Quick answers
- What is Tafamidis used for?
- The FDA-approved label (Vyndaqel, Pfizer Laboratories Div Pfizer Inc, May 12, 2026) says: “1. INDICATIONS AND USAGE VYNDAQEL and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tafamidis have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Tafamidis?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tafamidis been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Tafamidis?
- 1 company lists prescription products of Tafamidis in the FDA NDC Directory, including Pfizer Laboratories Div Pfizer Inc.
What Tafamidis is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
1. INDICATIONS AND USAGE VYNDAQEL and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. …
— FDA label: Vyndaqel, Pfizer Laboratories Div Pfizer Inc, effective May 12, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Pfizer Laboratories Div Pfizer Inc2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2168534, 2168540, 2168542, 2168548 |
|---|---|
| SPL set ID of the quoted label | 1b4121ee-a733-4456-a917-be2603477839 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA211996, NDA212161 |
| Active ingredients (FDA) | TAFAMIDIS |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Vyndaqel, Pfizer Laboratories Div Pfizer Inc, effective May 12, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →