Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Aliskiren hemifumarate
Drug ID BADD_D00074
Description Aliskiren is the first drug in the renin inhibitor drug class and is used for the treatment of hypertension.[A203624] It was developed by Speedel and Novartis and initially approved by the FDA in early 2007.[L14018] Aliskiren has been proven to efficacious in reducing blood pressure when used alone or in conjunction with other antihypertensive agents.[A203624]
Indications and Usage Aliskiren is used for the treatment of hypertension in children above 6 years and adults.[L13994] This drug may also be used in conjunction with antihypertensives such as calcium channel blockers and thiazides in products form to provide additional blood pressure control.[L14168,L14171]
Marketing Status approved; investigational
ATC Code C09XA02
DrugBank ID DB09026
KEGG ID D06412
MeSH ID C446481
PubChem ID 6918427
TTD Drug ID D03SVX
NDC Product Code 12666-0016; 66993-141; 14501-0062; 65372-1178; 71973-152; 71973-301; 66993-142; 70839-150; 70839-300
UNII C8A0P8G029
Synonyms aliskiren | rasilez | Tekturna | CGP 060536B | CGP060536B | CGP-060536B | 2(S),4(S),5(S),7(S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-(4-methoxy-3-(3-methoxypropoxy)phenyl)octanamid hemifumarate | SPP100
Chemical Information
Molecular Formula C64H110N6O16
CAS Registry Number 173334-58-2
SMILES CC(C)C(CC1=CC(=C(C=C1)OC)OCCCOC)CC(C(CC(C(C)C)C(=O)NCC(C)(C)C(=O)N)O)N.CC(C)C(CC 1=CC(=C(C=C1)OC)OCCCOC)CC(C(CC(C(C)C)C(=O)NCC(C)(C)C(=O)N)O)N.C(=CC(=O)O)C(=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--
Anaemia01.03.02.001--
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009---
Back pain15.03.04.005--
Blood creatine phosphokinase increased13.04.01.001--
Blood creatinine increased13.13.01.004--
Blood potassium increased13.11.01.011---
Blood urea increased13.13.01.006---
Blood uric acid increased13.02.04.001---
Cough22.02.03.001--
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.11.04.006--
Dyspepsia07.01.02.001--
Electroencephalogram abnormal13.07.03.001---
Erythema23.03.06.001---
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.003--
Fatigue08.01.01.002--
Gastrooesophageal reflux disease07.02.02.003--
Generalised oedema14.05.06.007; 08.01.07.004--
Generalised tonic-clonic seizure17.12.01.002---
Gout15.01.06.001; 14.09.01.001---
Haematocrit decreased13.01.05.001---
Haemoglobin decreased13.01.05.003---
Headache17.14.01.001--
Hepatic function abnormal09.01.02.001---
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Loss of consciousness17.02.04.004---
Nasopharyngitis11.01.13.002; 22.07.03.002---
Nausea07.01.07.001--
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