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Last reviewed on RxList: 6/2/2009
Aphthasol Side Effects Center

Last reviewed on RxList 2/5/2016

Aphthasol (amlexanox) Oral Paste is an anti-allergic and anti-inflammatory drug used to treat canker sores, also called aphthous ulcers, in the mouth. Aphthasol Oral Paste helps the sore heal faster so you can eat/speak more comfortably. Common side effects of Aphthasol (amlexanox) Oral Paste include temporary pain, stinging, or burning at the application site.

Aphthasol oral paste should be applied as soon as possible after noticing the symptoms of an aphthous ulcer and should be used in a four times daily dose, preferably following oral hygiene after breakfast, lunch, dinner, and at bedtime. Squeeze a dab of paste approximately ¼ inch (0.5 cm) onto a fingertip. With gentle pressure, dab the paste onto each ulcer in the mouth. Use until the ulcer heals. Other drugs may affect Aphthasol. Tell your doctor all medications and supplements you use. During pregnancy, Aphthasol should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Aphthasol (amlexanox) Oral Paste 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.

Aphthasol Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using amlexanox and call your doctor if you have any of these serious side effects:

  • skin rash;
  • new mouth ulcers; or
  • white patches or sores inside your mouth or on your lips.

Less serious side effects may include may a slight stinging or burning when you first apply the medication.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Aphthasol (Amlexanox)

Aphthasol Professional Information


Adverse reactions considered related or possibly related to amlexanox oral paste, 5%, were not reported by more than 5% of patients. Adverse reactions reported by 1-2% of patients were transient pain, stinging and/or burning at the site of application. Infrequent ( < 1%) adverse reactions in the clinical studies were contact mucositis, nausea, and diarrhea.

Read the entire FDA prescribing information for Aphthasol (Amlexanox)

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© Aphthasol Patient Information is supplied by Cerner Multum, Inc. and Aphthasol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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