Overview
Used in treatment of iron deficiency anemia.
Indication
Used in preventing and treating iron-deficiency anemia.
Associated Conditions
- Folic acid antagonist overdose
- Iron Deficiency (ID)
- Iron Deficiency Anemia (IDA)
Research Report
A Comprehensive Monograph on Ferrous Fumarate (DB14491): Chemistry, Pharmacology, and Clinical Application
Executive Summary
Ferrous fumarate is an orally administered iron salt, identified by DrugBank ID DB14491 and CAS Number 141-01-5, that serves as a cornerstone in the management of iron deficiency and iron deficiency anemia. As the iron(II) salt of fumaric acid, its chemical structure, C4H2FeO4, confers one of the highest concentrations of elemental iron among commonly used oral supplements, approximately 33% by weight. This high potency allows for the delivery of therapeutic iron doses in a comparatively smaller physical form, a factor that can enhance patient adherence. Its primary pharmacodynamic effect is the replenishment of systemic iron, an element indispensable for the synthesis of hemoglobin, myoglobin, and numerous metabolic enzymes, thereby restoring oxygen-carrying capacity and cellular function. The pharmacokinetics of ferrous fumarate are governed not by a simple dose-response relationship but by the body's sophisticated homeostatic mechanisms, with intestinal absorption being tightly regulated by iron stores via the hormone hepcidin. Recent evidence has expanded the understanding of its absorption beyond the canonical Divalent Metal Transporter 1 (DMT1) pathway to include clathrin-mediated endocytosis. This complex regulation has profound clinical implications, notably the finding that the acute hepcidin response to an oral dose transiently suppresses subsequent absorption, providing a strong physiological rationale for alternate-day dosing regimens over traditional daily administration. While effective and cost-efficient, the clinical utility of ferrous fumarate is frequently challenged by a high incidence of gastrointestinal adverse effects, including nausea, constipation, and mucosal irritation. Furthermore, its efficacy is subject to a wide array of clinically significant drug-drug and drug-food interactions that can impa
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2022/10/14 | Not Applicable | Recruiting | Leiden University Medical Center | ||
2022/07/13 | Phase 4 | Recruiting | Leiden University Medical Center | ||
2022/03/14 | Phase 4 | UNKNOWN | Martini Hospital Groningen | ||
2019/10/17 | Phase 3 | Completed | |||
2017/09/28 | Phase 4 | UNKNOWN | |||
2017/07/11 | Phase 3 | Completed | |||
2014/10/22 | Phase 4 | Completed | Rijnstate Hospital | ||
2014/09/18 | Phase 4 | UNKNOWN | |||
2014/08/29 | Phase 4 | Completed | Rijnstate Hospital | ||
2013/11/03 | Phase 4 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
AvPAK | 50268-677 | ORAL | 27 mg in 1 1 | 4/12/2022 | |
Marnel Pharmaceuticals, Inc. | 0682-3001 | ORAL | 27 mg in 1 1 | 5/2/2014 | |
Centurion Labs, LLC | 23359-105 | ORAL | 28 mg in 1 1 | 1/22/2024 | |
Avion Pharmaceuticals, LLC | 75854-320 | ORAL | 50 mg in 1 1 | 1/18/2021 | |
Carilion Materials Management | 68151-2640 | ORAL | 27 mg in 1 1 | 4/1/2013 | |
PureTek Corporation | 59088-112 | ORAL | 53 mg in 1 1 | 1/11/2023 | |
Novian Pharmaceuticals | 83146-003 | ORAL | 27 mg in 1 1 | 10/6/2023 | |
Acella Pharmaceuticals, LLC | 42192-321 | ORAL | 27 mg in 1 1 | 1/5/2018 | |
Amneal Pharmaceuticals LLC | 65162-668 | ORAL | 27 mg in 1 1 | 3/29/2022 | |
U.S. Pharmaceutical Corporation | 52747-620 | ORAL | 42.5 mg in 1 1 | 7/13/2022 |
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 |
---|---|---|---|---|---|
FBC FILMTAB | SIN05814P | TABLET, FILM COATED | 200 mg | 5/3/1991 |
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 |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Ferropods | 329091 | Medicine | A | 1/22/2020 | |
BLACKMORES SUPERKIDS MULTI CHEWABLES | 289492 | Medicine | A | 5/30/2017 | |
Blackmores Bio Iron (NZ) | 143952 | Medicine | A | 8/29/2007 | |
Calcium + D3 Corbiere | 291608 | Medicine | A | 7/17/2017 | |
HKSG Swisse Kids Multi | 321304 | Medicine | A | 8/5/2019 | |
Supervite Multivitamin + Ginseng | 312495 | Medicine | A | 12/13/2018 | |
Swisse Ultivite Children's Multivitamin | 276713 | Medicine | A | 6/17/2016 | |
Pro Saffron Mood | 377510 | Medicine | A | 11/5/2021 | |
Swisse Men's Multivitamins | 351919 | Medicine | A | 12/18/2020 | |
Swisse Ultivite Women's High Potency Multivitamin | 369430 | Medicine | A | 6/16/2021 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
FERROUS FUMARATE TAB 200MG | shoppers drug mart inc. | 00415030 | Tablet - Oral | 200 MG / TAB | 12/31/1977 |
CHILDREN'S VITAMINS W IRON CHEWABLE | vita health products inc | 00787116 | Tablet - Oral | 4 MG | 12/31/1990 |
FUSION AM FORMULA TAB | l & s research corporation | 01961152 | Tablet - Oral | 4 MG / TAB | 12/31/1993 |
NOVO-FUMAR 200MG | novopharm limited | 00021431 | Tablet - Oral | 200 MG | 12/31/1967 |
MATERNA TAB | cyanamid canada inc. | 01900587 | Tablet - Oral | 60 MG / TAB | 12/31/1991 |
BUGS BUNNY CHEW MULTI VIT PLUS IRON | miles canada inc. - consumer health care division | 00570532 | Tablet - Oral | 12 MG / TAB | 12/31/1983 |
CENTRUM JR. COMPLETE | lederle consumer health products | 00701076 | Tablet - Oral | 4 MG / TAB | 12/31/1986 |
FLINTSTONES COMPLETE | miles canada inc. - consumer health care division | 00585823 | Tablet - Oral | 4 MG | 12/31/1983 |
COMPLETE FORMULA FOR ADULTS TAB | ksl pharmaceuticals | 02047527 | Tablet - Oral | 10 MG / TAB | 12/31/1995 |
CHILDREN'S CHEWABLE MULTIPLE VIT.PLUS IRON | stanley pharmaceuticals, a division of vita health products inc. | 02202069 | Tablet - Oral | 4 MG | 10/10/1997 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
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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