Trovafloxacin Side Effects

Some side effects of trovafloxacin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to trovafloxacin: intravenous solution, oral tablet

Rarely, trovafloxacin has been associated with the development of serious liver injury that has resulted in liver transplant and/or death. Stop taking trovafloxacin and consult your doctor immediately if you develop fatigue, decreased appetite, yellowing of the skin or eyes, severe stomach pain with nausea and vomiting, or dark urine. These may be early signs of liver damage.

If you experience any of the following serious side effects, stop taking trovafloxacin and seek emergency medical attention or notify your doctor immediately :

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or

• muscle or joint pain or inflammation.

If you experience any of the following less serious side effects, continue taking trovafloxacin and talk to your doctor:

• dizziness or lightheadedness;

• nausea, vomiting, or diarrhea;

• abdominal pain;

• headache;

• itching or a rash; or

• increased sensitivity of the skin to sunlight.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to trovafloxacin: intravenous solution, oral tablet

General

In clinical trials, 90% of side effects were reported as mild or moderate. Therapy was discontinued due to side effects in 5% of patients, including dizziness (2.4%), nausea (1.9%), headache (1.1%), vomiting (1%).

Hepatic

Hepatic side effects have included 5 deaths from liver toxicity and 4 patients requiring liver transplantation (one of which died) out of 140 cases of liver toxicity reported since the approval of trovafloxacin in February 1998. Symptomatic hepatitis (sometimes associated with peripheral eosinophilia, liver failure (including acute hepatic necrosis with eosinophilic infiltration) have been reported. Increased liver enzymes, abnormal hepatic function, bilirubinemia, discolored feces, and jaundice have been reported in less than 1% of patients. Increased ALT, AST, and alkaline phosphatase have been reported in 1% or more of patients.

Liver enzyme abnormalities and/or symptomatic hepatitis have occurred during short-term or long-term therapy. Liver enzyme abnormalities were primarily observed in patients receiving extended courses of therapy (longer than 21 days).

Nervous system

Nervous system side effects have included dizziness (2% to 11%), headache (1% to 5%), and lightheadedness (<1% to 4%). Abnormal coordination, abnormal gait, ataxia, cold clammy skin, confusion, convulsions, dry mouth, dyskinesia, dysphonia, encephalopathy, flushing, hyperkinesia, hypertonia, hypoesthesia, hypokinesia, increased saliva, increased sweating, involuntary muscle contractions, migraine, paresthesia, speech disorder, tongue paralysis, tremor, and vertigo have been reported in less than 1% of patients. Peripheral neuropathy has also been reported. Quinolone class antibiotics have been associated with possible exacerbation of myasthenia gravis.

A case of alatrofloxacin related seizure activity has been reported in the medical literature. The patient was given alatrofloxacin at the manufacturer's recommended dosage, concentration, and rate of infusion. Fifteen minutes into the infusion, the patient experienced generalized tonic movement of the upper torso which lasted 10 seconds. A rechallenge was performed, this time at a rate twice as slow as the initial dose. The patient experienced jaw and arm twitching, and alatrofloxacin was discontinued. The authors determined that the causal relationship between the drug and the event qualified as probable based on the Naranjo adverse event scoring method.

Dizziness or lightheadedness may last for several hours after a dose; however, is generally mild. It may resolve with continued therapy. 3.1% and 0.6% of patients over 65 years, respectively, reported dizziness and lightheadedness.

Gastrointestinal

Gastrointestinal side effects have included nausea (4% to 8%), vomiting (1% to 3%), diarrhea (2%), and abdominal pain (1%). Other gastrointestinal effects including altered bowel habit, altered saliva, cheilitis, constipation, Clostridium difficile diarrhea, dyspepsia, dysphagia, eructation, flatulence, gastritis, gastroenteritis, gastrointestinal disorder, gingivitis,halitosis, increased appetite, loose stools, melena, pseudomembranous colitis, rectal disorder, stomatitis, tongue disorder, and tongue edema have been reported in less than 1% of treated patients. Pancreatitis has been reported during postmarketing experience. Quinolone class antibiotics have been associated with intestinal perforation.

Dermatologic

Dermatologic side effects have most commonly included pruritus and rash in <1% to 2% of patients. Pruritus ani, skin disorder, skin ulceration, angioedema, dermatitis, fungal dermatitis, photosensitivity, seborrhea, skin exfoliation, and urticaria have been reported in less than 1% of patients. Quinolone class antibiotics have been associated with erythema nodosum.

Hypersensitivity

Hypersensitivity reactions have included rash, Stevens-Johnson syndrome, photosensitivity, urticaria, exfoliative dermatitis, toxic epidermal necrolysis, angioedema, and anaphylaxis in less than 1% of patients. Phototoxicity was reported in less than 0.03% of study patients.

Genitourinary

Genitourinary side effects have included vaginitis (<1% to 2%), leukorrhea (<1%), and menstrual disorder (<1%) in females; balanoposthitis (<1%) in males. Dysuria, micturition frequency, and urinary incontinence have been reported in less than 1% of patients. Quinolone class antibiotics have been associated with albuminuria, candiduria, crystalluria, cylindruria, hematuria, and vaginal candidiasis.

Cardiovascular

Cardiovascular side effects have included arrhythmias, peripheral edema, chest pain, thrombophlebitis, hypotension, palpitations, hypertension, angina pectoris, postural hypotension, syncope, tachycardia, bradycardia, peripheral ischemia, edema, and face edema in less than 1% of treated patients.

Hematologic

Hematologic side effects have included anemia, granulocytopenia, hemorrhage, leukopenia, thrombocytopenia, thrombocythemia, and decreased prothrombin times in less than 1% of patients. Decreased hemoglobin and hematocrit, increased platelets, decreased and increased WBC, and eosinophilia have been reported in 1% or more of patients, although causality was not determined. Agranulocytosis, aplastic anemia, and pancytopenia have been reported during postmarketing experience. Quinolone class antibiotics have been associated with prothrombin time prolongation.

Metabolic

Metabolic side effects have included hyperglycemia, thirst, hyperglycemia, weight loss, and weight gain in less than 1% of patients. Decreased serum protein, albumin, sodium, and bicarbonate have been reported in 1% or more of patients, although causality was not determined. Quinolone class antibiotics have been associated with acidosis, symptomatic hypoglycemia, and elevations in serum triglycerides, serum cholesterol, blood glucose, and serum potassium.

Musculoskeletal

Musculoskeletal side effects including arthralgias, muscle cramps, myalgias, muscle weakness, skeletal pain, tendonitis, and arthropathy have been reported in less than 1% of patients. Quinolone class antibiotics have been associated with tendon rupture.

Respiratory

Respiratory side effects have included dyspnea, rhinitis, sinusitis, bronchospasm, asthma, increased cough, epistaxis, respiratory insufficiency, upper respiratory tract infection, respiratory disorder, hemoptysis, hypoxia, and stridor in less than 1% of patients. Quinolone class antibiotics have been associated with hiccough.

Ocular

Ocular side effects including conjunctivitis, photophobia, conjunctival hemorrhage, diplopia, eye pain, abnormal vision, scotoma, visual field defect, periorbital edema, and xerophthalmia have been reported in less than 1% of patients. Quinolone class antibiotics have been associated with nystagmus.

Psychiatric

Psychiatric side effects associated with the use of trovafloxacin are rarely reported (less than 1% of patients) and have included anxiety, anorexia, agitation, nervousness, somnolence, insomnia, depression, amnesia, impaired concentration, depersonalization, abnormal dreaming, emotional lability, euphoria, hallucination, impotence, decreased male libido, paroniria, and abnormal thinking. Quinolone class antibiotics have been associated with manic reactions.

Local

Local intravenous site side effects have included inflammation, pain, and edema in up to 5% of patients.

Renal

Renal side effects have included increased BUN and creatinine in 1% or more of patients, and interstitial nephritis, acute renal failure, and abnormal renal function in less than 1% of patients. Quinolone class antibiotics have been associated with renal calculi.

Other

Other side effects have included fever, fatigue, pain, asthenia, moniliasis, hot flushes, back pain, chills, infection, malaise, sepsis, alcohol intolerance, taste perversion, hyperacusis, and tinnitus in less than 1% of patients.

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