BENFOTIAMINE: 96 Adverse Event Reports & Safety Profile

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Total FAERS Reports

68 (70.8%)

Deaths Reported

Hospitalizations

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 20150818 · Latest Report: 20240510

What Are the Most Common BENFOTIAMINE Side Effects?

#1 Most Reported

Dyspnoea

62 reports (64.6%)

#2 Most Reported

Therapeutic product effect incomplete

58 reports (60.4%)

#3 Most Reported

Sleep disorder

45 reports (46.9%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Dyspnoea	62	64.6%	58	62
Therapeutic product effect incomplete	58	60.4%	54	58
Sleep disorder	45	46.9%	44	45
Condition aggravated	39	40.6%	35	39
Pain in extremity	38	39.6%	34	38
Wheezing	38	39.6%	33	37
Drug ineffective	37	38.5%	30	30
Off label use	37	38.5%	36	37
Confusional state	36	37.5%	34	34
Lung disorder	36	37.5%	32	36
Systemic lupus erythematosus	36	37.5%	36	36
Injection site reaction	35	36.5%	35	35
Onychomycosis	35	36.5%	35	35
Pemphigus	35	36.5%	35	35
Pericarditis	35	36.5%	35	35
Type 2 diabetes mellitus	35	36.5%	35	35
C-reactive protein increased	34	35.4%	34	34
Ill-defined disorder	34	35.4%	34	34
Loss of personal independence in daily activities	34	35.4%	30	34
Psoriatic arthropathy	34	35.4%	34	34

Gender: 47.3% female, 52.7% male. Average age: 56.8 years. Most reports from: CA. View detailed demographics →

Year	Reports	Deaths	Hosp.
2015	3	3	3
2018	1	0	1
2021	4	0	0
2024	1	0	0

Indication	Reports
Product used for unknown indication	72

Official prescribing information from the FDA-approved drug label.