Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Amlodipine besylate
Drug ID BADD_D00122
Description Amlodipine, initially approved by the FDA in 1987, is a popular antihypertensive drug belonging to the group of drugs called _dihydropyridine calcium channel blockers_. Due to their selectivity for the peripheral blood vessels, dihydropyridine calcium channel blockers are associated with a lower incidence of myocardial depression and cardiac conduction abnormalities than other calcium channel blockers [A175327]. Amlodipine is commonly used in the treatment of high blood pressure and angina. Amlodipine has antioxidant properties and an ability to enhance the production of nitric oxide (NO), an important vasodilator that decreases blood pressure [A175321]. The option for single daily dosing of amlodipine is an attractive feature of this drug [FDA label].
Indications and Usage Amlodipine may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of the following conditions [FDA label]: • Hypertension • Coronary artery disease • Chronic stable angina • Vasospastic angina (Prinzmetal’s or Variant angina) • Angiographically documented coronary artery disease in patients without heart failure or an ejection fraction < 40%
Marketing Status approved
ATC Code C08CA01
DrugBank ID DB00381
KEGG ID D00615
MeSH ID D017311
PubChem ID 60496
TTD Drug ID D08JIV
NDC Product Code 76282-237; 82009-026; 10135-761; 55111-025; 58159-068; 65862-103; 43063-764; 51655-291; 58118-1127; 68071-2312; 0480-7168; 70518-1971; 70934-330; 71205-488; 71205-506; 71335-0890; 71335-1597; 76282-238; 38779-2734; 57451-1188; 68981-016; 42708-066; 43063-041; 50090-1627; 50090-2524; 50090-4903; 63187-198; 63187-508; 63187-914; 68071-3453; 68382-122; 68645-580; 70934-075; 71093-146; 71335-0934; 71335-0945; 71335-1887; 72789-260; 76282-507; 65427-003; 66174-0020; 29300-397; 51655-586; 52605-041; 52605-042; 53002-3351; 55700-543; 60687-496; 61919-844; 68071-2270; 68071-2305; 68788-6386; 69097-126; 70518-0274; 70518-0835; 71335-0843; 0615-8282; 55700-541; 63187-197; 65841-620; 68071-2415; 68645-516; 68788-7679; 68788-7985; 68788-8313; 0480-0083; 69584-022; 70518-3592; 71093-147; 71093-148; 71335-0218; 0615-8283; 0615-8429; 72789-082; 76282-509; 0904-6369; 53104-7561; 10135-759; 65977-0005; 68724-0008; 72761-034; 43063-564; 52605-043; 55154-6875; 59762-2135; 60760-459; 60760-614; 61919-753; 61919-782; 67877-198; 68645-515; 71335-1278; 71610-691; 72789-261; 0904-6370; 52932-0723; 65691-0040; 42806-057; 53002-1249; 61919-805; 63629-1023; 67296-1876; 67877-197; 68071-4251; 69097-128; 71205-599; 71335-0833; 71335-1032; 71610-620; 0615-8284; 0615-8430; 76282-239; 51552-1438; 0069-1530; 57218-936; 42806-056; 43353-989; 53002-2352; 53808-1100; 65162-008; 65841-621; 68382-123; 68788-9345; 69097-836; 69584-021; 69584-023; 72789-262; 42185-7058; 53747-011; 65862-102; 29300-396; 29300-398; 42291-025; 42291-026; 55154-6892; 59762-2242; 60687-488; 61919-814; 65162-006; 65862-101; 68180-720; 68180-721; 68788-8263; 69097-838; 70518-2632; 72189-162; 65015-670; 43353-684; 55154-8093; 59762-2010; 60760-445; 63629-1024; 65162-007; 65841-622; 67296-1530; 67877-199; 68382-121; 68788-8451; 69097-837; 0480-7167; 70934-920; 71610-469; 71610-539; 71610-687; 82009-028; 49452-0429; 0069-1520; 10135-760; 64220-183; 42806-055; 63187-326; 63187-783; 67296-1529; 68180-719; 69097-127; 70518-2981; 71205-596; 71335-0473; 0615-8431; 76282-508; 82009-027; 82982-020; 0904-6371; 51927-0073; 0069-1540; 65862-344; 71052-266; 71859-001; 42291-027; 43353-691; 50090-2581; 53002-1351; 53002-1352
UNII 864V2Q084H
Synonyms Amlodipine | Amlodipine, (+-)-Isomer | Amlodipine Besylate | Amlodipine, (+-)-Isomer, Maleate (1:1) | Amlodipine, (S)-Isomer, Maleate (1:1) | Amlodis | Astudal | Norvasc | Istin | Amlor | Amlodipine Maleate | Amlodipine Maleate (1:1) | Amlodipine, (R)-Isomer
Chemical Information
Molecular Formula C26H31ClN2O8S
CAS Registry Number 111470-99-6
SMILES CCOC(=O)C1=C(NC(=C(C1C2=CC=CC=C2Cl)C(=O)OC)C)COCCN.C1=CC=C(C=C1)S(=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)
Vasculitis10.02.02.006; 24.12.04.027--
Ventricular tachycardia02.03.04.010--
Vertigo17.02.12.002; 04.04.01.003--
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Xerophthalmia06.06.03.008; 14.12.03.002--Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Lymphatic disorder01.09.01.003--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Affect lability19.04.01.001--Not Available
Female sexual dysfunction21.03.02.004; 19.08.05.001--Not Available
Male sexual dysfunction21.03.02.012; 19.08.05.003--Not Available
Angiopathy24.03.02.007--Not Available
Urine output increased13.13.03.002--Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.027--
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction21.03.01.007; 19.08.04.001--
Ill-defined disorder08.01.03.049--Not Available
Inner ear disorder04.04.02.002--Not Available
Blood disorder01.05.01.004--Not Available
Candida infection11.03.03.021--
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