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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

TAFAMIDIS: 9,202 Adverse Event Reports & Safety Profile

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9,202
Total FAERS Reports
3,343 (36.3%)
Deaths Reported
2,284
Hospitalizations
9,202
As Primary/Secondary Suspect
95
Life-Threatening
62
Disabilities
May 3, 2019
FDA Approved
Pfizer Laboratories Div Pfi...
Manufacturer
Prescription
Status

Manufacturer: Pfizer Laboratories Div Pfizer Inc · FDA Application: 212161 ·

Patent Expires: Dec 19, 2026 · First Report: 19870101 · Latest Report: 20250926

What Are the Most Common TAFAMIDIS Side Effects?

#1 Most Reported
Death
2,553 reports (27.7%)
#2 Most Reported
Dyspnoea
608 reports (6.6%)
#3 Most Reported
Off label use
571 reports (6.2%)

All TAFAMIDIS Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Death 2,553 27.7% 2,510 213
Dyspnoea 608 6.6% 98 248
Off label use 571 6.2% 218 157
Cardiac failure 444 4.8% 196 205
Fatigue 438 4.8% 45 114
Fall 372 4.0% 87 240
Malaise 301 3.3% 38 85
Hypoacusis 298 3.2% 30 44
Atrial fibrillation 296 3.2% 41 107
Asthenia 256 2.8% 45 125
Dizziness 255 2.8% 16 75
Weight decreased 253 2.8% 67 119
Cardiac failure congestive 241 2.6% 114 125
Cardiac disorder 234 2.5% 62 114
Cerebrovascular accident 219 2.4% 35 114
Condition aggravated 217 2.4% 55 79
Covid-19 216 2.4% 52 102
Product dose omission issue 215 2.3% 43 97
Illness 207 2.3% 32 82
Peripheral swelling 195 2.1% 27 100

Who Reports TAFAMIDIS Side Effects? Age & Gender Data

Gender: 20.7% female, 79.3% male. Average age: 80.7 years. Most reports from: US. View detailed demographics →

Is TAFAMIDIS Getting Safer? Reports by Year

YearReportsDeathsHosp.
2002 1 0 1
2006 1 0 0
2011 1 0 0
2014 2 0 0
2015 1 0 0
2016 2 1 1
2017 1 1 1
2018 13 1 4
2019 40 9 20
2020 308 144 95
2021 436 208 111
2022 675 345 233
2023 920 425 336
2024 978 488 302
2025 347 160 115

View full timeline →

What Is TAFAMIDIS Used For?

IndicationReports
Cardiac amyloidosis 2,450
Amyloidosis 2,264
Acquired attr amyloidosis 662
Cardiac disorder 255
Amyloidosis senile 222
Product used for unknown indication 177
Cardiomyopathy 163
Cardiac failure 117
Cardiac failure congestive 112
Familial amyloidosis 64

TAFAMIDIS vs Alternatives: Which Is Safer?

TAFAMIDIS vs TAFAMIDIS MEGLUMINE TAFAMIDIS vs TAFASITAMAB TAFAMIDIS vs TAFASITAMAB-CXIX TAFAMIDIS vs TAFINLAR TAFAMIDIS vs TAFLUPROST TAFAMIDIS vs TAGRAXOFUSP-ERZS TAFAMIDIS vs TAHOR TAFAMIDIS vs TALAZOPARIB TAFAMIDIS vs TALC TAFAMIDIS vs TALIGLUCERASE ALFA

Official FDA Label for TAFAMIDIS

Official prescribing information from the FDA-approved drug label.