Aminolevulinic Acid
Aminolevulinic acid (AMELUZ) is a topical photosensitizing agent used in photodynamic therapy for the treatment of actinic keratosis. When applied to the skin, it is converted to protoporphyrin IX, a light-sensitive compound that selectively accumulates in abnormal skin cells. Upon exposure to specific red light wavelengths, the compound activates and destroys the targeted cells.
A topical photodynamic therapy agent for actinic keratosis that becomes activated by red light to selectively destroy abnormal skin cells.
Key facts at a glance
- ATC
- L01XD04
- RxNorm
- 683
- Generic
- Aminolevulinic Acid
- Class
- atc-l01
- Brands
- Ameluz
- Availability
- rx
- Lactation
- unknown
- Routes
- topical
- Forms
- gel
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
10 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteruse only if clearly needed
use only if potential benefits justify potential risks to fetus
regular prenatal monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesteruse only if clearly needed
use only if potential benefits justify potential risks to fetus
regular fetal monitoring
Use with caution and monitor for adverse effects.
lactation
breastfeedingavoid or discontinue breastfeeding
it is unknown whether aminolevulinic acid passes into breast milk; discontinue breastfeeding or avoid drug
monitor infant for adverse effects
pediatric_age
children under 18contraindicated
not recommended for use in children; safety and efficacy have not been established
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderly 65 plusno specific adjustment required
use with standard precautions; no dose adjustment needed for topical application
monitor for skin irritation and photosensitivity
renal_impairment
mild to moderateno adjustment needed
no dose adjustment required due to minimal systemic absorption from topical formulation
standard monitoring
renal_impairment
severeuse with caution
use with caution due to limited data on severe renal impairment
monitor renal function
Use with caution and monitor for adverse effects.
hepatic_impairment
mild to moderateno adjustment needed
no dose adjustment required due to minimal systemic absorption
standard monitoring
hepatic_impairment
severeuse with caution
use with caution due to limited data on severe hepatic impairment
monitor liver function
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
FDA approval for Ameluz (10% aminolevulinic acid hydrochloride gel)
Drug class
ATC Code D11AX03 - Other dermatologicals
Primary indication
Approved therapeutic use
Treatment of actinic keratosis (AK) on the face and scalp, particularly for patients with mild to moderate lesions. May be used as part of a comprehensive skin cancer prevention strategy.
Aminolevulinic acid is a prodrug that penetrates skin and converts to protoporphyrin IX (PpIX) in abnormal keratinocytes. When exposed to red light at approximately 635nm wavelength, PpIX absorbs light energy and transfers it to oxygen, generating reactive oxygen species that cause cellular destruction through apoptosis and necrosis.
Must be activated by a compatible red light source; efficacy depends on proper light exposure. Patients should avoid sunlight and intense indoor light for 24-48 hours post-treatment to prevent unintended skin reactions. May cause significant erythema, edema, and discomfort at the treatment site. Contraindicated in patients with porphyria, cutaneous photosensitivity disorders, or known hypersensitivity to porphyrins. Only applied by or under supervision of qualified healthcare professionals.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy