FERRIC SUBSULFATE: 24 Adverse Event Reports & Safety Profile
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24
Total FAERS Reports
0
Deaths Reported
4
Hospitalizations
24
As Primary/Secondary Suspect
1
Life-Threatening
1
Disabilities
Premier Dental Products Com...
Manufacturer
Drug Class: Iron [CS] · Route: TOPICAL · Manufacturer: Premier Dental Products Company · HUMAN PRESCRIPTION DRUG · FDA Label: Available
First Report: 20150604 · Latest Report: 20230131
What Are the Most Common FERRIC SUBSULFATE Side Effects?
#1 Most Reported
Pain
4 reports (16.7%)
#2 Most Reported
Application site pain
4 reports (16.7%)
#3 Most Reported
Product label confusion
3 reports (12.5%)
All FERRIC SUBSULFATE Side Effects by Frequency
No side effect data available.
Who Reports FERRIC SUBSULFATE Side Effects? Age & Gender Data
Gender: 100.0% female, 0.0% male. Average age: 46.6 years. Most reports from: US. View detailed demographics →
Is FERRIC SUBSULFATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2015 | 1 | 0 | 0 |
| 2016 | 1 | 0 | 0 |
| 2017 | 1 | 0 | 0 |
| 2018 | 3 | 0 | 2 |
| 2019 | 1 | 0 | 0 |
| 2020 | 2 | 0 | 1 |
| 2021 | 3 | 0 | 0 |
| 2023 | 1 | 0 | 0 |
Other Drugs in Same Class: Iron [CS]
Official FDA Label for FERRIC SUBSULFATE
Official prescribing information from the FDA-approved drug label.
Dosage & Administration
Do not reuse, discard after one use.
Active Ingredient
Active Ingredients: Ferric Subsulfate...20-22% by weight
Inactive Ingredients
Other Ingredients include thickeners, preservatives, and purified water