{"id":"folic-acid","rwe":[{"pmid":"41906915","year":"2026","title":"Copper sulfide nanoparticles coated with Fe-EGCG networks for targeted MR imaging and chemo/photothermal/chemodynamic synergetic therapy of tumors.","finding":"","journal":"Biomaterials science","studyType":"Clinical Study"},{"pmid":"41906715","year":"2026","title":"Folic acid alleviates endothelial dysfunction caused by T2DM-induced ferroptosis by activating the SIRT6/NRF2/GPX4 signaling pathway.","finding":"","journal":"Food & function","studyType":"Clinical Study"},{"pmid":"41905984","year":"2026","title":"Maternal nutrition practices and its implications for child growth and development.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"},{"pmid":"41903436","year":"2026","title":"Hyperoside stabilizes ACAT1 to promote fatty acid oxidation and attenuate kidney fibrosis via the L-carnitine-SIRT3 axis.","finding":"","journal":"Phytomedicine : international journal of phytotherapy and phytopharmacology","studyType":"Clinical Study"},{"pmid":"41899717","year":"2026","title":"Awareness and Use of Folic Acid Among Pregnant Women in Western Ukraine: A Pilot Study.","finding":"","journal":"International journal of environmental research and public health","studyType":"Clinical Study"}],"_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":"folic acid","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Thymidylate synthase","category":"target"},{"label":"TYMS","category":"gene"},{"label":"AKR1B1","category":"gene"},{"label":"B03AD01","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Breastfeeding (mother)","category":"indication"},{"label":"Folic acid deficiency","category":"indication"},{"label":"Iron deficiency anemia","category":"indication"},{"label":"Megaloblastic anemia due to folate deficiency","category":"indication"},{"label":"Mineral Deficiency Prevention","category":"indication"},{"label":"Mineral deficiency","category":"indication"},{"label":"Wyeth Pharms Inc","category":"company"},{"label":"Approved 1940s","category":"decade"},{"label":"Hematinics","category":"pharmacology"},{"label":"Hematologic Agents","category":"pharmacology"},{"label":"Micronutrients","category":"pharmacology"},{"label":"Vitamin B Complex","category":"pharmacology"},{"label":"Vitamins","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"24820 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"23455 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"23193 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"19562 reports"},{"date":"","signal":"RHEUMATOID ARTHRITIS","source":"FDA FAERS","actionTaken":"17531 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"17367 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"15761 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"14300 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"14277 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"13648 reports"}],"commonSideEffects":[{"effect":"Anorexia","drugRate":"reported","severity":"unknown"},{"effect":"Nausea","drugRate":"reported","severity":"unknown"},{"effect":"Abdominal distention","drugRate":"reported","severity":"unknown"},{"effect":"Flatulence","drugRate":"reported","severity":"unknown"},{"effect":"Bitter or bad taste","drugRate":"reported","severity":"unknown"},{"effect":"Erythema","drugRate":"reported","severity":"unknown"},{"effect":"Skin rash","drugRate":"reported","severity":"unknown"},{"effect":"Itching","drugRate":"reported","severity":"unknown"},{"effect":"General malaise","drugRate":"reported","severity":"unknown"},{"effect":"Respiratory difficulty due to bronchospasm","drugRate":"reported","severity":"unknown"},{"effect":"Anaphylaxis","drugRate":"reported","severity":"unknown"},{"effect":"Altered sleep patterns","drugRate":"reported","severity":"unknown"},{"effect":"Difficulty in concentrating","drugRate":"reported","severity":"unknown"},{"effect":"Irritability","drugRate":"reported","severity":"unknown"},{"effect":"Overactivity","drugRate":"reported","severity":"unknown"},{"effect":"Mental depression","drugRate":"reported","severity":"unknown"},{"effect":"Confusion","drugRate":"reported","severity":"unknown"},{"effect":"Impaired judgment","drugRate":"reported","severity":"unknown"},{"effect":"Decreased vitamin B12 serum levels","drugRate":"reported","severity":"unknown"},{"effect":"Seizures","drugRate":"reported","severity":"unknown"},{"effect":"Decreased diphenylhydantoin serum levels","drugRate":"reported","severity":"unknown"}],"contraindications":["Anemia due to enzyme deficiency","Atrophic gastritis","Bipolar disorder","Constipation","Dehydration","Diabetes mellitus","Diarrhea","Diverticular disease","Esophageal dysmotility","Gastrectomy","Gastroenteritis","Hb SS disease","Hemochromatosis","Hemolytic anemia","Hemosiderosis","Hypercalcemia","Hyperparathyroidism","Hypokalemia","Hypomania","Kidney disease","Kidney stone","Leber's optic atrophy","Operation on stomach","Osteolysis","Peptic ulcer"],"specialPopulations":{"Pregnancy":"Folic acid requirements are markedly increased during pregnancy, and deficiency will result in fetal damage. Studies in pregnant women have not shown that folic acid increases the risk of fetal abnormalities if administered during pregnancy. If the drug is used during pregnancy, the possibility of fetal harm appears remote."}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.0312/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$11","description":"FOLIC ACID 1 MG TABLET","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=FOLIC ACID","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:46:38.456895+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:46:45.186625+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T03:46:37.094964+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FOLIC ACID","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:46:45.964065+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":"2026-04-20T03:46:35.897347+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:46:35.897370+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:46:35.897377+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":"2026-04-20T03:46:48.406274+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1622/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:46:47.244866+00:00"}},"allNames":["folic acid","acifolic","aspol","cytofol","folacid","pteroylglutamic acid","folate sodium","Adult Infuvite Multiple Vitamins (combination)","Adult Infuvite Multiple Vitamins for Infusion (combination)","Infuvite Adult Multiple Vitamins (combination)","PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSION (combination)","Pediatric Infuvite Multiple Vitamins (combination)"],"offLabel":[],"synonyms":["folic acid","acifolic","aspol","cytofol","folacid","pteroylglutamic acid","folate sodium"],"timeline":[{"date":"1946-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from LEDERLE to Wyeth Pharms Inc"},{"date":"1946-08-13","type":"positive","source":"DrugCentral","milestone":"FDA approval (Lederle)"},{"date":"2026-01-26","type":"positive","source":"FDA Orange Book","milestone":"Quiofic approved — 0.2MG/ML"}],"aiSummary":"Folic acid is a small molecule drug that targets thymidylate synthase, originally developed by Lederle and currently owned by Wyeth Pharmaceuticals. It was FDA-approved in 1946 for various indications, including folic acid deficiency, iron deficiency anemia, and pregnancy. Folic acid is now off-patent with 36 generic manufacturers. It has a bioavailability of 75% and a half-life of 2.6 hours. Key safety considerations include monitoring for adverse effects such as gastrointestinal symptoms and allergic reactions.","approvals":[{"date":"1946-08-13","orphan":false,"company":"LEDERLE","regulator":"FDA"}],"brandName":"Folic Acid","ecosystem":[{"indication":"Breastfeeding (mother)","otherDrugs":[{"name":"ascorbic acid","slug":"ascorbic-acid","company":""},{"name":"calcium phosphate","slug":"calcium-phosphate","company":""},{"name":"doconexent","slug":"doconexent","company":""},{"name":"docusate sodium","slug":"docusate-sodium","company":""}],"globalPrevalence":null},{"indication":"Folic acid deficiency","otherDrugs":[{"name":"leucovorin","slug":"leucovorin","company":""},{"name":"levofolinic acid","slug":"levofolinic-acid","company":"Spectrum Pharms"}],"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":"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},{"indication":"Mineral Deficiency Prevention","otherDrugs":[{"name":"ferrous sulfate","slug":"ferrous-sulfate","company":"Lederle"},{"name":"retinol","slug":"retinol","company":"Hospira"},{"name":"riboflavin","slug":"riboflavin","company":"Hospira"},{"name":"thiamine","slug":"thiamine","company":"Hospira"}],"globalPrevalence":null},{"indication":"Mineral deficiency","otherDrugs":[{"name":"ferrous sulfate","slug":"ferrous-sulfate","company":"Lederle"},{"name":"retinol","slug":"retinol","company":"Hospira"},{"name":"riboflavin","slug":"riboflavin","company":"Hospira"},{"name":"thiamine","slug":"thiamine","company":"Hospira"}],"globalPrevalence":null},{"indication":"Pregnancy, function","otherDrugs":[{"name":"calcium phosphate","slug":"calcium-phosphate","company":""},{"name":"doconexent","slug":"doconexent","company":""},{"name":"docusate sodium","slug":"docusate-sodium","company":""},{"name":"eicosapentaenoic acid","slug":"eicosapentaenoic-acid","company":""}],"globalPrevalence":null},{"indication":"Prevention of Vitamin B12 Deficiency","otherDrugs":[{"name":"cobalamin","slug":"cobalamin","company":""},{"name":"cobamamide","slug":"cobamamide","company":""},{"name":"cyanocobalamin","slug":"cyanocobalamin","company":""},{"name":"hydroxocobalamin","slug":"hydroxocobalamin","company":"Watson Labs"}],"globalPrevalence":null}],"mechanism":{"target":"Thymidylate synthase","novelty":"First-in-class","targets":[{"gene":"TYMS","source":"DrugCentral","target":"Thymidylate synthase","protein":"Thymidylate synthase"},{"gene":"AKR1B1","source":"DrugCentral","target":"Aldose reductase","protein":"Aldose reductase"}],"modality":"Small Molecule","drugClass":"Vitamin C [EPC]","explanation":"","oneSentence":"","technicalDetail":"Folic acid acts as a co-factor for the enzyme thymidylate synthase, which is necessary for the synthesis of thymidine monophosphate (TMP) from uracil monophosphate (UMP). This process is critical for DNA replication and repair, and folic acid's role in this pathway makes it essential for cell growth and division."},"commercial":{"launchDate":"1946","_launchSource":"DrugCentral (FDA 1946-08-13, LEDERLE)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1231","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=FOLIC%20ACID","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FOLIC ACID","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T11:35:18.667683","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:46:51.819690+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"ferrous fumarate","drugSlug":"ferrous-fumarate","fdaApproval":"1986-07-18","relationship":"same-class"},{"drugName":"ferrous sulfate","drugSlug":"ferrous-sulfate","fdaApproval":"1946-08-13","relationship":"same-class"},{"drugName":"ferrous gluconate","drugSlug":"ferrous-gluconate","fdaApproval":"1999-02-18","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"folic acid","indications":{"approved":[{"name":"Breastfeeding (mother)","source":"DrugCentral","snomedId":413712001,"regulator":"FDA"},{"name":"Folic acid deficiency","source":"DrugCentral","snomedId":190633005,"regulator":"FDA"},{"name":"Iron deficiency anemia","source":"DrugCentral","snomedId":87522002,"regulator":"FDA"},{"name":"Megaloblastic anemia due to folate deficiency","source":"DrugCentral","snomedId":85649008,"regulator":"FDA"},{"name":"Mineral Deficiency Prevention","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Mineral deficiency","source":"DrugCentral","snomedId":111379007,"regulator":"FDA"},{"name":"Pregnancy, function","source":"DrugCentral","snomedId":289908002,"regulator":"FDA"},{"name":"Prevention of Vitamin B12 Deficiency","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Vitamin Deficiency Prevention","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Vitamin deficiency","source":"DrugCentral","snomedId":85670002,"regulator":"FDA"}],"offLabel":[{"name":"Homocystinemia","source":"DrugCentral","drugName":"FOLIC ACID","evidenceCount":11,"evidenceLevel":"moderate"},{"name":"Homocystinuria","source":"DrugCentral","drugName":"FOLIC ACID","evidenceCount":270,"evidenceLevel":"strong"},{"name":"Prevention of Fetal Neural Tube Defects during Pregnancy","source":"DrugCentral","drugName":"FOLIC ACID","evidenceCount":377,"evidenceLevel":"strong"}],"pipeline":[]},"currentOwner":"Wyeth Pharms Inc","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"ferrous-fumarate","brandName":"ferrous fumarate","genericName":"ferrous fumarate","approvalYear":"1986","relationship":"same-class"},{"drugId":"ferrous-sulfate","brandName":"ferrous sulfate","genericName":"ferrous sulfate","approvalYear":"1946","relationship":"same-class"},{"drugId":"ferrous-gluconate","brandName":"ferrous gluconate","genericName":"ferrous gluconate","approvalYear":"1999","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT06317662","phase":"PHASE2","title":"Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2025-06-05","conditions":["Acute Leukemia of Ambiguous Lineage","B Acute Lymphoblastic Leukemia"],"enrollment":153,"completionDate":"2028-12-31"},{"nctId":"NCT03914625","phase":"PHASE3","title":"A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2019-07-03","conditions":["B Acute Lymphoblastic Leukemia","B Lymphoblastic Lymphoma","Down Syndrome"],"enrollment":6720,"completionDate":"2027-09-30"},{"nctId":"NCT06948448","phase":"PHASE2","title":"A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer","status":"RECRUITING","sponsor":"Ono Pharmaceutical Co. 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