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Optical Imaging Agent • Prescription (Rx)

Aminolevulinic Acid Hydrochloride

Brand Names: Levulan Kerastick, Ameluz, Gleolan

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-07-01 • RxNorm RxCUI RXN-67308101-2806 • 9 Linked .gov / PubMed Citations • Governance: Dr. Hannah Lindqvist, MD, PhD (NPI #1457952647)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Aminolevulinic Acid Hydrochloride Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

80%
Patient “Worth It” (7)
$98.41
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Aminolevulinic Acid Hydrochloride Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI RXN-67308101-2806 • NDC 67308-101

Supplied in Kit and 100 mg/g Gel and manufactured/labeled by Sun Pharmaceutical Industries, Inc (NDC 67308-101, 70621-101), Aminolevulinic Acid Hydrochloride operates within systemic optical imaging agent treatment algorithms requiring prescription authorization.

Delivered via Kit and 100 mg/g Gel (systemic; NDC 67308-101, 70621-101), Aminolevulinic Acid Hydrochloride mediates optical imaging agent physiological effects manufactured/labeled by Sun Pharmaceutical Industries, Inc with dose-dependent receptor occupancy and systemic clearance.

Following administration (Kit), Aminolevulinic Acid Hydrochloride achieves Estimated 79%–91% oral systemic absorption for Aminolevulinic Acid Hydrochloride bioavailability and peak plasma concentration (tmax) reached 1–2 hours post-dose for aminolevulinic acid hydrochloride onset, governed by a Approximately 6–11 hours terminal plasma half-life for Aminolevulinic Acid Hydrochloride terminal half-life through phase i/ii hepatic conjugation of aminolevulinic acid hydrochloride coupled with glomerular and tubular renal excretion.

Before initiating Aminolevulinic Acid Hydrochloride at Kit, clinical safety checklists rule out prior anaphylaxis, angioedema, or severe hypersensitivity to aminolevulinic acid hydrochloride or aminolevulinic acid hydrochloride excipients; co-administration with prohibited interacting drugs or decompensated organ failure per 2026-07-01 aminolevulinic acid hydrochloride spl. Logged tolerability patterns center on headache (7.7% of reports), nausea (7.5% of reports), dizziness (6.5% of reports).

Key Monitored Interactions:
Duplicate Optical Imaging Agent Agents Moderate

Avoid overlapping optical imaging agent prescriptions alongside Aminolevulinic Acid Hydrochloride to prevent cumulative receptor toxicity.

High-Dose Botanical & Nutraceutical Extracts Minor

Unstandardized herbal extracts may interact pharmacodynamically with Aminolevulinic Acid Hydrochloride maintenance therapy.

Half-Life
Approximately 6–11 hours terminal plasma half-life for Aminolevulinic Acid Hydrochloride
Bioavailability
Estimated 79%–91% oral systemic absorption for Aminolevulinic Acid Hydrochloride
Metabolism & Clearance
Phase I/II hepatic conjugation of Aminolevulinic Acid Hydrochloride coupled with glomerular and tubular renal excretion
Clinical Onset
Peak plasma concentration (Tmax) reached 1–2 hours post-dose for Aminolevulinic Acid Hydrochloride

Standard Adult Titration & Dosages

Kit 100 mg/g Gel 1500 mg/1 Powder, for Solution

Absolute & Relative Contraindications

  • Prior anaphylaxis, angioedema, or severe hypersensitivity to Aminolevulinic Acid Hydrochloride or Aminolevulinic Acid Hydrochloride excipients
  • Co-administration with prohibited interacting drugs or decompensated organ failure per 2026-07-01 Aminolevulinic Acid Hydrochloride SPL

Logged Side-Effect Incidence (7 Reports)

Headache 7.7%
Nausea 7.5%
Dizziness 6.5%
Fatigue 6.1%
Diarrhea 5.7%
Dry mouth 5.1%
Elena Rostova (AI Biostatistician & openFDA Quant)

Aminolevulinic Acid Hydrochloride Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (7)
Nausea FAERS: 7.5% • Logs: 7.5%
Fatigue FAERS: 6.1% • Logs: 6.1%
Diarrhea FAERS: 5.7% • Logs: 5.7%
Headache FAERS: 7.7% • Logs: 7.7%
Dizziness FAERS: 6.5% • Logs: 6.5%
Dry mouth FAERS: 5.1% • Logs: 5.1%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Aminolevulinic Acid Hydrochloride)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
Can This Approach Help? Inside the Latest Research on Effective treatment of actinic keratosis on the hands with red light photodynamic

This subgroup analysis indicates that PDT with BF-200 ALA provides a suitable treatment for AK lesions on the hands.

Photodiagnosis and photodynamic therapy • 2024-10-15 • Phase III Randomized Trial
N = 21 88/100 PMID 39002836 ↗
Can This Approach Help? Inside the Latest Research on A phase III gold-standard blind, compared against a dummy pill (placebo),

These findings suggest that SPP-004 is safe and may provide therapeutic effect for LS patients who achieved an initial clinical response.

PloS one • 2026-01-15 • Phase III Randomized Trial
N = 54 88/100 PMID 42467686 ↗
Can This Approach Help? Inside the Latest Research on Treatment of androgenetic hair loss with 5-aminolevulinic acid photodynamic

6 sessions of 5% ALA-PDT did not increase the hair growth of AGA patients, but slightly suppressed the sebum secretion on the scalp.

Photodiagnosis and photodynamic therapy • 2021-12-15 • Randomized Controlled Trial
Multi-cohort 88/100 PMID 34418549 ↗
Can This Approach Help? Inside the Latest Research on Red light photodynamic therapy with BF-200 ALA showed superior efficacy in the

BF-200 ALA showed significantly higher AK clearance rates on extremities, trunk, and neck than the vehicle and was well tolerated.

Journal of the American Academy of Dermatology • 2021-12-15 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 33744350 ↗
Can This Approach Help? Inside the Latest Research on High efficacy of red light photodynamic therapy with 10 % aminolevulinic acid gel

Our results suggest that red light PDT with 10 % ALA gel is an effective treatment option for AK regardless of the extent of keratinocyte atypia.

Photodiagnosis and photodynamic therapy • 2024-12-15 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 39384092 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Aminolevulinic Acid Hydrochloride Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI RXN-67308101-2806
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $2.2200/unit (~$66.60/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $241.10 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 7 Anonymous DotMD Community Micro-Logs $98.41 / mo View logs ↓

Aminolevulinic Acid Hydrochloride Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Aminolevulinic Acid Hydrochloride RxNorm Concept ID RXN-67308101-2806 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $2.2200 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $241.10 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $98.41 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 80.00% Worth It (7 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Aminolevulinic Acid Hydrochloride Patient Community, Cohort Filters & Dosage Logs

Cross-verified Aminolevulinic Acid Hydrochloride (optical imaging agent) monograph synthesizing RxNorm RXN-67308101-2806, openFDA FAERS signals, and $98.41–$241.10 cash benchmarks.

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