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)
Parosmia22.04.03.007; 17.04.04.0020.001184%Not Available
Pericardial effusion02.06.01.0020.001346%
Peripheral coldness23.06.04.008; 24.04.03.006; 08.01.09.0100.003284%Not Available
Peripheral vascular disorder24.03.01.0030.001184%Not Available
Petechiae24.07.06.004; 23.06.01.003; 01.01.03.0020.001830%Not Available
Pleural effusion22.05.02.0020.005653%
Pollakiuria20.02.02.0070.003176%
Polymyalgia rheumatica15.06.01.001; 10.04.05.0030.000538%Not Available
Polyneuropathy17.09.03.0120.003230%Not Available
Polyuria20.02.03.0020.001830%Not Available
Pre-existing condition improved08.01.03.0430.004199%Not Available
Presyncope24.06.02.010; 02.11.04.013; 17.02.05.0090.001077%
Productive cough22.02.03.0050.001077%
Pulmonary hypertension24.08.03.002; 22.06.01.0010.002423%
Pulmonary oedema22.01.03.003; 02.05.02.0030.002153%
Rash pruritic23.03.13.0300.006676%Not Available
Renal disorder20.01.02.0020.002261%Not Available
Renal failure20.01.03.0050.004307%Not Available
Restrictive cardiomyopathy02.04.01.0050.000538%
Rheumatoid arthritis15.01.03.001; 10.04.06.0010.000808%Not Available
Rhinitis allergic10.01.04.003; 22.04.04.0030.000808%
Sciatica17.10.03.001; 15.10.01.0010.001992%Not Available
Seizure17.12.03.001--
Sinus bradycardia02.03.03.0090.000808%
Sinus congestion22.04.06.0010.000808%Not Available
Skin fissures23.03.03.0080.001184%Not Available
Skin odour abnormal23.03.03.0120.001830%
Skin ulcer24.04.03.007; 23.07.03.0030.000808%
Sleep apnoea syndrome19.02.05.002; 17.15.05.001; 22.02.01.0130.002423%
Sleep disorder19.02.04.0010.004199%Not Available
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