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 Isosorbide mononitrate is indicated for the prevention and management of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid to be useful in aborting an acute anginal episode.[L11698]
Marketing Status approved
ATC Code C01DA14
DrugBank ID DB01020
KEGG ID D00630
MeSH ID C030397
PubChem ID 27661
TTD Drug ID D0YS7D
NDC Product Code 50742-176; 51407-210; 55154-7292; 59651-539; 62135-586; 62175-107; 62175-128; 71335-2194; 0615-7767; 42677-101; 13668-104; 43063-313; 53002-1570; 62175-119; 62175-129; 63187-900; 68084-592; 70518-3585; 59651-541; 62135-588; 62175-362; 63187-700; 71335-2192; 55154-7291; 62135-587; 62175-361; 70518-1485; 0615-7768; 0228-2620; 23155-519; 50742-177; 51407-209; 51655-922; 59651-540; 63629-1823; 70518-2000; 70518-2692; 70518-3081; 0228-2631; 23155-628; 50742-175; 70934-972; 71335-0037; 0904-6450; 50090-4009; 51407-208; 62175-106; 42799-960; 63629-1424; 71335-1117; 0615-8043; 0615-8044; 13668-105; 13668-106; 23155-178; 42799-958; 42799-959; 68084-591; 70518-2956; 0904-6449; 42677-307; 50090-5686; 70518-2122; 70518-3132; 42677-102
UNII LX1OH63030
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
*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 distension07.01.04.0010.000070%
Abdominal pain07.01.05.002--
Acne23.02.01.001--Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Agitation19.06.02.001; 17.02.05.012--
Alanine aminotransferase increased13.03.04.005--
Albuminuria20.02.01.001--Not Available
Amaurosis fugax06.02.10.002; 24.04.06.006; 17.08.04.002--Not Available
Amblyopia06.02.01.001--Not Available
Amnesia19.20.01.001; 17.03.02.001--
Anaemia01.03.02.0010.000105%
Angina pectoris24.04.04.002; 02.02.02.0020.000105%
Anxiety19.06.02.002--
Arrhythmia02.03.02.001--Not Available
Arrhythmia supraventricular02.03.03.001--Not Available
Arteriospasm coronary02.02.02.005; 12.02.01.031; 24.04.04.0050.000070%Not Available
Arthralgia15.01.02.001--
Arthritis15.01.01.001--
Arthropathy15.01.01.003--Not Available
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001--Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Atrial fibrillation02.03.03.002--
Atrioventricular block02.03.01.002--Not Available
Atrioventricular block complete02.03.01.0030.000070%
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
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