Skip to Content

Ameluz Side Effects

Generic Name: aminolevulinic acid topical

Note: This document contains side effect information about aminolevulinic acid topical. Some of the dosage forms listed on this page may not apply to the brand name Ameluz.

For the Consumer

Applies to aminolevulinic acid topical: topical gel/jelly, topical kit, topical solution, topical stick

Along with its needed effects, aminolevulinic acid topical (the active ingredient contained in Ameluz) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking aminolevulinic acid topical:

More common
  • Pain, burning, itching, redness, or swelling at the application site
Less common
  • Bleeding during lesion preparation
Incidence not known
  • Difficulty seeing at night
  • double vision
  • increased sensitivity of the eyes to sunlight
  • loss of memory
  • problems with memory
  • red, sore eyes
  • seeing double
  • swelling of the eyelids

Some side effects of aminolevulinic acid topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Burning, crawling, itching, numbness, prickling, “pins and needles,” stinging, or tingling feelings
  • darkening or lightening of the treated skin
  • scaling or crusting
  • skin sore
  • small, red, raised, itchy bumps
  • swelling of the skin
Less common
  • Blister
  • oozing
  • open sore on the skin
  • pain
  • pus filled blister or pimple
  • raw skin
  • scabbing
  • tenderness

For Healthcare Professionals

Applies to aminolevulinic acid topical: topical gel, topical solution

General

The most commonly reported side effects were scaling/crusting, hypo-/hyper-pigmentation, and itching.[Ref]

Dermatologic

Very common (10% or more): Scaling/Crusting (up to 71%), hypo-/hyper-pigmentation (up to 36%), erosion (up to 14%), itching (up to 25%), pruritus
Common (1% to 10%): Wheal/flare, skin disorders NOS, ulceration, bleeding/hemorrhage, vesiculation, pustules, dysesthesia, scabbing, excoriation, oozing, skin tightness
Uncommon (0.1% to 1%): Pustular rash, dry skin, petechiae, hyperkeratosis[Ref]

Other

Very Common (10% or more): Irritation, erythema, pain, edema, exfoliation, induration
Common (1% to 10%): Pain, tenderness, ulceration
Uncommon (0.1% to 1%): Discharge, discoloration, ulcer, chills, feeling hot, pyrexia, wound secretion

Nervous system

Common (1% to 10%): Headache, paraesthesia, hyperalgesia[Ref]

Ocular

Uncommon (0.1% to 1%): Eyelid edema[Ref]

Psychiatric

Uncommon (0.1% to 1%): Nervousness[Ref]

References

1. "Product Information. Levulan Kerastick (aminolevulinic acid)" Berlex, Richmond, CA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Hide