By Medically reviewed by hellodoktor

Generic Name: Amlexanox Brand Name(s): Generics only. No brands available.


What is amlexanox used for?

Amlexanox is commonly used for treating canker sores.

Amlexanox is an anti-inflammatory agent. How amlexanox works is not fully known. It appears to stop inflammatory reactions (e.g., pain, redness, swelling) and allow sores to heal.

How should I take amlexanox?

Use amlexanox as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Apply amlexanox after oral hygiene after breakfast, lunch, dinner, and at bedtime unless otherwise directed by your doctor.

Apply the paste as soon as possible after noticing the symptoms of canker sores.

Dry the ulcers by gently patting with a soft, clean cloth.

Wash your hands before and immediately after applying amlexanox.

Moisten the tip of your index finger. Squeeze a dab of paste approximately one-fourth of an inch onto your fingertip. Dab paste onto each ulcer in the mouth using gentle pressure.

Use the paste until the ulcer heals. If significant healing or pain reduction has not occurred within 10 days, consult your dentist or doctor.

How do I store amlexanox?

Amlexanox is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store amlexanox in the bathroom or the freezer. There may be different brands of amlexanox that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush amlexanox down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using amlexanox?

Before using this drug, tell your doctor if:

  • You are pregnant or breastfeeding. This is because, while you are expecting or feeding a baby, you should only take medicines on the recommendation of a doctor.
  • You are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
  • You have allergy with any of active or inactive ingredients of amlexanox or other medications.
  • You have any other illnesses, disorders, or medical conditions.

Avoid getting amlexanox in your eyes. Wash eyes promptly if paste gets into eyes.

Use amlexanox with extreme caution in children. Safety and effectiveness have not been confirmed.

Is it safe during pregnancy or breastfeeding?

There are no adequate studies in women for determining risk when using this medication during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking this medication. This medication is pregnancy risk category B, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk
  • B=No risk in some studies
  • C=There may be some risk
  • D=Positive evidence of risk
  • X=Contraindicated
  • N=Unknown


Side effects

What side effects can occur from amlexanox?

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most common side effects persist or become bothersome:

  • Short-term pain, stinging, or burning at the application site

Seek medical attention right away if any of these severe side effects occur:

  • Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue)
  • Inflammation of the lining of the mouth

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.


What drugs may interact with amlexanox?

Amlexanox may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with amlexanox?

Amlexanox may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with amlexanox?

Amlexanox may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.


The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using amlexanox.

What is the dose of amlexanox for an adult?

Topical as a 5% oral paste: Apply approximately 0.5 cm of oral paste directly on to each ulcer 4 times/day; following oral hygiene after meals and at bedtime.

Initiate treatment at earliest symptom of an aphthous ulcer. Continue treatment until mouth ulcer is healed, not exceeding 10 days.

As a 2% mucoadhesive patch: Apply one patch to each ulcer 4 times/day; following oral hygiene after meals and before bedtime.

If multiple ulcers present, up to 3 patches may be used at one time.

Continue treatment until mouth ulcer is healed, not exceeding 10 days.

What is the dose of amlexanox for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is amlexanox available?

Amlexanox is available in the following dosage forms and strengths:

  • Patch

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of amlexanox, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: October 4, 2017 | Last Modified: September 11, 2019