ameluz
Ameluz (Aminolevulinic Acid Hydrochloride) is an optical imaging agent used to treat Actinic Keratosis.
Aminolevulinic Acid Hydrochloride · by Biofrontera
Key facts
- Active ingredient
- Aminolevulinic Acid Hydrochloride
- Drug class
- Optical Imaging Agent
- Form
- Topical
- Strength
- Aminolevulinic Acid Hydrochloride 10%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- actinic keratosis
- Manufacturer
- Biofrontera
- FDA application
- NDA208081
Drug class
May treat (source: NIH RxClass)
See how Ameluz ranks — best-rated optical imaging agent for:
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Ameluz treat?
- Ameluz (Aminolevulinic Acid Hydrochloride) may be used to treat actinic keratosis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Ameluz?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ameluz. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Ameluz?
- Ameluz is marketed by Biofrontera. You can see Biofrontera's full profile, rating, and other products on pharmaranks.
- Is Ameluz a brand-name or generic drug?
- Ameluz is a brand-name product with the active ingredient Aminolevulinic Acid Hydrochloride.
- Is Ameluz available over the counter?
- No. Ameluz is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Ameluz come in?
- Ameluz is currently marketed as topical, per the FDA's National Drug Code Directory.
- What class of drug is Ameluz?
- Ameluz is classified as optical imaging agent, porphyrin precursor, per the FDA's Established Pharmacologic Class.
- Is Ameluz FDA-registered?
- Ameluz is on record with the U.S. FDA under application number NDA208081. You can verify this on its official FDA label.
Information is sourced from public FDA regulatory data. Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
What people report to the FDA about AMINOLEVULINIC ACID HYDROCHLORIDE
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 71 reports naming AMINOLEVULINIC ACID HYDROCHLORIDE — the active ingredient in Ameluz, 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 HYDROCHLORIDE 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.
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