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)
General physical health deterioration08.01.03.0180.005760%Not Available
Tachyarrhythmia02.03.02.0080.000538%Not Available
Left ventricular dysfunction02.04.02.0110.001077%
Bradyarrhythmia02.03.02.0150.000538%Not Available
Left ventricular hypertrophy02.04.02.0140.002961%Not Available
Balance disorder17.02.02.007; 08.01.03.0810.008990%Not Available
Dysstasia08.01.03.089; 17.02.02.012; 15.03.05.0110.000538%Not Available
Intervertebral disc protrusion15.10.01.0040.000538%Not Available
Exercise tolerance decreased08.01.03.0360.001184%Not Available
Large intestine polyp16.05.02.006; 07.20.01.0100.000808%Not Available
Diastolic dysfunction02.04.02.0220.001077%Not Available
Cardiac flutter02.03.02.0120.000808%Not Available
Fluid intake reduced14.05.10.0010.001184%Not Available
Pulmonary mass22.02.07.0040.001077%Not Available
Temperature intolerance08.01.09.0220.001830%Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.005437%
Vascular dementia24.04.06.017; 19.20.04.001; 17.03.01.0030.000538%Not Available
Major depression19.15.01.0030.000538%Not Available
Dyslipidaemia14.08.04.0150.001346%Not Available
Restless legs syndrome17.02.07.008; 15.05.03.0120.001723%Not Available
Early satiety08.01.09.004; 14.03.01.010; 07.01.06.0270.002369%Not Available
Prostate cancer21.04.02.002; 16.25.01.0010.002153%Not Available
Monoclonal gammopathy16.23.01.003; 01.14.01.0030.000538%Not Available
Cardiac disorder02.11.01.0030.006568%Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.001992%Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Limb discomfort15.03.04.0140.001454%Not Available
Intervertebral disc degeneration15.10.01.0020.001346%Not Available
Erectile dysfunction21.03.01.007; 19.08.04.0010.002153%
Urinary tract obstruction20.08.01.0040.000538%
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