Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Hexaminolevulinate hydrochloride
Drug ID BADD_D01069
Description Hexaminolevulinate is an optical imaging drug. In solution form it is instilled intravesically for use with photodynamic blue light cystoscopy as an adjunct to white light cystoscopy. On May 28, 2010, the U.S. Food and Drug Administration (FDA) granted approval for hexaminolevulinate hydrochloride (Cysview for Intravesical Solution, Photocure ASA), as an optical imaging agent for use in combination with the Karl Storz Photodynamic Diagnostic D-Light C (PDD) System for cystoscopic detection of non-muscle invasive papillary cancer of the bladder for patients suspected or known to have lesion(s) on the basis of a prior cystoscopy. Hexaminolevulinate is manufactured under the brand Cysview® by Photocure ASA. In Europe, Hexaminolevulinate is marketed under the brand Hexvix®.
Indications and Usage Hexaminolevulinate is indicated for use in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy.
Marketing Status approved
ATC Code V04CX06
DrugBank ID DB06261
KEGG ID D04436
MeSH ID C419924
PubChem ID 6433082
TTD Drug ID Not Available
NDC Product Code 10511-3001; 68225-068
UNII D4F329SL1O
Synonyms 5-aminolevulinic acid hexyl ester | aminolevulinic acid hexylester | hexa ALA | hexyl-aminolevulinate | hexylaminolevulinate | ALA hexyl ester | 5-ALAHE | hexaminolevulinate | (14C)-hexaminolevulinate | hexaminolevulinate hydrochloride
Chemical Information
Molecular Formula C11H22ClNO3
CAS Registry Number 140898-91-5
SMILES CCCCCCOC(=O)CCC(=O)CN.Cl
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Anaphylactic shock10.01.07.002; 24.06.02.004---
Anaphylactoid reaction10.01.07.003; 24.06.03.007---
Bladder pain20.02.02.001---
Cystitis11.01.14.001; 20.03.02.002--
Dysuria20.02.02.002--
Haematuria20.02.01.006; 21.10.01.018; 24.07.01.047--
Hypersensitivity10.01.03.003--
Bladder spasm20.02.02.013--
Urine analysis abnormal13.13.02.008---
Cystitis noninfective20.03.02.001--
Anaphylactoid shock10.01.07.004; 24.06.02.005---
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