Ferrous Fumarate

Mechanism-of-action class: Electrolyte Activity.

• Integra FTM is indicated for the treatment of iron deficiency anemia, and folate deficiency anemia. Integra FTM is indicated in pregnancy for the prevention and treatment of iron deficiency and to supply a maintenance dosage of folic acid.ICD-10: D64.9, E61.1

• Integra FTM is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.contraindicated

Adults (persons over 12 years of age), One (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12.

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. WARNING: Folic acid alone is improper therapy in the treatment for pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. PRECAUTIONS: General: Anemia is a manifestation that requires appropriate investigation to determine its cause or causes. No single regimen fits all cases and the status of the patient observed in follow-up is the final criterion for adequacy of therapy. Periodic clinical and laboratory studies are considered essential. Blood examinations including hemoglobin and hematacrit should be done at the usual intervals to make certain that therapy is adequate. Use with care in the presence of peptic ulcer, regional enteritis, and ulcerative colitis. Folic acid, especially in doses above 0.1 mg -0.4 mg daily may obscure pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive.

Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid. Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation, heartburn and vomiting) occur occasionally, but are usually mild and may subside with continuation of therapy. Reducing the dose and administering it with meals will minimize these effects in the sensitive patient. Increasing fiber in the diet can relieve constipation. Iron may turn stools black. This is a harmless effect that is a result of unabsorbed iron. Although the absorption of iron is best when taken between meals, giving Integra FTM after meals may control occasional G.I. disturbances. Integra FTM is best absorbed when taken at bedtime.

USAGE IN PREGNANCY: Before Integra FTM is prescribed for megaloblastic anemia in pregnancy, appropriate diagnostic exclusion of Addisonian pernicious anemia, (due to faulty or blocked absorption of vitamin B12, or extrinsic factor or either a genetic, immunological or surgical basis) should be carried out.

OVERDOSE: Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300-mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Integra FTM should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of the reach of children. Treatment: For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

• Sep 18, 2003ANDAANDA076064Barr
• Sep 18, 2003ANDAANDA076081Barr
• Oct 21, 2010NDANDA022501Apil
• Apr 19, 2013NDANDA204426Apil
• Aug 23, 2013ANDAANDA091453Novast Labs
• Aug 26, 2013ANDAANDA091454Novast Labs
• Nov 14, 2013ANDAANDA202772Xiromed
• Apr 23, 2014ANDAANDA203371Xiromed

1. 1Nausea5387.5%
2. 2Off Label Use5267.3%
3. 3Headache4426.1%
4. 4Fatigue3885.4%
5. 5Drug Ineffective3855.3%
6. 6Anxiety3114.3%
7. 7Pain2733.8%
8. 8Dizziness2693.7%
9. 9Amenorrhoea2553.5%
10. 10Depression2483.4%
11. 11Diarrhoea2483.4%
12. 12Metrorrhagia2423.4%
13. 13Vomiting2403.3%
14. 14Product Dose Omission Issue2333.2%
15. 15Rash2032.8%

Recent PubMed references pinned to Ferrous Fumarate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• In vitro biocompatiability and mechanical properties of bone adhesive tape composite based on poly(butyl fumarate)/poly(propylene fumarate)-diacrylate networks.
  Journal of the mechanical behavior of biomedical materials · 2022 · Wang L, Zhang GQ, He XH, et al.
  PMID 34991046DOI 10.1016/j.jmbbm.2021.105049
• Uptake of Encapsulated Ferrous Fumarate Double Fortified Salt in the Public Distribution System in India: A Value Chain Analysis.
  Global health, science and practice · 2021 · Jadhav MH, Mannar MGV
  PMID 34933979DOI 10.9745/GHSP-D-20-00448
• Multicentre randomized controlled trial comparing ferric(III)carboxymaltose infusion with oral iron supplementation in the treatment of preoperative anaemia in colorectal cancer patients.
  BMC surgery · 2015 · Borstlap WAA, Buskens CJ, Tytgat KMAJ, et al.
  PMID 26123286DOI 10.1186/s12893-015-0065-6
• An in vitro study of bare and poly(ethylene glycol)-co-fumarate-coated superparamagnetic iron oxide nanoparticles: a new toxicity identification procedure.
  Nanotechnology · 2009 · Mahmoudi M, Simchi A, Imani M, et al.
  PMID 19433870DOI 10.1088/0957-4484/20/22/225104
• Spectroelectrochemical study of hemoglobin A, alpha- and beta-fumarate crosslinked hemoglobins; implications to autoxidation reaction.
  Bioelectrochemistry (Amsterdam, Netherlands) · 2008 · Dragan SA, Olsen KW, Moore EG, et al.
  PMID 18515189DOI 10.1016/j.bioelechem.2008.04.013
• Metabolic characterization of lactic acid bacterium Lactococcus garvieae sk11, capable of reducing ferric iron, nitrate, and fumarate.
  Journal of microbiology and biotechnology · 2007 · Yun SH, Hwang TS, Park DH, et al.
  PMID 18051752
• Ferrous fumarate with ascorbic acid in chronic hypoferremia.
  Minnesota medicine · 1970 · Schleicher EM
  PMID 5414435
• [A case of acute poisoning caused by ferrous fumarate. (Anatomo-clinical, physiopathological and therapeutic findings)].
  Il Policlinico. Sezione pratica · 1969 · Cartei G, Barry M
  PMID 4986016

The 10 most recently updated of 107 ClinicalTrials.gov registrations naming Ferrous Fumarate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
  Recruiting · Early phase 1 · Interventional · 20 enrolled · Massachusetts General Hospital
  NCT07568509updated 2026-05-15
• Identifying Oxytocin Deficiency in Adults With Pituitary Disease
  Completed · Early phase 1 · Interventional · 28 enrolled · Elizabeth Austen Lawson
  NCT06460948updated 2026-05-13
• Comparison of Ferrous Salt vs. Liposomal Iron in Adult Women With Iron-Deficiency Anemia
  Not yet recruiting · Phase 3 · Interventional · 100 enrolled · Hospital General de Mexico
  NCT07556731updated 2026-04-29
• Efficacy and Adverse Side Effects of Two Forms of Iron in Pregnancy
  Recruiting · Interventional · 172 enrolled · University of British Columbia
  NCT06014983updated 2026-04-24
• Nutritional Educational Program On Therapy in Iron Deficiency Anemia
  Active not recruiting · Interventional · 150 enrolled · Hawler Medical University
  NCT06642337updated 2026-04-07
• Levonorgestrel Intrauterine System Effects on Hemoglobin and Serum Ferritin Among Anemic Women in Kenya
  Active not recruiting · Interventional · 405 enrolled · FHI 360
  NCT05233956updated 2026-04-03
• Iron Absorption From IFA and MMS Supplements in Kenyan Women During the Second Trimester of Pregnancy
  Recruiting · Interventional · 50 enrolled · ETH Zurich
  NCT07435766updated 2026-02-27
• Ferric Citrate in Iron Deficiency Anemia During Pregnancy
  Not yet recruiting · Phase 3 · Interventional · 680 enrolled · Dhaka Medical College
  NCT07381426updated 2026-02-03
• Alternative vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA)
  Recruiting · Interventional · 114 enrolled · Phramongkutklao College of Medicine and Hospital
  NCT07014371updated 2026-01-07
• The Effect of Oral Iron Supplements on Insulin and Glucose Metabolism in Overweight and Obese Women
  Recruiting · Interventional · 70 enrolled · Nicole Stoffel
  NCT07315282updated 2026-01-02

Frequently asked questions

How does Ferrous Fumarate work?

Mechanism-of-action class: Electrolyte Activity.

What is Ferrous Fumarate used for?

According to FDA labeling, Ferrous Fumarate carries indications including: Integra FTM is indicated for the treatment of iron deficiency anemia, and folate deficiency anemia. Integra FTM is indicated in pregnancy for the prevention and treatment of iron deficiency and to supply a maintenance dosage of folic acid.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ferrous Fumarate?

Ferrous Fumarate is classified as Iron bivalent, oral preparations, Electrolyte Activity, Increased Erythroid Cell Production.

What are the brand names for Ferrous Fumarate?

Ferrous Fumarate is marketed under brand names including Concept OB, Dialyvite 800 with Iron, Ferocon, Ferrimin 150, Ferrocite, Folivane-F, Hematogen, Hemocyte.

What are the contraindications for Ferrous Fumarate?

Ferrous Fumarate labeling lists contraindications including: Integra FTM is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.. Always consult the full prescribing information and a clinician.