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)
Seizure17.12.03.001--
Skin disorder23.03.03.007--Not Available
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.0030.000609%Not Available
Stevens-Johnson syndrome23.03.01.007; 12.03.01.014; 11.07.01.005; 10.01.01.045--
Swelling08.01.03.015--Not Available
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.0180.001341%Not Available
Syncope17.02.04.008; 02.11.04.015; 24.06.02.0120.001523%
Tachycardia02.03.02.007--Not Available
Toxic epidermal necrolysis23.03.01.008; 12.03.01.015; 11.07.01.006; 10.01.01.006--
Transient ischaemic attack17.08.04.001; 24.04.06.0050.001523%
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urethral disorder20.07.01.002--Not Available
Urinary tract disorder20.08.01.001--Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria10.01.06.001; 23.04.02.0010.001341%
Ventricular tachycardia02.03.04.0100.000609%
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.0070.001341%
Vomiting07.01.07.0030.001828%
Mobility decreased15.03.05.023; 17.02.05.018; 08.01.03.0300.000609%Not Available
Sudden cardiac death08.04.01.008; 02.03.04.0160.000609%Not Available
Left ventricular dysfunction02.04.02.0110.000609%
Bradyarrhythmia02.03.02.0150.000609%Not Available
Left ventricular hypertrophy02.04.02.0140.000609%Not Available
Blood pressure inadequately controlled24.06.01.007--Not Available
Foetor hepaticus09.01.05.006; 07.01.06.026--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Angiopathy24.03.02.007--Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
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