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Methyl aminolevulinate topical Side Effects

For the Consumer

Applies to methyl aminolevulinate topical: topical application cream

Along with its needed effects, methyl aminolevulinate topical 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 methyl aminolevulinate topical:

More common
  • Breakdown of the skin
  • irritation and redness of the skin
  • scabbing
  • swelling of the eyelid
  • swelling of the skin
Less common
  • Discharge at the site of application
  • sores on the skin that do not heal
Incidence not known
  • Blistering, burning, crusting, dryness, or flaking of the skin
  • blurred vision or other change in vision
  • eye redness, irritation, or pain
  • hives or welts
  • itching, scaling, or severe redness of the skin
  • persistent non-healing sore
  • pink growth on the skin
  • reddish patch or irritated area on the skin
  • seeing flashes or sparks of light
  • seeing floating spots before the eyes, or a veil or curtain appearing across part of the vision
  • shiny bump on the skin
  • skin rash, encrusted, scaly and oozing
  • white, yellow, or waxy scar-like area on the skin

Some side effects of methyl aminolevulinate 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:

Less common
  • Darkening of the skin

For Healthcare Professionals

Applies to methyl aminolevulinate topical: topical cream

Hypersensitivity

In a cumulative irritancy and sensitization study, methyl aminolevulinate cream was applied three times each week for 3 weeks to separate sites on the back of healthy volunteers. Following a 2-week interval without further applications, 30 out of 58 subjects (52%) who were rechallenged with the cream for 48 hours showed contact sensitization.

The potential for sensitization was also assessed by patch testing in a total of 21 patients with actinic keratoses previously treated with methyl aminolevulinate cream on at least four occasions. Methyl aminolevulinate cream and vehicle cream were applied to different sites on the lower back for 48 hours. Three patients (14%) showed contact sensitization associated with erythema scores of 4 or higher (strong erythema spreading outside the patch), edema, vesiculation, papules, and glazing.[Ref]

Postmarketing reports: Eczema, allergic contact dermatitis, urticaria, . Most cases were localized to the treatment area, but rarely, erythema and swelling have been more extensive. Contact sensitization has been demonstrated in dermal safety studies.[Ref]

Ocular

Very common (10% or more): Eyelid edema (18%)
Postmarketing reports: Edema, eyelid swelling, macular edema, vitreous detachment, keratitis[Ref]

Local

Very common (10% or more): Skin burning/pain/discomfort (86%; 20% severe), erythema (63%; 6% severe), scabbing/crusting/blister/erosions (29%; 2% severe), pruritus (22%), skin or eyelid edema (18%; 2% severe), skin exfoliation (14%; 3% severe)
Common (1% to 10%): Skin warmth (4%), application site discharge (2%), skin hemorrhage (2%), skin tightness (2%), and skin hyperpigmentation (2%)
Postmarketing reports: Angioedema[Ref]

Treatment site reactions occurred in 113 out of 126 (90%) patients treated with methyl aminolevulinate cream in two clinical trials. The most frequent adverse reactions were associated with phototoxicity at the treatment site. Pain and burning sensation typically begin during illumination and resolve completely within a few minutes or hours, but may last up to a few days. Erythema and other signs generally resolve within a few days to 3 weeks.[Ref]

References

1. "Product Information. Metvixia (methyl aminolevulinate topical)." Galderma Laboratories Inc, Cranbury, NJ.

Some side effects of methyl aminolevulinate topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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