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What the label lists and what reports show

Tafamidis side effects

Tafamidis's FDA label lists its adverse reactions in its own words. FAERS holds 16,240 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is cardiac failure (1,123 reports).

  • No generic listed

Check it at the source: the tafamidis FDA label on DailyMed (effective May 12, 2026, Pfizer Laboratories Div Pfizer Inc); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of VYNDAQEL and VYNDAMAX?

There were no known side effects that happened during treatment with VYNDAQEL or VYNDAMAX in people with cardiomyopathy of transthyretin-mediated amyloidosis. You may report side effects to FDA at 1-800-FDA-1088.

Source: FDA drug label, NDA211996 (Foldrx Pharms), as published by Pfizer Laboratories Div Pfizer Inc, effective May 12, 2026 (SPL set 1b4121ee-a733-4456-a917-be2603477839), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data reflect exposure of 377 ATTR-CM patients to 20 mg or 80 mg (administered as four 20-mg capsules) of VYNDAQEL administered daily for an average of 24.5 months (ranging from 1 day to 111 months). Adverse events were assessed from ATTR-CM clinical trials with VYNDAQEL, primarily a 30-month placebo-controlled trial [see Clinical Studies (14) ]. The frequency of adverse events in patients treated with VYNDAQEL 20 mg (n=88) or 80 mg (n=176; …

Source: FDA drug label, NDA211996 (Foldrx Pharms), as published by Pfizer Laboratories Div Pfizer Inc, effective May 12, 2026 (SPL set 1b4121ee-a733-4456-a917-be2603477839), via openFDA; the full label on DailyMed

What do FAERS reports show?

16,240 reports list tafamidis among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5,821 are coded as a death and 4,611 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, none is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Death (an outcome recorded in the report)4,410
  • Cardiac Failure1,123
  • Off Label Use (a use or a product term, not a reaction)1,054
  • Dyspnoea990
  • Fatigue727
  • Fall587
  • Atrial Fibrillation554
  • Dizziness466
  • Asthenia446
  • Condition Aggravated (a use or a product term, not a reaction)438
  • Malaise429
  • Weight Decreased389
  • Cardiac Failure Congestive372
  • Disease Progression (a use or a product term, not a reaction)350
  • Hypoacusis338
  • Cardiac Disorder333
  • Diarrhoea321
  • Cerebrovascular Accident318
  • Cardiac Failure Chronic304
  • Peripheral Swelling302
  • Cardiac Amyloidosis296
  • Drug Ineffective (a use or a product term, not a reaction)295
  • Product Dose Omission Issue (a use or a product term, not a reaction)294
  • Fluid Retention293
  • Pneumonia287

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Tafamidis: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions