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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: 2,728 Adverse Event Reports & Safety Profile

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2,728
Total FAERS Reports
325 (11.9%)
Deaths Reported
932
Hospitalizations
2,728
As Primary/Secondary Suspect
110
Life-Threatening
48
Disabilities
Uriel Pharmacy Inc.
Manufacturer

Route: ORAL · Manufacturer: Uriel Pharmacy Inc. · HUMAN OTC DRUG · FDA Label: Available

First Report: 1995 · Latest Report: 20250818

What Are the Most Common IRON Side Effects?

#1 Most Reported
Nausea
287 reports (10.5%)
#2 Most Reported
Diarrhoea
265 reports (9.7%)
#3 Most Reported
Drug ineffective
263 reports (9.6%)

All IRON Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Nausea 287 10.5% 29 136
Diarrhoea 265 9.7% 12 124
Drug ineffective 263 9.6% 22 96
Dyspnoea 257 9.4% 35 126
Fatigue 255 9.4% 8 115
Constipation 253 9.3% 29 104
Off label use 241 8.8% 27 103
Drug hypersensitivity 220 8.1% 21 71
Vomiting 219 8.0% 23 120
Abdominal pain 197 7.2% 29 104
Anaemia 195 7.2% 26 111
Headache 185 6.8% 8 72
Pain 174 6.4% 9 69
Maternal exposure during pregnancy 163 6.0% 2 51
Foetal exposure during pregnancy 161 5.9% 10 42
Rash 160 5.9% 2 28
Asthma 153 5.6% 4 16
Asthenia 151 5.5% 12 82
Exposure during pregnancy 145 5.3% 0 32
Malaise 145 5.3% 7 67

Who Reports IRON Side Effects? Age & Gender Data

Gender: 73.2% female, 26.8% male. Average age: 52.3 years. Most reports from: US. View detailed demographics →

Is IRON Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 1 0 0
2006 2 0 1
2007 1 0 1
2008 3 0 3
2009 8 0 3
2010 19 0 16
2011 25 1 12
2012 24 12 7
2013 21 1 10
2014 44 1 23
2015 63 5 38
2016 73 18 34
2017 73 3 39
2018 103 26 48
2019 89 6 51
2020 86 13 43
2021 89 6 38
2022 109 9 34
2023 115 10 34
2024 87 7 22
2025 34 2 11

View full timeline →

What Is IRON Used For?

IndicationReports
Product used for unknown indication 1,363
Anaemia 277
Mineral supplementation 110
Iron deficiency anaemia 85
Supplementation therapy 75
Blood iron decreased 71
Iron deficiency 53
Foetal exposure during pregnancy 52
Rheumatoid arthritis 47
Haemoglobin decreased 34

IRON vs Alternatives: Which Is Safer?

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

Official FDA Label for IRON

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Uses Temporarily relieves occasional severe headaches associated with ringing sensations in the ears before menses, abnormal heart rhythm, and weak pulse.* *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. This product is not intended to diagnose, treat, cure, or prevent any disease.

Dosage & Administration

Directions for Use: Place globules under tongue for 30 seconds. Adults~3-5 globules 3 times a day.

Children

2-12 years ~ 1-3 globules 3 times a day.

Under

2 years, consult your doctor. Use until symptoms are relieved or as directed by your health care provider.

Warnings

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Contains sugar. Diabetics and persons intolerant of sucrose (sugar): Consult a doctor before use. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

Active Ingredient

Active Ingredients: Ferr met D15+100C 0.10mL each (HPUS), Lobelia inf. D4+40C 0.10mL each (HPUS), Mag phos D10+80C 0.10mL each (HPUS), Pulsatilla D7+40C 0.10mL each (HPUS), Ratanhia D4+40C 0.10mL each (HPUS), Senecio D3+30C 0.10mL each (HPUS), Viburnum op. D4+40C 0.10mL each (HPUS)

Inactive Ingredients

Other Ingredients: Almond Oil, Beeswax, Citric Acid, Emulsifying Wax, Jojoba Oil, Kokum Butter, Lavender Essential Oil, Potassium Sorbate, Vegetable Glycerine, Vitamin E, Water.