What is Auralgan (antipyrine and benzocaine otic)?

Auralgan (antipyrine and benzocaine otic) is a combination of an analgesic and a topical anesthetic used to clean earwax (cerumen) from the ear canal and to treat the symptoms of  middle ear infections (otitis media). It reduces pressure, congestion, inflammation, pain, and discomfort in the ear. 

In 2015 the FDA asked manufacturers of Auralgan and all antipyrine and benzocaine otic products (other brand name: Aurodex) to stop selling these products because they have not been proven to be safe and effective.

Common side effects of Auralgan include:

  • stinging in the ear,
  • burning in the ear,
  • and redness around the ear.

Serious side effects of Auralgan include:

There are no listed drug interactions of Auralgan.

The use of Auralgan by pregnant women has not been adequately evaluated. It is unknown if Auralgan is secreted in breast milk. Consult your doctor before breastfeeding.

    Auralgan (antipyrine and benzocaine otic) side effects list for healthcare professionals

    Common side effects include:

    • Stinging in the ear
    • Burning in the ear
    • Redness around the ear

    Possible serious side effects include:

    • Allergic reactions
    • Methemoglobinemia

    Is Auralgan (antipyrine and benzocaine otic) safe to use in pregnant or breastfeeding women?

    • The use of antipyrine/benzocaine by pregnant women has not been adequately evaluated.
    • It is not known if antipyrine/benzocaine is secreted in breast milk.

    What drugs interact with Auralgan (antipyrine and benzocaine otic)?

    • There are no drug interactions listed for antipyrine/benzocaine otic solution.

    Summary

    Auralgan (antipyrine and benzocaine otic) is a combination of an analgesic and a topical anesthetic used to clean earwax (cerumen) from the ear canal and to treat the symptoms of middle ear infections (otitis media). It reduces pressure, congestion, inflammation, pain, and discomfort in the ear. Common side effects of Auralgan include stinging in the ear, burning in the ear, and redness around the ear. Serious side effects of Auralgan include allergic reactions and methemoglobinemia. There are no listed drug interactions of Auralgan. The use of Auralgan by pregnant women has not been adequately evaluated. It is unknown if Auralgan is secreted in breast milk. Auralgan was discontinued by the FDA in 2015.

    Treatment & Diagnosis

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    References
    FDA Prescribing Information