What the label lists and what reports show
Aminolevulinic acid side effects
Aminolevulinic acid's FDA label lists its adverse reactions in its own words. FAERS holds 1,521 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is poor quality product administered (177 reports).
- No generic listed
Check it at the source: the aminolevulinic acid FDA label on DailyMed (effective January 29, 2026, NX DEVELOPMENT CORP); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsAdverse reactions occurring in >1% of patients in the week following surgery were pyrexia, hypotension, nausea, and vomiting. ( 6.1 ) Adverse reactions occurring in < 1% of patients in the first 6 weeks after surgery were: chills, photosensitivity reaction, solar dermatitis, hypotension, abnormal liver function test, and diarrhea. ( 6.1 ) Neurologic events related to the surgical procedure occurred in 29% of patients and included: aphasia, hemiparesis, hemianopia, headache, seizure, hemiplegia, monoparesis, hypoesthesia, and brain edema. ( 6.1 ) Elevated liver enzymes occurred in clinical studies. There were no cases of liver failure. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact NXDC toll-free at (844) 517-5252 and adverseevents@nxdevcorp.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
TABLE 2 Post-PDT Cutaneous Adverse Events – ALA-018/ALA-019 For the Face and Scalp
This table is printed in the LEVULAN KERASTICK label published by Sun Pharmaceutical Industries, Inc of September 12, 2024; the label quoted above does not print one.
| Degree of Severity | Mild/ Moderate | Severe | Mild/ Moderate | Severe | Mild/ Moderate | Severe | Mild/ Moderate | Severe |
|---|---|---|---|---|---|---|---|---|
| Scaling/Crusting | 71% | 1% | 12% | 0% | 64% | 2% | 19% | 0% |
| Pain | 1% | 0% | 0% | 0% | 0% | 0% | 0% | 0% |
| Tenderness | 1% | 0% | 0% | 0% | 2% | 0% | 0% | 0% |
| Itching | 25% | 1% | 7% | 0% | 14% | 7% | 19% | 0% |
| Edema | 1% | 0% | 0% | 0% | 0% | 0% | 0% | 0% |
| Ulceration | 4% | 0% | 0% | 0% | 2% | 0% | 0% | 0% |
| Bleeding/Hemorrhage | 4% | 0% | 0% | 0% | 2% | 0% | 0% | 0% |
| Vesiculation | 4% | 0% | 0% | 0% | 5% | 0% | 0% | 0% |
| Pustules | 4% | 0% | 0% | 0% | 0% | 0% | 0% | 0% |
| Oozing | 1% | 0% | 0% | 0% | 0% | 0% | 0% | 0% |
| Dysesthesia | 2% | 0% | 0% | 0% | 0% | 0% | 0% | 0% |
| Scabbing | 2% | 1% | 0% | 0% | 0% | 0% | 0% | 0% |
| Erosion | 14% | 1% | 0% | 0% | 2% | 0% | 0% | 0% |
| Excoriation | 1% | 0% | 0% | 0% | 0% | 0% | 0% | 0% |
| Wheal/Flare | 7% | 1% | 0% | 0% | 2% | 0% | 0% | 0% |
| Skin disorder NOS | 5% | 0% | 0% | 0% | 12% | 0% | 5% | 0% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, 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
What do FAERS reports show?
1,521 reports list aminolevulinic acid among the medicines taken, 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. Of the 18 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Aminolevulinic acid: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions