Drug · FAERS side-effect profile with label screen
Tafamidis Meglumine side effects: what 4,725 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Tafamidis (Vyndamax)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
4,725 reports · 87% serious · 1,861 with death outcome · 17% female
openFDA FAERS counts, all years, deduplication not applied
Used for
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, Indications and Usage
What it is
11. DESCRIPTION VYNDAQEL (tafamidis meglumine) and VYNDAMAX (tafamidis) contain tafamidis as the active moiety, which is a selective stabilizer of transthyretin.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Reporting / coding artifact 3Lab value / disease marker 5Outcome field, not a reaction 2No label text to screen 30
What the badges mean
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 51 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Cardiac failure (heart failure) | 534 | 29.7 27.4–32.2ROR 33.3 · χ² 14,731 / p <1e-300 | 29.5 EB05 27.4 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.6 | no trial data cached |
| Polyneuropathy | 34 | 12.7 9.1–17.8ROR 12.8 · χ² 355 / p 2e-79 | 12.3 EB05 9.0 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 | no trial data cached |
| Sudden death | 25 | 10.4 7.0–15.4ROR 10.4 · χ² 203 / p 3e-46 | 9.6 EB05 6.6 · IC025 +2.5 3/3 methods agree | Outcome field, not a reaction | serious PRR 6.9 · 96% clinician | no trial data cached |
| Mitral valve incompetence | 24 | 9.4 6.3–14.1ROR 9.5 · χ² 172 / p 1e-39 | 8.5 EB05 5.8 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 · 92% clinician | no trial data cached |
| Glomerular filtration rate decreased | 23 | 8.4 5.6–12.7ROR 8.5 · χ² 143 / p 3e-33 | 7.5 EB05 5.2 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 5.4 | no trial data cached |
| Cardiomyopathy | 27 | 8.1 5.6–11.8ROR 8.2 · χ² 161 / p 3e-37 | 7.4 EB05 5.2 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.4 · 74% consumer | no trial data cached |
| Atrial fibrillation | 176 | 8.0 6.9–9.3ROR 8.3 · χ² 1,078 / p 1e-236 | 7.9 EB05 6.9 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.2 | no trial data cached |
| Body height decreased | 19 | 7.8 5.0–12.2ROR 7.8 · χ² 106 / p 4e-25 | 6.8 EB05 4.5 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=6 | no trial data cached |
| Gout | 30 | 7.4 5.2–10.6ROR 7.5 · χ² 160 / p 5e-37 | 6.8 EB05 4.9 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial data cached |
| Dizziness postural | 16 | 7.4 4.5–12.1ROR 7.4 · χ² 82 / p 6e-20 | 6.3 EB05 4.0 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Carpal tunnel syndrome | 22 | 7.0 4.6–10.6ROR 7.0 · χ² 106 / p 3e-25 | 6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.2 | no trial data cached |
| Death | 1,346 | 6.9 6.6–7.3ROR 9.3 · χ² 7,126 / p <1e-300 | 6.9 EB05 6.6 · IC025 +2.7 3/3 methods agree | Outcome field, not a reaction | serious PRR 4.5 | no trial data cached |
| Ejection fraction decreased | 21 | 6.0 3.9–9.2ROR 6.0 · χ² 82 / p 6e-20 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 4.4 · 90% clinician | no trial data cached |
| Hyperlipidaemia | 16 | 5.9 3.6–9.7ROR 5.9 · χ² 61 / p 3e-15 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.3 | no trial data cached |
| Dyspnoea exertional | 48 | 5.7 4.3–7.5ROR 5.7 · χ² 181 / p 2e-41 | 5.4 EB05 4.2 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | no trial data cached |
| Ventricular tachycardia | 21 | 5.6 3.7–8.6ROR 5.6 · χ² 75 / p 2e-18 | 5.0 EB05 3.5 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 · 95% clinician | no trial data cached |
| Disease progression | 146 | 5.5 4.7–6.5ROR 5.6 · χ² 535 / p 1e-118 | 5.4 EB05 4.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 | no trial data cached |
| Cerebral infarction | 30 | 5.4 3.8–7.8ROR 5.5 · χ² 105 / p 8e-25 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.6 · 97% clinician | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 20 | 5.1 3.3–7.9ROR 5.1 · χ² 62 / p 2e-15 | 4.6 EB05 3.1 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | no trial data cached |
| Fluid retention | 55 | 4.8 3.7–6.2ROR 4.8 · χ² 162 / p 2e-37 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | no trial data cached |
| Weight fluctuation | 11 | 4.7 2.6–8.5ROR 4.7 · χ² 28 / p 5e-8 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=7 | no trial data cached |
| Pericardial effusion | 23 | 4.4 3.0–6.7ROR 4.5 · χ² 58 / p 1e-14 | 4.1 EB05 2.9 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.0 | no trial data cached |
| Malnutrition | 11 | 4.4 2.4–7.9ROR 4.4 · χ² 26 / p 2e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.0 | no trial data cached |
| Subdural haematoma | 14 | 4.3 2.6–7.3ROR 4.3 · χ² 33 / p 6e-9 | 3.8 EB05 2.5 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.9 | no trial data cached |
| Cardiac failure congestive | 75 | 4.1 3.3–5.1ROR 4.2 · χ² 174 / p 6e-40 | 4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial data cached |
| Hypoacusis | 39 | 4.0 2.9–5.5ROR 4.1 · χ² 86 / p 9e-21 | 3.9 EB05 3.0 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.8 · 77% consumer | no trial data cached |
| Neoplasm | 10 | 3.9 2.1–7.2ROR 3.9 · χ² 18 / p 9e-6 | 3.4 EB05 2.0 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 2.8 | no trial data cached |
| Product use in unapproved indication | 190 | 3.5 3.0–4.0ROR 3.6 · χ² 332 / p 1e-74 | 3.4 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 | no trial data cached |
| Blood urea increased | 13 | 3.4 2.0–5.9ROR 3.4 · χ² 20 / p 4e-6 | 3.1 EB05 2.0 · IC025 +0.7 | Lab value / disease marker | serious PRR 1.9 | no trial data cached |
| Cardiogenic shock | 11 | 3.4 1.9–6.2ROR 3.4 · χ² 17 / p 2e-5 | 3.1 EB05 1.9 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | no trial data cached |
| Gamma-glutamyltransferase increased | 17 | 3.4 2.1–5.5ROR 3.4 · χ² 26 / p 1e-7 | 3.2 EB05 2.1 · IC025 +0.9 3/3 methods agree | Lab value / disease marker | serious PRR 2.3 | no trial data cached |
| Pneumonia aspiration | 19 | 3.4 2.2–5.3ROR 3.4 · χ² 30 / p 3e-8 | 3.2 EB05 2.2 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial data cached |
| Dysphagia (difficulty swallowing) | 72 | 3.4 2.7–4.2ROR 3.4 · χ² 119 / p 6e-28 | 3.3 EB05 2.7 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | no trial data cached |
| Pulmonary oedema | 33 | 3.3 2.3–4.6ROR 3.3 · χ² 50 / p 9e-13 | 3.1 EB05 2.4 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.2 · 72% consumer | no trial data cached |
| Gynaecomastia (male breast enlargement) | 23 | 3.3 2.2–4.9ROR 3.3 · χ² 34 / p 3e-9 | 3.1 EB05 2.2 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 | no trial data cached |
| Therapeutic response unexpected | 33 | 3.3 2.3–4.6ROR 3.3 · χ² 49 / p 1e-12 | 3.1 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 | no trial data cached |
| Dementia | 20 | 3.2 2.1–4.9ROR 3.2 · χ² 28 / p 6e-8 | 3.0 EB05 2.1 · IC025 +0.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | no trial data cached |
| Oedema | 38 | 3.1 2.3–4.3ROR 3.1 · χ² 53 / p 2e-13 | 3.0 EB05 2.3 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial data cached |
| Haematocrit decreased | 14 | 3.1 1.8–5.3ROR 3.1 · χ² 18 / p 1e-5 | 2.9 EB05 1.8 · IC025 +0.6 | Lab value / disease marker | serious PRR 1.8 | no trial data cached |
| Arrhythmia | 33 | 3.1 2.2–4.3ROR 3.1 · χ² 44 / p 1e-11 | 3.0 EB05 2.2 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Death | 1,346 | 6.9 6.6–7.3ROR 9.3 · χ² 7,126 / p <1e-300 | 6.9 EB05 6.6 · IC025 +2.7 3/3 methods agree | Outcome field, not a reaction | serious PRR 4.5 | no trial data cached |
| Cardiac failure (heart failure) | 534 | 29.7 27.4–32.2ROR 33.3 · χ² 14,731 / p <1e-300 | 29.5 EB05 27.4 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.6 | no trial data cached |
| Off label use (used outside approved label) | 418 | 2.1 2.0–2.3ROR 2.2 · χ² 263 / p 2e-59 | 2.1 EB05 2.0 · IC025 +0.9 | Reporting / coding artifact | serious PRR 1.8 | no trial data cached |
| Product use in unapproved indication | 190 | 3.5 3.0–4.0ROR 3.6 · χ² 332 / p 1e-74 | 3.4 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 | no trial data cached |
| Atrial fibrillation | 176 | 8.0 6.9–9.3ROR 8.3 · χ² 1,078 / p 1e-236 | 7.9 EB05 6.9 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.2 | no trial data cached |
| Disease progression | 146 | 5.5 4.7–6.5ROR 5.6 · χ² 535 / p 1e-118 | 5.4 EB05 4.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 | no trial data cached |
| Cardiac failure congestive | 75 | 4.1 3.3–5.1ROR 4.2 · χ² 174 / p 6e-40 | 4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial data cached |
| Dysphagia (difficulty swallowing) | 72 | 3.4 2.7–4.2ROR 3.4 · χ² 119 / p 6e-28 | 3.3 EB05 2.7 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | no trial data cached |
| Cerebrovascular accident (stroke) | 65 | 1.7 1.3–2.2ROR 1.7 · χ² 18 / p 1e-5 | 1.7 EB05 1.4 · IC025 +0.3 | No label text to screen label has no adverse-reaction text | serious PRR 1.1 | no trial data cached |
| Cardiac disorder | 59 | 2.8 2.2–3.6ROR 2.8 · χ² 66 / p 2e-16 | 2.7 EB05 2.2 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial data cached |
| Fluid retention | 55 | 4.8 3.7–6.2ROR 4.8 · χ² 162 / p 2e-37 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 52 | 2.4 1.9–3.2ROR 2.5 · χ² 43 / p 3e-11 | 2.4 EB05 1.9 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | no trial data cached |
| Dyspnoea exertional | 48 | 5.7 4.3–7.5ROR 5.7 · χ² 181 / p 2e-41 | 5.4 EB05 4.2 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | no trial data cached |
| Renal impairment | 47 | 2.5 1.9–3.3ROR 2.5 · χ² 41 / p 9e-11 | 2.5 EB05 1.9 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | no trial data cached |
| Syncope (fainting) | 46 | 2.0 1.5–2.7ROR 2.0 · χ² 23 / p 6e-7 | 2.0 EB05 1.6 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 1.4 | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Tafamidis Meglumine?
In FDA FAERS, the most frequently co-reported reaction terms for Tafamidis Meglumine are cardiac failure, atrial fibrillation, cardiac failure congestive, dysphagia, cerebrovascular accident, cardiac disorder. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Tafamidis Meglumine have an FDA boxed warning?
No. The FDA label retrieved for Tafamidis Meglumine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Tafamidis Meglumine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 1b4121ee-a733-4456-a917-be2603477839, effective 20260512; matched on
openfda.generic_name.exact:"TAFAMIDIS MEGLUMINE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 91 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.