FERROUS: 4,067 Adverse Event Reports & Safety Profile
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Active Ingredient: FERROUS SULFATE · Route: ORAL · Manufacturer: Richmond Pharmaceuticals Inc. · FDA Application: 090938 · HUMAN OTC DRUG · FDA Label: Available
First Report: 19780101 · Latest Report: 20250721
What Are the Most Common FERROUS Side Effects?
All FERROUS Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Dyspnoea | 366 | 9.0% | 101 | 304 |
| Drug ineffective | 331 | 8.1% | 28 | 248 |
| Vomiting | 330 | 8.1% | 76 | 136 |
| Foetal exposure during pregnancy | 316 | 7.8% | 34 | 30 |
| Off label use | 316 | 7.8% | 75 | 141 |
| Pneumonia | 313 | 7.7% | 23 | 148 |
| Fatigue | 312 | 7.7% | 12 | 116 |
| Condition aggravated | 311 | 7.7% | 119 | 256 |
| Diarrhoea | 302 | 7.4% | 3 | 66 |
| Abdominal pain | 299 | 7.4% | 71 | 93 |
| Rash | 297 | 7.3% | 1 | 106 |
| Exposure during pregnancy | 268 | 6.6% | 4 | 62 |
| Anxiety | 236 | 5.8% | 16 | 56 |
| Malaise | 222 | 5.5% | 7 | 34 |
| Dizziness | 221 | 5.4% | 0 | 41 |
| Depression | 217 | 5.3% | 0 | 28 |
| Cough | 216 | 5.3% | 2 | 174 |
| Abdominal pain upper | 207 | 5.1% | 3 | 22 |
| Nausea | 206 | 5.1% | 65 | 121 |
| Asthma | 200 | 4.9% | 24 | 96 |
Who Reports FERROUS Side Effects? Age & Gender Data
Gender: 64.8% female, 35.2% male. Average age: 58.8 years. Most reports from: CA. View detailed demographics →
Is FERROUS Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 2 | 0 | 1 |
| 2002 | 7 | 0 | 6 |
| 2003 | 4 | 0 | 2 |
| 2004 | 21 | 14 | 6 |
| 2005 | 1 | 0 | 0 |
| 2006 | 9 | 0 | 3 |
| 2008 | 4 | 0 | 2 |
| 2009 | 3 | 0 | 1 |
| 2010 | 12 | 0 | 9 |
| 2011 | 23 | 2 | 15 |
| 2012 | 16 | 1 | 5 |
| 2013 | 43 | 11 | 24 |
| 2014 | 49 | 7 | 27 |
| 2015 | 83 | 25 | 45 |
| 2016 | 183 | 41 | 125 |
| 2017 | 246 | 28 | 91 |
| 2018 | 248 | 44 | 145 |
| 2019 | 230 | 31 | 122 |
| 2020 | 202 | 55 | 107 |
| 2021 | 133 | 6 | 77 |
| 2022 | 120 | 6 | 83 |
| 2023 | 101 | 10 | 62 |
| 2024 | 57 | 6 | 37 |
| 2025 | 27 | 9 | 12 |
What Is FERROUS Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 1,905 |
| Iron deficiency | 465 |
| Anaemia | 374 |
| Iron deficiency anaemia | 258 |
| Mineral supplementation | 109 |
| Normochromic normocytic anaemia | 69 |
| Foetal exposure during pregnancy | 53 |
| Supplementation therapy | 52 |
| Nutritional supplementation | 40 |
| Blood iron decreased | 23 |
FERROUS vs Alternatives: Which Is Safer?
Official FDA Label for FERROUS
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Use: For temporary relief of digestive complaints. Help with shyness. May also be used for standard homeopathic indications or as directed by your physician.
Dosage & Administration
Directions Use as directed Take 30 minutes away from food Adults : Acute dose: Chew 1 tablet every 30 minutes until symptoms subside up to 6 times per day. Maintenance dose: Chew 1 tablet, 4 times daily.
Children
6 years and older : Acute dose: Crush 1/2 tablet, dissolve in water, and take every 30 minutes until symptoms subside, up to six times per day. Maintenance dose :Crush 1/2 tablet, dissolve in water, 4 times per day.
FDA Boxed Warning
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.
Warnings
WARNING: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children . In case of accidental overdose, call a doctor or Poison Control Center immediately. WARNINGS: Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of doctor. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing medication may occasionally cause constipation or diarrhea. As with any drug, if you are pregnant or nursing baby, seek the advice of a health professional before using this product.
Active Ingredient
Active Ingredients (in each spray)
Purpose Ferrum Phosphoricum
6X HPUS first stage of respiratory ailments, inflammation, mild fever " HPUS " is the Homeopathic Pharmacopoeia of the United States
Inactive Ingredients
INACTIVE INGREDIENTS: croscarmellose sodium, dicalcium phosphate, FD&C red #40 (Al-lake), FD&C yellow #6 (Al-lake), hypromellose, magnesium stearate, microcrystalline cellulose, PEG 400, titanium dioxide