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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

IRON ISOMALTOSIDE 1000: 256 Adverse Event Reports & Safety Profile

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256
Total FAERS Reports
10 (3.9%)
Deaths Reported
85
Hospitalizations
256
As Primary/Secondary Suspect
52
Life-Threatening
9
Disabilities

First Report: 20090224 · Latest Report: 20250824

What Are the Most Common IRON ISOMALTOSIDE 1000 Side Effects?

#1 Most Reported
Dyspnoea
36 reports (14.1%)
#2 Most Reported
Maternal exposure during pregnancy
31 reports (12.1%)
#3 Most Reported
Hypotension
22 reports (8.6%)

All IRON ISOMALTOSIDE 1000 Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dyspnoea 36 14.1% 2 9
Maternal exposure during pregnancy 31 12.1% 0 7
Bradycardia 22 8.6% 0 4
Hypotension 22 8.6% 2 9
Flushing 18 7.0% 0 4
Chest discomfort 17 6.6% 0 4
Nausea 16 6.3% 0 3
Chest pain 15 5.9% 1 5
Dizziness 15 5.9% 0 4
Foetal exposure during pregnancy 15 5.9% 1 0
Hypersensitivity 15 5.9% 0 6
Back pain 14 5.5% 0 5
Cardiac arrest 14 5.5% 2 6
Malaise 14 5.5% 0 1
Anaphylactic reaction 13 5.1% 1 7
Fishbane reaction 12 4.7% 0 1
Headache 12 4.7% 0 5
Hyperhidrosis 12 4.7% 0 3
Normal newborn 12 4.7% 0 1
Tachycardia 12 4.7% 0 8

Who Reports IRON ISOMALTOSIDE 1000 Side Effects? Age & Gender Data

Gender: 67.4% female, 32.6% male. Average age: 46.8 years. Most reports from: GB. View detailed demographics →

Is IRON ISOMALTOSIDE 1000 Getting Safer? Reports by Year

YearReportsDeathsHosp.
2009 3 0 3
2014 2 0 1
2015 3 0 1
2016 7 0 0
2017 4 0 1
2018 6 0 3
2019 5 0 1
2020 27 2 7
2021 38 2 15
2022 43 1 13
2023 39 1 12
2024 28 1 10
2025 15 1 4

View full timeline →

What Is IRON ISOMALTOSIDE 1000 Used For?

IndicationReports
Iron deficiency anaemia 62
Product used for unknown indication 55
Anaemia 54
Iron deficiency 46
Haemoglobin decreased 5

IRON ISOMALTOSIDE 1000 vs Alternatives: Which Is Safer?

IRON ISOMALTOSIDE 1000 vs IRON POLYMALTOSE IRON ISOMALTOSIDE 1000 vs IRON SUCROSE IRON ISOMALTOSIDE 1000 vs IRON\VITAMINS IRON ISOMALTOSIDE 1000 vs ISATUXIMAB IRON ISOMALTOSIDE 1000 vs ISATUXIMAB-IRFC IRON ISOMALTOSIDE 1000 vs ISAVUCONAZOLE IRON ISOMALTOSIDE 1000 vs ISAVUCONAZONIUM IRON ISOMALTOSIDE 1000 vs ISCALIMAB IRON ISOMALTOSIDE 1000 vs ISENTRESS IRON ISOMALTOSIDE 1000 vs ISOFLURANE

Official FDA Label for IRON ISOMALTOSIDE 1000

Official prescribing information from the FDA-approved drug label.