Patient-Oriented Evidence That Matters

Rates of Adverse Effects of Treatment for Otitis Media Vary by Antibiotic and Dose


Am Fam Physician. 2020 Aug 1;102(3):186.

Clinical Question

How often do children experience adverse effects from the antibiotics used to treat otitis media?

Bottom Line

The rates of diarrhea and rashes associated with the treatment of children with acute otitis media (AOM) vary depending on each specific antibiotic and its dosing. The rates of diarrhea and generalized rash were highest with amoxicillin/clavulanate (Augmentin) and high-dose amoxicillin, and lowest with azithromycin (Zithromax). (Level of Evidence = 2a−)


The authors searched Medline for published studies that reported the frequency of common adverse effects (e.g., diarrhea, generalized rash, diaper rash, Candida diaper dermatitis) associated with the use of amoxicillin, amoxicillin/clavulanate, azithromycin, cefdinir (Omnicef), and placebo in children treated for AOM. The authors included English-language randomized trials, cohort studies, and cross-sectional studies in which treatment lasted at least seven days (or five days in the case of azithromycin). The authors only included studies of amoxicillin/clavulanate that used a high dose (90/6.4 mg per kg per day) and studies of azithromycin that used a low dose (less than 10 mg per kg per day) because these are the only formulations currently available for AOM. The authors used narrow definitions of adverse effects. For example, they only included studies that used the word diarrhea and excluded those that used terms such as loose stools, stool changes, or gastrointestinal effects. Because of this, the rates they report are likely to be underestimates. They included 82 studies, most at high risk of bias. The number of children in the studies varied from 40 to 810. The authors correctly point out the inconsistent reporting of adverse effects across studies, resulting in heterogeneity.

Diarrhea was the most common adverse effect, but it ranged from 2.2% (azithromycin) to 18.9% (amoxicillin/clavulanate). The placebo caused diarrhea in approximately 7% of children, perhaps a reflection of

POEMs (patient-oriented evidence that matters) are provided by Essential Evidence Plus, a point-of-care clinical decision support system published by Wiley-Blackwell. For more information, see http://www.essentialevidenceplus.com. Copyright Wiley-Blackwell. Used with permission.

For definitions of levels of evidence used in POEMs, see http://www.essentialevidenceplus.com/product/ebm_loe.cfm?show=oxford.

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This series is coordinated by Sumi Sexton, MD, editor-in-chief.

A collection of POEMs published in AFP is available at https://www.aafp.org/afp/poems.



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