OpenClaim

Aminolevulinic Side Effects

The most commonly reported side effects of aminolevulinic include wrong technique in product usage process, off label use, and product quality issue, based on 1,694 FDA adverse event reports from 2004 to 2025. 17.3% of reports found the drug to be ineffective.

#1 Reported: Wrong Technique In Product Usage ProcessAll side effects ↓Top Co-Medication: LevetiracetamDrug interactions ↓50% of Reports Are ElderlyDemographics ↓

Aminolevulinic side effects

Percentages show how often each reaction appears relative to total reports for aminolevulinic.

1
Drug Ineffective17.3%293
2
Wrong Technique In Product Usage Process10.2%173
3
Off Label Use8.7%148
4
Product Quality Issue7.8%132
5
Poor Quality Product Administered7.3%124
6
Erythema6.8%115
7
Product Dose Omission Issue5.5%94
8
Application Site Pain5.5%93
9
Application Site Erythema4.8%82
10
Accidental Exposure To Product4.3%73
11
Pain4.2%71
12
Blister3.1%52
13
Product Physical Issue2.8%48
14
Eye Irritation2.1%35
15
Skin Exfoliation2.1%35

These are voluntary reports and do not establish that aminolevulinic caused these reactions.

Report severity

18.3%Serious310 reports
5.3%Hospitalizations90 reports
1.2%Fatal20 reports

Seriousness is determined by the reporter, not by OpenClaim.

Aminolevulinic drug interactions

Other drugs that appear in adverse event reports alongside aminolevulinic. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Levetiracetam0.6%10
2
Carmustine0.5%9
3
Dexamethasone0.5%8
4
Fluorouracil0.3%5
5
Temozolomide0.3%5
6
Fentanyl0.3%5
7
Propofol0.3%5
8
Lidocaine0.3%5
9
Imiquimod0.2%4
10
Rocuronium-bromide0.2%4
11
Bupivacaine0.2%4
12
Lenalidomide0.1%2
13
Doxycycline0.1%2
14
Epinephrine0.1%2
15
Lansoprazole0.1%2

Taken alongside

1
Aspirin1.5%25
2
Levothyroxine-sodium1.4%24
3
Acetaminophen1.3%22
4
Lisinopril1.1%19
5
Atorvastatin-calcium1.1%18
6
Omeprazole1.1%18
7
Levetiracetam1.0%17
8
Hydrochlorothiazide0.9%16
9
Dexamethasone0.9%16
10
Rosuvastatin0.9%15
11
Ergocalciferol0.9%15
12
Cefazolin-sodium0.8%14
13
Fish0.8%13
14
Amlodipine0.8%13
15
Propofol0.8%13

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports aminolevulinic side effects

39.0% of aminolevulinic adverse event reports involve female patients and 32.2% involve male patients. The largest age group is elderly at 50%. These figures reflect who reports side effects, not underlying risk.

Sex

Female39.0%
Male32.2%
Unknown28.8%

Age group

< 20.1%
2–111.2%
12–172.2%
18–6446.5%
65+49.9%

What is aminolevulinic used for

Conditions and purposes for which patients were taking aminolevulinic when the adverse event was reported.

AcneActinic KeratosisAlopecia AreataAnaplastic OligodendrogliomaAnogenital WartsAstrocytomaAcneActinic ElastosisActinic KeratosisAnogenital WartsArsenical KeratosisBarrett's OesophagusBasal Cell CarcinomaBasal Cell Naevus SyndromeBowen^s Disease

Showing 15 of 90 indications

Aminolevulinic brand names and reporting trend

Aminolevulinic is sold under the brand name Levulan.

Brand names

Levulan112

Quarterly reports (2004–2025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking aminolevulinic with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.

Check my medications