IRON: 2,728 Adverse Event Reports & Safety Profile
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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?
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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 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 |
What Is IRON Used For?
| Indication | Reports |
|---|---|
| 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?
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.