Tafamidis
Tafamidis is a transthyretin stabilizer used to treat the heart disease caused by wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Tafamidis (Vyndaqel, Vyndamax) treats ATTR-CM, a heart disease where a protein called transthyretin breaks apart and builds up in the heart, by holding that protein in its normal shape; it is usually the first medicine specialists choose to slow the disease and lower heart-related deaths and hospital stays. It is well tolerated and most people notice few side effects, but its benefit builds over many months rather than something you feel. Avoid it in pregnancy and while breastfeeding, and use effective birth control, since animal studies show harm to a developing baby. It can also raise levels of rosuvastatin, methotrexate and imatinib, so tell every prescriber you take it.
Clinical pearls
- Vyndaqel and Vyndamax are two different capsule versions of one drug, so never swap them without a new prescription.
- Swallow the once-daily capsules whole, never crushed or cut; food makes no difference, so choose a time you will remember.
- If you also take rosuvastatin, report new muscle aches or weakness, since tafamidis can push its levels higher.
- Tafamidis can lower total thyroid hormone on blood tests because it binds the carrier protein, usually without true thyroid problems.
Patient information guide A plain-language walkthrough of Tafamidis, written from its FDA label.
What Tafamidis is used for
▾
Tafamidis is approved to treat a specific type of heart disease caused by abnormal protein deposits.
- Vyndaqel and Vyndamax are both indicated for the treatment of transthyretin-mediated amyloidosis cardiomyopathy (ATTR-CM) in adults — this includes both the wild-type (non-inherited) and hereditary (gene-related) forms of the disease.
- The treatment goal is to reduce cardiovascular mortality (death from heart-related causes) and cardiovascular-related hospitalization (hospital stays due to heart problems).
How Tafamidis works
▾
Tafamidis targets a protein in the blood called transthyretin (TTR). In ATTR-CM, TTR breaks apart from its normal four-piece (tetramer) structure into single pieces (monomers) that fold incorrectly and clump together as amyloid deposits in the heart. Tafamidis binds to specific sites on TTR — the same sites where the thyroid hormone thyroxine normally attaches — and locks the protein in its stable four-piece shape. By slowing this breakup process, tafamidis reduces the rate at which damaging amyloid builds up in heart tissue.
One measurable effect of this binding is that tafamidis can lower total thyroxine levels in the blood, since it competes with thyroxine for the same binding sites on TTR. However, thyroid-stimulating hormone (TSH) levels are unaffected, and no signs of an underactive thyroid (hypothyroidism) have been observed in clinical studies.
Tafamidis dosage
▾
Tafamidis is taken by mouth once daily. Both Vyndaqel and Vyndamax come as capsules and should be swallowed whole — do not crush or cut them. They can be taken with or without food.
- Vyndaqel: taken as four 20-mg capsules once daily.
- Vyndamax: taken as one 61-mg capsule once daily.
- Vyndaqel and Vyndamax are not interchangeable on a per-milligram basis — do not switch between them without your prescriber's direction.
- If you miss a dose, take it as soon as you remember — or skip it and take your next dose at the regular time. Do not take two doses at once.
Dosing details from the FDA-approved label
From the Tafamidis prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosage (VYNDAQEL)
- VYNDAQEL 80 mg (four 20-mg tafamidis meglumine capsules) orally once daily
- VYNDAMAX and VYNDAQEL are not substitutable on a per mg basis
- Recommended dosage (VYNDAMAX)
- VYNDAMAX 61 mg (one 61-mg tafamidis capsule) orally once daily
- VYNDAMAX and VYNDAQEL are not substitutable on a per mg basis
Read the label’s full dosing text
2. DOSAGE AND ADMINISTRATION The recommended dosage is either: • VYNDAQEL 80 mg orally once daily, or • VYNDAMAX 61 mg orally once daily ( 2.1 ) • VYNDAMAX and VYNDAQEL are not substitutable on a per mg basis. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage is either VYNDAQEL 80 mg (four 20-mg tafamidis meglumine capsules) orally once daily or VYNDAMAX 61 mg (one 61-mg tafamidis capsule) orally once daily. VYNDAMAX and VYNDAQEL are not substitutable on a per mg basis [see Clinical Pharmacology (12.3) ] . 2.2 Administration Instructions The capsules should be swallowed whole and not crushed or cut. If a dose is missed, instruct patients to take the dose as soon as remembered or to skip the missed dose and take the next dose at the regularly scheduled time. Do not double the dose.
Read the full Dosage and Administration section on DailyMed →
Tafamidis side effects
▾
In clinical trials, the overall rate of side effects in patients taking Vyndaqel was similar to those taking placebo (an inactive treatment), making it difficult to identify effects clearly caused by the drug.
- No specific adverse reactions were identified as occurring more frequently with tafamidis than with placebo in the main clinical trial.
However, tafamidis can raise blood levels of certain other medications (such as rosuvastatin, methotrexate, and imatinib), which could cause side effects related to those drugs. Tell your doctor right away if you notice any new or unusual symptoms after starting tafamidis, especially if you take any of those medications.
Tafamidis warnings and precautions
▾
- Pregnancy risk: Animal studies show tafamidis can cause serious harm to a developing baby, including fetal death, low birth weight, and abnormalities. Women who can become pregnant should use effective birth control during treatment. If pregnancy occurs, contact your doctor immediately and report it to Pfizer at 1-800-438-1985.
- Breastfeeding: Tafamidis passes into animal milk and may harm a nursing infant. Breastfeeding is not recommended while taking Vyndaqel or Vyndamax.
- Drug interactions via BCRP inhibition: Tafamidis blocks a drug transporter called BCRP, which can significantly increase blood levels of drugs like rosuvastatin, methotrexate, and imatinib. This raises the risk of toxicity from those medications. Your doctor should monitor you carefully if you take them.
- Thyroid hormone levels: Tafamidis may reduce total thyroxine levels in blood tests, but this has not been associated with any actual thyroid symptoms. Inform your doctor so they can interpret thyroid lab results correctly.
Tafamidis interactions
▾
Tafamidis affects certain drug transporters and enzymes in the body, which can change how other medications work.
- BCRP substrate drugs (e.g., rosuvastatin, methotrexate, imatinib): Tafamidis inhibits the BCRP transporter, which can nearly double the blood levels of these drugs — increasing the risk of their side effects. Your doctor may need to reduce their doses.
- CYP3A4 substrates (e.g., midazolam): No clinically significant interaction was found in studies.
- Food: No meaningful effect on tafamidis levels — it can be taken with or without food.
Interactions listed in the FDA-approved label
From the Tafamidis prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- BCRP substrates (e.g., methotrexate, rosuvastatin, imatinib): Tafamidis inhibits BCRP in humans; coadministration may increase the exposure of substrates of this transporter and the risk of the substrate-related toxicities. Monitor for signs of BCRP substrate-related toxicities and modify dosage of the substrate if appropriate.
Read the label’s full interactions text
7. DRUG INTERACTIONS 7.1 BCRP Substrates Tafamidis inhibits breast cancer resistant protein (BCRP) in humans [see Clinical Pharmacology (12.3) ] . Coadministration of tafamidis and drugs that are BCRP substrates may increase the exposure of substrates of this transporter (e.g., methotrexate, rosuvastatin, imatinib) and the risk of the substrate-related toxicities. Monitor for signs of BCRP substrate-related toxicities and modify dosage of the substrate if appropriate.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Tafamidis
▾
- Pregnancy: Tell your doctor if you are pregnant, trying to conceive, or could become pregnant. Tafamidis may harm a developing baby. Discuss effective contraception with your doctor before starting treatment.
- Breastfeeding: Do not breastfeed while taking tafamidis.
- Children: Vyndaqel and Vyndamax have not been studied in pediatric patients and are not approved for use in children.
- Older adults: No dose adjustment is needed for patients 65 and older. The majority of patients in clinical trials were 65 or older.
- Kidney problems: No dose adjustment is needed for kidney impairment based on available data.
- Liver problems: No adjustment is needed for mild or moderate liver impairment. The effect of severe liver disease on tafamidis is not known — tell your doctor about any liver conditions.
- All medications: Tell your doctor and pharmacist about every medication you take, especially rosuvastatin, methotrexate, or imatinib, as tafamidis can increase their levels.
Tafamidis overdose
▾
There is very limited experience with tafamidis overdose. In clinical trials, two patients accidentally took twice the usual Vyndaqel dose in a single day without any reported side effects. The highest single dose given to healthy volunteers in a study was much larger, and only one mild side effect (a small eyelid bump called a hordeolum) was reported at that level. If you suspect an overdose, contact a poison control center or seek emergency care right away.
What Tafamidis does in the body
▾
Tafamidis stabilizes the TTR protein tetramer in the blood, slowing the process by which it breaks apart and forms harmful amyloid deposits. Studies show a dose-dependent trend toward greater TTR stabilization at higher doses of Vyndaqel, though whether higher stabilization translates to better heart outcomes is not yet known. Heart failure biomarkers (NT-proBNP and Troponin I) favored Vyndaqel over placebo in clinical studies. Tafamidis may lower total thyroxine levels in blood tests by competing with the hormone for binding sites on TTR, but thyroid-stimulating hormone (TSH) levels remain normal and no thyroid symptoms have been observed.
How your body processes Tafamidis
▾
After taking tafamidis by mouth, peak blood levels are reached within about 4 hours, and there is no meaningful difference whether taken with or without food. The drug has a half-life of approximately 49 hours, meaning it stays active in the body for about two days, and it accumulates to about 2.5 times a single dose's level with daily use. Tafamidis is more than 99% bound to proteins in the blood, primarily TTR itself. It is partly broken down by a process called glucuronidation and is eliminated mainly through the feces (mostly as unchanged drug) and to a lesser extent in urine. No significant differences in how the body handles tafamidis were found based on age, race, or kidney function.
How to store Tafamidis
▾
Store VYNDAQEL and VYNDAMAX at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Tafamidis
17 supplements and herbal products have documented interactions with Tafamidis in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Tafamidis: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Tafamidis — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is ATTR-CM and why do I need this medication?
▾
Can I take Vyndaqel and Vyndamax interchangeably — they seem like the same drug?
▾
How do I take these capsules — does it matter if I take them with food?
▾
What side effects should I watch out for?
▾
Is it safe to take this if I'm pregnant or trying to get pregnant?
▾
My blood test showed my thyroid hormone level dropped — should I be worried?
▾
Is Tafamidis available over the counter?
▾
When was Tafamidis first available?
▾
Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Tafamidis on HelloPharmacist
Tafamidis forms and strengths (how it comes)
Tafamidis is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Tafamidis inactive ingredients by manufacturer.
Capsule
How this form is used
- Vyndaqel is indicated to treat the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
- Vyndamax is indicated to treat the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
- Vyndaqel is taken as four 20-mg capsules once daily by mouth.
- Vyndamax is taken as one 61-mg capsule once daily by mouth.
- Vyndamax and Vyndaqel are not substitutable on a per-milligram basis — do not switch between them without your prescriber's guidance.
- Both Vyndaqel and Vyndamax capsules should be swallowed whole; do not crush or cut them. They can be taken with or without food.
Tafamidis on the U.S. market: products, makers and brands
How Tafamidis appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 2 Tafamidis product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2001. Brand names on the directory include Vyndamax, Vyndaqel; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (23) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Tafamidis is used (Medicaid data)
A general measure of how commonly Tafamidis is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Tafamidis is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Tafamidis prescribed? Of the 1,601 medications we measure, Tafamidis ranks #1,323 by Medicaid prescriptions — more than 17% of them.
Utilization by Tafamidis product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
tafamidis 61 MG Oral Capsule
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2168534
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Tafamidis, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 3 listed Tafamidis NDCs with Medicaid activity.
Compare Tafamidis products
A representative set of FDA-listed product records for Tafamidis — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 20 mg | Oral | Pfizer Laboratories Div Pfizer Inc | NDA | View NDC → |
| 61 mg | Oral | Pfizer Laboratories Div Pfizer Inc | NDA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Tafamidis NDCs →
Tafamidis side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Tafamidis — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Tafamidis in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Tafamidis FDA approval history
How Tafamidis went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Tafamidis recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Tafamidis recalls since July 2021.
✅No Tafamidis recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1545063 1 dose form · 2 strengths
-
Dose form (SCDF) Oral Capsule RxCUI 1545067In current FDA listings
Look up RxCUI 1545063 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Tafamidis supply and shortage status
Whether Tafamidis is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Tafamidis brand names
Tafamidis is sold under 2 brand names in the FDA directory — Vyndamax, Vyndaqel. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Tafamidis: manufacturers and labelers
One company lists Tafamidis products with the FDA. By number of product records, the largest are Pfizer Laboratories Div Pfizer Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Tafamidis drug class (RxNorm)
Tafamidis belongs to the Other nervous system drugs class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Tafamidis page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Pfizer Laboratories Div Pfizer Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →