Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Amlodipine
Drug ID BADD_D00121
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 D07450
MeSH ID D017311
PubChem ID 2162
TTD Drug ID D08JIV
NDC Product Code 46287-035; 52652-5001; 69238-2026
UNII 1J444QC288
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 C20H25ClN2O5
CAS Registry Number 88150-42-9
SMILES CCOC(=O)C1=C(NC(=C(C1C2=CC=CC=C2Cl)C(=O)OC)C)COCCN
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)
Hypoglycaemia14.06.03.001; 05.06.03.0010.000029%
Hypoglycaemic coma17.02.09.005; 14.06.03.004; 05.06.03.0040.000006%Not Available
Hypokalaemia14.05.03.0020.000073%
Hyponatraemia14.05.04.0020.000054%
Hypotension24.06.03.0020.000432%
Hypothermia12.05.03.001; 08.05.01.0030.000006%
Hypothyroidism14.11.01.012; 05.02.03.0010.000010%
Hypoxia22.02.02.0030.000035%
Immune system disorder10.02.01.001--Not Available
Increased appetite14.03.01.003; 08.01.09.027--Not Available
Injection site bruising24.07.06.017; 23.03.11.015; 12.07.03.042; 08.02.03.042--Not Available
Injection site pain12.07.03.011; 08.02.03.010--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Interstitial lung disease22.01.02.003; 10.02.01.0330.000051%Not Available
Intestinal ischaemia24.04.08.001; 07.15.02.0010.000016%Not Available
Intestinal obstruction07.13.01.0020.000016%Not Available
Jaundice09.01.01.004; 01.06.04.004; 23.03.03.030--Not Available
Joint swelling15.01.02.0040.000109%Not Available
Lactic acidosis14.01.01.0020.000051%Not Available
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.0080.000030%
Leukaemoid reaction01.02.01.0010.000006%Not Available
Leukocytosis01.02.01.0020.000025%
Leukopenia01.02.02.001--Not Available
Lichen planus23.03.08.0010.000006%Not Available
Linear IgA disease10.04.02.006; 23.03.01.0150.000010%Not Available
Lip oedema23.04.01.006; 10.01.05.004; 07.05.04.0040.000010%Not Available
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.0050.000020%Not Available
Loss of consciousness17.02.04.0040.000090%Not Available
Macular degeneration06.09.03.0010.000006%Not Available
Malabsorption14.02.01.004; 07.17.01.0010.000006%
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