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: Patient Information Guide
A plain-language walkthrough of Tafamidis — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Tafamidis is used to treat a specific type of heart muscle disease caused by amyloid protein deposits. Both Vyndaqel and Vyndamax are approved for the same condition:
- Vyndaqel and Vyndamax are both indicated for the treatment of the cardiomyopathy (heart muscle disease) of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults, to reduce cardiovascular mortality and cardiovascular-related hospitalization.
⚙️How it works▾
Your body makes a protein called transthyretin (TTR) that normally circulates in the blood. In ATTR-CM, TTR becomes unstable and breaks apart into smaller pieces that clump into amyloid deposits in the heart, damaging its ability to pump properly. Tafamidis binds directly to TTR at sites normally used by the thyroid hormone thyroxine, locking the protein into a stable four-part structure (tetramer) and dramatically slowing the breakdown process that leads to amyloid buildup.
Because tafamidis occupies the thyroxine-binding sites on TTR, it can cause a measurable drop in total thyroxine levels on blood tests — but this is not a sign of thyroid disease, and thyroid-stimulating hormone (TSH) levels and thyroid function remain normal.
💊How it's taken▾
Tafamidis is taken by mouth once a day. Vyndaqel and Vyndamax are each taken once daily as oral capsules and can be taken with or without food — a high-fat, high-calorie meal does not meaningfully change how the drug is absorbed.
- Vyndaqel is taken as four capsules once daily.
- Vyndamax is taken as one capsule once daily.
- These two products 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 resume your regular schedule. Never take two doses at once.
Swallow the capsules whole — do not crush or cut them.
🤒Side effects — in detail▾
In clinical trials, the overall rate of side effects with Vyndaqel was similar to that seen with placebo, and no specific adverse reactions were identified as more common with tafamidis. The most important reactions to watch for are related to the drug's known effects on certain lab values and other medications you may be taking.
- A decrease in total thyroxine (thyroid hormone) levels on blood tests — this has not been linked to thyroid symptoms or changes in TSH
- Potential increased effects or toxicity from other medications that interact with tafamidis (see Interactions)
If you notice any new or concerning symptoms while taking this medication, contact your doctor promptly.
⚠️Warnings & precautions▾
- Pregnancy: Based on animal studies, tafamidis may cause serious harm to a developing baby, including fetal death, reduced fetal growth, and physical defects. Women who could become pregnant should use effective contraception during treatment. Report any pregnancy to your doctor and to Pfizer at 1-800-438-1985.
- Breastfeeding: Tafamidis passes into animal milk and is likely to pass into human breast milk. Breastfeeding is not recommended while taking Vyndaqel or Vyndamax due to the potential for serious harm to the nursing infant.
- Thyroid lab values: Tafamidis may lower total thyroxine levels on blood tests without affecting actual thyroid function. No thyroid symptoms or TSH changes have been observed — inform your doctor so they can interpret lab results correctly.
- Liver disease: Moderate liver impairment reduces tafamidis levels in the blood, though the drug appears to remain effective. The effect of severe liver impairment is not known.
🔀What it interacts with▾
Tafamidis can affect how certain other drugs are processed in your body. The most important interaction to know about involves a drug transport protein called BCRP:
- BCRP substrate drugs (such as rosuvastatin, methotrexate, and imatinib): Tafamidis blocks the BCRP transporter, which can raise blood levels of these drugs significantly — increasing the risk of their side effects. Your doctor may need to monitor you more carefully or adjust the dose of those medications.
- CYP3A4 substrates: Lab studies suggest tafamidis may increase the activity of certain drug-processing enzymes, but clinical testing did not show a meaningful effect on drugs like midazolam that use this pathway.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: Do not use tafamidis if you are pregnant unless your doctor has carefully weighed the risks. Use contraception if you could become pregnant.
- Breastfeeding: Do not breastfeed while taking Vyndaqel or Vyndamax.
- Liver disease: Tell your doctor if you have moderate or severe liver problems — your body may process tafamidis differently, and the effect of severe liver impairment is unknown.
- Kidney disease: Kidney problems do not appear to significantly affect tafamidis levels, but always share your full health history with your prescriber.
- Children: Vyndaqel and Vyndamax have not been studied in pediatric patients and are not established as safe or effective in children.
- Older adults: No dose adjustment is needed for patients 65 and older. Most patients in the clinical trials were in this age group.
- Other medications: Tell your doctor and pharmacist about all medications you take, especially rosuvastatin, methotrexate, or imatinib, as tafamidis can raise their levels in your blood.
🚑If you take too much▾
There is very limited information about what happens if someone takes too much tafamidis. In clinical trials, two patients accidentally took double the recommended dose in a single day with no reported adverse effects. In a study of healthy volunteers, a very large single dose led to only one reported mild side effect (a small eyelid bump called a hordeolum). If you think you or someone else has taken too much, contact a poison control center or seek medical attention right away.
📡Pharmacodynamics — effects in the body▾
Tafamidis stabilizes the TTR protein tetramer (the normal four-part structure of the protein), slowing the process by which it breaks apart and forms harmful amyloid deposits. Because tafamidis binds to the same sites on TTR that the thyroid hormone thyroxine uses, it can measurably reduce total thyroxine levels in the blood — but thyroid-stimulating hormone (TSH) remains unaffected, and no signs of hypothyroidism have been observed. Heart failure biomarkers (NT-proBNP and Troponin I), which reflect stress on the heart, have shown more favorable trends with Vyndaqel compared to placebo. At levels well above the recommended dose, tafamidis does not cause meaningful changes in heart rhythm (QTc interval).
🔬Pharmacokinetics — how your body processes it▾
After an oral dose, tafamidis reaches peak levels in the blood within about 4 hours, and it can be taken with or without food without affecting absorption. The drug has a long half-life of approximately 49 hours, meaning it stays in your system for an extended period and builds up gradually with daily dosing — reaching about 2.5 times the single-dose level at steady state. Tafamidis is heavily bound to proteins in the blood (more than 99%), primarily to TTR itself. It is broken down in part through a process called glucuronidation, and most of the drug leaves the body through the stool, with a smaller portion eliminated in the urine.
📦How to store it▾
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 Tafamidis’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. 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.
🩺 Pharmacist Counseling Corner
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? ▾
I've been prescribed Vyndamax. Is that the same as Vyndaqel? ▾
Do I need to take this with food? ▾
What should I do if I miss a dose? ▾
My doctor mentioned that this drug could interact with my cholesterol medication. Should I be worried? ▾
Is it safe to take this if I'm pregnant or trying to become pregnant? ▾
Is Tafamidis available over the counter? ▾
When was Tafamidis first available? ▾
Who makes Tafamidis? ▾
💬 Answers drafted from Tafamidis’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Tafamidis 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.
Capsule
How this form is used
- Vyndaqel is approved 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 approved 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 orally once daily.
- Vyndamax is taken as one 61-mg capsule orally once daily.
- Vyndamax and Vyndaqel are NOT interchangeable on a per-milligram basis — do not substitute one for the other without your prescriber's guidance.
- Both Vyndaqel and Vyndamax capsules should be swallowed whole and not crushed or cut; they can be taken with or without food.
📊 Tafamidis across the U.S. market
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.
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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Tafamidis is used
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 1,596 medications we measure, Tafamidis ranks #1,322 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 | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 61 mg | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 20 mg | Oral | Pfizer Laboratories Div Pfizer Inc × 3 listings | NDA | View NDC → |
| 61 mg | Oral | Pfizer Laboratories Div Pfizer Inc × 3 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Alivus Life Sciences Limited × 2 listings | BULK INGREDIENT | View NDC → |
| 0.999 kg/0.999 kg | — | Apothecon Pharmaceuticals Pvt Ltd | BULK INGREDIENT | View NDC → |
| 50 kg/50 kg | — | Aurobindo Pharma Limited × 2 listings | BULK INGREDIENT | View NDC → |
| 25 kg/25 kg | — | Biophore india pharmaceutical PVT Ltd | BULK INGREDIENT | View NDC → |
| 25 kg/25 kg | — | Biophore India Pharmaceuticals Pvt. Ltd | BULK INGREDIENT | View NDC → |
| 1 kg | — | Catalent Micron Technologies, Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 1 kg/kg | — | Delmar Chemicals Inc | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Honour Lab Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Inke SA | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Laboratories Private Limited × 2 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Neuland Laboratories Limited × 2 listings | BULK INGREDIENT | View NDC → |
| 35 kg/35 kg | — | Nuray Chemicals Private Limited × 3 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Pfizer Asia Manufacturing Pte Ltd | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Pfizer Ireland Pharmaceuticals Unlimited Company × 2 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | TAPI Croatia Industries Ltd. × 2 listings | BULK INGREDIENT | View NDC → |
Showing 31 of 31 products — FDA National Drug Code Directory. See every product, package size and price: browse all 31 Tafamidis NDCs →
📈 What people report — real-world data (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.
🏛️ The road to your pharmacy
How Tafamidis went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
Source: openFDA drug enforcement (recall) reports.
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.
📦 Supply & 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.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
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.
🔬 Where this comes from
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 we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Pfizer Laboratories Div Pfizer Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.