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)
Abdominal pain07.01.05.002--
Abnormal dreams17.15.02.001; 19.02.03.001---
Accommodation disorder06.02.04.001---
Agitation19.06.02.001; 17.02.05.012--
Alopecia23.02.02.001--
Amnesia19.20.01.001; 17.03.02.001--
Angina pectoris24.04.04.002; 02.02.02.002--
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009---
Anxiety19.06.02.002--
Apathy19.04.04.002---
Arrhythmia02.03.02.001---
Arthralgia15.01.02.001--
Arthropathy15.01.01.003---
Asthenia08.01.01.001---
Ataxia17.02.02.001; 08.01.02.004--
Atrial fibrillation02.03.03.002--
Back pain15.03.04.005--
Bradycardia02.03.02.002---
Cardiac failure02.05.01.001--
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.011---
Chills08.01.09.001; 15.05.03.016--
Cholestasis09.01.01.001---
Cold sweat23.02.03.002; 08.01.03.024---
Conjunctivitis11.01.06.012; 06.04.01.002--
Constipation07.02.02.001--
Cough22.02.03.001--
Depression19.15.01.001--
Dermatitis23.03.04.002---
Diarrhoea07.02.01.001--
Diplopia17.17.01.005; 06.02.06.002---
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