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

Applies to aminolevulinic acid topical: topical gel/jelly, topical solution.

Serious side effects of Ameluz

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

• Bleeding
• hives
• persistent non-healing sore
• pink growth
• reddish patch or irritated area
• scabbing
• shiny bump
• spots on your skin resembling a blister or pimple
• stinging, burning, pain, redness, swelling, scaling, crusting, lightening or darkening of the skin, itching, cracking, crusting, or dryness of the skin at the application site
• tenderness
• white, yellow or waxy scar-like area

Less common

• Bleeding during lesion preparation
• blistering or irritation of the skin
• flaking, pain, peeling, itching rash, breaking down of the skin

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

Other side effects of Ameluz

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
• skin sore
• small, red, raised, itchy bumps
• swelling of the skin

Less common

• Cough
• fever
• headache
• oozing
• open sore on the skin
• pain
• pain or tenderness around the eyes and cheekbones
• pus filled blister or pimple
• raw skin
• stuffy or runny nose
• tenderness
• tightness of the chest
• troubled breathing

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]