Overview
A metallic element found in certain minerals, in nearly all soils, and in mineral waters. It is an essential constituent of hemoglobin, cytochrome, and other components of respiratory enzyme systems. Its chief functions are in the transport of oxygen to tissue (hemoglobin) and in cellular oxidation mechanisms. Depletion of iron stores may result in iron-deficiency anemia. Iron is used to build up the blood in anemia.
Indication
Used in preventing and treating iron-deficiency anemia.
Associated Conditions
- Anemia
- Iron Deficiency (ID)
- Iron Deficiency Anemia (IDA)
- Restless Legs Syndrome (RLS)
- Concomitant myelosuppressive chemotherapy
Research Report
Iron (DB01592): A Comprehensive Monograph on its Pharmacology, Clinical Utility, and Safety Profile
Introduction to Iron: An Essential Element
Iron stands as a fundamental element not only in the Earth's crust but also within the intricate biological machinery of virtually all living organisms. Its unique chemical properties allow it to participate in a vast array of metabolic processes, making it indispensable for life. However, this same chemical reactivity renders it potentially toxic, necessitating a complex and tightly regulated system of absorption, transport, and storage within the body. This monograph provides a comprehensive examination of iron, identified by DrugBank ID DB01592, from its basic chemical profile to its complex pharmacology, diverse clinical applications, and extensive safety considerations. It synthesizes current knowledge to offer a detailed resource on iron's dual role as an essential nutrient and a critical therapeutic agent.
Chemical and Physical Profile
Elemental iron is a small molecule drug with the chemical symbol Fe.[1] It is unequivocally identified in scientific and regulatory databases by its Chemical Abstracts Service (CAS) Number 7439-89-6.[1] As a fundamental element, its molecular properties are defined by its atomic characteristics.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/11 | Not Applicable | Completed | Muhammad Aamir Latif | ||
2025/08/08 | Not Applicable | Completed | Federal Teaching Hospital Abakaliki | ||
2025/06/26 | Phase 4 | Not yet recruiting | Cardiochirurgia E.H. | ||
2025/05/29 | Not Applicable | Recruiting | |||
2025/04/04 | Phase 4 | Completed | CMH Multan Institute of Medical Sciences | ||
2024/11/25 | Phase 4 | Completed | |||
2024/11/18 | Phase 2 | Recruiting | NanoEcho AB | ||
2024/11/05 | Phase 1 | Completed | |||
2024/11/01 | Phase 4 | Recruiting | |||
2024/10/15 | N/A | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| MISSION PHARMACAL COMPANY | 0178-0812 | ORAL | 27 mg in 1 1 | 5/3/2010 | |
| Mission Pharmacal Company | 0178-0813 | ORAL | 88.5 mg in 1 1 | 1/5/2024 | |
| Exeltis USA, Inc. | 0642-7473 | ORAL | 90 mg in 1 1 | 2/14/2023 | |
| Mylan Institutional LLC | 67457-639 | INTRAVENOUS | 200 mg in 10 mL | 6/12/2025 | |
| Mission Pharmacal Company | 0178-0089 | ORAL | 90 mg in 1 1 | 1/8/2024 | |
| Deseret Biologicals, Inc. | 43742-2108 | ORAL | 12 [hp_X] in 1 mL | 5/27/2025 | |
| American Regent, Inc. | 0517-2325 | INTRAVENOUS | 20 mg in 1 mL | 6/1/2022 | |
| Newton Laboratories, Inc. | 55714-4748 | ORAL | 15 [hp_X] in 1 mL | 8/20/2025 | |
| U.S. Pharmaceutical Corporation | 52747-620 | ORAL | 42.5 mg in 1 1 | 7/13/2022 | |
| A-S Medication Solutions | 50090-4541 | INTRAVENOUS | 20 mg in 1 mL | 10/1/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| FERROCYTE TABLET 50 mg | SIN06142P | TABLET, FILM COATED | 50 mg | 6/17/1991 | |
| MALTOFER DROPS 50 mg/ml | SIN05699P | SOLUTION | 50 mg/ml | 4/8/1991 | |
| AVOFER INJECTION 100MG/5ML | SIN16513P | INJECTION | 100mg/5ml | 6/16/2022 | |
| Velphoro® Chewable Tablets 500mg | SIN14727P | TABLET, CHEWABLE | 500 mg | 1/29/2015 | |
| MALTOFER SYRUP 50mg/5ml | SIN05700P | SYRUP | 50mg/5ml | 4/8/1991 | |
| HAEMO CAPSULE 100MG | SIN16565P | CAPSULE | 100 MG | 8/5/2022 | |
| EUROFER CHEW TABLETS | SIN12633P | TABLET | 100 mg | 12/23/2004 | |
| IBERET-FOLIC-500 TABLET | SIN05447P | TABLET, FILM COATED | 105 mg | 2/19/1991 | |
| VENOFER SOLUTION FOR INJECTION 100 mg/5 ml | SIN11354P | INJECTION | 100 mg/5 ml | 7/20/2000 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| VENOFER INJ 100MG/5ML | N/A | N/A | N/A | 3/14/2003 | |
| MONOFER SOLUTION FOR INJECTION/INFUSION 100MG/ML | N/A | N/A | N/A | 12/18/2012 | |
| MONOFER SOLUTION FOR INJECTION/INFUSION 1000MG/10ML | N/A | N/A | N/A | 12/18/2012 | |
| MONOFER SOLUTION FOR INJECTION/INFUSION 500MG/5ML | N/A | N/A | N/A | 12/18/2012 | |
| VELPHORO CHEWABLE TABLETS 500MG | N/A | N/A | N/A | 3/3/2020 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| BIOME IRON + | 464031 | Medicine | A | 10/10/2024 | |
| DANMOT HERBALIX CHELATION FORMULA tablet bulk | 52268 | Danmot Pty Ltd | Medicine | A | 4/18/1995 |
| Conceive Plus Men's Fertility Support | 347978 | Medicine | A | 11/11/2020 | |
| ACTIVATED PROBIOTICS BIOME IRON + | 442603 | Medicine | A | 2/27/2024 | |
| VENOFER iron 100mg/5mL (as iron(III) hydroxide sucrose complex) injection | 98236 | Medicine | A | 5/19/2004 | |
| ACTIVATED PROBIOTICS BIOME IRON + | 315955 | Medicine | A | 3/29/2019 | |
| Vitamin C with Hesperidin Complex | 159838 | Medicine | A | 3/6/2009 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| FERRUM METALLICUM GOUTTE 4CH-30CH | dolisos laboratoires s.a. | 00667641 | Drops - Oral | 3 CH / CH | 12/31/1987 |
| VITA VIM TAB | jamieson laboratories ltd | 00575895 | Tablet - Oral | 4 MG / TAB | 12/31/1983 |
| TIMED RELEASE IRON 50MG TABLETS | swiss herbal remedies ltd. | 02236777 | Tablet (Extended-Release) - Oral | 50 MG | 1/26/1998 |
| MULTIVITAMINES ET MINERAUX | le groupe m. vachon inc. | 02238301 | Tablet - Oral | 5 MG | N/A |
| FERRUM METAL GRANULE 4CH-30CH | boiron laboratoires | 00671339 | Tablet - Oral | 4 CH / CH | 12/31/1986 |
| FERRUM METAL GOUTTE 4CH-30CH | boiron laboratoires | 00677906 | Drops - Oral | 4 CH / CH | 12/31/1987 |
| FERRUM METALLICUM GRANULE(3X-30X) | laboratoires holis inc. | 01949721 | Tablet - Oral | 3 X / TAB | 12/31/1984 |
| FERRUM METALLICUM OINTMENT | weleda ag heilmittelbetriebe | 02232597 | Ointment - Topical | 1 D / 1 D | 3/4/1998 |
| HEMATONE THUNAS | thuna herbal remedies ltd. | 00190438 | Capsule - Oral | 57.7 MG / CAP | 12/30/1992 |
| CATALIGO FER-CUIVRE-COBALT - LIQ | laboratoires holis inc. | 02132265 | Liquid - Oral | 4 D / ML | 12/31/1986 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| TOTYLEM 60 MG/0,4 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 89136 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Sin Receta | Not Commercialized | |
| ELEVIT COMPRIMIDOS RECUBIERTOS CON PELICULA | Bayer Hispania S.L. | 67267 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Sin Receta | Not Commercialized |
| HIDROPOLIVIT A MINERAL COMPRIMIDOS MASTICABLES | Laboratorios Menarini S.A. | 44019 | COMPRIMIDO MASTICABLE | Sin Receta | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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