"The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear "...
Auralgan Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Auralgan (antipyrine, benzocaine, and dehydrated glycerin) is a combination of an analgesic, a topical anesthetic, and glycerin that helps to soften earwax, used to relieve pain, congestion, and swelling caused by middle ear inflammation (acute otitis media), and it is also used to help remove earwax (cerumen). Many people using Auralgan do not have serious side effects. Rarely, side effects of Auralgan include:
- burning/stinging/redness/new pain in or around the ears.
Tell your doctor if you have rare but very serious side effects of Auralgan including:
- bluish skin, or
- severe tiredness or weakness.
To treat acute otitis media, the dose of Auralgan is to instill the solution into the wall of the ear canal until it is filled. Repeat every one to two hours per doctor's instructions until pain and congestion are relieved. Auralgan may interact with other ear medications. Tell your doctor all medications and supplements you use. During pregnancy, Auralgan should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Auralgan (antipyrine, benzocaine, and dehydrated glycerin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Auralgan Overview - Patient Information: Side Effects
Tell your doctor immediately if any of these unlikely but serious side effects occur: burning/stinging/redness/new pain in or around the ears.
Tell your doctor immediately if any of these rare but very serious side effects occur: bluish skin, severe tiredness/weakness.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Auralgan (Antipyrine, Benzocaine and Glycerin Dehydrated)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Auralgan FDA Prescribing Information: Side Effects
No Information Provided.
Read the entire FDA prescribing information for Auralgan (Antipyrine, Benzocaine and Glycerin Dehydrated)
Additional Auralgan Information
Auralgan - User Reviews
Auralgan User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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