Dirithromycin Side Effects
Applies to dirithromycin: oral delayed release tablet
Gastrointestinal side effects are common. In clinical trials consisting of more than 3000 patients treated with daily doses of 500 mg for approximately 7 to 14 days, 2.6% discontinued therapy because of adverse reactions, of which 40% were due to nausea or abdominal pain. Overall, abdominal pain has been reported in 10%, nausea or diarrhea in 8%, vomiting or dyspepsia in 3%, and flatulence in approximately 2% of patients. Anorexia, constipation, dry mouth, epistaxis, gastritis, gastroenteritis, and mouth ulceration have been reported in less than 1% of patients.
Nervous system side effects have included headache (9%), dizziness/vertigo (2%), asthenia (2%), nonspecific pain (2%), and insomnia (1%). Amblyopia, anxiety, depression, malaise, paresthesias, somnolence, taste alterations, tinnitus, and tremors have been reported in less than 1% of patients. Although not observed among patients taking dirithromycin, a few cases of transient deafness have been associated with the use of high doses of a related macrolide, erythromycin.[Ref]
Hypersensitivity reactions are rare. Rash and pruritus/urticaria have been reported in 1.4% and 1.2% of patients, respectively. Although not observed among patients taking dirithromycin, bullous fixed eruptions and serious allergic reactions including anaphylaxis have been rarely associated with the use of macrolide antibiotics.[Ref]
QT prolongation associated with the use of some macrolide antibiotics has been reported both in otherwise healthy patients and in patients with a history of heart disease or who were on other potentially arrhythmogenic drugs. Most affected patients were receiving erythromycin intravenously.[Ref]
Cardiovascular side effects have not been observed among patients taking dirithromycin. Other macrolide antibiotics including azithromycin, clarithromycin and erythromycin, have rarely been associated with QT segment prolongation. Ventricular arrhythmias such as torsade de pointes have been reported with these agents.[Ref]
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3. "Product Information. Dynabac (dirithromycin)." Lilly, Eli and Company, Indianapolis, IN.
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11. Williams JD, Sefton AM "Comparison of macrolide antibiotics." J Antimicrob Chemother 31 Suppl C (1993): 11-26
12. Jacobson K "Clinical efficacy of dirithromycin in pneumonia." J Antimicrob Chemother 31 Suppl C (1993): 121-9
13. Brandriss MW, Richardson WS, Barold SS "Erythromycin-induced QT prolongation and polymorphic ventricular tachycardia (torsades de pointes): case report and review." Clin Infect Dis 18 (1994): 995-8
14. Nattel S, Ranger S, Talajic M, et al "Erythromycin-induced long QT syndrome: concordance with quinidine and underlying cellular electrophysiologic mechanism." Am J Med 89 (1990): 235-8
15. Orban Z, Macdonald LL, Peters MA, Guslits B "Erythromycin-induced cardiac toxicity." Am J Cardiol 75 (1995): 859-61
16. Freedman RA, Anderson KP, Green LS, Mason JW "Effect of erythromycin on ventricular arrhythmias and ventricular repolarization in ideopathic long T syndrome." Am J Cardiol 59 (1987): 168-9
17. Guelon D, Bedock B, Chartier C, Haberer JP "QT prolongation and recurrent "torsades de pointes" during erythromycin lactobionate infusion." Am J Cardiol 58 (1986): 666
18. McComb JM, Campbell NP, Cleland J "Recurrent ventricular tachycardia associated with QT prolongation after mitral valve replacement with intravenous administration of erythromycin." Am J Cardiol 54 (1984): 922-3
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Some side effects may not be reported. You may report them to the FDA.