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)
Gastritis07.08.02.0010.000538%
Gastrooesophageal reflux disease07.02.02.0030.005168%
Gastrointestinal disorder07.11.01.0010.006999%Not Available
Generalised oedema14.05.06.007; 08.01.07.0040.000808%
Glaucoma06.03.01.0020.001077%
Gout15.01.06.001; 14.09.01.0010.006083%Not Available
Haematochezia24.07.02.012; 07.12.02.0030.001346%Not Available
Haematuria20.02.01.006; 21.10.01.018; 24.07.01.0470.003553%
Haemoptysis02.11.04.009; 24.07.01.006; 22.02.03.0040.001992%Not Available
Hemiparesis17.01.04.0010.000538%
Hernia08.01.04.0010.000808%Not Available
Hyperbilirubinaemia01.06.04.003; 14.11.01.010; 09.01.01.0030.000538%Not Available
Hypercholesterolaemia14.08.01.0010.000538%Not Available
Hyperkalaemia14.05.03.0010.001615%
Hypertension24.08.02.0010.007375%
Hypertensive heart disease02.11.02.001; 24.08.05.0020.000808%Not Available
Hyperthyroidism14.11.01.011; 05.02.02.0010.001346%
Hypertonic bladder20.03.03.003; 17.10.01.0030.000538%Not Available
Hypervolaemia02.05.04.019; 14.05.06.0030.004253%Not Available
Hypoaesthesia23.03.03.081; 17.02.06.0230.015881%Not Available
Hypokalaemia14.05.03.0020.002423%
Hypotension24.06.03.002--
Hypothyroidism14.11.01.012; 05.02.03.0010.002961%
Impaired healing08.03.02.0010.002746%Not Available
Infection11.01.08.002--Not Available
Inguinal hernia07.16.02.0010.000538%Not Available
Insomnia19.02.01.002; 17.15.03.002--
Iron deficiency anaemia14.13.02.001; 01.03.01.0020.000808%Not Available
Joint stiffness15.01.02.0030.000808%Not Available
Joint swelling15.01.02.0040.005383%Not Available
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