Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ubrogepant
Drug ID BADD_D02604
Description Ubrogepant is indicated for the acute treatment of migraine headaches with or without aura in adults.[L10926] It was approved by the FDA on December 23, 2019, and is the first oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine.[L10959] Several oral small molecule CGRP receptor antagonists, belonging to a class of medications referred to as "gepants", have been investigated for migraines, but only ubrogepant and [rimegepant] remain in clinical development.[A189207,A189213] Previous agents within this class were efficacious but limited by liver toxicity - this led to the development of ubrogepant, which was designed to be a hepatoxicity-free alternative to its predecessors.[A189195] Several parenteral monoclonal antibodies acting against the CGRP pathway (e.g. [erenumab], [fremanezumab], [galcanezumab]) have also been approved in recent years.[A189207] Compared to the current standard of therapy for migraine treatment, namely triptans such as [sumatriptan] and [almotriptan], CGRP antagonists present several advantages.[A189195] They appear to be better tolerated, do not contribute to medication overuse headaches, and carry no apparent cardiovascular risk, making them suitable for use in patients with cardiovascular disease.[A189195] The development of oral gepants, including ubrogepant, may therefore constitute a significant advance in migraine headache treatment and may become the new standard of therapy in the treatment of this debilitating condition.
Indications and Usage Ubrogepant is indicated for the acute treatment of migraine with or without aura in adults.[L10926]
Marketing Status approved; investigational
ATC Code N02CD04
DrugBank ID DB15328
KEGG ID D10673
MeSH ID C000615620
PubChem ID 68748835
TTD Drug ID D07GXR
NDC Product Code 0023-6499; 69037-0077; 0023-6501; 0023-6502; 0023-6498
UNII AD0O8X2QJR
Synonyms ubrogepant | ubrelvy | MK-1602 | 1',2',5,7-tetrahydro-N-((3S,5S,6R)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)-3-piperidinyl)-2'-oxo-, (6S)- spiro(6H-cyclopenta(b)pyridine-6,3'-(3H)pyrrolo(2,3-b)pyridine)-3-carboxamide
Chemical Information
Molecular Formula C29H26F3N5O3
CAS Registry Number 1374248-77-7
SMILES CC1C(CC(C(=O)N1CC(F)(F)F)NC(=O)C2=CC3=C(CC4(C3)C5=C(NC4=O)N=CC=C5)N=C2)C6=CC=CC= C6
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)
Abdominal pain upper07.01.05.0030.000340%
Acute psychosis19.03.01.0010.000067%-
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.0030.000486%-
Chills08.01.09.001; 15.05.03.0160.000340%
Constipation07.02.02.0010.000226%
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.0070.000793%
Drug ineffective08.06.01.0060.004076%-
Dysphoria19.04.02.0040.000226%-
Euphoric mood19.04.02.0060.000226%
Feeling abnormal08.01.09.0140.000453%-
Feeling drunk08.01.09.0150.000226%-
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.0160.000147%
Headache17.14.01.0010.001052%
Hypersensitivity10.01.03.0030.000226%
Hypertension24.08.02.0010.000340%
Influenza like illness08.01.03.0100.000226%
Insomnia17.15.03.002; 19.02.01.0020.000226%
Mania19.16.02.0020.000147%
Migraine17.14.02.001; 24.03.05.0030.000859%-
Mouth ulceration07.05.06.0040.000226%-
Nausea07.01.07.0010.001585%
Nephrolithiasis20.04.01.0020.000226%
Palpitations02.11.04.0120.000147%
Paraesthesia17.02.06.005; 23.03.03.0940.000486%
Pruritus23.03.12.0010.000679%
Rash23.03.13.0010.000566%-
Seizure17.12.03.0010.000147%
Somnolence17.02.04.006; 19.02.05.0030.000713%
Swelling08.01.03.0150.000226%-
Therapeutic response decreased08.06.01.0160.000226%-
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