Skip to main content
PlainMeds

What the label lists and what reports show

Benzoyl peroxide and erythromycin side effects

Benzoyl peroxide and erythromycin's FDA label lists its adverse reactions in its own words. FAERS holds 162 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 inflammatory bowel disease (18 reports).

  • Generic listed

Check it at the source: the benzoyl peroxide and erythromycin FDA label on DailyMed (effective June 3, 2019, Oceanside Pharmaceuticals); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

In controlled clinical trials, the incidence of adverse reactions associated with the use of Erythromycin-Benzoyl Peroxide Topical Gel was approximately 3%. These were dryness and urticarial reaction. The following additional local adverse reactions have been reported occasionally: irritation of the skin including peeling, itching, burning sensation, erythema, inflammation of the face, eyes and nose, and irritation of the eyes. Skin discoloration, oiliness and tenderness of the skin have also been reported. To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Source: FDA drug label, NDA050557 (Valeant Intl), as published by Oceanside Pharmaceuticals, effective June 3, 2019 (SPL set be5bce27-bbb7-4503-b609-d89a77ee1e05), via openFDA; the full label on DailyMed

What do FAERS reports show?

162 reports list benzoyl peroxide and erythromycin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 31 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, 1 is 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.

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)19
  • Inflammatory Bowel Disease18
  • Colitis Ulcerative15
  • Depression14
  • Anxiety11
  • Product Physical Consistency Issue11
  • Colitis (named in the label)10
  • Rash10
  • Crohn^S Disease9
  • Off Label Use (a use or a product term, not a reaction)9
  • Dry Skin8
  • Irritable Bowel Syndrome8
  • Polyarteritis Nodosa8
  • Acne (a use or a product term, not a reaction)7
  • Application Site Pain7
  • Fatigue7
  • No Adverse Event (a use or a product term, not a reaction)6
  • Product Quality Issue (a use or a product term, not a reaction)6
  • Pruritus6
  • Weight Decreased6
  • Back Pain5
  • Decreased Appetite5
  • Emotional Distress5
  • Gastrointestinal Disorder5
  • Intestinal Obstruction5

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

What next?

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