Fumarate

• 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.

• Mar 26, 1993NDANDA020186Teva Branded Pharm
• Dec 28, 1995NDANDA020491Pfizer
• Oct 26, 2001NDANDA021356Gilead Sciences Inc
• Jul 21, 2006NDANDA021929Astrazeneca
• Dec 1, 2006NDANDA021996Bausch And Lomb
• May 11, 2007NDANDA022007Viatris Specialty
• Oct 31, 2008NDANDA022030Pfizer
• Oct 21, 2010NDANDA022501Apil

1. 1Dyspnoea35,4416.7%
2. 2Drug Ineffective27,3095.2%
3. 3Fatigue26,6825.0%
4. 4Nausea25,9874.9%
5. 5Diarrhoea23,8444.5%
6. 6Pain23,3964.4%
7. 7Bone Density Decreased21,0954.0%
8. 8Headache20,1183.8%
9. 9Flushing20,0173.8%
10. 10Off Label Use19,4193.7%
11. 11Vomiting17,6073.3%
12. 12Dizziness17,3443.3%
13. 13Malaise17,0683.2%
14. 14Asthma16,3063.1%
15. 15Anxiety16,1583.1%

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

• Fumaric acid regulates morphine tolerance in bone cancer pain through spinal MrgC receptor modulation.
  Pakistan journal of pharmaceutical sciences · 2026 · Liu S, Tang M, Zhao J, et al.
  PMID 42262207DOI 10.36721/PJPS.2026.39.8.233.1
• Dimethyl fumarate ameliorates quinolinic acid-induced ageing and neurodegeneration in Caenorhabditis elegans.
  Biogerontology · 2026 · Sun Y, Zhou K, Cui J, et al.
  PMID 42250035DOI 10.1007/s10522-026-10455-8
• Sustainable RP-HPLC Method Development for Simultaneous Estimation of Fampridine and Monomethyl Fumarate in Lipid Nanocarriers and Biological Fluids: Application of AQbd Principles.
  Archiv der Pharmazie · 2026 · Muppayyanamath A, Mastiholimath V
  PMID 42246625DOI 10.1002/ardp.70274
• The Emerging Role of Dimethyl Fumarate in Alzheimer's Disease-A Systematic Review of Available Preclinical Studies.
  International journal of molecular sciences · 2026 · Mouaimi M, Metaxas A, Kourti M, et al.
  PMID 42196209DOI 10.3390/ijms27104227
• Pain in the NEK: Dimethyl fumarate inactivates the NRLP3 inflammasome by covalent inhibition of NEK7.
  Cell chemical biology · 2026 · Choi W, Bollong MJ
  PMID 42167140DOI 10.1016/j.chembiol.2026.04.013
• Targeted delivery of dimethyl fumarate via CD40-directed PLGA nanoparticles to fibroblast-like synoviocytes suppresses inflammation in rheumatoid arthritis.
  International journal of biological macromolecules · 2026 · Zadeh RQ, Mansouri R, Tahoori MT, et al.
  PMID 42119875DOI 10.1016/j.ijbiomac.2026.152508
• Potential of Antioxidant and Cardioprotective Activity of a New Pyridoxine and Fumaric Acid Derivative as an Inductor of Transcription Factor Nrf2.
  Bulletin of experimental biology and medicine · 2026 · Balakina AA, Podgurskaya AD, Mumyatova VA, et al.
  PMID 42043707DOI 10.1007/s10517-026-06667-0
• Dimethyl fumarate alleviates oxidative stress and inflammation in noise-induced hearing loss by activating Nrf2/HO-1 signaling in cochlear hair cells.
  International immunopharmacology · 2026 · Li M, Zhang W, Huang X, et al.
  PMID 42030895DOI 10.1016/j.intimp.2026.116675

The 10 most recently updated of 1,978 ClinicalTrials.gov registrations naming Fumarate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study
  Recruiting · Phase 2 · Interventional · 120 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT05652478updated 2026-06-12
• A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
  Recruiting · Phase 4 · Interventional · 350 enrolled · Gilead Sciences
  NCT06337032updated 2026-06-10
• Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial
  Recruiting · Phase 4 · Interventional · 100 enrolled · University of Witwatersrand, South Africa
  NCT06485154updated 2026-06-09
• SM-1 Combined With Temozolomide in Subjects With Refractory or Recurrent High-Grade Gliomas
  Completed · Phase 1 · Interventional · 35 enrolled · Shenzhen Zhenxing Medical Technology Co., Ltd
  NCT07635173updated 2026-06-09
• Comparative Trial Between Ainuovirine(ANV)/Lamivudine(3TC)/Tenofovir(TDF) and Efavirenz(EFV)/Lamivudine/Tenofovir Regimens
  Not yet recruiting · Phase 4 · Interventional · 60 enrolled · Shanghai Public Health Clinical Center
  NCT07631897updated 2026-06-08
• A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
  Recruiting · Phase 3 · Interventional · 4,390 enrolled · Merck Sharp & Dohme LLC
  NCT07044297updated 2026-06-08
• Exercise as an Immune Adjuvant for Allogeneic Cell Therapies
  Recruiting · Early phase 1 · Interventional · 200 enrolled · University of Arizona
  NCT06643221updated 2026-06-05
• Physiological Effects Ketone Ester in Heart
  Active not recruiting · Interventional · 50 enrolled · The Cleveland Clinic
  NCT05924802updated 2026-06-05
• A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies
  Active not recruiting · Observational · 1,178 enrolled · Biogen
  NCT05688436updated 2026-06-04
• A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation
  Recruiting · Phase 4 · Interventional · 56 enrolled · AstraZeneca
  NCT07073950updated 2026-06-03

Frequently asked questions

What is Fumarate used for?

According to FDA labeling, 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 are the contraindications for Fumarate?

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.