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)
Rash pruritic23.03.13.030--Not Available
Rectal haemorrhage07.12.03.001; 24.07.02.018--
Renal cyst20.01.04.001; 16.27.01.0010.000006%Not Available
Renal disorder20.01.02.0020.000027%Not Available
Respiratory acidosis22.02.02.004; 14.01.04.0020.000006%Not Available
Respiratory distress22.02.01.0120.000016%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.000025%
Retinal haemorrhage24.07.05.003; 06.10.01.0010.000006%Not Available
Retinal oedema24.03.07.006; 06.04.06.0070.000006%Not Available
Rhabdomyolysis15.05.05.0020.000060%
Rhinitis11.01.13.004; 22.07.03.006--
Sensory disturbance17.02.07.0060.000010%Not Available
Sexual dysfunction21.03.02.003; 19.08.05.002--Not Available
Shock24.06.02.0020.000159%Not Available
Sinoatrial block02.03.01.0100.000006%Not Available
Sinus bradycardia02.03.03.0090.000019%
Sinus tachycardia02.03.03.0100.000074%
Skin discolouration23.03.03.005--Not Available
Skin disorder23.03.03.007--Not Available
Skin exfoliation23.03.07.003--Not Available
Skin fissures23.03.03.0080.000006%Not Available
Skin hyperpigmentation23.05.01.003--
Skin irritation23.03.04.009--Not Available
Skin reaction23.03.03.013; 10.01.03.0190.000014%Not Available
Sleep disorder19.02.04.001--Not Available
Sleep terror19.02.03.008; 17.15.02.006--Not Available
Sluggishness08.01.01.0040.000006%Not Available
Sneezing22.12.03.0240.000020%
Somnolence19.02.05.003; 17.02.04.006--
Stevens-Johnson syndrome23.03.01.007; 12.03.01.014; 11.07.01.005; 10.01.01.0450.000013%
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