Prescription medicine

Aminolevulinic acid Brand names: Levulan, Gleolan, Ameluz

Aminolevulinic acid (Gleolan) is a prescription medicine with an FDA approval on record since 1999. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the aminolevulinic acid FDA label on DailyMed (effective January 29, 2026, NX DEVELOPMENT CORP); the NDA 20965 record on Drugs@FDA; every aminolevulinic acid label on DailyMed.

Highlights of the record

FDA label of January 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
Gleolan is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery.

Forms and strengths

1500 mg
100 mg/g

Kit; powder for solution; gel.

On the market

Earliest approval on file: December 3, 1999 Levulan, Sun Pharm Inds Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 3 of which 0 under generic applications, 3 under brand applications, repackagers included
Last listed patent: December 8, 2043 Ameluz gel; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 1,521 through July 30, 2026

What is aminolevulinic acid used for?

From the label: indications and usage
Gleolan is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery. Gleolan is an optical imaging agent indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery.

FDA pharmacologic class: Optical Imaging Agent and Porphyrin Precursor.

Source: FDA drug label (GLEOLAN), NDA208630 (Nxdc), as published by NX DEVELOPMENT CORP, effective January 29, 2026 (SPL set cdeded66-0017-42cf-9471-13f231014323), via openFDA; the full label on DailyMed

Is there a generic for aminolevulinic acid (Gleolan)?

No generic aminolevulinic acid is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists no patent for Gleolan for solution; a patent listed only for Ameluz gel runs to December 8, 2043. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

1999 earliest approval on file
2043 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the aminolevulinic acid label say about other medicines?

The aminolevulinic acid label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name aminolevulinic acid. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Griseofulvin	drug interactions	Due to the risk of possible phototoxic reactions, avoid administering phototoxic drugs such as St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines, and topical preparations containing ALA for 24 hours before and after administration of Gleolan.

Other labels that name aminolevulinic acid

Hexaminolevulinate

Check aminolevulinic acid against other medicines

What do FAERS reports show for aminolevulinic acid?

The FDA Adverse Event Reporting System holds 1,521 reports that list aminolevulinic acid among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9 are coded as a death and 54 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Drug Ineffective (a use or a product term, not a reaction)290
Wrong Technique In Product Usage Process (a use or a product term, not a reaction)182
Poor Quality Product Administered177
Product Quality Issue (a use or a product term, not a reaction)153
Product Dose Omission Issue (a use or a product term, not a reaction)114
Erythema (named in the label)106
Accidental Exposure To Product80
Off Label Use (a use or a product term, not a reaction)79

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Other optical imaging agents: the pharmacologic class, with prices and generics
Aminolevulinic acid side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other