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Updated: Jul 10, 2026

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Published on: March 16, 2018
Sensorineural hearing loss as a probable serious adverse drug reaction associated with low-dose oral azithromycin
Paul Mick1, Brian D Westerberg
1Division of Otolaryngology, University of British Columbia, Vancouver, BC, Canada.
Background:
Hearing loss as a possible side effect of azithromycin has been recognized since 1994. Most reports suggesting a link between sensorineural hearing loss (SNHL) and this drug have been in association with prolonged doses for treatment of Mycobacterium lung disease. Mild-moderate, gradual, and reversible SNHL in the speech frequencies has been most often reported.
Materials And Methods:
We describe irreversible SNHL in a patient in association with low-dose oral azithromycin prescribed for acute otitis media. We summarize the available evidence, including a systematic literature review, in support of a possible causal association between SNHL and low-dose azithromycin therapy.
Interpretation/Discussion:
Physicians should be aware of the potential for even low-dose, oral azithromycin to cause irreversible SNHL as a serious adverse drug reaction in some patients.
Insights
Azithromycin can cause hearing loss, even at low doses. This study highlights irreversible sensorineural hearing loss (SNHL) as a potential serious adverse reaction to low-dose azithromycin.
Area of Science:
- Pharmacology
- Otolaryngology
- Adverse Drug Reactions
Background:
- The association between azithromycin and hearing loss, particularly sensorineural hearing loss (SNHL), has been documented since 1994.
- Previous reports primarily linked prolonged azithromycin use for Mycobacterium lung disease with mild, reversible SNHL in speech frequencies.
Observation:
- This report details a case of irreversible SNHL in a patient receiving low-dose oral azithromycin for acute otitis media.
- A systematic literature review was conducted to evaluate the evidence for SNHL associated with low-dose azithromycin.
Findings:
- The case study and literature review suggest a potential causal link between low-dose oral azithromycin and irreversible SNHL.
- This contrasts with previous observations of predominantly mild and reversible hearing impairment.
Implications:
- Healthcare providers should recognize that even low-dose oral azithromycin may lead to irreversible SNHL.
- This underscores the importance of considering SNHL as a serious adverse drug reaction to azithromycin, irrespective of dosage or duration.
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Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

