Dirithromycin Side Effects

Applies to dirithromycin: oral tablet enteric coated.

Precautions

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

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:

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:

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]

See also:

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.

Medical Disclaimer