FOLIC ACID\IRON POLYMALTOSE: 40 Adverse Event Reports & Safety Profile
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40
Total FAERS Reports
4 (10.0%)
Deaths Reported
27
Hospitalizations
40
As Primary/Secondary Suspect
20
Life-Threatening
2
Disabilities
First Report: 20141208 · Latest Report: 20240613
What Are the Most Common FOLIC ACID\IRON POLYMALTOSE Side Effects?
#1 Most Reported
Stenotrophomonas infection
15 reports (37.5%)
#2 Most Reported
Skin ulcer
15 reports (37.5%)
#3 Most Reported
Enterococcal infection
15 reports (37.5%)
All FOLIC ACID\IRON POLYMALTOSE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Acinetobacter infection | 15 | 37.5% | 0 | 15 |
| Disease progression | 15 | 37.5% | 0 | 15 |
| Enterococcal infection | 15 | 37.5% | 0 | 15 |
| Skin ulcer | 15 | 37.5% | 0 | 15 |
| Stenotrophomonas infection | 15 | 37.5% | 0 | 15 |
| Anaemia | 8 | 20.0% | 0 | 7 |
| Thrombocytopenia | 8 | 20.0% | 0 | 8 |
| Diarrhoea | 7 | 17.5% | 0 | 7 |
| Haemodynamic instability | 7 | 17.5% | 0 | 7 |
| Impaired healing | 7 | 17.5% | 0 | 7 |
| Morganella infection | 7 | 17.5% | 0 | 7 |
| Neutropenia | 7 | 17.5% | 0 | 7 |
| Vomiting | 7 | 17.5% | 0 | 7 |
| Wound haemorrhage | 7 | 17.5% | 0 | 7 |
| Wound infection bacterial | 7 | 17.5% | 0 | 7 |
| Haemostasis | 5 | 12.5% | 0 | 5 |
Who Reports FOLIC ACID\IRON POLYMALTOSE Side Effects? Age & Gender Data
Gender: 80.0% female, 20.0% male. Average age: 57.4 years. Most reports from: HU. View detailed demographics →
Is FOLIC ACID\IRON POLYMALTOSE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 1 | 1 | 0 |
| 2015 | 1 | 0 | 0 |
| 2017 | 1 | 0 | 0 |
| 2018 | 18 | 0 | 17 |
| 2019 | 6 | 1 | 5 |
| 2020 | 1 | 0 | 0 |
| 2023 | 1 | 1 | 1 |
| 2024 | 1 | 0 | 1 |
What Is FOLIC ACID\IRON POLYMALTOSE Used For?
| Indication | Reports |
|---|---|
| Iron deficiency anaemia | 21 |
| Product used for unknown indication | 7 |
Official FDA Label for FOLIC ACID\IRON POLYMALTOSE
Official prescribing information from the FDA-approved drug label.