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Trovafloxacin Side Effects

Applies to trovafloxacin: oral tablet.

Serious side effects of Trovafloxacin

Along with its needed effects, trovafloxacin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking trovafloxacin:

Rare

Note: Some of the above side effects may also occur up to several weeks after you Stop taking trovafloxacin.

Other side effects of Trovafloxacin

Some side effects of trovafloxacin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common or rare

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%).[Ref]

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.[Ref]

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).[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Local

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

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.[Ref]

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.[Ref]

References

1. Product Information. Trovan (trovafloxacin). Pfizer U.S. Pharmaceuticals. 2001;PROD.

2. FDA. FDA issues public health advisory on liver toxicity associated with the antibiotic Trovan. FDA Talk Paper http://www.fda.gov/bbs/topics/ANSWERS/ANS00958.html 2001.

3. Chen HJ, Bloch KJ, Maclean JA. Acute eosinophilic hepatitis from trovafloxacin. N Engl J Med. 2000;342:359-60.

4. Lucena MI, Andrade RJ, Rodrigo L, Salmeron J, Alvarez A, LopezGarrido MJ, Camargo R, Alcantara R. Trovafloxacin-induced acute hepatitis. Clin Infect Dis. 2000;30:400-1.

5. Ernst ME, Ernst EJ, Klepser ME. Levofloxacin and trovafloxacin: the next generation of fluoroquinolones? Am J Health Syst Pharm. 1997;54:2569-84.

6. Jones RB, Schwebke J, Thorpe EM Jr, Dalu ZA, Leone P, Johnson RB. Randomized trial of trovafloxacin and ofloxacin for single-dose therapy of gonorrhea. Trovafloxacin Gonorrhea Study Group. Am J Med. 1998;104:28-32.

7. Wise R, Mortiboy D, Child J, Andrews JM. Pharmacokinetics and penetration into inflammatory fluid of trovafloxacin (CP-99,219). Antimicrob Agents Chemother. 1996;40:47-9.

8. Haria M, Lamb HM. Trovafloxacin. Drugs. 1997;54:435-45;disc. 446.

9. Teng R, Harris SC, Nix DE, Schentag JJ, Foulds G, Liston TE. Pharmacokinetics and safety of trovafloxacin (CP-99,219), a new quinolone antibiotic, following administration of single oral dose to healthy male volunteers. J Antimicrob Chemother. 1995;36:385-94.

10. Trovafloxacin. Med Lett Drugs Ther. 1998;40:30-1.

11. Williams D, Hopkins S. Safety of trovafloxacin in treatment of lower respiratory tract infections. Eur J Clin Microbiol Infect Dis. 1998;17:454-8.

12. Menzies D, Klein NC, Cunha BA. Trovafloxacin neurotoxicity. Am J Med. 1999;107:298-9.

13. Murray CK, Wortmann GW. Trovafloxacin-induced weakness due to a demyelinating polyneuropathy. South Med J. 2000;93:514-5.

14. Melvani S, Speed BR. Alatrofloxacin-induced seizures during slow intravenous infusion. Ann Pharmacother. 2000;34:1017-9.

15. Cohen JS. Peripheral neuropathy associated with fluoroquinolones. Ann Pharmacother. 2001;35:1540-7.

16. Overholser BR, Kays MB, Forrest A, Sowinski KM. Sex-related differences in the pharmacokinetics of oral ciprofloxacin. J Clin Pharmacol. 2004;44:1012-22.

17. Matthews MR, Caruso DM, Phillips BJ, Csontos LG. Fulminant toxic epidermal necrolysis induced by trovafloxacin. Arch Intern Med. 1999;159:2225.

18. Goel K, Menzies D, Cunha BA. Elevated international normalized ratio associated with trovafloxacin. Ann Intern Med. 1999;131:72.

19. Gales BJ, Sulak LB. Severe thrombocytopenia associated with alatrofloxacin. Ann Pharmacother. 2000;34:330-4.

20. Mitropoulos FA, Angood PB, Rabinovici R. Trovafloxacin-associated leukopenia. Ann Pharmacother. 2001;35:41-4.

21. Vincent J, Venitz J, Teng R, Baris BA, Willavize SA, Polzer RJ, Friedman HL. Pharmacokinetics and safety of trovafloxacin in healthy male volunteers following administration of single intravenous doses o the prodrug, alatrofloxacin. J Antimicrob Chemother. 1997;39 Suppl B:75-80.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.