Aphthasol Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Aphthasol (amlexanox) Oral Paste is used to treat canker sores, also called aphthous ulcers, in the mouth. It helps the sore heal faster so that you can eat/speak more comfortably. Common side effects 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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Aphthasol in Detail - Patient Information: Side Effects
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) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Aphthasol Overview - Patient Information: Side Effects
Remember that your doctor/dentist has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor/dentist immediately if any of these unlikely but serious side effects occur: increased mouth sores, nausea, diarrhea.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 Aphthasol (Amlexanox)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Aphthasol FDA Prescribing Information: Side Effects
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) »
Additional Aphthasol Information
Aphthasol - User Reviews
Aphthasol 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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