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)
Sluggishness08.01.01.0040.001830%-
Small intestinal obstruction07.13.06.0010.000538%
Spinal osteoarthritis15.01.04.0030.001615%-
Sudden death02.03.04.013; 08.04.01.0030.002961%
Swollen tongue07.14.02.003; 10.01.05.015; 23.04.01.0140.001723%-
Syncope02.11.04.015; 17.02.04.008; 24.06.02.0120.004576%
Therapeutic response unexpected08.06.01.0010.017550%-
Transient ischaemic attack17.08.04.001; 24.04.06.0050.001346%
Tricuspid valve incompetence02.07.05.0010.001077%-
Trigger finger15.07.01.0050.000538%-
Urinary incontinence17.05.01.008; 20.02.02.0100.001077%
Urinary retention20.02.02.0110.001346%
Urinary tract infection11.01.14.004; 20.08.02.001--
Vaginal infection11.01.10.002; 21.14.02.002--
Varicose vein24.10.04.0010.001723%-
Ventricular extrasystoles02.03.04.0070.001346%-
Ventricular hypertrophy02.04.02.0120.000538%-
Ventricular tachycardia02.03.04.0100.002423%
Vertigo04.04.01.003; 17.02.12.002--
Vision blurred06.02.06.007; 17.17.01.010--
Vitamin B12 deficiency14.12.02.0040.001346%-
Vitamin D deficiency14.12.03.0030.002692%-
Intracardiac thrombus02.11.01.017; 24.01.05.0030.000538%-
Energy increased08.01.03.0170.002746%-
Ischaemic cardiomyopathy02.04.01.004; 24.04.04.0190.000808%-
Hypoacusis04.02.01.0060.009206%
Seasonal allergy06.04.01.013; 10.01.04.001; 22.04.04.0080.000808%-
Peripheral swelling02.05.04.015; 08.01.03.0530.016581%-
Weight fluctuation14.03.02.0020.003015%-
Sudden cardiac death02.03.04.016; 08.04.01.0080.001346%-
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