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%-
Tachyarrhythmia02.03.02.0080.000538%-
Left ventricular dysfunction02.04.02.0110.001077%
Bradyarrhythmia02.03.02.0150.000538%-
Left ventricular hypertrophy02.04.02.0140.002961%-
Balance disorder08.01.03.081; 17.02.02.0070.008990%-
Dysstasia08.01.03.089; 15.03.05.011; 17.02.02.0120.000538%-
Intervertebral disc protrusion15.10.01.0040.000538%-
Exercise tolerance decreased08.01.03.0360.001184%-
Large intestine polyp07.20.01.010; 16.05.02.0060.000808%-
Diastolic dysfunction02.04.02.0220.001077%-
Cardiac flutter02.03.02.0120.000808%-
Fluid intake reduced14.05.10.0010.001184%-
Pulmonary mass22.02.07.0040.001077%-
Temperature intolerance08.01.09.0220.001830%-
Cognitive disorder17.03.03.003; 19.21.02.0010.005437%
Vascular dementia17.03.01.003; 19.20.04.001; 24.04.06.0170.000538%-
Major depression19.15.01.0030.000538%-
Dyslipidaemia14.08.04.0150.001346%-
Restless legs syndrome15.05.03.012; 17.02.07.0080.001723%-
Early satiety07.01.06.027; 08.01.09.004; 14.03.01.0100.002369%-
Prostate cancer16.25.01.001; 21.04.02.0020.002153%-
Monoclonal gammopathy01.14.01.003; 16.23.01.0030.000538%-
Cardiac disorder02.11.01.0030.006568%-
Feeding disorder14.03.02.003; 19.09.01.0030.001992%-
Infestation11.09.01.001; 23.11.01.002---
Limb discomfort15.03.04.0140.001454%-
Intervertebral disc degeneration15.10.01.0020.001346%-
Erectile dysfunction19.08.04.001; 21.03.01.0070.002153%
Urinary tract obstruction20.08.01.0040.000538%
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