MAGALDRATE: 62 Adverse Event Reports & Safety Profile

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Total FAERS Reports

4 (6.5%)

Deaths Reported

Hospitalizations

As Primary/Secondary Suspect

Life-Threatening

First Report: 19911214 · Latest Report: 20210101

What Are the Most Common MAGALDRATE Side Effects?

#1 Most Reported

Drug ineffective

10 reports (16.1%)

#2 Most Reported

Stevens-johnson syndrome

9 reports (14.5%)

#3 Most Reported

Gastritis

8 reports (12.9%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Drug ineffective	10	16.1%	1	10
Stevens-johnson syndrome	9	14.5%	2	0
Gastritis	8	12.9%	0	8
Alanine aminotransferase increased	7	11.3%	0	7
Aspartate aminotransferase increased	7	11.3%	0	7
Gamma-glutamyltransferase increased	7	11.3%	0	7
Hepatotoxicity	7	11.3%	0	7
Liver function test increased	7	11.3%	0	7
Off label use	7	11.3%	1	7
Pancreatitis necrotising	7	11.3%	0	7
Steatohepatitis	7	11.3%	0	7
No adverse event	6	9.7%	1	6
Abdominal pain upper	5	8.1%	0	1
Anaemia	5	8.1%	0	5
Exposure during pregnancy	5	8.1%	0	0
Foetal exposure during pregnancy	5	8.1%	1	0
Haematemesis	5	8.1%	0	5
Premature baby	5	8.1%	0	0
Toxic epidermal necrolysis	5	8.1%	2	1

Gender: 63.5% female, 36.5% male. Average age: 54.0 years. Most reports from: DE. View detailed demographics →

Year	Reports	Hosp.
2014	1	0
2015	5	4
2016	5	5
2017	5	0
2018	8	7
2019	2	1
2020	1	0
2021	4	4

Indication	Reports
Product used for unknown indication	26
Ulcer	7
Cancer pain	6
Antacid therapy	5

Official prescribing information from the FDA-approved drug label.