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%-
Sinus disorder22.04.06.0020.002100%
Poor quality sleep17.15.04.002; 19.02.05.0050.002100%-
Chronic kidney disease20.01.03.0170.006460%
Pulmonary arterial hypertension22.06.01.002; 24.08.03.0030.000808%-
Oropharyngeal discomfort07.05.05.008; 22.12.03.0150.001184%-
Acute kidney injury20.01.03.0160.006460%
Functional gastrointestinal disorder07.11.01.0160.001184%-
Lower urinary tract symptoms20.02.02.0230.000538%-
Peripheral venous disease24.04.02.0220.001615%-
Sinus node dysfunction02.03.03.0170.002153%
Multiple organ dysfunction syndrome08.01.03.0570.001346%
Anal incontinence07.01.06.029; 17.05.01.0210.001184%
Frustration tolerance decreased19.04.02.0160.000538%-
Cardiac failure chronic02.05.01.0090.022880%-
Chronic respiratory failure14.01.04.005; 22.02.06.0050.000538%-
Dermatitis exfoliative generalised10.01.01.029; 23.03.07.0020.000538%-
Lumbar spinal stenosis15.10.04.008; 17.10.03.0040.001615%-
Lymphadenopathy mediastinal01.09.01.025; 22.09.03.0060.000538%-
Overweight14.03.02.0210.000538%-
Restrictive pulmonary disease22.01.02.0250.000538%-
Cervical radiculopathy17.10.02.0030.000808%-
Right ventricular hypertrophy02.04.02.0340.000538%-
Aortic dilatation24.03.04.0070.000538%-
Aortic valve disease02.07.03.0020.000538%
Chronic left ventricular failure02.05.02.0060.003499%-
Left atrial dilatation02.04.02.0250.000538%-
Cardiorenal syndrome02.05.01.012; 20.01.03.0180.001346%-
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