{"id":"ferrous-sulfate","rwe":[],"_fda":{"id":"3a749d62-0e21-0c15-e063-6394a90ac1a8","set_id":"3a749d62-0e20-0c15-e063-6394a90ac1a8","openfda":{"unii":["39R4TAN1VT"],"route":["ORAL"],"spl_id":["3a749d62-0e21-0c15-e063-6394a90ac1a8"],"brand_name":["FERRUM SULPHURICUM"],"spl_set_id":["3a749d62-0e20-0c15-e063-6394a90ac1a8"],"package_ndc":["0220-2113-41"],"product_ndc":["0220-2113"],"generic_name":["FERROUS SULFATE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["FERROUS SULFATE"],"manufacturer_name":["Boiron"],"is_original_packager":[true]},"purpose":[""],"version":"1","stop_use":["Stop use and ask a doctor if symptoms persist for more than 3 days or worsen."],"warnings":[""],"questions":["BoironUSA.com Info@boiron.com 1-800-BOIRON-1 (1-800-264-7661) Distributed by Boiron, Inc. Newtown Square, PA 19073"],"effective_time":"20250721","active_ingredient":["FERRUM SULPHURICUM 200CK HPUS Active ingredient**: See product name on front panel (contains 0.443 mg of the active ingredient per pellet)."],"inactive_ingredient":["lactose, sucrose"],"indications_and_usage":["Uses: See symptoms on front panel. Relieves hot flashes with headaches *"],"spl_unclassified_section":["Do not use if pellet dispenser seal is broken. Contains approx.80 pellets. How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue. *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. **C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details."],"dosage_and_administration":["Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor."],"spl_product_data_elements":["FERRUM SULPHURICUM FERROUS SULFATE SUCROSE FERROUS SULFATE FERROUS CATION LACTOSE, UNSPECIFIED FORM"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"keep_out_of_reach_of_children":["Keep out of reach of children."],"package_label_principal_display_panel":["Label"]},"tags":[{"label":"ferrous sulfate","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"B03AA07","category":"atc"},{"label":"Oral","category":"route"},{"label":"Elixir","category":"form"},{"label":"Liquid","category":"form"},{"label":"Tablet","category":"form"},{"label":"Active","category":"status"},{"label":"Anemia of prematurity","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":"Vitamin Deficiency Prevention","category":"indication"},{"label":"Lederle","category":"company"},{"label":"Approved 1940s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"3325 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"3102 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"2746 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"2724 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"2345 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"2306 reports"},{"date":"","signal":"ACUTE KIDNEY INJURY","source":"FDA FAERS","actionTaken":"2070 reports"},{"date":"","signal":"ANAEMIA","source":"FDA FAERS","actionTaken":"1967 reports"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"1943 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"1922 reports"}],"drugInteractions":[{"url":"/drug/dolutegravir","drug":"dolutegravir","action":"Monitor closely","effect":"May interact with Dolutegravir","source":"DrugCentral","drugSlug":"dolutegravir"},{"url":"/drug/dolutegravir","drug":"dolutegravir","action":"Monitor closely","effect":"May interact with Dolutegravir, Iron","source":"DrugCentral","drugSlug":"dolutegravir"},{"url":"/drug/enoxacin","drug":"enoxacin","action":"Monitor closely","effect":"May interact with Enoxacin","source":"DrugCentral","drugSlug":"enoxacin"},{"url":"/drug/enoxacin","drug":"enoxacin","action":"Monitor closely","effect":"May interact with Enoxacin, Iron","source":"DrugCentral","drugSlug":"enoxacin"},{"url":"/drug/gatifloxacin","drug":"gatifloxacin","action":"Monitor closely","effect":"May interact with Gatifloxacin","source":"DrugCentral","drugSlug":"gatifloxacin"},{"url":"/drug/levodopa","drug":"levodopa","action":"Monitor closely","effect":"May interact with Levodopa","source":"DrugCentral","drugSlug":"levodopa"},{"url":"/drug/levodopa","drug":"levodopa","action":"Monitor closely","effect":"May interact with Iron, Levodopa","source":"DrugCentral","drugSlug":"levodopa"},{"url":"/drug/levofloxacin","drug":"levofloxacin","action":"Monitor closely","effect":"May interact with Levofloxacin","source":"DrugCentral","drugSlug":"levofloxacin"},{"url":"/drug/levofloxacin","drug":"levofloxacin","action":"Monitor closely","effect":"May interact with Iron, 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/levothyroxine-sodium","drug":"levothyroxine sodium","action":"Monitor closely","effect":"May interact with Iron, Levothyroxine Sodium","source":"DrugCentral","drugSlug":"levothyroxine-sodium"},{"url":"/drug/lomefloxacin","drug":"lomefloxacin","action":"Monitor closely","effect":"May interact with Iron, Lomefloxacin","source":"DrugCentral","drugSlug":"lomefloxacin"},{"url":"/drug/minocycline","drug":"minocycline","action":"Monitor closely","effect":"May interact with Minocycline","source":"DrugCentral","drugSlug":"minocycline"},{"url":"/drug/minocycline","drug":"minocycline","action":"Monitor closely","effect":"May interact with Iron, Minocycline","source":"DrugCentral","drugSlug":"minocycline"},{"url":"/drug/moxifloxacin","drug":"moxifloxacin","action":"Monitor closely","effect":"May interact with Moxifloxacin","source":"DrugCentral","drugSlug":"moxifloxacin"},{"url":"/drug/moxifloxacin","drug":"moxifloxacin","action":"Monitor closely","effect":"May interact with Iron, 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/mycophenolate-mofetil","drug":"mycophenolate mofetil","action":"Monitor closely","effect":"May interact with Iron, 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/norfloxacin","drug":"norfloxacin","action":"Monitor closely","effect":"May interact with Iron, 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(EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:17:07.863060+00:00"}},"allNames":["ferrous sulfate","ferrous sulfate, dried"],"offLabel":[],"synonyms":["ferrous sulfate","ferrous sulfate, dried"],"timeline":[{"date":"1946-08-13","type":"positive","source":"DrugCentral","milestone":"FDA approval (Lederle)"}],"approvals":[{"date":"1946-08-13","orphan":false,"company":"LEDERLE","regulator":"FDA"}],"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":"iron","slug":"iron","company":""}],"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":"folic acid","slug":"folic-acid","company":"Lederle"}],"globalPrevalence":null},{"indication":"Mineral Deficiency Prevention","otherDrugs":[{"name":"folic acid","slug":"folic-acid","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":"folic acid","slug":"folic-acid","company":"Lederle"},{"name":"retinol","slug":"retinol","company":"Hospira"},{"name":"riboflavin","slug":"riboflavin","company":"Hospira"},{"name":"thiamine","slug":"thiamine","company":"Hospira"}],"globalPrevalence":null},{"indication":"Vitamin Deficiency Prevention","otherDrugs":[{"name":"cyanocobalamin","slug":"cyanocobalamin","company":""},{"name":"ergocalciferol","slug":"ergocalciferol","company":"Sanofi Aventis Us"},{"name":"folic acid","slug":"folic-acid","company":"Lederle"},{"name":"retinol","slug":"retinol","company":"Hospira"}],"globalPrevalence":null},{"indication":"Vitamin deficiency","otherDrugs":[{"name":"colecalciferol","slug":"colecalciferol","company":"Sandoz"},{"name":"cyanocobalamin","slug":"cyanocobalamin","company":""},{"name":"ergocalciferol","slug":"ergocalciferol","company":"Sanofi Aventis Us"},{"name":"folic acid","slug":"folic-acid","company":"Lederle"}],"globalPrevalence":null}],"mechanism":{"novelty":"First-in-class","modality":"Small Molecule","drugClass":"ferrous sulfate","explanation":"","oneSentence":"","technicalDetail":"Ferrous sulfate acts as an iron supplement, increasing the levels of circulating iron in the body, which is then utilized for the production of hemoglobin and red blood cells through the action of erythropoietin and other regulatory mechanisms."},"commercial":{"launchDate":"1946","_launchSource":"DrugCentral (FDA 1946-08-13, LEDERLE)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4528","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=FERROUS%20SULFATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FERROUS SULFATE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T11:30:45.064549","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:17:12.111792+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"ferrous fumarate","drugSlug":"ferrous-fumarate","fdaApproval":"1986-07-18","relationship":"same-class"},{"drugName":"ferrous gluconate","drugSlug":"ferrous-gluconate","fdaApproval":"1999-02-18","relationship":"same-class"}],"genericName":"ferrous sulfate","indications":{"approved":[{"name":"Anemia of prematurity","source":"DrugCentral","snomedId":47100003,"regulator":"FDA"},{"name":"Iron deficiency anemia","source":"DrugCentral","snomedId":87522002,"regulator":"FDA","eligibility":"therapy for simple iron deficiency and iron deficiency anemia"},{"name":"Megaloblastic anemia due to folate deficiency","source":"DrugCentral","snomedId":85649008,"regulator":"FDA"},{"name":"Mineral Deficiency 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Laboratories","startDate":"2025-05-06","conditions":["Iron Deficiency Anemia"],"enrollment":74,"completionDate":"2026-03-30"},{"nctId":"NCT06884280","phase":"PHASE3","title":"Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study","status":"RECRUITING","sponsor":"Hull University Teaching Hospitals NHS Trust","startDate":"2025-11-13","conditions":["Peritoneal Dialysis","Anaemia","Iron Deficiency, Anaemia"],"enrollment":30,"completionDate":"2027-10"},{"nctId":"NCT06875947","phase":"NA","title":"EFFECTS of MORINGA OLEIFERA LEAF POWDERS on HEMATOLOGICAL PROFILES IN PREGNANT WOMEN WITH IRON DEFICIENCY ANAEMIA","status":"ACTIVE_NOT_RECRUITING","sponsor":"Fakultas Kedokteran Universitas Padjadjaran","startDate":"2025-05-23","conditions":["Iron Deficiency Anemia of Pregnancy","Pregnancy Complications","Inflammation","Moringa Oleifera","Cytokines (IL-1, IL-6)","Hepcidin"],"enrollment":59,"completionDate":"2026-05-31"},{"nctId":"NCT07435766","phase":"NA","title":"Iron Absorption From IFA and MMS Supplements in Kenyan Women During the Second Trimester of Pregnancy","status":"RECRUITING","sponsor":"ETH Zurich","startDate":"2026-03-02","conditions":["Pregnancy"],"enrollment":50,"completionDate":"2026-12-31"},{"nctId":"NCT07414199","phase":"PHASE4","title":"The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency Department","status":"NOT_YET_RECRUITING","sponsor":"Children's Hospital of Orange County","startDate":"2026-01-31","conditions":["Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease","Iron Deficiency Anaemia Due to Dietary Causes","Iron Deficiency Anemia Treatment","Iron Deficiency Anemia Secondary to IBD or Gastric Bypass","Iron Deficiency Anemias"],"enrollment":150,"completionDate":"2026-12-31"},{"nctId":"NCT07143890","phase":"NA","title":"Iron Absorption From Plant Heme Iron","status":"RECRUITING","sponsor":"ETH Zurich","startDate":"2025-09-22","conditions":["Iron Deficiency (ID)","Iron Absorption"],"enrollment":45,"completionDate":"2026-05"},{"nctId":"NCT07394972","phase":"NA","title":"Absorption of Iron From Stabilized Lactoferrin: A Study in Women With Iron Deficiency","status":"RECRUITING","sponsor":"Nicole Stoffel","startDate":"2026-02-17","conditions":["Iron Deficiency (Without Anemia)"],"enrollment":45,"completionDate":"2026-05"},{"nctId":"NCT07397572","phase":"","title":"Iron Supplementation and Anemia After Sleeve Gastrectomy","status":"RECRUITING","sponsor":"Cairo University","startDate":"2026-01-17","conditions":["Iron Deficiency Anemia","Obesity","Sleeve Gastrectomy"],"enrollment":66,"completionDate":"2027-01"},{"nctId":"NCT05340465","phase":"PHASE2","title":"Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants","status":"RECRUITING","sponsor":"University of 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Iron Substitution in Patients With Diagnosed Iron Deficiency","status":"COMPLETED","sponsor":"Prof. Dr. Frank Behrens","startDate":"2018-09-18","conditions":["Iron Deficiency Anemia"],"enrollment":187,"completionDate":"2024-10-21"},{"nctId":"NCT07142590","phase":"NA","title":"Determination of Iron Absorption and Losses in People Living at High Altitude to Investigate the Requirements in This Population Group Using a Newly Developed Technique","status":"RECRUITING","sponsor":"Diego Moretti","startDate":"2025-08-22","conditions":["Iron Absorption","Iron Requirements","Altitude"],"enrollment":120,"completionDate":"2028-02"},{"nctId":"NCT07014371","phase":"NA","title":"Alternative vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA)","status":"RECRUITING","sponsor":"Phramongkutklao College of Medicine and Hospital","startDate":"2025-06-09","conditions":["Iron Deficiency Anemia Treatment"],"enrollment":114,"completionDate":"2027-12-31"},{"nctId":"NCT03645863","phase":"PHASE3","title":"Effects of Iron Supplements on the Pharmacokinetics of MT-6548","status":"COMPLETED","sponsor":"Tanabe Pharma Corporation","startDate":"2018-08-27","conditions":["Healthy"],"enrollment":61,"completionDate":"2018-09-30"},{"nctId":"NCT06238895","phase":"PHASE4","title":"Optimizing Dosing Strategies in Oral Iron Supplementation","status":"COMPLETED","sponsor":"Luzerner Kantonsspital","startDate":"2024-03-01","conditions":["Iron Deficiencies","Iron Deficiency Anemia","Iron Deficiency Anemia Treatment"],"enrollment":29,"completionDate":"2025-11-18"},{"nctId":"NCT05309499","phase":"NA","title":"An Open Study on the Efficacy of Iron Therapy Using iv Iron Relative to Oral Iron for Increasing LV Systolic Function","status":"COMPLETED","sponsor":"Kazan State Medical University","startDate":"2021-12-05","conditions":["Myocardial Infarction","Iron-deficiency"],"enrollment":298,"completionDate":"2025-09-15"},{"nctId":"NCT07315282","phase":"NA","title":"The Effect of Oral Iron Supplements on Insulin and Glucose Metabolism in Overweight and Obese Women","status":"RECRUITING","sponsor":"Nicole Stoffel","startDate":"2025-12-23","conditions":["Overweight and Obese Women"],"enrollment":70,"completionDate":"2026-06-30"},{"nctId":"NCT05919472","phase":"NA","title":"Effects of Oral Iron Supplementation on Vaccine Response in Iron Deficient Kenyan Women","status":"COMPLETED","sponsor":"Nicole Stoffel","startDate":"2023-07-01","conditions":["Iron Deficiency Anemia"],"enrollment":180,"completionDate":"2024-07-16"},{"nctId":"NCT07267975","phase":"PHASE3","title":"Effectiveness of Oral Iron Therapy in Iron Deficiency Anemia With Daily vs Alternate Day Dosing","status":"COMPLETED","sponsor":"University of Child Health Sciences and Children's Hospital, Lahore","startDate":"2025-01-07","conditions":["Iron Deficiency Anemia","Iron Deficiency Anemia Treatment"],"enrollment":60,"completionDate":"2025-05-07"},{"nctId":"NCT07263529","phase":"NA","title":"Risk of Anemia and Effects of Oral Iron Therapy in Non-Anemic Iron-Deficient Women (18-55 Years)","status":"RECRUITING","sponsor":"Istanbul University - 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