"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 "...
Cerumenex Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Cerumenex Eardrops (triethanolamine polypeptide oleate-condensate) is an emulsion that breaks down natural oils used in the ear to break down and loosen earwax that has built up inside the ear canal. Common side effects of Cerumenex Eardrops include a temporary burning feeling in your ear for 1 to 2 minutes when it is first applied. Other side effects of Cerumenex Eardrops include swelling, itching, redness, allergic reactions, skin ulcerations, rash, scaling of the skin around the ear, crusting, irritation, or pain.
Fill the ear canal with the dose of Cerumenex Eardrops with the patient's head tilted at a 45° angle. Insert cotton plug and allow to remain 15-30 minutes. Gently flush with lukewarm water, using a soft rubber syringe. The procedure may be repeated if the first application fails to clear the impaction. Follow your doctor's instructions. Other drugs may interact with Cerumenex Eardrops. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Cerumenex Eardrops should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Cerumenex Eardrops (triethanolamine polypeptide oleate-condensate) 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.
Cerumenex Overview - Patient Information: Side Effects
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 Cerumenex (Triethanolamine Polypeptide)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Cerumenex FDA Prescribing Information: Side Effects
Clinical Reactions Of Possible Allergic Origin
Localized dermatitis reactions were reported in about 1% of 2,700 patients treated, ranging from a very mild erythema and pruritus of the external canal to a severe eczematoid reaction involving the external ear and periauricular tissue, generally with duration of 2-10 days.
Other reactions which have been reported in connection with the use of CERUMENEX Eardrops include allergic contact dermatitis, skin ulcerations, burning and pain at the application site and skin rash.
Read the entire FDA prescribing information for Cerumenex (Triethanolamine Polypeptide)
Additional Cerumenex Information
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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