BISMUTH SUBGALLATE\BUFEXAMAC\LIDOCAINE\TITANIUM DIOXIDE: 49 Adverse Event Reports & Safety Profile

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Total FAERS Reports

49 (100.0%)

Deaths Reported

Hospitalizations

As Primary/Secondary Suspect

Life-Threatening

Disabilities

Active Ingredient: BISMUTH SUBGALLATE\BUFEXAMAC\LIDOCAINE HYDROCHLORIDE\TITANIUM DIOXIDE ·

First Report: 20200101 · Latest Report: 20210605

What Are the Most Common BISMUTH SUBGALLATE\BUFEXAMAC\LIDOCAINE\TITANIUM DIOXIDE Side Effects?

#1 Most Reported

Abdominal distension

43 reports (87.8%)

#2 Most Reported

Vomiting

41 reports (83.7%)

#3 Most Reported

Stress

41 reports (83.7%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Abdominal distension	43	87.8%	43	33
Stress	41	83.7%	41	31
Vomiting	41	83.7%	41	31
Abdominal pain	40	81.6%	40	30
Appendicitis	40	81.6%	40	30
Ascites	40	81.6%	40	30
Hyponatraemia	40	81.6%	40	30
Ventricular fibrillation	40	81.6%	40	30
Appendicolith	39	79.6%	39	29
Cardiogenic shock	39	79.6%	39	29
Constipation	39	79.6%	39	29
General physical health deterioration	39	79.6%	39	29
Multiple organ dysfunction syndrome	39	79.6%	39	29
Off label use	39	79.6%	39	30
Somnolence	39	79.6%	39	30
Blood phosphorus increased	38	77.6%	38	28
Condition aggravated	38	77.6%	38	29
Dry mouth	38	77.6%	38	29
Nausea	38	77.6%	38	28
Sepsis	38	77.6%	38	28

Gender: 0.0% female, 100.0% male. Average age: 80.0 years. Most reports from: CA. View detailed demographics →

Year	Reports	Deaths	Hosp.
2020	15	15	12
2021	6	6	1

Indication	Reports
Constipation	49

Official prescribing information from the FDA-approved drug label.