Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Aliskiren
Drug ID BADD_D00073
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 D03208
MeSH ID C446481
PubChem ID 5493444
TTD Drug ID D03SVX
NDC Product Code 49884-425; 49884-424
UNII 502FWN4Q32
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 C30H53N3O6
CAS Registry Number 173334-57-1
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
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)
Hepatic failure09.01.03.002--
Hepatic function abnormal09.01.02.001--Not Available
Hepatitis09.01.07.004--Not Available
Hepatocellular injury09.01.07.008--Not Available
Hepatomegaly09.01.05.0010.000609%Not Available
Hyperhidrosis23.02.03.004; 08.01.03.0280.000609%
Hyperkalaemia14.05.03.0010.003656%
Hypersensitivity10.01.03.0030.002376%
Hypertension24.08.02.0010.003473%
Hypervolaemia02.05.04.019; 14.05.06.0030.000609%Not Available
Hypoglycaemia05.06.03.001; 14.06.03.0010.001219%
Hypokalaemia14.05.03.0020.000914%
Hyponatraemia14.05.04.0020.000609%
Hypotension24.06.03.0020.002864%
Hypothyroidism14.11.01.012; 05.02.03.0010.000609%
Hypovolaemia14.05.05.0020.000609%Not Available
Immune system disorder10.02.01.001--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.004--Not Available
Joint swelling15.01.02.004--Not Available
Laryngeal pain22.12.03.010--
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.0080.001950%
Leukocytosis01.02.01.0020.000609%
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.005--Not Available
Liver disorder09.01.08.001--Not Available
Loss of consciousness17.02.04.0040.000914%Not Available
Malaise08.01.01.0030.002864%
Microalbuminuria14.07.02.002; 05.07.02.002; 20.02.01.026--Not Available
Mitral valve incompetence02.07.01.0020.000609%Not Available
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