Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Tafamidis
Drug ID BADD_D02107
Description Tafamidis and tafamidis meglumine (FX-1006A) are benzoxazole derivatives[A27206] developed by FoldRX.[A189717] Tafamidis is structurally similar to diflusinal.[A189717] Tafamidis was granted an EMA market authorisation on 16 November 2011[L6247] and FDA approval on 3 May 2019.[L11280]
Indications and Usage Tafamidis is indicated to treat cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis in adults.[A189708,A189711,L11280]
Marketing Status approved; investigational
ATC Code N07XX08
DrugBank ID DB11644
KEGG ID D09673
MeSH ID C547076
PubChem ID 11001318
TTD Drug ID D04DFR
NDC Product Code 60715-0647; 59651-743; 66039-960; 73435-031; 14501-0102; 58159-079; 60715-4344; 0069-8730; 11014-0390; 69988-0039
UNII 8FG9H9D31J
Synonyms tafamidis | Vyndamax | Vyndaqel | FX 1006A | FX1006A | FX-1006A | tafamidis meglumine
Chemical Information
Molecular Formula C14H7Cl2NO3
CAS Registry Number 594839-88-0
SMILES C1=CC2=C(C=C1C(=O)O)OC(=N2)C3=CC(=CC(=C3)Cl)Cl
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)
Disease progression08.01.03.0380.021857%
Hyperlipidaemia14.08.03.0010.005922%
Renal impairment20.01.03.0100.005383%Not Available
Sinus disorder22.04.06.0020.002100%
Poor quality sleep19.02.05.005; 17.15.04.0020.002100%Not Available
Chronic kidney disease20.01.03.0170.006460%
Pulmonary arterial hypertension24.08.03.003; 22.06.01.0020.000808%Not Available
Oropharyngeal discomfort22.12.03.015; 07.05.05.0080.001184%Not Available
Acute kidney injury20.01.03.0160.006460%
Functional gastrointestinal disorder07.11.01.0160.001184%Not Available
Lower urinary tract symptoms20.02.02.0230.000538%Not Available
Peripheral venous disease24.04.02.0220.001615%Not Available
Sinus node dysfunction02.03.03.0170.002153%
Multiple organ dysfunction syndrome08.01.03.0570.001346%
Anal incontinence17.05.01.021; 07.01.06.0290.001184%
Frustration tolerance decreased19.04.02.0160.000538%Not Available
Cardiac failure chronic02.05.01.0090.022880%Not Available
Chronic respiratory failure22.02.06.005; 14.01.04.0050.000538%Not Available
Dermatitis exfoliative generalised23.03.07.002; 10.01.01.0290.000538%Not Available
Lumbar spinal stenosis17.10.03.004; 15.10.04.0080.001615%Not Available
Lymphadenopathy mediastinal22.09.03.006; 01.09.01.0250.000538%Not Available
Overweight14.03.02.0210.000538%Not Available
Restrictive pulmonary disease22.01.02.0250.000538%Not Available
Cervical radiculopathy17.10.02.0030.000808%Not Available
Right ventricular hypertrophy02.04.02.0340.000538%Not Available
Aortic dilatation24.03.04.0070.000538%Not Available
Aortic valve disease02.07.03.0020.000538%
Chronic left ventricular failure02.05.02.0060.003499%Not Available
Left atrial dilatation02.04.02.0250.000538%Not Available
Cardiorenal syndrome20.01.03.018; 02.05.01.0120.001346%Not Available
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