Tafamidis: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 15, 2026🚩 Report this page

Tafamidis

Other Nervous System Drugs

Sold as Vyndaqel · VYNDAMAX

GB MHRAEU EMACA Health Canada

Drug class: Other Nervous System Drugs
Availability: See label
Routes: Oral
Markets covered: 3
Products on record: 5

N07XXOther Nervous System Drugs

Overview

Tafamidis is an active pharmaceutical ingredient in the Other Nervous System Drugs group (N07XX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	3	May 15, 2026
EU European Union	EMA	1	April 22, 2026
CA Canada	Health Canada	1	May 13, 2026

GBUnited Kingdom· MHRA

3 products

Uses

GBOfficial regulatory label· revised May 15, 2026[1]

Vyndaqel is indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).

How to take

GB

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised April 22, 2026[2]

Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage 1 symptomatic polyneuropathy to delay peripheral neurologic impairment.

How to take

EU

CACanada· Health Canada

1 product

1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].

Brands in Canada (1)

VYNDAMAXPFIZER CANADA ULC

Drug interactions

Known interactions involving Tafamidis. Select one for details. This list is informational and not a complete interaction checker.

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PLGB000571695 · revised May 15, 2026
[2]European Medicines Agency · EMEA/H/C/002294 · revised April 22, 2026
[3]Health Canada (DPD) · 02517841 · revised May 13, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised May 15, 2026[1]

1). The frequency of adverse events in patients treated with 80 mg tafamidis meglumine was generally similar and comparable to placebo. 1%)]. A causal relationship has not been established. Safety data for tafamidis 61 mg are available from its open-label long-term extension study.
Tabulated list of adverse reactions Adverse reactions are listed below by MedDRA System Organ Class (SOC) and frequency categories using the standard convention: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), and Uncommon (≥ 1/1,000 to < 1/100).
Within the frequency group, adverse reactions are presented in order of decreasing seriousness. Adverse reactions listed in the table below are from cumulative clinical data in ATTR-CM participants. System Organ Class Common Gastrointestinal disorders Diarrhoea Skin and subcutaneous tissue disorders Rash Pruritus Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised May 15, 2026[1]

6). Tafamidis should be added to the standard of care for the treatment of patients with transthyretin amyloidosis. Physicians should monitor patients and continue to assess the need for other therapy, including the need for organ transplantation, as part of this standard of care.
As there are no data available regarding the use of tafamidis in organ transplantation, tafamidis should be discontinued in patients who undergo organ transplantation. 8). This medicinal product contains no more than 44 mg sorbitol in each capsule.
Sorbitol is a source of fructose. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised April 22, 2026[2]

Summary of the safety profile The overall clinical data reflect exposure of 127 patients with ATTR-PN to 20 mg of tafamidis meglumine administered daily for an average of 538 days (ranging from 15 to 994 days). The adverse reactions were generally mild or moderate in severity.
Tabulated list of adverse reactions Adverse reactions are listed below by MedDRA System Organ Class (SOC) and frequency categories using the standard convention: Very common ( 1/10), Common ( 1/100 to < 1/10), and Uncommon ( 1/1,000 to < 1/100).
Within the frequency group, adverse reactions are presented in order of decreasing seriousness. Adverse reactions reported from the clinical programme in the tabular listing below reflect the rates at which they occurred in the Phase 3, double-blind, placebo-controlled study (Fx-005).
System Organ Class Very Common Infections and infestations Urinary tract infection Gastrointestinal disorders Diarrhoea Upper abdominal pain Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised April 22, 2026[2]

6). Tafamidis meglumine should be added to the standard of care for the treatment of patients with ATTR-PN. Physicians should monitor patients and continue to assess the need for other therapy, including the need for liver transplantation, as part of this standard of care.
As there are no data available regarding the use of tafamidis meglumine post-liver transplantation, tafamidis meglumine should be discontinued in patients who undergo liver transplantation. Co-administration of tafamidis meglumine with substrates of the breast cancer resistant protein (BCRP) may increase exposure to the BCRP substrate.
5). This medicinal product contains no more than 44 mg sorbitol in each capsule. Sorbitol is a source of fructose. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.

This is not medical advice. Consult a qualified healthcare professional.