Aminolevulinic Acid: uses, dosing, side effects & brands
Aminolevulinic Acid is an optical imaging agent sold in the U.S. under 2 brand and generic names, for actinic keratosis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Optical Imaging Agent
- Treats (across its forms)
- Actinic Keratosis
- Available as
- Topical · Kit
- Sold as
- 2 products — Ameluz and Levulan
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How Levulan is dosed
From the FDA label for Levulan (application NDA020965). Other aminolevulinic acid products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
LEVULAN KERASTICK photodynamic therapy is a two-stage process for administration by a health care provider.( 2.1 ) Apply the drug product to the target lesions. ( 2.1 ) Illuminate with blue light using the BLU-U ® Blue Light Photodynamic Therapy Illuminator after the incubation time of( 2.2 ): 14 to 18 hours for scalp or face 3 hours for upper extremities, with occlusion LEVULAN KERASTICK photodynamic therapy may be repeated a second time for lesions that have not completely resolved after 8 weeks ( 2.1 ) For topical use only. ( 2.1) See full prescribing information for complete dosage and administration instruction. ( 2 ) See BLU-U user manual for detailed lamp safety and operating instructions. ( 2.2 ) 2.1 Preparation and Administration Overview After mixing, the LEVULAN KERASTICK topical solution 20% is intended for direct application to individual lesions diagnosed as actinic keratoses and not to perilesional skin. This product is not intended for application by patients or unqualified medical personnel. Application should involve lesions on the scalp, face or upper extremities; multiple lesions can be treated within a treatment region, but multiple treatment regions should not be treated simultaneously. The recommended treatment frequency is: one application of the LEVULAN KERASTICK topical solution and one dose of illumination per treatment region per 8-week treatment…
Everything below is the FDA label for Levulan (kit). Aminolevulinic Acid is also sold as topical, and those are different medicines to take — follow the label for the one you were prescribed.
Levulan side effects
The following adverse reactions are discussed in greater detail in the other sections of the labeling: Transient Amnestic Episodes [see Warnings and Precautions (5.1) ] Increased Photosensitivity [see Warnings and Precautions (5.2) ] Irritation [see Warnings and Precautions (5.3) ] Coagulation defects [see Warnings and Precautions (5.4) ] The most common local adverse reactions (incidence ≥ 10%) were erythema, edema, stinging/burning, scaling/crusting, itching, erosion, hypo/hyperpigmentation, oozing/vesiculation/crusting, scaling and dryness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Dermatology at 877-533-3872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, no non-cutaneous adverse events were found to be consistently associated with LEVULAN KERASTICK photodynamic therapy. Photodynamic Therapy Response: The constellation of transient local symptoms of stinging and/or burning, itching, erythema and edema as a result of LEVULAN KERASTICK photodynamic therapy (PDT) was observed in all clinical trials for actinic keratoses treatment. Stinging and/or…
Who shouldn’t take Levulan
The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is contraindicated in patients with: Cutaneous photosensitivity at wavelengths of 400-450 nm [see Warnings and Precautions (5.2) ] Porphyria or known allergies to porphyrins [see Warnings and Precautions (5.2) ] Known sensitivity to any of the components of the LEVULAN KERASTICK. Cutaneous photosensitivity at wavelengths of 400-450 nm. ( 4 ) Porphyria or known allergies to porphyrins. ( 4 ) Sensitivity to any of the components of the LEVULAN KERASTICK. ( 4 )
Levulan drug interactions
There have been no formal studies of the interaction of LEVULAN KERASTICK topical solution with any other drugs, and no drug-specific interactions were noted during any of the controlled clinical trials. It is, however, possible that concomitant use of other known photosensitizing agents such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines might increase the photosensitivity reaction of actinic keratoses treated with LEVULAN KERASTICK topical solution [see Warnings and Precautions (5.2) ] . Concomitant use of other known photosensitizing agents such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines might increase the photosensitivity reaction. ( 7 )
Every aminolevulinic acid product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Topical | No data | — | View → | |
| 2 | Not yet rated | Prescription | Kit | No data | — | View → |
How long aminolevulinic acid keeps
No aminolevulinic acid label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
What people report to the FDA about aminolevulinic acid
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 71 reports naming aminolevulinic acid, and the FDA flagged 96% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- hypotension27 reports
- vomiting8 reports
- blood pressure decreased6 reports
- atrial fibrillation5 reports
- hepatic function abnormal5 reports
- loss of consciousness5 reports
- nausea5 reports
- shock5 reports
Read these as a signal, not a rate. A report does not mean aminolevulinic acid caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
Related calculators
Frequently asked questions
What is Levulan?
LEVULAN KERASTICK (aminolevulinic acid HCl) for topical solution, 20%, a porphyrin precursor, contains the hydrochloride salt of aminolevulinic acid (ALA), an endogenous 5-carbon aminoketone. ALA HCl is a white to off-white, odorless crystalline solid that is very soluble in water, slightly soluble in methanol and ethanol, and practically insoluble in chloroform, hexane and mineral oil.
What kind of drug is aminolevulinic acid?
The FDA classifies aminolevulinic acid as an optical imaging agent. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take aminolevulinic acid with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run aminolevulinic acid against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is aminolevulinic acid sold under?
We track 2 aminolevulinic acid-containing products in the U.S.: Ameluz and Levulan. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does aminolevulinic acid come in?
Across the brands we track, aminolevulinic acid is currently marketed as topical and kit, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic aminolevulinic acid?
We do not currently list a generic-labelled aminolevulinic acid product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Aminolevulinic Acid: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/aminolevulinic-acid
- MLA
- “Aminolevulinic Acid: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/aminolevulinic-acid.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for aminolevulinic acid on DailyMed (NIH) ↗.