IRON POLYMALTOSE: 257 Adverse Event Reports & Safety Profile

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257

Total FAERS Reports

13 (5.1%)

Deaths Reported

111

Hospitalizations

257

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 19910101 · Latest Report: 20241207

What Are the Most Common IRON POLYMALTOSE Side Effects?

#1 Most Reported

Off label use

47 reports (18.3%)

#2 Most Reported

Maternal exposure during pregnancy

38 reports (14.8%)

#3 Most Reported

Product use in unapproved indication

27 reports (10.5%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Off label use	47	18.3%	2	17
Maternal exposure during pregnancy	38	14.8%	1	19
Product use in unapproved indication	27	10.5%	1	7
Hair follicle tumour benign	26	10.1%	1	1
Nausea	26	10.1%	3	22
Drug ineffective	24	9.3%	2	11
Premature delivery	24	9.3%	0	17
Vomiting	24	9.3%	3	17
Anaemia	21	8.2%	2	13
Foetal exposure during pregnancy	21	8.2%	0	6
Contraindicated product administered	18	7.0%	0	16
Diarrhoea	18	7.0%	0	11
Haemoglobin decreased	18	7.0%	0	14
Premature rupture of membranes	16	6.2%	0	16
Product availability issue	16	6.2%	1	2
Asthenia	15	5.8%	0	8
Exposure during pregnancy	15	5.8%	0	9
Live birth	15	5.8%	0	14
Pyrexia	14	5.5%	1	14
Dyspnoea	13	5.1%	3	10

Gender: 72.0% female, 28.0% male. Average age: 43.3 years. Most reports from: BR. View detailed demographics →

Year	Reports	Deaths	Hosp.
2008	2	1	2
2010	1	0	1
2012	1	0	1
2013	2	0	2
2014	4	0	3
2015	15	0	14
2016	5	0	3
2017	5	1	4
2018	13	1	6
2019	18	1	10
2020	18	2	8
2021	19	1	4
2022	9	0	2
2023	5	1	3
2024	9	2	3

Indication	Reports
Product used for unknown indication	111
Anaemia	41
Iron deficiency	14
Iron deficiency anaemia	12

Official prescribing information from the FDA-approved drug label.