TAFAMIDIS

N/A

Manufactured by Pfizer Laboratories Div Pfizer Inc

17,433 FDA adverse event reports analyzed

Last updated: 2026-04-14

About TAFAMIDIS

TAFAMIDIS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. The most commonly reported adverse reactions for TAFAMIDIS include DEATH, DYSPNOEA, OFF LABEL USE, CARDIAC FAILURE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TAFAMIDIS.

Top Adverse Reactions

DEATH2,785 reports
DYSPNOEA712 reports
OFF LABEL USE649 reports
CARDIAC FAILURE544 reports
FATIGUE526 reports
FALL422 reports
ATRIAL FIBRILLATION349 reports
MALAISE331 reports
DIZZINESS328 reports
ASTHENIA307 reports
HYPOACUSIS303 reports
CARDIAC FAILURE CONGESTIVE285 reports
WEIGHT DECREASED283 reports
CARDIAC DISORDER271 reports
CONDITION AGGRAVATED256 reports
CEREBROVASCULAR ACCIDENT243 reports
PRODUCT DOSE OMISSION ISSUE233 reports
COVID 19231 reports
PERIPHERAL SWELLING225 reports
FLUID RETENTION218 reports
ILLNESS217 reports
CARDIAC AMYLOIDOSIS210 reports
DISEASE PROGRESSION207 reports
DIARRHOEA206 reports
PNEUMONIA202 reports
DRUG INEFFECTIVE201 reports
GAIT DISTURBANCE194 reports
DYSPHAGIA180 reports
PAIN140 reports
URINARY TRACT INFECTION137 reports
OEDEMA PERIPHERAL136 reports
HYPOTENSION135 reports
MEMORY IMPAIRMENT133 reports
PAIN IN EXTREMITY129 reports
COUGH126 reports
CONFUSIONAL STATE124 reports
ARTHRALGIA121 reports
WEIGHT INCREASED121 reports
DEMENTIA120 reports
DYSPNOEA EXERTIONAL119 reports
NEUROPATHY PERIPHERAL118 reports
RENAL FAILURE118 reports
BACK PAIN117 reports
ACUTE KIDNEY INJURY114 reports
DRUG INTERACTION113 reports
CARDIAC FAILURE CHRONIC112 reports
NAUSEA111 reports
AMYLOIDOSIS108 reports
DECREASED APPETITE108 reports
PRURITUS108 reports
BALANCE DISORDER106 reports
HYPERTENSION98 reports
MYOCARDIAL INFARCTION98 reports
CONSTIPATION96 reports
PRODUCT USE IN UNAPPROVED INDICATION96 reports
SOMNOLENCE93 reports
THERAPEUTIC RESPONSE UNEXPECTED93 reports
HOSPITALISATION91 reports
INSOMNIA91 reports
CHEST PAIN90 reports
HEADACHE87 reports
PLEURAL EFFUSION87 reports
VOMITING87 reports
BODY HEIGHT DECREASED85 reports
FEELING ABNORMAL84 reports
HYPOAESTHESIA79 reports
DEHYDRATION78 reports
SEPSIS78 reports
RENAL DISORDER77 reports
RENAL IMPAIRMENT77 reports
PULMONARY OEDEMA74 reports
RASH73 reports
ARTHRITIS72 reports
CARDIAC PACEMAKER INSERTION71 reports
CHRONIC KIDNEY DISEASE71 reports
CARDIAC ARREST70 reports
GASTROINTESTINAL DISORDER69 reports
CARPAL TUNNEL SYNDROME66 reports
RHABDOMYOLYSIS66 reports
SYNCOPE65 reports
ANXIETY64 reports
BLOOD CREATININE INCREASED64 reports
GENERAL PHYSICAL HEALTH DETERIORATION63 reports
THERAPY INTERRUPTED63 reports
HEART RATE DECREASED62 reports
MUSCULAR WEAKNESS61 reports
VISUAL IMPAIRMENT61 reports
ABDOMINAL DISTENSION60 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES60 reports
SWELLING60 reports
DEPRESSION59 reports
LOSS OF CONSCIOUSNESS59 reports
NASOPHARYNGITIS59 reports
ABDOMINAL DISCOMFORT57 reports
PYREXIA57 reports
OEDEMA56 reports
HAEMORRHAGE54 reports
INFLUENZA54 reports
ABDOMINAL PAIN UPPER53 reports
ANAEMIA53 reports

Report Outcomes

Out of 10,707 classified reports for TAFAMIDIS:

Serious 76.4%Non-Serious 23.6%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male7,650 (79.6%)
Female1,950 (20.3%)
Unknown8 (0.1%)

Reports by Age

Age 80487 reports
Age 85473 reports
Age 84470 reports
Age 83454 reports
Age 82444 reports
Age 81437 reports
Age 86395 reports
Age 78367 reports
Age 79366 reports
Age 87366 reports
Age 88346 reports
Age 77318 reports
Age 76317 reports
Age 89300 reports
Age 75285 reports
Age 90274 reports
Age 74266 reports
Age 73211 reports
Age 72200 reports
Age 91181 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with TAFAMIDIS?

This profile reflects 17,433 FDA FAERS reports that mention TAFAMIDIS. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TAFAMIDIS?

Frequently reported terms in FAERS include DEATH, DYSPNOEA, OFF LABEL USE, CARDIAC FAILURE, FATIGUE, FALL. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures TAFAMIDIS?

Labeling and FAERS entries often list Pfizer Laboratories Div Pfizer Inc in connection with TAFAMIDIS. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.