Amlexanox Brand Name– Aphthasol

What is Amlexanox

Amlexanox is a topical anti-inflammatory agent indicated for the topical treatment of aphthous ulcers (i.e., canker sores) in immune competent individuals.

Amlexanox has been shown to accelerate the healing of aphthous ulcers as compared to placebo or no treatment.

In addition, significant pain relief is also noted.

The FDA originally granted approval of amlexanox 5% oral paste (Aphthasol) in December 1996.

Amlexanox paste was also under study for the prevention of aphthous ulcers.

Other formulations of amlexanox are being investigated for the treatment of mucositis (oral solution), atopic dermatitis (cream), and oral lichen planus (mucoadhesive gel).

In addition, an oral formulation of amlexanox is available outside the U.S. for the treatment of allergic rhinitis and asthma.

In September 2004, the FDA approved OraDisc A 2 mg patch, which is a bioerodible polymer mucoadhesive disc (e.g.,patch) formulation of amlexanox.


  • aphthous ulcer
  • stomatitis

For the treatment of an aphthous ulcer (canker sore) in immune competent patients

Side Effects

  1. diarrhea
  2. headache
  3. nausea
  4. paresthesias
  5. rash
  6. skin irritation
  7. stomatitis
  8. vomiting

Monitoring Parameters

  • laboratory monitoring not necessary


  • benzyl alcohol hypersensitivity
  • breast-feeding
  • children
  • immunosuppression
  • ocular exposure
  • pregnancy


There are no drug interactions associated with Amlexanox products.


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