{"id":"iron","rwe":[],"_fda":{"id":"7aa8c3c6-7a91-4217-9e48-e1dfcf938060","set_id":"025fee85-53a8-4161-a806-44fd95d0ca74","openfda":{"nui":["N0000193618","M0001797","N0000175594","M0014839"],"unii":["PQ6CK8PD0R","H7426RGB3L","R5L488RY0Q","935E97BOY8","2679MF687A"],"route":["ORAL"],"rxcui":["999823","999826"],"spl_id":["7aa8c3c6-7a91-4217-9e48-e1dfcf938060"],"brand_name":["Integra F"],"spl_set_id":["025fee85-53a8-4161-a806-44fd95d0ca74"],"package_ndc":["52747-711-60","52747-711-30"],"product_ndc":["52747-711"],"generic_name":["FERROUS FUMARATE AND POLYSACCHRIDE IRON COMPLEX AND FOLIC ACID"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_cs":["Ascorbic Acid [CS]","Nicotinic Acids [CS]"],"substance_name":["ASCORBIC ACID","FERROUS ASPARTO GLYCINATE","FERROUS FUMARATE","FOLIC ACID","NIACIN"],"pharm_class_epc":["Vitamin C [EPC]","Nicotinic Acid [EPC]"],"manufacturer_name":["U.S. Pharmaceutical Corporation"],"is_original_packager":[true]},"version":"5","pregnancy":["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."],"overdosage":["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."],"description":["DESCRIPTION: Each capsule contains: Ferrous Fumarate (anhydrous) ..................................191.1 mg Polysaccharide Iron Complex..................................... 135.9 mg (Equivalent to about 125 mg of elemental iron) Folic Acid ....................................................................................1 mg Ascorbic Acid (from ProAscorb C‡) ................................ 40 mg Vitamin B3 (from ProAscorb C‡) ........................................3 mg CLINICAL PHARMACOLOGY: Integra FTM is unique in that it utilizes two (2) different forms of iron, i.e., Ferrous Fumarate and Polysaccharide Iron Complex (as cell-contracted akaganèite), making available a total of 125 mg of elemental iron per capsule as follows: Ferrous Fumarate (anhydrous) 191.1 mg Polysaccharide iron complex (PIC) 135.9 mg Ferrous Fumarate: Provides about 62.5 mg of elemental iron per dose. Ferrous Fumarate is an anhydrous salt of a combination of ferrous iron and fumaric acid, containing 33% of iron per weight. The acute toxicity in experimental animals is low and Ferrous Fumarate is well tolerated clinically. As a ferrous salt, it is more efficiently absorbed in the duodenum. Ferrous Fumarate contrasts very favorably with the availability of the 20% of elemental iron of ferrous sulfate, and the 13% of elemental iron of ferrous gluconate. Polysaccharide Iron Complex: Provides about 62.5 mg elemental iron, as a cell-contracted akaganèite. It is a product of ferric iron complexed to a low molecular weight polysaccharide. This polysaccharide is produced by the extensive hydrolysis of starch and is a dark brown powder that dissolves in water to form a very dark brown solution, which is virtually odorless and tasteless. Folic Acid: Folic Acid is one of the important hematopoetic agents necessary for proper regeneration of the blood-forming elements and their function. Folic acid is a precursor of a large family of compounds which serve as coenzymes in carbon transfer reactions. These reactions are required for the synthesis of purine and pyrimidine bases, inter-conversion of glycine and serine, biosynthesis of methionine methyl groups and degradation of histidine. Additionally, folic acid increases jejunal glycolytic enzymes and is involved in the desaturation and hydroxylation of long-chain fatty acids in the brain. A deficiency in folic acid results in megaloblastic anemia. All IntegraTM products include a unique patented source of iron, e.g. Ferrous Fumarate and Polysaccharide Iron Complex (U.S. Patent No: 11/243,043 Pending). \"An increase in tolerability is observed with the (patented formulation) and is believed to occur as the result of distributing the total iron content in the composition among compounds that provide iron to the patient's blood stream via two different mechanisms. The ferrous salts are readily absorbed in the upper gut, by direct dissolution and absorption of the ferrous iron by the bloodstream. However, the iron available from PIC is absorbed in the lower gut, via an active protein transport mechanism\". Clinical Studies: Because Ferrous Fumarate is an organic complex, it contains no free ions, either ferric or ferrous. Polysaccharide Iron Complex is clinically non-toxic. Prior studies in rats demonstrated that Polysaccharide Iron Complex (PIC), administered as a single oral dose to Sprague Dawley rats did not produce evidence of toxicity at a dosage level of 5000 mg Iron/kg: (An Acute Oral Toxicity Study in Rats with Polysaccharide-Iron Complex. T.N.Merriman, M. Aikman and R.E. Rush, Springborn Laboratories. Inc. Spencerville, Ohio Study No. 3340.1 March - April 1994). Other clinical studies had demonstrated that Polysaccharide Iron gives a good hematopoietic response with an almost complete absence of the side effects usually associated with oral iron therapy. Picinni and Ricciotti suggested in 1982, that \"the therapeutic effectiveness of Polysaccharide Iron Complex when compared with iron fumarate in the treatment of iron deficiency anemia, appears to be as active as the iron fumarate and as well tolerated, however, it exerted a greater influence on the level of hemoglobin and on the number of red cells...\" and that, \"it has been exceptionally well tolerated by all patients\" (Picinni, L.-Ricciotti, M. 1982. Therapeutic effectiveness of an iron-polysaccharide complex in comparison with iron fumarate in the treatment of iron deficiency anemias): PANMINERVA MEDICA-EUROPA MEDICA, Vol. 24, No. 3, pp. 213-220 (July-September 1982). As mentioned above, the patented source of iron used in Integra FTM (Ferrous Fumarate and Polysaccharide Iron Complex) provides a high level of elemental iron with a low incidence of gastric distress. CONCLUSION: Based on the results of this study, the oral combination of Ferrous Fumarate and Polysaccharide Iron Complex was better tolerated and safer than the oral administration of Ferrous Fumarate alone. The conclusion of this research stated, that the addition of PIC to Ferrous Fumarate surprisingly allows the same concentration of Ferrous Fumarate to be better tolerated than the Ferrous Fumarate alone. INDICATIONS: 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. CONTRAINDICATIONS: 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. WARNING: 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. 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. Pediatric Use: Safety and effectiveness of this product have not been established in pediatric patients. Geriatric Use: No clinical studies have been performed in patients age 65 and over to determine whether older persons respond differently from younger persons. Dosage should always begin at the low end of the dosage scale and should consider that elderly persons may have decreased hepatic, renal, or cardiac function and or concomitant diseases. Adverse Reactions: 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. 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. DOSAGE AND ADMINISTRATION: 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. HOW SUPPLIED: Integra F TM are maroon Vcaps ® capsules printed in white with \"Integra F\" on the cap and \"US\" logo on the body. Packed in child resistant caps and light resistant bottles of 90 capsules (52747-0711-60) and 30 capsules (52747-0711-30). The listed product numbers are not National Drug Codes. Instead, US Pharmaceutical Corporation has assigned these product codes formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems. CAUTION: Rx only."],"how_supplied":["HOW SUPPLIED: Integra F TM are maroon Vcaps ® capsules printed in white with \"Integra F\" on the cap and \"US\" logo on the body. Packed in child resistant caps and light resistant bottles of 90 capsules (52747-0711-60) and 30 capsules (52747-0711-30). The listed product numbers are not National Drug Codes. Instead, US Pharmaceutical Corporation has assigned these product codes formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems. CAUTION: Rx only."],"geriatric_use":["Geriatric Use: No clinical studies have been performed in patients age 65 and over to determine whether older persons respond differently from younger persons. Dosage should always begin at the low end of the dosage scale and should consider that elderly persons may have decreased hepatic, renal, or cardiac function and or concomitant diseases."],"pediatric_use":["Pediatric Use: Safety and effectiveness of this product have not been established in pediatric patients."],"effective_time":"20221108","clinical_studies":["Clinical Studies: Because Ferrous Fumarate is an organic complex, it contains no free ions, either ferric or ferrous. Polysaccharide Iron Complex is clinically non-toxic. Prior studies in rats demonstrated that Polysaccharide Iron Complex (PIC), administered as a single oral dose to Sprague Dawley rats did not produce evidence of toxicity at a dosage level of 5000 mg Iron/kg: (An Acute Oral Toxicity Study in Rats with Polysaccharide-Iron Complex. T.N.Merriman, M. Aikman and R.E. Rush, Springborn Laboratories. Inc. Spencerville, Ohio Study No. 3340.1 March - April 1994). Other clinical studies had demonstrated that Polysaccharide Iron gives a good hematopoietic response with an almost complete absence of the side effects usually associated with oral iron therapy. Picinni and Ricciotti suggested in 1982, that \"the therapeutic effectiveness of Polysaccharide Iron Complex when compared with iron fumarate in the treatment of iron deficiency anemia, appears to be as active as the iron fumarate and as well tolerated, however, it exerted a greater influence on the level of hemoglobin and on the number of red cells...\" and that, \"it has been exceptionally well tolerated by all patients\" (Picinni, L.-Ricciotti, M. 1982. Therapeutic effectiveness of an iron-polysaccharide complex in comparison with iron fumarate in the treatment of iron deficiency anemias): PANMINERVA MEDICA-EUROPA MEDICA, Vol. 24, No. 3, pp. 213-220 (July-September 1982). As mentioned above, the patented source of iron used in Integra FTM (Ferrous Fumarate and Polysaccharide Iron Complex) provides a high level of elemental iron with a low incidence of gastric distress. CONCLUSION: Based on the results of this study, the oral combination of Ferrous Fumarate and Polysaccharide Iron Complex was better tolerated and safer than the oral administration of Ferrous Fumarate alone. The conclusion of this research stated, that the addition of PIC to Ferrous Fumarate surprisingly allows the same concentration of Ferrous Fumarate to be better tolerated than the Ferrous Fumarate alone."],"adverse_reactions":["Adverse Reactions: 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."],"contraindications":["CONTRAINDICATIONS: 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."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY: Integra FTM is unique in that it utilizes two (2) different forms of iron, i.e., Ferrous Fumarate and Polysaccharide Iron Complex (as cell-contracted akaganèite), making available a total of 125 mg of elemental iron per capsule as follows: Ferrous Fumarate (anhydrous) 191.1 mg Polysaccharide iron complex (PIC) 135.9 mg Ferrous Fumarate: Provides about 62.5 mg of elemental iron per dose. Ferrous Fumarate is an anhydrous salt of a combination of ferrous iron and fumaric acid, containing 33% of iron per weight. The acute toxicity in experimental animals is low and Ferrous Fumarate is well tolerated clinically. As a ferrous salt, it is more efficiently absorbed in the duodenum. Ferrous Fumarate contrasts very favorably with the availability of the 20% of elemental iron of ferrous sulfate, and the 13% of elemental iron of ferrous gluconate. Polysaccharide Iron Complex: Provides about 62.5 mg elemental iron, as a cell-contracted akaganèite. It is a product of ferric iron complexed to a low molecular weight polysaccharide. This polysaccharide is produced by the extensive hydrolysis of starch and is a dark brown powder that dissolves in water to form a very dark brown solution, which is virtually odorless and tasteless. Folic Acid: Folic Acid is one of the important hematopoetic agents necessary for proper regeneration of the blood-forming elements and their function. Folic acid is a precursor of a large family of compounds which serve as coenzymes in carbon transfer reactions. These reactions are required for the synthesis of purine and pyrimidine bases, inter-conversion of glycine and serine, biosynthesis of methionine methyl groups and degradation of histidine. Additionally, folic acid increases jejunal glycolytic enzymes and is involved in the desaturation and hydroxylation of long-chain fatty acids in the brain. A deficiency in folic acid results in megaloblastic anemia. All IntegraTM products include a unique patented source of iron, e.g. Ferrous Fumarate and Polysaccharide Iron Complex (U.S. Patent No: 11/243,043 Pending). \"An increase in tolerability is observed with the (patented formulation) and is believed to occur as the result of distributing the total iron content in the composition among compounds that provide iron to the patient's blood stream via two different mechanisms. The ferrous salts are readily absorbed in the upper gut, by direct dissolution and absorption of the ferrous iron by the bloodstream. However, the iron available from PIC is absorbed in the lower gut, via an active protein transport mechanism\"."],"indications_and_usage":["INDICATIONS: 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."],"warnings_and_cautions":["WARNING: 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."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: 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."],"spl_product_data_elements":["Integra F Ferrous Fumarate and Polysacchride Iron Complex and Folic Acid FERROUS FUMARATE FERROUS CATION FERROUS ASPARTO GLYCINATE FERROUS CATION FOLIC ACID FOLIC ACID ASCORBIC ACID ASCORBIC ACID NIACIN NIACIN HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE FD&C RED NO. 40 TITANIUM DIOXIDE FD&C BLUE NO. 1 Maroon body and cap Integra;F;US"],"package_label_principal_display_panel":["Packaging Integra F Integra F"]},"tags":[{"label":"iron","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"A11AA01","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Anemia of prematurity","category":"indication"},{"label":"Iron deficiency anemia","category":"indication"},{"label":"Magnetic resonance imaging of liver","category":"indication"},{"label":"Megaloblastic anemia due to folate deficiency","category":"indication"},{"label":"Hippocration General Hospital","category":"company"},{"label":"Micronutrients","category":"pharmacology"},{"label":"Trace Elements","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"6212 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"5728 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"5666 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"5370 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"4639 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"4503 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"4253 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"3989 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"3630 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"3506 reports"}],"drugInteractions":[{"url":"/drug/dolutegravir","drug":"dolutegravir","action":"Monitor closely","effect":"May interact with Dolutegravir","source":"DrugCentral","drugSlug":"dolutegravir"},{"url":"/drug/enoxacin","drug":"enoxacin","action":"Monitor closely","effect":"May interact with Enoxacin","source":"DrugCentral","drugSlug":"enoxacin"},{"url":"/drug/levodopa","drug":"levodopa","action":"Monitor closely","effect":"May interact with Levodopa","source":"DrugCentral","drugSlug":"levodopa"},{"url":"/drug/levofloxacin","drug":"levofloxacin","action":"Monitor closely","effect":"May interact with Levofloxacin","source":"DrugCentral","drugSlug":"levofloxacin"},{"url":"/drug/levothyroxine-sodium","drug":"levothyroxine sodium","action":"Monitor closely","effect":"May interact with Levothyroxine Sodium","source":"DrugCentral","drugSlug":"levothyroxine-sodium"},{"url":"/drug/lomefloxacin","drug":"lomefloxacin","action":"Monitor closely","effect":"May interact with Lomefloxacin","source":"DrugCentral","drugSlug":"lomefloxacin"},{"url":"/drug/minocycline","drug":"minocycline","action":"Monitor closely","effect":"May interact with Minocycline","source":"DrugCentral","drugSlug":"minocycline"},{"url":"/drug/moxifloxacin","drug":"moxifloxacin","action":"Monitor closely","effect":"May interact with Moxifloxacin","source":"DrugCentral","drugSlug":"moxifloxacin"},{"url":"/drug/mycophenolate-mofetil","drug":"mycophenolate mofetil","action":"Monitor closely","effect":"May interact with Mycophenolate Mofetil","source":"DrugCentral","drugSlug":"mycophenolate-mofetil"},{"url":"/drug/norfloxacin","drug":"norfloxacin","action":"Monitor closely","effect":"May interact with Norfloxacin","source":"DrugCentral","drugSlug":"norfloxacin"},{"url":"/drug/ofloxacin","drug":"ofloxacin","action":"Monitor closely","effect":"May interact with Ofloxacin","source":"DrugCentral","drugSlug":"ofloxacin"}],"commonSideEffects":[{"effect":"Blood iron decreased","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Colitis ulcerative","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Pemphigus","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Haemoglobin decreased","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Hand deformity","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Haematochezia","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Glossodynia","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Inappropriate schedule of product administration","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Drug abuse","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Toxicity to various agents","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Weight decreased","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Pericarditis","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Anaemia","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Frequent bowel movements","drugRate":"","severity":"common","_validated":false,"_confidence":0.3}],"contraindications":["Diverticular disease","Gastroenteritis","Hemochromatosis","Hemolytic anemia","Hemosiderosis","Peptic ulcer","Repeated Blood Transfusions","Ulcerative colitis"]},"trials":[],"aliases":["oral iron","Ferretab","Ferli-6 (ferrous fumarate 200 mg, folic acid 0.5 mg, B6 5 mg)","No other name","Noripurum"],"company":"Hippocration General Hospital","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Iron","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:40:26.918538+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Iron","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:40:34.618799+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:40:33.208110+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T03:40:26.010107+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Iron","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:40:33.548105+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:40:13.469895+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:40:13.469929+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:40:13.469935+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T03:40:35.097061+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200823/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:40:34.277492+00:00"}},"allNames":"elemental iron (as carbonyl iron)","offLabel":[],"synonyms":["iron","elemental iron (as carbonyl iron)"],"timeline":[{"date":"1996-02-23","type":"positive","source":"FDA Orange Book","milestone":"Dexferrum approved — EQ 50MG IRON/ML"}],"aiSummary":"Elemental Iron (As Carbonyl Iron) is a small molecule iron drug developed by Hippocration General Hospital and currently owned by Allergan. It is used to treat various forms of anemia, including anemia of prematurity, iron deficiency anemia, and megaloblastic anemia due to folate deficiency. The commercial status of Elemental Iron is off-patent, with no active Orange Book patents. Key safety considerations include the potential for gastrointestinal side effects. It is used to replenish iron stores in the body.","approvals":[{"date":"","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Elemental Iron (As Carbonyl Iron)","ecosystem":[{"indication":"Anemia of prematurity","otherDrugs":[{"name":"ferric oxide","slug":"ferric-oxide","company":""},{"name":"ferrous fumarate","slug":"ferrous-fumarate","company":"Gd Searle Llc"},{"name":"ferrous gluconate","slug":"ferrous-gluconate","company":"Sanofi Aventis Us"},{"name":"ferrous sulfate","slug":"ferrous-sulfate","company":"Lederle"}],"globalPrevalence":null},{"indication":"Iron deficiency anemia","otherDrugs":[{"name":"cyanocobalamin","slug":"cyanocobalamin","company":""},{"name":"docusate sodium","slug":"docusate-sodium","company":""},{"name":"ferric carboxymaltose","slug":"ferric-carboxymaltose","company":"Luitpold"},{"name":"ferric citrate","slug":"ferric-citrate","company":"Keryx Biopharms"}],"globalPrevalence":null},{"indication":"Magnetic resonance imaging of liver","otherDrugs":[{"name":"mangafodipir","slug":"mangafodipir","company":""}],"globalPrevalence":null},{"indication":"Megaloblastic anemia due to folate deficiency","otherDrugs":[{"name":"cyanocobalamin","slug":"cyanocobalamin","company":""},{"name":"docusate sodium","slug":"docusate-sodium","company":""},{"name":"ferrous fumarate","slug":"ferrous-fumarate","company":"Gd Searle Llc"},{"name":"ferrous sulfate","slug":"ferrous-sulfate","company":"Lederle"}],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","drugClass":"Vitamin C [EPC]","explanation":"","oneSentence":"","technicalDetail":"Elemental Iron (As Carbonyl Iron) is a form of iron that is easily absorbed by the body, allowing it to replenish iron stores and support the production of hemoglobin and red blood cells."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Iron","title":"Iron","extract":"Iron is a chemical element; it has symbol Fe and atomic number 26. It is a metal that belongs to the first transition series and group 8 of the periodic table. It is, by mass, the most common element on Earth, forming much of Earth's outer and inner core. It is the fourth most abundant element in the Earth's crust. In its metallic state it was mainly deposited by meteorites.","wiki_history":"==History==\n\n\n===Development of iron metallurgy===\nIron is one of the elements undoubtedly known to the ancient world. It has been worked, or wrought, for millennia. However, iron artefacts of great age are much rarer than objects made of gold or silver due to the ease with which iron corrodes. The technology developed slowly, and even after the discovery of smelting it took many centuries for iron to replace bronze as the metal of choice for tools and weapons.\n\n====Meteoritic iron====\nthumb|Iron harpoon head from [[Greenland. The iron edge covers a narwhal tusk harpoon using meteorite iron from the Cape York meteorite, one of the largest iron meteorites known.]]\nBeads made from meteoric iron in 3500 BC or earlier were found in Gerzeh, Egypt by G. A. Wainwright.<!-- Typo on page 31 refers to \"G. W.\" but reference at end of chapter says \"G. A.\" --> The beads contain 7.5% nickel, which is a signature of meteoric origin since iron found in the Earth's crust generally has only minuscule nickel impurities.\n\nMeteoric iron was highly regarded due to its origin in the heavens and was often used to forge weapons and tools. For example, a dagger made of meteoric iron was found in the tomb of Tutankhamun, containing similar proportions of iron, cobalt, and nickel to a meteorite discovered in the area, deposited by an ancient meteor shower. Items that were likely made of iron by Egyptians date from 3000 to 2500 BC.\n\nMeteoritic iron is comparably soft and ductile and easily cold forged but may get brittle when heated because of the nickel content.\n\n====Wrought iron====\n\n\nleft|thumb|upright=0.5|alt=A circle, with a short, simple arrow shape extending diagonally upwards and rightwards from its edge|The symbol for [[Mars has been used since antiquity to represent iron.]] thumb|alt=A pillar, slightly fluted, with some ornamentation at its top. It is black, slightly weathered to a dark brown near the base. It is around  tall. It stands upon a raised circular base of stone, and is sur"},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4277","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Iron","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Iron","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Iron","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T14:00:17.350026","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:40:37.361006+00:00","fieldsConflicting":15,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"iron","indications":{"approved":[{"name":"Anemia of prematurity","source":"DrugCentral","snomedId":47100003,"regulator":"FDA","eligibility":"No information available"},{"name":"Iron deficiency anemia","source":"DrugCentral","snomedId":87522002,"regulator":"FDA","eligibility":"No information available"},{"name":"Magnetic resonance imaging of liver","source":"DrugCentral","snomedId":241622002,"regulator":"FDA","eligibility":"No information available"},{"name":"Megaloblastic anemia due to folate deficiency","source":"DrugCentral","snomedId":85649008,"regulator":"FDA","eligibility":"No information available"}],"offLabel":[],"pipeline":[]},"currentOwner":"Allergan","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[],"trialDetails":[{"nctId":"NCT00007150","phase":"PHASE2","title":"Treatment of Hemochromatosis","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Institutes of Health Clinical Center (CC)","startDate":"2001-01-01","conditions":["Hemochromatosis"],"enrollment":622,"completionDate":"2026-12-31"},{"nctId":"NCT04404881","phase":"PHASE2","title":"Bevacizumab In Hereditary Hemorrhagic Telangiectasia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hanny Al-Samkari, MD","startDate":"2020-11-23","conditions":["Hereditary Hemorrhagic Telangiectasia"],"enrollment":33,"completionDate":"2027-02-01"},{"nctId":"NCT07332091","phase":"PHASE2","title":"Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis","status":"RECRUITING","sponsor":"CSL Behring","startDate":"2026-01-22","conditions":["Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis"],"enrollment":84,"completionDate":"2028-04-06"},{"nctId":"NCT06435546","phase":"NA","title":"Adherence to Oral Therapies in Advanced Breast and Prostate Cancers","status":"COMPLETED","sponsor":"Institut de Cancérologie de Lorraine","startDate":"2024-06-04","conditions":["Breast Cancer","Prostate Cancer"],"enrollment":200,"completionDate":"2025-12-12"},{"nctId":"NCT07064005","phase":"PHASE1","title":"Enrichment of Glutathione Using Gamma-glutamylcysteine Supplementation in Parkinson's Disease Patients.","status":"ENROLLING_BY_INVITATION","sponsor":"Pravat Mandal","startDate":"2026-03-20","conditions":["Parkinsons Disease (PD)"],"enrollment":12,"completionDate":"2027-11-27"},{"nctId":"NCT05385042","phase":"NA","title":"Iron and Immune Response to Vaccine (IRONMUM)","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2022-06-18","conditions":["Pregnancy 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