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ERYTHROMYCIN


DIR Classification


Classification:Most-DIQT concern
Severity Score:4.0

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • WARNINGS
  • QT Prolongation
  • Erythromycin has been associated with prolongation of the QT interval and infrequent cases of arrhythmia. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving erythromycin. Fatalities have been reported. Erythromycin should be avoided in patients with known prolongation of the QT interval, patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval.
  • PRECAUTIONS
  • Drug Interactions
  • In addition, there have been reports of interactions of erythromycin with drugs not thought to be metabolized by CYP3A, including hexobarbital, phenytoin, and valproate.
  • Erythromycin has been reported to significantly alter the metabolism of the nonsedating antihistamines terfenadine and astemizole when taken concomitantly. Rare cases of serious cardiovascular adverse events, including electrocardiographic QT/QT c interval prolongation, cardiac arrest, torsades de pointes, and other ventricular arrhythmias have been observed. (See CONTRAINDICATIONS.) In addition, deaths have been reported rarely with concomitant administration of terfenadine and erythromycin.
  • There have been post-marketing reports of drug interactions when erythromycin was co-administered with cisapride, resulting in QT prolongation, cardiac arrhythmias, ventricular tachycardia, ventricular fibrillation, and torsades de pointes, most likely due to the inhibition of hepatic metabolism of cisapride by erythromycin. Fatalities have been reported. (See CONTRAINDICATIONS.)
  • ADVERSE REACTIONS
  • Erythromycin has been associated with QT prolongation and ventricular arrhythmias, including ventricular tachycardia and torsades de pointes. (See WARNINGS).

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
36
24056
Other ADRs
9357
38372230

Odds Ratio = 6.138

Drug Property Information



ATC Code(s):
  • J01FA01 - erythromycin
    • J01FA - Macrolides
    • J01F - "MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS"
    • J01 - ANTIBACTERIALS FOR SYSTEMIC USE
    • J - ANTIINFECTIVES FOR SYSTEMIC USE
  • D10AF02 - erythromycin
    • D10AF - Antiinfectives for treatment of acne
    • D10A - ANTI-ACNE PREPARATIONS FOR TOPICAL USE
    • D10 - ANTI-ACNE PREPARATIONS
    • D - DERMATOLOGICALS
  • S01AA17 - erythromycin
    • S01AA - Antibiotics
    • S01A - ANTIINFECTIVES
    • S01 - OPHTHALMOLOGICALS
    • S - SENSORY ORGANS
Active Ingredient:ERYTHROMYCIN
Active Ingredient UNII:63937KV33D
Drugbank ID:DB00199
PubChem Compound:12560
CTD ID:D004917
PharmGKB:PA449493
CAS Number:114-07-8
Dosage Form(s):tablet, delayed release
Route(s) Of Administrator:oral
Daily Dose:
  • 1000.0 mg/day J01FA01
Chemical Structure:
SMILE Code:
CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]2O[C@H](C)C[C@@H]([C@H]2O)N(C)C)[C@](C)(O)C[C@@H](C)C(=O)[C@H](C)[C@@H](O)[C@]1(C)O

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