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 Ameluz is dosed
From the FDA label for Ameluz (application NDA208081). Other aminolevulinic acid products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer AMELUZ only by a health care provider ( 2.1 ). AMELUZ is for topical use only ( 2.1 ). Use AMELUZ in combination with red light photodynamic therapy (PDT). See BF-RhodoLED or RhodoLED XL user manual for detailed lamp safety and operating instructions ( 2.1 ). Photodynamic therapy with AMELUZ involves preparation of lesions, application of the product, occlusion and illumination with BF-RhodoLED or RhodoLED XL lamp ( 2.3 ). Apply an approximately 1 mm thick layer of AMELUZ to skin lesion(s). Cover individual lesions or the entire AK-field with AMELUZ. Include approximately 5 mm of the surrounding skin. Do not exceed an application area of 60 cm 2 . Do not use more than 6 grams of AMELUZ (3 tubes) at one time ( 2.2 ). Retreat lesions that have not completely resolved 3 months after the initial treatment ( 2.2 ). 2.1 Important Administration Information AMELUZ, in conjunction with lesion preparation, is only to be administered by a health care provider. AMELUZ is for topical use only. Not for ophthalmic, oral, or intravaginal use. Treat single lesions or an entire field affected by multiple lesions with AMELUZ, in combination with red light photodynamic therapy (PDT). PDT requires administration of both AMELUZ and BF-RhodoLED or RhodoLED XL light. Refer to BF-RhodoLED or RhodoLED XL user manual for detailed lamp safety and operating instructions. Adhere to all safety…
Everything below is the FDA label for Ameluz (topical). Aminolevulinic Acid is also sold as kit, and those are different medicines to take — follow the label for the one you were prescribed.
Ameluz side effects
The following adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity [ see Warnings and Precautions (5.1) ]. Transient Amnestic Episodes [ see Warnings and Precautions (5.2) ] . Risk of BF-RhodoLED or RhodoLED XL Lamp Induced Eye Injury [see Warnings and Precautions (5.3) ] . Ophthalmic Adverse Reactions [see Warnings and Precautions (5.4) ]. Increased Photosensitivity [see Warnings and Precautions (5.5) ] . Most common adverse reactions (≥10%) were application site erythema, pain/burning, irritation, edema, pruritus, exfoliation, scab, induration, and vesicles ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Biofrontera Inc. at 1-844-829-7434 or FDA at 1-800-332-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates 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. The clinical program for AMELUZ included three double-blind and placebo-controlled phase 3 trials (Trials 1, 2, and 3), enrolling a total of 299 subjects that were treated with narrow band light. Trial subjects were adults greater than or equal to 49 years of age, and the majority had Fitzpatrick skin type I, II, or III. No subjects had…
Who shouldn’t take Ameluz
AMELUZ is contraindicated in patients with: Known hypersensitivity to porphyrins. Known hypersensitivity to any of the components of AMELUZ, which includes soybean phosphatidylcholine [see Warnings and Precautions (5.1) ] . Porphyria. AMELUZ use may cause uncontrolled phototoxic effects [see Warnings and Precautions (5.5) ] . Photodermatoses. PDT may worsen the phototoxic or photoallergic reactions [see Warnings and Precautions (5.5) ] . Known hypersensitivity to porphyrins ( 4 ). Known hypersensitivity to any component of AMELUZ, which includes soybean phosphatidylcholine ( 4 ). Porphyria ( 4 ). Photodermatoses ( 4 ).
Ameluz drug interactions
There have been no formal studies of the interaction of AMELUZ with other drugs. It is possible that concomitant use of other known photosensitizing agents such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines may enhance the phototoxic reaction to PDT [see Warnings and Precautions (5.3) ] . Concomitant use of the following medications may enhance the phototoxic reaction to photodynamic therapy: St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones, and tetracyclines ( 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.
Does aminolevulinic acid expire? The in-use limits and storage rules from its labelsWhat 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 section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
Related calculators
Frequently asked questions
What is Ameluz?
AMELUZ (aminolevulinic acid hydrochloride) topical gel, 10% is a non-sterile white-to-yellowish gel. The gel formulation contains a nanoemulsion. Aminolevulinic acid, a porphyrin precursor, is a white to off-white crystalline solid. It is readily soluble in water, methanol, and dimethylformamide.
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) ↗.