Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Latanoprostene bunod
Drug ID BADD_D02404
Description Latanoprostene Bunod has been used in trials studying the treatment of Glaucoma, Ocular Hypertension, Open-Angle Glaucoma, Open Angle Glaucoma, and Intraocular Pressure. As of November 2, 2017 the FDA approved Bausch + Lomb's Vyzulta (latanoprostene bunod opthalmic solution), 0.024% for the indication of reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Latanoprostene bunod is the first prostaglandin analog with one of its metabolites being nitric oxide (NO). The novelty of this agent subsequently lies in the proposed dual mechanism of action that stems from both its prostaglandin F2-alpha analog latanoprost acid metabolite and its ability to donate NO for proposed tissue/cell relaxation effects. In comparison, both latanoprost and latanoprostene bunod contain a latanoprost acid backbone. Conversely however, latanoprostene bunod integrates an NO-donating moiety in lieu of the isopropyl ester typically found in latanoprost.
Indications and Usage Latanoprostene bunod opthalmic solution is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension [FDA Label].
Marketing Status approved; investigational
ATC Code S01EE06
DrugBank ID DB11660
KEGG ID D10441
MeSH ID C568859
PubChem ID 11156438
TTD Drug ID D05LQX
NDC Product Code 63415-0527; 82231-112; 76397-029; 61556-090; 24208-504; 54893-0091; 65035-155
UNII I6393O0922
Synonyms BOL 303259-X | BOL303259-X | BOL-303259-X | latanoprostene bunod | NCX 116 | NCX116 | NCX-116 | PF 3187207 | PF3187207 | PF-3187207
Chemical Information
Molecular Formula C27H41NO8
CAS Registry Number 860005-21-6
SMILES C1C(C(C(C1O)CC=CCCCC(=O)OCCCCO[N+](=O)[O-])CCC(CCC2=CC=CC=C2)O)O
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)
Burning sensation08.01.09.029; 17.02.06.0010.000548%-
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.0070.000731%
Drug ineffective08.06.01.0060.000731%-
Erythema23.03.06.0010.000365%-
Erythema of eyelid06.04.04.003; 23.03.06.0060.000365%-
Eye irritation06.04.05.0030.000967%-
Eye pain06.08.03.0020.001096%
Headache17.14.01.0010.000365%
Hyperaemia24.03.02.0020.000731%-
Hypersensitivity10.01.03.0030.000913%
Iritis06.04.03.002; 10.02.01.0220.000236%-
Macular oedema06.04.06.0050.000107%-
Ocular hyperaemia06.04.05.0040.001644%-
Pain08.01.08.0040.000913%
Paraesthesia17.02.06.005; 23.03.03.0940.000365%
Rash23.03.13.0010.000548%-
Visual impairment06.02.10.0130.000365%-
Foreign body sensation in eyes06.01.01.0060.000365%-
Conjunctival hyperaemia06.04.01.0040.000419%-
Eye pruritus06.04.05.0060.000602%-
Cystoid macular oedema06.04.06.010; 12.02.02.0050.000107%-
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