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Dirithromycin Side Effects

Applies to dirithromycin: oral tablet enteric coated.

Common side effects of dirithromycin

Some side effects of dirithromycin 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:

Less common side effects

Serious side effects of dirithromycin

Along with its needed effects, dirithromycin 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 dirithromycin:

Rare side effects

  • abdominal tenderness
  • fever
  • severe abdominal or stomach cramps and pain
  • watery and severe diarrhea, which may also be bloody
Managing side effects (general information)

For healthcare professionals

Applies to dirithromycin: oral delayed release tablet.

Gastrointestinal adverse events

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.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including dirithromycin, and may range in severity from mild to life-threatening.[Ref]

Although not observed among patients taking dirithromycin, rare cases of cholestatic hepatitis have been associated with the use of macrolide antibiotics in general.[Ref]

Nervous system

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

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]

Cardiovascular

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]

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]

Respiratory

Respiratory system side effects have rarely included dyspnea and/or cough.[Ref]

References

1. Eckernas SA, Grahnen A, Nord CE (1991) "Impact of dirithromycin on the normal oral and intestinal microflora." Eur J Clin Microbiol Infect Dis, 10, p. 688-92

2. Muller O, Wettich K (1993) "Clinical efficacy of dirithromycin in pharyngitis and tonsillitis." J Antimicrob Chemother, 31 Suppl C, p. 97-102

3. Derriennic M, Conforti PM, Sides GD (1993) "Dirithromycin in the treatment of streptococcal pharyngitis." J Antimicrob Chemother, 31 Suppl C, p. 89-95

4. Sides GD, Conforti PM (1993) "Safety profile of dirithromycin." J Antimicrob Chemother, 31 Suppl C, p. 175-85

5. Derriennic M, Escande JP (1993) "Dirithromycin in the treatment of skin and skin structure infections." J Antimicrob Chemother, 31 Suppl C, p. 159-68

6. Pozzi E (1993) "Clinical efficacy of dirithromycin versus miocamycin in the treatment of acute bronchitis or acute exacerbations of chronic bronchitis." J Antimicrob Chemother, 31 Suppl C, p. 153-8

7. Gaillat J (1993) "A multicentre study comparing the safety and efficacy of dirithromycin with erythromycin in the treatment of bronchitis." J Antimicrob Chemother, 31 Suppl C, p. 139-51

8. Sides GD (1993) "Clinical efficacy of dirithromycin in acute exacerbations of chronic bronchitis." J Antimicrob Chemother, 31 Suppl C, p. 131-8

9. Jacobson K (1993) "Clinical efficacy of dirithromycin in pneumonia." J Antimicrob Chemother, 31 Suppl C, p. 121-9

10. Williams JD, Sefton AM (1993) "Comparison of macrolide antibiotics." J Antimicrob Chemother, 31 Suppl C, p. 11-26

11. Hosie J, Quinn P, Smits P, Sides G (1995) "A comparison of 5 days of dirithromycin and 7 days of clarithromycin in acute bacterial exacerbation of chronic bronchitis." J Antimicrob Chemother, 36, p. 173-83

12. (2001) "Product Information. Dynabac (dirithromycin)." Lilly, Eli and Company

13. McComb JM, Campbell NP, Cleland J (1984) "Recurrent ventricular tachycardia associated with QT prolongation after mitral valve replacement with intravenous administration of erythromycin." Am J Cardiol, 54, p. 922-3

14. Guelon D, Bedock B, Chartier C, Haberer JP (1986) "QT prolongation and recurrent "torsades de pointes" during erythromycin lactobionate infusion." Am J Cardiol, 58, p. 666

15. Freedman RA, Anderson KP, Green LS, Mason JW (1987) "Effect of erythromycin on ventricular arrhythmias and ventricular repolarization in ideopathic long T syndrome." Am J Cardiol, 59, p. 168-9

16. Nattel S, Ranger S, Talajic M, et al. (1990) "Erythromycin-induced long QT syndrome: concordance with quinidine and underlying cellular electrophysiologic mechanism." Am J Med, 89, p. 235-8

17. Brandriss MW, Richardson WS, Barold SS (1994) "Erythromycin-induced QT prolongation and polymorphic ventricular tachycardia (torsades de pointes): case report and review." Clin Infect Dis, 18, p. 995-8

18. Orban Z, Macdonald LL, Peters MA, Guslits B (1995) "Erythromycin-induced cardiac toxicity." Am J Cardiol, 75, p. 859-61

Further information

Dirithromycin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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