Drug · FAERS side-effect profile with label screen
Tafamidis side effects: what 11,706 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Vyndamax, Vyndaqel
openFDA label
Who reports
11,706 reports · 77% serious · 4,024 with death outcome · 20% 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
Lab value / disease marker 3No label text to screen 37
What the badges mean
- 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.
- 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. 959 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 |
|---|---|---|---|---|---|---|
| Amyloidosis senile | 13 | 998.2 505.8–1,970.1ROR 999.3 · χ² 7,649 / p <1e-300 | 329.0 EB05 204.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Acquired attr amyloidosis | 11 | 719.5 357.0–1,450.2ROR 720.2 · χ² 5,109 / p <1e-300 | 270.9 EB05 161.4 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Cardiac amyloidosis | 212 | 434.9 374.6–504.8ROR 442.9 · χ² 73,291 / p <1e-300 | 338.5 EB05 301.9 · IC025 +7.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=212 | no trial data cached |
| Congenital coronary artery malformation | 16 | 188.4 112.5–315.3ROR 188.6 · χ² 2,528 / p <1e-300 | 141.9 EB05 92.6 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Chronic left ventricular failure | 26 | 142.2 95.4–211.9ROR 142.5 · χ² 3,244 / p <1e-300 | 120.2 EB05 86.2 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=26 | no trial data cached |
| Amyloidosis | 112 | 124.2 102.6–150.3ROR 125.4 · χ² 12,671 / p <1e-300 | 113.9 EB05 97.2 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=109 | no trial data cached |
| Pancreatic steatosis | 16 | 114.4 69.0–189.6ROR 114.6 · χ² 1,584 / p <1e-300 | 95.6 EB05 62.4 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Heart transplant | 41 | 85.6 62.6–117.0ROR 85.9 · χ² 3,189 / p <1e-300 | 78.8 EB05 60.5 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=41 · 75% consumer | no trial data cached |
| Cardiac failure chronic | 118 | 51.1 42.6–61.3ROR 51.6 · χ² 5,580 / p <1e-300 | 49.3 EB05 42.3 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=118 | no trial data cached |
| Cardiorenal syndrome | 11 | 35.2 19.4–63.9ROR 35.2 · χ² 326 / p 4e-73 | 32.7 EB05 19.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| N-terminal prohormone brain natriuretic peptide increased | 20 | 25.9 16.7–40.3ROR 25.9 · χ² 448 / p 1e-99 | 25.0 EB05 17.0 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Cardioversion | 20 | 25.8 16.6–40.2ROR 25.9 · χ² 447 / p 2e-99 | 24.9 EB05 17.0 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 · 75% consumer | no trial data cached |
| Aortic valve replacement | 17 | 24.9 15.4–40.2ROR 25.0 · χ² 362 / p 6e-81 | 24.0 EB05 15.8 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 | no trial data cached |
| Cardiac pacemaker insertion | 81 | 24.6 19.8–30.6ROR 24.8 · χ² 1,787 / p <1e-300 | 24.2 EB05 20.1 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=81 · 71% consumer | no trial data cached |
| Sinus arrhythmia | 17 | 23.6 14.7–38.1ROR 23.7 · χ² 342 / p 1e-76 | 22.8 EB05 15.0 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 | no trial data cached |
| Urine protein/creatinine ratio increased | 11 | 22.4 12.4–40.6ROR 22.4 · χ² 201 / p 6e-46 | 21.1 EB05 12.1 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious n=10 | no trial data cached |
| Essential hypertension | 31 | 21.7 15.2–30.9ROR 21.7 · χ² 584 / p 3e-129 | 21.2 EB05 15.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 · 94% clinician | no trial data cached |
| Brain natriuretic peptide increased | 30 | 17.6 12.3–25.2ROR 17.6 · χ² 449 / p 7e-100 | 17.2 EB05 12.5 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious n=28 | no trial data cached |
| Left ventricular hypertrophy | 41 | 17.3 12.7–23.5ROR 17.3 · χ² 607 / p 2e-134 | 17.0 EB05 13.0 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=39 · 93% clinician | no trial data cached |
| Obstructive sleep apnoea syndrome | 13 | 16.8 9.7–29.0ROR 16.8 · χ² 176 / p 2e-40 | 15.7 EB05 9.0 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Spinal stenosis | 35 | 15.5 11.1–21.6ROR 15.5 · χ² 456 / p 2e-101 | 15.1 EB05 11.2 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=27 | no trial data cached |
| Implantable defibrillator insertion | 11 | 15.1 8.3–27.3ROR 15.1 · χ² 130 / p 2e-30 | 13.5 EB05 7.0 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Arterial thrombosis | 16 | 14.9 9.1–24.3ROR 14.9 · χ² 192 / p 7e-44 | 13.9 EB05 8.5 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Cardiac ablation | 14 | 14.3 8.4–24.1ROR 14.3 · χ² 158 / p 1e-36 | 13.1 EB05 7.5 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Body height decreased | 85 | 14.2 11.5–17.5ROR 14.3 · χ² 1,021 / p 3e-224 | 14.0 EB05 11.6 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=54 · 87% consumer | no trial data cached |
| Left atrial dilatation | 10 | 14.0 7.5–26.1ROR 14.1 · χ² 108 / p 2e-25 | 12.1 EB05 6.0 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Cardiac failure (heart failure) | 601 | 13.5 12.5–14.6ROR 14.2 · χ² 6,911 / p <1e-300 | 13.4 EB05 12.5 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.0 | no trial data cached |
| Hypoacusis | 303 | 12.7 11.4–14.2ROR 13.0 · χ² 3,242 / p <1e-300 | 12.6 EB05 11.4 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 · 91% consumer | no trial data cached |
| Heart valve replacement | 10 | 12.3 6.6–22.9ROR 12.3 · χ² 92 / p 4e-22 | 10.2 EB05 5.2 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Foreign body in throat | 20 | 11.9 7.6–18.4ROR 11.9 · χ² 187 / p 8e-43 | 10.9 EB05 7.0 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 | no trial data cached |
| Hypervolaemia | 31 | 11.6 8.2–16.6ROR 11.7 · χ² 289 / p 4e-65 | 11.0 EB05 7.9 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=29 | no trial data cached |
| Aortic valve disease | 10 | 11.1 6.0–20.7ROR 11.1 · χ² 82 / p 7e-20 | 9.0 EB05 4.7 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Cardiac failure acute | 41 | 11.1 8.2–15.1ROR 11.1 · χ² 365 / p 1e-81 | 10.6 EB05 8.0 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=41 | no trial data cached |
| Diastolic dysfunction | 19 | 11.0 7.0–17.3ROR 11.0 · χ² 162 / p 2e-37 | 9.9 EB05 6.3 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 | no trial data cached |
| Sinus node dysfunction | 11 | 10.8 6.0–19.6ROR 10.8 · χ² 88 / p 3e-21 | 8.9 EB05 4.8 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Atrial flutter | 47 | 10.6 7.9–14.1ROR 10.6 · χ² 395 / p 3e-88 | 10.1 EB05 7.8 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 | no trial data cached |
| Atrial thrombosis | 12 | 10.4 5.9–18.3ROR 10.4 · χ² 92 / p 4e-22 | 8.6 EB05 4.8 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Orthopnoea | 18 | 10.1 6.4–16.1ROR 10.2 · χ² 139 / p 3e-32 | 8.9 EB05 5.7 · IC025 +2.2 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 | 75 | 9.6 7.7–12.0ROR 9.7 · χ² 567 / p 1e-125 | 9.3 EB05 7.6 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 | no trial data cached |
| Dizziness postural | 51 | 9.6 7.3–12.6ROR 9.6 · χ² 380 / p 6e-85 | 9.1 EB05 7.1 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=41 | 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 | 3,105 | 6.5 6.3–6.7ROR 8.5 · χ² 14,933 / p <1e-300 | 6.5 EB05 6.3 · IC025 +2.6 3/3 methods agree | Outcome field, not a reaction | serious PRR 4.7 | no trial data cached |
| Dyspnoea (shortness of breath) | 775 | 2.5 2.3–2.6ROR 2.6 · χ² 685 / p 3e-151 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | no trial data cached |
| Off label use (used outside approved label) | 658 | 1.4 1.3–1.5ROR 1.4 · χ² 64 / p 5e-16 | 1.4 EB05 1.3 · IC025 +0.3 | Reporting / coding artifact | serious PRR 1.3 · 71% consumer | no trial data cached |
| Cardiac failure (heart failure) | 601 | 13.5 12.5–14.6ROR 14.2 · χ² 6,911 / p <1e-300 | 13.4 EB05 12.5 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.0 | no trial data cached |
| Fatigue (tiredness) | 569 | 1.3 1.2–1.4ROR 1.3 · χ² 43 / p 2e-11 | 1.3 EB05 1.2 · IC025 +0.3 | No label text to screen label has no adverse-reaction text | serious PRR 1.2 | no trial data cached |
| Fall | 457 | 2.5 2.3–2.7ROR 2.5 · χ² 402 / p 1e-89 | 2.5 EB05 2.3 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | no trial data cached |
| Atrial fibrillation | 387 | 7.1 6.5–7.9ROR 7.3 · χ² 2,035 / p <1e-300 | 7.1 EB05 6.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.4 | no trial data cached |
| Dizziness | 348 | 1.3 1.1–1.4ROR 1.3 · χ² 18 / p 1e-5 | 1.3 EB05 1.1 · IC025 +0.1 | No label text to screen label has no adverse-reaction text | serious PRR 1.1 | no trial data cached |
| Malaise (feeling unwell) | 343 | 1.4 1.3–1.6ROR 1.4 · χ² 39 / p 2e-10 | 1.4 EB05 1.3 · IC025 +0.3 | No label text to screen label has no adverse-reaction text | serious PRR 1.0 · 85% consumer | no trial data cached |
| Asthenia (weakness) | 325 | 1.5 1.4–1.7ROR 1.6 · χ² 64 / p 8e-16 | 1.5 EB05 1.4 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 1.3 | no trial data cached |
| Hypoacusis | 303 | 12.7 11.4–14.2ROR 13.0 · χ² 3,242 / p <1e-300 | 12.6 EB05 11.4 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 · 91% consumer | no trial data cached |
| Cardiac failure congestive | 301 | 6.7 6.0–7.5ROR 6.8 · χ² 1,445 / p <1e-300 | 6.6 EB05 6.0 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 | no trial data cached |
| Weight decreased (weight loss) | 294 | 1.9 1.7–2.1ROR 1.9 · χ² 123 / p 6e-29 | 1.9 EB05 1.7 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 1.6 · 70% consumer | no trial data cached |
| Condition aggravated | 292 | 1.7 1.5–1.9ROR 1.8 · χ² 91 / p 8e-22 | 1.7 EB05 1.6 · IC025 +0.6 | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Cardiac disorder | 280 | 5.4 4.8–6.0ROR 5.5 · χ² 988 / p 4e-217 | 5.3 EB05 4.8 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 · 75% consumer | 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?
In FDA FAERS, the most frequently co-reported reaction terms for Tafamidis are dyspnoea, cardiac failure, fatigue, fall, atrial fibrillation, dizziness. 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 have an FDA boxed warning?
No. The FDA label retrieved for Tafamidis has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Tafamidis 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" 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, 999 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.