DAPSONE\FERROUS OXALATE: 69 Adverse Event Reports & Safety Profile

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Total FAERS Reports

2 (2.9%)

Deaths Reported

Hospitalizations

As Primary/Secondary Suspect

Life-Threatening

First Report: 20110630 · Latest Report: 20241110

What Are the Most Common DAPSONE\FERROUS OXALATE Side Effects?

#1 Most Reported

Foetal growth restriction

12 reports (17.4%)

#2 Most Reported

Autism spectrum disorder

12 reports (17.4%)

#3 Most Reported

Preterm premature rupture of membranes

9 reports (13.0%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Autism spectrum disorder	12	17.4%	0	12
Foetal growth restriction	12	17.4%	0	12
Preterm premature rupture of membranes	9	13.0%	0	9
Foetal exposure during pregnancy	7	10.1%	0	7
Hypoalbuminaemia	7	10.1%	0	7
Maternal exposure during pregnancy	7	10.1%	0	7
Oedema peripheral	7	10.1%	0	7
Off label use	7	10.1%	0	5
Thrombotic microangiopathy	7	10.1%	0	0
Low birth weight baby	6	8.7%	0	6
Premature baby	6	8.7%	0	6
Agranulocytosis	5	7.3%	0	5
Drug reaction with eosinophilia and systemic symptoms	5	7.3%	2	4
Haemolytic anaemia	5	7.3%	0	3
Methaemoglobinaemia	5	7.3%	0	3

Gender: 40.0% female, 60.0% male. Average age: 56.7 years. Most reports from: FR. View detailed demographics →

Year	Reports	Deaths	Hosp.
2011	1	0	1
2012	1	0	1
2015	8	2	6
2016	2	0	2
2017	1	0	1
2018	5	0	4
2019	5	0	3
2020	18	0	11
2021	1	0	1
2023	5	0	3
2024	5	0	5

Official prescribing information from the FDA-approved drug label.