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What the label lists and what reports show

Erythromycin side effects

Erythromycin's FDA label lists its adverse reactions in its own words. FAERS holds 18,956 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is drug hypersensitivity (4,155 reports).

  • Generic listed

Check it at the source: the erythromycin FDA label on DailyMed (effective August 1, 2024, Teva Pharmaceuticals USA, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most frequent side effects of oral erythromycin preparations are gastrointestinal and are dose-related. They include nausea, vomiting, abdominal pain, diarrhea and anorexia. Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test results may occur (see WARNINGS ). Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS ). Erythromycin has been associated with QT prolongation and ventricular arrhythmias, including ventricular tachycardia and torsades de pointes (see WARNINGS ). Allergic reactions ranging from urticaria to anaphylaxis have occurred. Skin reactions ranging from mild eruptions to erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported rarely. There have been reports of interstitial nephritis coincident with erythromycin use. …

Source: FDA drug label, Teva Pharmaceuticals USA, Inc., effective August 1, 2024 (SPL set 75a0bd5a-d09f-483b-bfd8-f8343b149eb2), via openFDA; the full label on DailyMed

What do FAERS reports show?

18,956 reports list erythromycin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,709 are coded as a death and 5,040 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Drug Hypersensitivity4,155
  • Nausea (named in the label)1,317
  • Vomiting (named in the label)1,155
  • Diarrhoea (named in the label)1,110
  • Drug Ineffective (a use or a product term, not a reaction)1,100
  • Dyspnoea1,074
  • Fatigue1,060
  • Rash1,039
  • Off Label Use (a use or a product term, not a reaction)987
  • Headache889
  • Pain808
  • Dizziness801
  • Pyrexia725
  • Malaise713
  • Hypersensitivity697
  • Pneumonia (a use or a product term, not a reaction)684
  • Arthralgia677
  • Pruritus649
  • Drug Interaction (a use or a product term, not a reaction)632
  • Chronic Kidney Disease629
  • Anxiety618
  • Abdominal Pain Upper589
  • Abdominal Pain (named in the label)574
  • Condition Aggravated (a use or a product term, not a reaction)573
  • Urticaria (named in the label)570

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Erythromycin: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions