Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Isosorbide mononitrate
Drug ID BADD_D01211
Description Isosorbide mononitrate is an organic nitrate with vasodilating properties. It is an anti-anginal agent that works by relaxing the smooth muscles of both arteries and veins, but but predominantly veins to reduce cardiac preload.[L11698, L11743] Isosorbide mononitrate is an active metabolite of [isosorbide dinitrate]. Like other organic nitrates, isosorbide mononitrate acts as a prodrug for its active metabolite, [nitric oxide], which mediates the therapeutic action of isosorbide mononitrate.[L11743] Isosorbide mononitrate has a longer duration of action than [nitroglycerin] due to its slow onset of absorption and metabolism.[T28] First approved by the FDA in 1991,[L11743] isosorbide mononitrate is used for the prevention and management of angina pectoris caused by coronary artery disease; however, the onset of action of orally-administered isosorbide mononitrate is not rapid enough to offset an acute anginal episode.[L11698] It is available in oral tablets generically and under the brand name ISMO and Monoket. The extended-release forms of the drug are also available generically and under the brand name Imdur.[L11743]
Indications and Usage For the prevention of angina pectoris due to coronary artery disease and the treatment of acute and chronic angina pectoris, hypertension, and myocardial infarction.
Marketing Status Prescription; Discontinued
ATC Code C01DA14
DrugBank ID DB01020
KEGG ID D00630
MeSH ID C030397
PubChem ID 27661
TTD Drug ID D0YS7D
NDC Product Code 71335-0037; 68071-3081; 70518-2207; 71335-1117; 71610-338; 0228-2620; 0228-2631; 50090-5572; 62175-106; 62175-362; 62175-107; 55154-4786; 0615-7768; 50268-453; 43353-917; 70518-2000; 62175-129; 51407-210; 42677-113; 55154-7292; 62175-119; 13668-105; 0904-6450; 51407-208; 70518-2122; 55154-4785; 71610-337; 0615-8043; 70518-2206; 70518-3081; 55154-7291; 63629-1823; 67544-224; 70518-2201; 23155-519; 70518-1485; 23155-178; 51407-209; 50742-175; 50090-5686; 23155-628; 50268-451; 0615-8044; 13668-104; 70518-2692; 63629-1424; 68382-651; 50742-177; 62175-128; 68084-592; 53002-1570; 68071-4390; 50090-4047; 13668-106; 62175-361; 63187-700; 0615-7767; 42677-101; 50742-176; 42677-102; 0904-6449; 68071-4689; 68071-4290; 68382-652; 43063-313; 70518-3132; 67544-236; 71610-321; 68084-591; 63187-900; 50090-4009; 70518-2956; 68382-650; 50268-452
Synonyms isosorbide-5-mononitrate | isosorbide mononitrate | monocinque | 5-ISMN | isosorbide-5-nitrate | Elantan | Imdur | Ismo | Olicard-retard | Mono Mac 50D | Monoket | Mononit | Olicard 40 | 5-ISMN Durules | Monizid
Chemical Information
Molecular Formula C6H9NO6
CAS Registry Number 16051-77-7
SMILES C1C(C2C(O1)C(CO2)O[N+](=O)[O-])O
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Acne23.02.01.001--Not Available
Acute myocardial infarction02.02.02.001; 24.04.04.001--Not Available
Agitation17.02.05.012; 19.06.02.001--
Alanine aminotransferase increased13.03.01.003--
Albuminuria20.02.01.001--Not Available
Amaurosis fugax06.02.02.005; 17.08.04.002; 24.04.06.006--Not Available
Amblyopia06.02.01.001--Not Available
Amnesia17.03.02.001; 19.20.01.001--
Anaemia01.03.02.001--
Angina pectoris02.02.02.002; 24.04.04.0020.000471%
Anxiety19.06.02.002--
Arrhythmia02.03.02.001--Not Available
Arrhythmia supraventricular02.03.03.001--Not Available
Arteriospasm coronary02.02.02.005; 24.04.04.0050.000314%Not Available
Arthralgia15.01.02.001--
Arthritis15.01.01.001--
Arthropathy15.01.01.003--Not Available
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001--Not Available
Asthma10.01.03.010; 22.03.01.002--Not Available
Atrial fibrillation02.03.03.002--
Atrioventricular block02.03.01.002--Not Available
Atrioventricular block complete02.03.01.0030.000314%
Atrophic vulvovaginitis21.02.01.003--Not Available
Back pain15.03.04.005--
Biliary colic09.02.01.001--Not Available
Bladder diverticulum20.03.01.009--Not Available
Blood uric acid increased13.02.04.001--Not Available
Body temperature increased13.15.01.001--Not Available
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