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)
Abdominal discomfort07.01.06.001---
Abdominal distension07.01.04.0010.000032%
Abdominal pain07.01.05.0020.000077%
Abdominal pain upper07.01.05.0030.000070%
Abnormal dreams19.02.03.001; 17.15.02.001---
Accommodation disorder06.02.04.001---
Acidosis14.01.03.0020.000025%
Acne23.02.01.001---
Acute myocardial infarction02.02.02.001; 24.04.04.0010.000035%-
Acute pulmonary oedema22.01.03.005; 02.05.02.0040.000016%-
Acute respiratory distress syndrome24.03.02.034; 10.02.01.067; 22.01.03.0010.000035%
Acute respiratory failure22.02.06.001; 14.01.04.0040.000013%-
Ageusia17.02.07.001; 07.14.03.003---
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.0010.000010%-
Alopecia23.02.02.001--
Altered state of consciousness19.07.01.003; 17.02.04.0010.000022%-
Amaurosis06.02.10.0010.000006%-
Amaurosis fugax06.02.10.002; 24.04.06.006; 17.08.04.0020.000006%-
Amnesia19.20.01.001; 17.03.02.001--
Anaemia01.03.02.0010.000079%
Anaphylactic reaction10.01.07.001; 24.06.03.0060.000025%
Anaphylactic shock24.06.02.004; 10.01.07.0020.000013%-
Anaphylactoid reaction24.06.03.007; 10.01.07.0030.000010%-
Angina pectoris24.04.04.002; 02.02.02.0020.000016%
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.0010.000074%-
Anterograde amnesia19.20.01.005; 17.03.02.0050.000006%-
Anuria20.01.03.0020.000025%-
Anxiety19.06.02.002--
Aortic aneurysm24.02.03.0010.000006%-
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