reactions, shock, purpura, serum sickness, erythema multiforme, erythema nodosum, exfoliative dermatitis, toxic epidermal necrolysis, photosensitivity, and vesiculobullous eruption.^[Ref]

Metabolic

Metabolic side effects reported in 0.1% to 3% of patients have included peripheral edema and thirst. Severe hyperglycemia, hyperosmolar nonketotic hyperglycemia, severe hypoglycemia, hypoglycemia coma, increased serum amylase, and electrolyte abnormalities have also been reported. Quinolone class antibiotics have been associated with acidosis and elevations in serum triglycerides, serum cholesterol, and serum potassium.^[Ref]

Cardiovascular

Gatifloxacin (the active ingredient contained in Tequin) was associated with 8 cases of torsade de pointes reported to the FDA between 1996 and 2001. Four cases of torsade de pointes or ventricular fibrillation (including 2 fatalities) have also been reported.^[Ref]

Cardiovascular side effects have included palpitation and hypertension in 0.1% to 3% of patients. Bradycardia, cyanosis, edema, substernal chest pain, and tachycardia have been reported in less than 0.1% of patients. Prolongation of the QTc interval, syncope, torsade de pointes, and hypotension have also been reported.^[Ref]

Endocrine

Endocrine side effects have included diabetes mellitus (less than 0.1%) and blood glucose disturbances, in some cases severe and/or life-threatening. Elderly patients may be at a greater risk of developing hyperglycemia or hypoglycemia.^[Ref]

In patients with Type II diabetes, increases in serum insulin and decreases in serum glucose have been reported. Hypoglycemia, in some cases severe, has occurred in patients being treated with oral hypoglycemic agents, usually within 1 to 3 days of initiating gatifloxacin therapy. Three elderly patients developed severe hypoglycemia that did not respond to intravenous dextrose until the gatifloxacin was stopped. Hyperglycemia, including nonketotic hyperglycemic coma, has occurred in diabetic patients and previously undiagnosed diabetics, usually within 4 to 10 days of initiating therapy.

Symptomatic and/or severe hypoglycemia and hyperglycemia have also been reported in nondiabetic patients, usually after 3 days of therapy. Fatal hyperglycemia has been reported in two elderly nondiabetic patients.

As of 2002, 10 cases of severe hyperglycemia have been reported to the US Food and Drug Administration (age range 53 to 98 years); 6 patients had no history of diabetes. As of 2003, 19 cases of hypoglycemia and 7 cases of hyperglycemia were reported in Canada. It has been suggested that hyperglycemia may be related to high drug exposure in patients with age-associated renal dysfunction.

Hyperglycemia (blood glucose 607 mg/L) occurred in a nondiabetic 64-year-old woman after 3 days of gatifloxacin 400 mg/day intravenously. Her serum creatinine upon initiation of therapy was 2.3 mg/dL.^[Ref]

Genitourinary

Genitourinary side effects have included vaginitis (6%), breast pain (less than 0.1%), dysuria (0.1% to 3%), hematuria (0.1% to 3%), and metrorrhagia (less than 0.1%). Quinolone class antibiotics have been associated with albuminuria, candiduria, crystalluria, cylindruria, hematuria, and vaginal candidiasis.^[Ref]

Local

Local injection site reactions have been reported in 5% of patients receiving intravenous gatifloxacin (the active ingredient contained in Tequin) ^[Ref]

Hematologic

Hematologic side effects reported in less than 0.1% of patients have included ecchymosis, epistaxis, and neutropenia. Increased INR/prothrombin time and thrombocytopenia have also been reported. Quinolone class antibiotics have been associated with agranulocytosis.^[Ref]

Ocular

Ocular side effects have included abnormal vision and eye pain in 0.1% to 3% of patients. Ptosis, eye photosensitivity, and photophobia have been reported in less than 0.1% of patients. Quinolone class antibiotics have been associated with nystagmus, cataracts, and multiple punctate lenticular opacities.^[Ref]

Other

Nonspecific side effects have included back pain, chest pain, chills, face edema, and fever in 0.1% to 3% of patients. Other side effects reported in less than 0.1% of patients include alcohol intolerance, cheilitis, generalized edema, lymphadenopathy, mouth edema, and tongue edema. False positive results on urine drug screens for opiates have also been reported.^[Ref]

Tinnitus and taste perversion have been reported in 0.1% to 3% of patients. Ear pain and parosmia (distortion of odor quality) have been reported in less than 0.1% of patients.^[Ref]

Respiratory

Respiratory side effects reported in 0.1% to 3% of patients have included dyspnea and pharyngitis. Other respiratory side effects reported in less than 0.1% of patients include asthma (bronchospasm) and hyperventilation. Hemoptysis has also been reported. Quinolone class antibiotics have been associated with hiccough.^[Ref]

Musculoskeletal

Musculoskeletal side effects have included arthralgia and leg cramp in 0.1% to 3% of patients. Arthritis, bone pain, hypertonia, myalgia, myasthenia, and neck pain have been reported in less than 0.1% of patients. Tendon rupture has also been reported.^[Ref]

Psychiatric

Psychiatric side effects have included abnormal dreams, agitation, anxiety, and confusion in 0.1% to 3% of patients. Abnormal thinking, depersonalization, depression, euphoria, hallucination, hostility, panic attack, paranoia, psychosis, and stress have been reported in less than 0.1%. Quinolone class antibiotics have been associated with manic reactions.^[Ref]

Hepatic

A 76-year-old male developed symptoms of hepatocellular necrosis, including jaundice and significantly elevated ALT, AST, INR, APTT, and ammonia concentrations, after a 10-day course of oral gatifloxacin (the active ingredient contained in Tequin) A liver biopsy showed micronodular cirrhosis with intranodular hepatocellular necrosis. He died of multiple organ failure 25 days later.

A 44-year-old woman developed signs of hepatitis after taking oral gatifloxacin for 5 days, including nausea, lethargy, abdominal pain, jaundice, icterus, eosinophilia, and elevated liver function tests (including bilirubin peaking at 9.4 mg/dL). A liver biopsy showed acute hepatitis with eosinophilic infiltrates.^[Ref]

Hepatic side effects have included increased ALT, AST, alkaline phosphatase, and bilirubin in less than 1% of patients. Hepatitis, cholestasis with concomitant pancreatitis, and fulminant hepatic failure have also been reported. Quinolone class antibiotics have been associated with hepatic necrosis.^[Ref]

Renal

Renal side effects have included abnormal renal function, including acute renal failure. Quinolone class antibiotics have been associated with renal calculi.^[Ref]