Polysaccharide Iron Complex
/api/v1/drug/polysaccharide-iron-complexMechanism of action
Sourced from openFDAMechanism-of-action class: Electrolyte Activity.
Indications
Sourced from openFDA- PureVit DualFe Plus is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. Also for treatment of condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.ICD-10: D64.9, E61.1
Contraindications
Sourced from openFDA- PureVit DualFe Plus 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
Dosage & administration
Sourced from openFDAAdults (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.
Warnings & precautions
Sourced from openFDAAccidental overdose of Iron-containing products is the leading cause of fatal poisoning of children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately. Folic acid alone is improper therapy in the treatment for pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient.
Adverse reactions
Sourced from openFDAFolic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid. Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving PureVit DualFe Plus after meals may control occasional gastrointestinal disturbances. PureVit DualFe Plus is best absorbed when taken at bedtime. Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088.
Overdosage
Sourced from openFDAOVERDOSE: 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. PureVit DualFe Plus should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of 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.
FAERS reports
- 1Acute Kidney Injury1100%
- 2Chronic Kidney Disease1100%
- 3End Stage Renal Disease1100%
- 4Renal Tubular Necrosis1100%
Clinical trials
The 10 most recently updated of 107 ClinicalTrials.gov registrations naming Polysaccharide Iron Complex as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Daily and Weekly Iron Supplementation in InfantsCompleted · Interventional · 287 enrolled · Mahidol UniversityNCT06318858updated 2026-06-01
- Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm InfantsRecruiting · Phase 2 · Interventional · 120 enrolled · University of WashingtonNCT05340465updated 2026-05-26
- Pediatric Outcomes and Recovery With Peri-Operative Iron Supplement EvaluationRecruiting · Interventional · 180 enrolled · University of British ColumbiaNCT07095244updated 2026-05-14
- Sucrosomial Iron and Iron Sulphate to Blood DonorsCompleted · Interventional · 120 enrolled · Uppsala University HospitalNCT05678647updated 2026-04-29
- The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency DepartmentNot yet recruiting · Phase 4 · Interventional · 150 enrolled · Children's Hospital of Orange CountyNCT07414199updated 2026-02-17
- EFFICACY OF IV VERSUS ORAL IRON IN THE TREATMENT OF IRON DEFICIENCY ANEMIA DURING PREGNANCYCompleted · Phase 1 · Interventional · 112 enrolled · Dr Salaha AzamNCT07384663updated 2026-02-03
- Daily Iron vs Every-other-day Iron for Pediatric Patients With IDANot yet recruiting · Phase 4 · Interventional · 100 enrolled · Loma Linda UniversityNCT06550362updated 2026-01-30
- Alternative vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA)Recruiting · Interventional · 114 enrolled · Phramongkutklao College of Medicine and HospitalNCT07014371updated 2026-01-07
- Effects of Oral Iron Supplementation on Vaccine Response in Iron Deficient Kenyan WomenCompleted · Interventional · 180 enrolled · Nicole StoffelNCT05919472updated 2025-12-26
- Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical PatientRecruiting · Phase 3 · Interventional · 104 enrolled · Auerbach Hematology Oncology Associates P CNCT04268849updated 2025-10-03
Frequently asked questions
- How does Polysaccharide Iron Complex work?
- Mechanism-of-action class: Electrolyte Activity.
- What is Polysaccharide Iron Complex used for?
- According to FDA labeling, Polysaccharide Iron Complex carries indications including: PureVit DualFe Plus is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. Also for treatment of condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Polysaccharide Iron Complex?
- Polysaccharide Iron Complex is classified as Electrolyte Activity, Increased Erythroid Cell Production.
- What are the brand names for Polysaccharide Iron Complex?
- Polysaccharide Iron Complex is marketed under brand names including Bifera, Concept OB, EZFE, Ferrex 150 Forte, Ferrex 150 Forte Plus, Ferrex 150 Plus, Ferrex-150, Folivane-F.
- What are the contraindications for Polysaccharide Iron Complex?
- Polysaccharide Iron Complex labeling lists contraindications including: PureVit DualFe Plus 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.
polysaccharide-iron-complex is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.