TROVAN,Pfizer's Deadly Drug

Skip to Content Menu Close Account Drugs A-Z Pill Identifier Interactions Checker News Q & A Pro Edition Apps More Videos Slideshows Mobile Apps Pricing & Coupon Guide Trovan Side Effects Generic Name: trovafloxacin Side Effects Dosage Interactions Professional More Note: This page contains side effects data for the generic drug trovafloxacin. It is possible that some of the dosage forms included below may not apply to the brand name Trovan. For the Consumer Applies to trovafloxacin: oral tablet As well as its needed effects, trovafloxacin (the active ingredient contained in Trovan) may cause unwanted side effects that require medical attention. Severity: Moderate If any of the following side effects occur while taking trovafloxacin, check with your doctor or nurse as soon as possible: Rare: Note: Some of the above side effects may also occur up to several weeks after you Stop taking trovafloxacin. Abdominal or stomach cramps and pain (severe) abdominal tenderness agitation confusion dark urine diarrhea (watery and severe, which may also be bloody) difficulty in breathing or swallowing fever hallucinations (seeing, hearing, or feeling things that are not there) loss of appetite nausea or vomiting pain at place of injection pain in calves that spreads to heels rapid heartbeat shakiness or tremors shortness of breath skin rash, itching, or redness swelling of calves or lower legs swelling of face, throat, or tongue unusual tiredness or weakness yellow eyes or skin Severity: Minor Some trovafloxacin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them: More common: Diarrhea (mild) dizziness or lightheadedness headache vaginal pain and discharge Less common or rare: Increased sensitivity of skin to sunlight 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 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] 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] 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 (the active ingredient contained in Trovan) 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 US Pharmaceuticals, New York, NY. 2. Chen HJ, Bloch KJ, Maclean JA "Acute eosinophilic hepatitis from trovafloxacin." N Engl J Med 342 (2000): 359-60 3. FDA "FDA issues public health advisory on liver toxicity associated with the antibiotic Trovan. FDA Talk Paper Available from: URL: http://www.fda.gov/bbs/topics/ANSWERS/ANS00958.html." ([1999 Jun 9]): 4. Lucena MI, Andrade RJ, Rodrigo L, Salmeron J, Alvarez A, LopezGarrido MJ, Camargo R, Alcantara R "Trovafloxacin-induced acute hepatitis." Clin Infect Dis 30 (2000): 400-1 5. Overholser BR, Kays MB, Forrest A, Sowinski KM "Sex-related differences in the pharmacokinetics of oral ciprofloxacin." J Clin Pharmacol 44 (2004): 1012-22 6. Cohen JS "Peripheral neuropathy associated with fluoroquinolones." Ann Pharmacother 35 (2001): 1540-7 7. Ernst ME, Ernst EJ, Klepser ME "Levofloxacin and trovafloxacin: the next generation of fluoroquinolones?" Am J Health Syst Pharm 54 (1997): 2569-84 8. 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 104 (1998): 28-32 9. Menzies D, Klein NC, Cunha BA "Trovafloxacin neurotoxicity." Am J Med 107 (1999): 298-9 10. Williams D, Hopkins S "Safety of trovafloxacin in treatment of lower respiratory tract infections." Eur J Clin Microbiol Infect Dis 17 (1998): 454-8 11. Haria M, Lamb HM "Trovafloxacin." Drugs 54 (1997): 435-45;disc. 446 12. Wise R, Mortiboy D, Child J, Andrews JM "Pharmacokinetics and penetration into inflammatory fluid of trovafloxacin (CP-99,219)." Antimicrob Agents Chemother 40 (1996): 47-9 13. Melvani S, Speed BR "Alatrofloxacin-induced seizures during slow intravenous infusion." Ann Pharmacother 34 (2000): 1017-9 14. Murray CK, Wortmann GW "Trovafloxacin-induced weakness due to a demyelinating polyneuropathy." South Med J 93 (2000): 514-5 15. "Trovafloxacin." Med Lett Drugs Ther 40 (1998): 30-1 16. 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 36 (1995): 385-94 17. Matthews MR, Caruso DM, Phillips BJ, Csontos LG "Fulminant toxic epidermal necrolysis induced by trovafloxacin." Arch Intern Med 159 (1999): 2225 18. Mitropoulos FA, Angood PB, Rabinovici R "Trovafloxacin-associated leukopenia." Ann Pharmacother 35 (2001): 41-4 19. Goel K, Menzies D, Cunha BA "Elevated international normalized ratio associated with trovafloxacin." Ann Intern Med 131 (1999): 72 20. Gales BJ, Sulak LB "Severe thrombocytopenia associated with alatrofloxacin." Ann Pharmacother 34 (2000): 330-4 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 39 Suppl B (1997): 75-80 It is possible that some side effects of Trovan may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice. Next → Dosage More about Trovan (trovafloxacin) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Images Drug Interactions Support Group 0 Reviews - Add your own review/rating Professional resources Trovan (FDA) Related treatment guides Bacterial Infection Intraabdominal Infection Nosocomial Pneumonia Pelvic Infections Pneumonia More (1) » Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. The information is not a substitute for the knowledge and judgement of a healthcare professional. Always consult with your doctor, nurse, or pharmacist before taking medication. Was this page helpful? YesNo Drugs.com Mobile Apps The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices. 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