Aminolevulinic Acid Topical
Aminolevulinic acid topical is a light-activated skin treatment used with photodynamic therapy to treat actinic keratoses (rough, precancerous sun-damage spots) on the face and scalp.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Aminolevulinic Acid Topical: Patient Information Guide
A plain-language walkthrough of Aminolevulinic Acid Topical — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Aminolevulinic Acid Topical is used for
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Aminolevulinic acid topical is used with light therapy for a sun-related skin condition.
- Ameluz gel, with BF-RhodoLED or RhodoLED XL red light PDT, treats mild-to-moderate actinic keratoses (AKs) on the face and scalp.
- It can be used for individual lesions or for a whole affected field of skin.
How Aminolevulinic Acid Topical works
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Aminolevulinic acid is a prodrug. Your skin turns it into protoporphyrin IX (PpIX), a light-sensitive compound that builds up in the treated skin.
When red light hits PpIX in the presence of oxygen, it forms reactive oxygen species. These damage cell parts and eventually destroy the cells.
How Aminolevulinic Acid Topical is taken (dosage)
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Ameluz is given only by a health care provider, as part of a multi-step in-office treatment.
- The skin is cleaned with alcohol, and scales and crusts are removed.
- A thin layer of gel is applied to lesions and a small border of nearby skin.
- The area is covered with a light-blocking dressing for 3 hours.
- The gel is wiped off and the area is lit right away with a red lamp.
Lesions that have not fully cleared after 3 months may be retreated. Eye protection is worn during the light treatment.
Aminolevulinic Acid Topical side effects in detail
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Skin reactions at the treated area are very common and usually start during or soon after the light treatment.
- Redness
- Pain or burning
- Irritation
- Swelling
- Itching
- Peeling
- Scabbing
- Hardened skin and small blisters
Most reactions are mild or moderate and last 1 to 4 days, though some last 1 to 2 weeks or longer. Severe pain or burning occurred in up to 30% of people in studies. Call your provider about allergic reactions, memory loss or confusion, or eye problems.
Aminolevulinic Acid Topical warnings and precautions
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- Light sensitivity: avoid sun, tanning beds and sun lamps on treated skin for about 48 hours.
- Allergic reactions: these can be severe, including anaphylaxis. The gel is washed off if one occurs.
- Temporary memory loss: reported after treatment. Contact your provider if it happens.
- Eye injury: the lamp can injure eyes. Protective eyewear is required. Eyelid swelling and dry eyes have also occurred.
- Mucous membranes: avoid contact with the eyes, nose, mouth and ears. Rinse with water if contact occurs.
- Bleeding disorders: take special care to avoid bleeding during skin preparation.
Aminolevulinic Acid Topical interactions: what it interacts with
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No formal interaction studies were done. Medicines that increase light sensitivity may strengthen the skin reaction to PDT.
- St. John’s wort
- Griseofulvin
- Thiazide diuretics
- Sulfonylureas
- Phenothiazines
- Sulphonamides
- Quinolones
- Tetracyclines
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
Before taking Aminolevulinic Acid Topical
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- Do not use with a known allergy to porphyrins or to any Ameluz ingredient, including soybean phosphatidylcholine.
- Do not use with porphyria or photodermatoses.
- Tell your provider if you have a bleeding or clotting disorder.
- Pregnancy and breastfeeding: little is absorbed into the body, so exposure of the baby is not expected. There is no human pregnancy data.
- Under 18: safety and effectiveness have not been established.
- Older adults: no overall differences were seen, but some may be more sensitive.
Pharmacodynamics: what Aminolevulinic Acid Topical does in the body
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Aminolevulinic acid itself does not glow, but PpIX does. How Ameluz acts on the body in AK treatment has not been defined. Light-activated PpIX is what damages the targeted cells.
Pharmacokinetics: how your body processes Aminolevulinic Acid Topical
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Very little aminolevulinic acid gets into the bloodstream after skin application. Blood levels rose up to about 2.5-fold, peaking around 3 hours. Levels of the active PpIX in the blood were mostly very low or undetectable, so absorption into the body is considered negligible.
How to store Aminolevulinic Acid Topical
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AMELUZ (aminolevulinic acid hydrochloride) topical gel, 10% is a white-to-yellowish gel. Store AMELUZ in a refrigerator, 2°C – 8°C (36°F – 46°F). stored for up to 12 weeks in a refrigerator at 2°C – 8°C (36°F – 46°F) if the tube is tightly closed.
📄 Written from Aminolevulinic Acid Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Aminolevulinic Acid Topical: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Aminolevulinic Acid Topical — the kind of thing our pharmacy team would talk through with you at the counter.
What is this treatment for?
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Can I use it at home?
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What side effects should I expect?
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Do I need to protect my skin afterward?
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When should I call my provider?
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Do my other medicines matter?
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Is Aminolevulinic Acid Topical available over the counter?
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When was Aminolevulinic Acid Topical first available?
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💬 Answers drafted from Aminolevulinic Acid Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Aminolevulinic Acid Topical on HelloPharmacist
💊 Aminolevulinic Acid Topical forms and strengths (how it comes)
Aminolevulinic Acid Topical is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Topical cream, ointment or gel
How this form is used
- Ameluz gel with red light PDT treats mild-to-moderate actinic keratoses on the face and scalp.
- Ameluz can be used for single lesions or for a whole affected area.
- Ameluz is applied only by a health care provider and is for skin use only, not for the eyes, mouth or vagina.
- Ameluz stays on under a light-blocking dressing for 3 hours before red light treatment.
- After Ameluz treatment, protect the skin from sunlight and intense light for about 48 hours.
📊 Aminolevulinic Acid Topical on the U.S. market: products, makers and brands
How Aminolevulinic Acid Topical appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
📈 How widely Aminolevulinic Acid Topical is used (Medicaid data)
A general measure of how commonly Aminolevulinic Acid Topical is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Aminolevulinic Acid Topical is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Aminolevulinic Acid Topical prescribed? Of the 1,599 medications we measure, Aminolevulinic Acid Topical ranks #1,359 by Medicaid prescriptions — more than 15% of them.
Utilization by Aminolevulinic Acid Topical product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
aminolevulinic acid hydrochloride 0.1 MG/MG Topical Gel
Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1806645
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Aminolevulinic Acid Topical, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 5 listed Aminolevulinic Acid Topical NDCs with Medicaid activity.
🔍 Compare Aminolevulinic Acid Topical products
A representative set of FDA-listed product records for Aminolevulinic Acid Topical — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Topical cream, ointment or gel | ||||
| 100 mg/g | Topical | Biofrontera Inc. × 7 listings | NDA | View NDC → |
Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Aminolevulinic Acid Topical NDCs →
📈 Aminolevulinic Acid Topical side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Aminolevulinic Acid Topical — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Aminolevulinic Acid Topical in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Aminolevulinic Acid Topical FDA approval history
How Aminolevulinic Acid Topical went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Aminolevulinic Acid Topical recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 683 1 dose form · 1 strength
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Dose form (SCDF) Topical Gel RxCUI 1806644In current FDA listingsClinical drug / strength (SCD) hydrochloride 0.1 MG/MGRxCUI 1806645
Look up RxCUI 683 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Aminolevulinic Acid Topical supply and shortage status
Whether Aminolevulinic Acid Topical is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Aminolevulinic Acid Topical brand names
🏭 Who makes Aminolevulinic Acid Topical: manufacturers and labelers
Aminolevulinic Acid Topical drug class (RxNorm)
Aminolevulinic Acid Topical belongs to the Porphyrin Precursor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Sources for this Aminolevulinic Acid Topical page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Biofrontera Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.