Aminolevulinic Acid side effects: what 1,521 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Aminolevulinic Acid Hydrochloride (Levulan Kerastick)
Who reports
1,521 reports · 13% serious · 9 with death outcome · 55% female
Used for
The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities.
What it is
LEVULAN KERASTICK (aminolevulinic acid HCl) for topical solution, 20%, a porphyrin precursor, contains the hydrochloride salt of aminolevulinic acid (ALA), an endogenous 5-carbon aminoketone. .
Boxed warning
None in the current label
Causality screen of the 26 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 17 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Poor quality product administered | 177 | 213.0 185.0–245.2ROR 237.0 · χ² 36,495 / p <1e-300 | 204.6 EB05 180.6 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Application site pain | 95 | 52.4 43.1–63.7ROR 55.3 · χ² 4,720 / p <1e-300 | 51.6 EB05 43.5 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious n=5 | no trial data cached |
| Application site erythema | 85 | 39.2 31.8–48.2ROR 41.1 · χ² 3,116 / p <1e-300 | 38.7 EB05 32.3 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=5 | no trial data cached |
| Product packaging quantity issue | 34 | 37.8 27.1–52.7ROR 38.5 · χ² 1,177 / p 3e-258 | 36.9 EB05 27.6 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | 91% clinician | no trial data cached |
| Product physical issue | 62 | 37.7 29.5–48.2ROR 39.1 · χ² 2,174 / p <1e-300 | 37.2 EB05 30.1 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Photosensitivity reaction (sun sensitivity) | 27 | 19.9 13.7–28.9ROR 20.2 · χ² 464 / p 3e-103 | 19.6 EB05 14.0 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.9 | no trial data cached |
| Laceration | 13 | 16.5 9.6–28.4ROR 16.6 · χ² 174 / p 5e-40 | 15.5 EB05 8.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Photophobia (light sensitivity) | 23 | 14.9 9.9–22.4ROR 15.1 · χ² 285 / p 4e-64 | 14.4 EB05 9.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 21.5 | no trial data cached |
| Product quality issue | 153 | 13.7 11.8–16.0ROR 15.0 · χ² 1,803 / p <1e-300 | 13.7 EB05 11.9 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 1.9 | no trial data cached |
| Blister | 52 | 11.2 8.6–14.7ROR 11.5 · χ² 475 / p 1e-105 | 10.9 EB05 8.5 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.0 | no trial data cached |
| Wrong technique in product usage process | 182 | 10.9 9.5–12.5ROR 12.1 · χ² 1,641 / p <1e-300 | 10.8 EB05 9.5 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 14.8 | no trial data cached |
| Accidental exposure to product | 81 | 9.8 7.9–12.1ROR 10.2 · χ² 634 / p 3e-140 | 9.6 EB05 7.9 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 14.0 | no trial data cached |
| Eye irritation | 36 | 7.8 5.7–10.8ROR 8.0 · χ² 207 / p 3e-47 | 7.2 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 27.7 | no trial data cached |
| Basal cell carcinoma | 10 | 7.7 4.2–14.4ROR 7.8 · χ² 52 / p 3e-13 | 6.0 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Lacrimation increased | 19 | 7.7 4.9–12.0ROR 7.8 · χ² 104 / p 1e-24 | 6.7 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Device defective | 10 | 7.5 4.0–13.9ROR 7.5 · χ² 50 / p 9e-13 | 5.8 EB05 3.3 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Erythema (skin redness) | 116 | 6.8 5.7–8.1ROR 7.3 · χ² 577 / p 8e-128 | 6.7 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 · ♀ 77% (drug 55%) | no trial data cached |
| Product complaint | 14 | 6.8 4.0–11.4ROR 6.8 · χ² 63 / p 8e-16 | 5.7 EB05 3.6 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Product administration error | 11 | 6.7 3.7–12.0ROR 6.7 · χ² 47 / p 3e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Eye swelling | 20 | 6.5 4.2–10.1ROR 6.6 · χ² 89 / p 3e-21 | 5.8 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Application site pruritus | 11 | 5.9 3.3–10.6ROR 5.9 · χ² 40 / p 2e-10 | 4.8 EB05 2.9 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Burning sensation | 31 | 5.3 3.8–7.6ROR 5.4 · χ² 105 / p 5e-25 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.6 · 83% consumer | no trial data cached |
| Skin exfoliation | 36 | 5.2 3.8–7.2ROR 5.3 · χ² 120 / p 4e-28 | 4.9 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 71% consumer | no trial data cached |
| Product dose omission issue | 114 | 4.8 4.1–5.8ROR 5.1 · χ² 348 / p 5e-78 | 4.7 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Skin burning sensation | 19 | 3.2 2.1–5.0ROR 3.3 · χ² 27 / p 1e-7 | 3.0 EB05 2.1 · IC025 +0.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 26.9 | no trial data cached |
| Device issue | 15 | 2.1 1.3–3.4ROR 2.1 · χ² 7 / p 0.003 | 2.0 EB05 1.3 · IC025 +0.1 | Reporting / coding artifact | – | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Wrong technique in product usage process | 182 | 10.9 9.5–12.5ROR 12.1 · χ² 1,641 / p <1e-300 | 10.8 EB05 9.5 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 14.8 | no trial data cached |
| Poor quality product administered | 177 | 213.0 185.0–245.2ROR 237.0 · χ² 36,495 / p <1e-300 | 204.6 EB05 180.6 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Product quality issue | 153 | 13.7 11.8–16.0ROR 15.0 · χ² 1,803 / p <1e-300 | 13.7 EB05 11.9 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 1.9 | no trial data cached |
| Erythema (skin redness) | 116 | 6.8 5.7–8.1ROR 7.3 · χ² 577 / p 8e-128 | 6.7 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 · ♀ 77% (drug 55%) | no trial data cached |
| Product dose omission issue | 114 | 4.8 4.1–5.8ROR 5.1 · χ² 348 / p 5e-78 | 4.7 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Application site pain | 95 | 52.4 43.1–63.7ROR 55.3 · χ² 4,720 / p <1e-300 | 51.6 EB05 43.5 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious n=5 | no trial data cached |
| Application site erythema | 85 | 39.2 31.8–48.2ROR 41.1 · χ² 3,116 / p <1e-300 | 38.7 EB05 32.3 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=5 | no trial data cached |
| Accidental exposure to product | 81 | 9.8 7.9–12.1ROR 10.2 · χ² 634 / p 3e-140 | 9.6 EB05 7.9 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 14.0 | no trial data cached |
| Product physical issue | 62 | 37.7 29.5–48.2ROR 39.1 · χ² 2,174 / p <1e-300 | 37.2 EB05 30.1 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Blister | 52 | 11.2 8.6–14.7ROR 11.5 · χ² 475 / p 1e-105 | 10.9 EB05 8.5 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.0 | no trial data cached |
| Skin exfoliation | 36 | 5.2 3.8–7.2ROR 5.3 · χ² 120 / p 4e-28 | 4.9 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 71% consumer | no trial data cached |
| Eye irritation | 36 | 7.8 5.7–10.8ROR 8.0 · χ² 207 / p 3e-47 | 7.2 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 27.7 | no trial data cached |
| Product packaging quantity issue | 34 | 37.8 27.1–52.7ROR 38.5 · χ² 1,177 / p 3e-258 | 36.9 EB05 27.6 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | 91% clinician | no trial data cached |
| Burning sensation | 31 | 5.3 3.8–7.6ROR 5.4 · χ² 105 / p 5e-25 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.6 · 83% consumer | no trial data cached |
| Photosensitivity reaction (sun sensitivity) | 27 | 19.9 13.7–28.9ROR 20.2 · χ² 464 / p 3e-103 | 19.6 EB05 14.0 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.9 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Poor quality product administered — n=177, PRR 213.0
- Photophobia — n=23, PRR 14.9
- Eye swelling — n=20, PRR 6.5
- Skin exfoliation — n=36, PRR 5.2
✓ A hand-written Bradford Hill causality assessment exists for this drug: Zoledronic acid (bisphosphonates) ↔ Osteonecrosis of the jaw.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Aminolevulinic Acid?
In FDA FAERS, the most frequently co-reported reaction terms for Aminolevulinic Acid are poor quality product administered, erythema, application site pain, application site erythema, blister, skin exfoliation. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Aminolevulinic Acid have an FDA boxed warning?
No. The FDA label retrieved for Aminolevulinic Acid has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Aminolevulinic Acid causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID e45cc371-9ebc-4904-12bc-65cb4e2817ad, effective 20240912; matched on
openfda.generic_name.exact:"AMINOLEVULINIC ACID HYDROCHLORIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 43 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.