Drug Landscape ›
HEXAMINOLEVULINATE ›
Regulatory · United States
Marketing authorisation
FDA
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
Window: 20 April 2025 – 20 April 2026
Total reports: 13
Most-reported reactions
Arthritis Reactive — 2 reports (15.38%) Cystitis Noninfective — 2 reports (15.38%) Post Procedural Complication — 2 reports (15.38%) Agitation — 1 report (7.69%) Anaphylactic Shock — 1 report (7.69%) Angina Pectoris — 1 report (7.69%) Arthralgia — 1 report (7.69%) Blood Pressure Decreased — 1 report (7.69%) Blood Urine Present — 1 report (7.69%) Conjunctival Hyperaemia — 1 report (7.69%)
Source database →
HEXAMINOLEVULINATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is HEXAMINOLEVULINATE approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for HEXAMINOLEVULINATE in United States?
Marketing authorisation holder not available in our data.