Dynabac D5-Pak Side Effects

Generic name: dirithromycin

Note: This document contains side effect information about dirithromycin. Some of the dosage forms listed on this page may not apply to the brand name Dynabac D5-Pak.

Some side effects of Dynabac D5-Pak may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to dirithromycin: oral delayed release tablet

If you experience any of the following serious side effects, stop taking dirithromycin (the active ingredient contained in Dynabac D5-Pak) and seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives); or

• liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue).

Other, less serious side effects may be more likely to occur. Continue to take dirithromycin and talk to your doctor if you experience

• nausea, vomiting, diarrhea, or abdominal pain;

• dizziness, fatigue, or headache;

• vaginal yeast infection; or

• a rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to dirithromycin: oral delayed release tablet

Gastrointestinal

Although not observed among patients taking dirithromycin (the active ingredient contained in Dynabac D5-Pak) rare cases of cholestatic hepatitis have been associated with the use of macrolide antibiotics in general.

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.

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 (the active ingredient contained in Dynabac D5-Pak) a few cases of transient deafness have been associated with the use of high doses of a related macrolide, erythromycin.

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 (the active ingredient contained in Dynabac D5-Pak) bullous fixed eruptions and serious allergic reactions including anaphylaxis have been rarely associated with the use of macrolide antibiotics.

Cardiovascular

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.

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.

Respiratory

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

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