{"id":"iron-dextran","rwe":[],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Intramuscular","category":"route"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Injection","category":"form"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Hematinics","category":"pharmacology"},{"label":"Hematologic Agents","category":"pharmacology"}],"phase":"discontinued","safety":{"safetySignals":[{"llr":103.684,"date":"","count":62,"signal":"Anaphylactic reaction","source":"DrugCentral FAERS","actionTaken":"Reported 62 times (LLR=104)"},{"llr":97.093,"date":"","count":171,"signal":"Dyspnoea","source":"DrugCentral FAERS","actionTaken":"Reported 171 times (LLR=97)"},{"llr":88.742,"date":"","count":92,"signal":"Infusion related reaction","source":"DrugCentral FAERS","actionTaken":"Reported 92 times (LLR=89)"},{"llr":80.216,"date":"","count":54,"signal":"Flushing","source":"DrugCentral FAERS","actionTaken":"Reported 54 times (LLR=80)"},{"llr":67.719,"date":"","count":19,"signal":"Calciphylaxis","source":"DrugCentral FAERS","actionTaken":"Reported 19 times (LLR=68)"},{"llr":62.679,"date":"","count":82,"signal":"Back pain","source":"DrugCentral FAERS","actionTaken":"Reported 82 times (LLR=63)"},{"llr":56.408,"date":"","count":15,"signal":"Product preparation issue","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=56)"},{"llr":48.946,"date":"","count":26,"signal":"Throat tightness","source":"DrugCentral FAERS","actionTaken":"Reported 26 times (LLR=49)"},{"llr":46.91,"date":"","count":67,"signal":"Chest pain","source":"DrugCentral FAERS","actionTaken":"Reported 67 times (LLR=47)"},{"llr":41.362,"date":"","count":7,"signal":"Central nervous system injury","source":"DrugCentral FAERS","actionTaken":"Reported 7 times (LLR=41)"},{"llr":41.345,"date":"","count":44,"signal":"Chest discomfort","source":"DrugCentral FAERS","actionTaken":"Reported 44 times (LLR=41)"},{"llr":40.639,"date":"","count":16,"signal":"Product preparation error","source":"DrugCentral FAERS","actionTaken":"Reported 16 times (LLR=41)"},{"llr":38.596,"date":"","count":33,"signal":"Therapeutic response decreased","source":"DrugCentral FAERS","actionTaken":"Reported 33 times (LLR=39)"},{"llr":36.58,"date":"","count":7,"signal":"Splenic injury","source":"DrugCentral FAERS","actionTaken":"Reported 7 times (LLR=37)"},{"llr":31.837,"date":"","count":16,"signal":"Drug ineffective","source":"DrugCentral FAERS","actionTaken":"Reported 16 times (LLR=32)"}],"commonSideEffects":[{"effect":"Anaphylactic reactions","drugRate":"reported","severity":"serious"},{"effect":"Cardiovascular collapse","drugRate":"reported","severity":"serious"},{"effect":"Respiratory difficulty","drugRate":"reported","severity":"serious"},{"effect":"Cardiac arrest","drugRate":"reported","severity":"serious"},{"effect":"Shock","drugRate":"reported","severity":"serious"},{"effect":"Hypertension","drugRate":"reported","severity":"mild"},{"effect":"Hypotension","drugRate":"reported","severity":"mild"},{"effect":"Tachycardia","drugRate":"reported","severity":"mild"},{"effect":"Bradycardia","drugRate":"reported","severity":"mild"},{"effect":"Flushing","drugRate":"reported","severity":"mild"},{"effect":"Arrhythmias","drugRate":"reported","severity":"mild"},{"effect":"Urticaria","drugRate":"reported","severity":"unknown"},{"effect":"Pruritus","drugRate":"reported","severity":"unknown"},{"effect":"Purpura","drugRate":"reported","severity":"unknown"},{"effect":"Rash","drugRate":"reported","severity":"unknown"},{"effect":"Cyanosis","drugRate":"reported","severity":"unknown"},{"effect":"Abdominal pain","drugRate":"reported","severity":"unknown"},{"effect":"Nausea","drugRate":"reported","severity":"unknown"},{"effect":"Vomiting","drugRate":"reported","severity":"unknown"},{"effect":"Diarrhea","drugRate":"reported","severity":"unknown"},{"effect":"Leucocytosis","drugRate":"reported","severity":"unknown"},{"effect":"Lymphadenopathy","drugRate":"reported","severity":"unknown"},{"effect":"Arthralgia","drugRate":"reported","severity":"unknown"},{"effect":"Arthritis","drugRate":"reported","severity":"unknown"},{"effect":"Myalgia","drugRate":"reported","severity":"unknown"},{"effect":"Backache","drugRate":"reported","severity":"unknown"},{"effect":"Sterile abscess","drugRate":"reported","severity":"unknown"},{"effect":"Atrophy/fibrosis","drugRate":"reported","severity":"unknown"},{"effect":"Brown skin and/or underlying tissue discoloration","drugRate":"reported","severity":"unknown"},{"effect":"Cellulitis","drugRate":"reported","severity":"unknown"}],"specialPopulations":{"Lactation":"Trace amounts of unmetabolized iron dextran are present in human milk. There are no data on the effects of iron dextran in breastfed infants or effects on milk production.","Pregnancy":"Parenteral iron administration may be associated with hypersensitivity reactions, which may have serious consequences, such as fetal bradycardia. Advise pregnant persons of the potential risk to the fetus. Trace amounts of unmetabolized iron dextran are present in human milk.","Paediatric use":"INFeD is not recommended for use in infants under 3 months of age. Reports in the literature have suggested that the use of intramuscular iron dextran in neonates has been associated with an increased incidence of gram-negative sepsis, primarily due to E. Coli."}},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"imferon","offLabel":[],"synonyms":["iron dextran","iron dextran complex","imferon"],"timeline":[{"date":"1996-02-23","type":"positive","source":"FDA Orange Book","milestone":"Dexferrum approved — EQ 50MG IRON/ML"}],"aiSummary":"Imferon, also known as Iron Dextran, is a medication used to treat iron deficiency anemia. It is a complex of iron and dextran, a type of sugar molecule. Imferon is administered intramuscularly or intravenously and is available in the United States as a brand-name product due to its off-patent status. The medication is not well-characterized in terms of its pharmacokinetic properties, and its exact mechanism of action is not fully understood. As a result, it is primarily used as a treatment for iron deficiency anemia in patients who are unable to take oral iron supplements.","approvals":[{"date":"","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Imferon","ecosystem":[],"mechanism":{"modality":"Small Molecule","explanation":"The circulating iron released from iron dextran, which is subject to physiological control, replenishes hemoglobin and depleted iron stores.","oneSentence":"Imferon works by providing the body with iron, a crucial component for the production of hemoglobin, which carries oxygen in the blood.","technicalDetail":"Iron Dextran is a complex of iron and dextran, a polysaccharide that serves as a carrier molecule. The iron is slowly released from the dextran complex, allowing it to be absorbed by the body and utilized for the production of hemoglobin."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Iron_supplement","title":"Iron supplement","extract":"Iron supplements, also known as iron salts and iron pills, are a number of iron formulations used to treat and prevent iron deficiency including iron-deficiency anemia. For prevention they are only recommended in those with poor absorption, heavy menstrual periods, pregnancy, hemodialysis, or a diet low in iron. Prevention may also be used in low birth weight babies. They are taken by mouth, injection into a vein, or injection into a muscle. While benefits may be seen in days, up to two months may be required until iron levels return to normal.","wiki_history":"==History==\nThe first pills were commonly known as Blaud's pills, which were named after P. Blaud of Beaucaire, the French physician who introduced and started the use of these medications as a treatment for patients with anemia."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5562","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=IRON%20DEXTRAN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=IRON DEXTRAN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Iron_supplement","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":"2026-03-30T12:09:39.359965","biosimilars":[],"competitors":[],"genericName":"iron dextran","indications":{"approved":[],"offLabel":[],"pipeline":[]},"currentOwner":"Allergan","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[],"trialDetails":[{"nctId":"NCT01011920","phase":"PHASE2","title":"Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma","status":"COMPLETED","sponsor":"International Extranodal Lymphoma Study Group (IELSG)","startDate":"2009-11","conditions":["Central Nervous System Lymphoma"],"enrollment":227,"completionDate":"2024-12-19"},{"nctId":"NCT07330245","phase":"","title":"Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab.","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2025-12-31","conditions":["Lupus Erythematosus, Systemic"],"enrollment":218,"completionDate":"2028-09-30"},{"nctId":"NCT06678724","phase":"","title":"Establishment of a Microfluidic Based Liquid Biopsy Platform for 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Therapy for Anemia After Orthopaedic Trauma","status":"RECRUITING","sponsor":"Oregon Health and Science University","startDate":"2022-06-01","conditions":["Acute Blood Loss Anemia","Fracture"],"enrollment":150,"completionDate":"2026-05-31"},{"nctId":"NCT07110935","phase":"PHASE1,PHASE2","title":"Efficacy of Treatment of Postpartum Anaemia With Intravenous Iron Versus Oral Iron in a Tertiary Hospital in South East, Nigeria.","status":"COMPLETED","sponsor":"Federal Teaching Hospital Abakaliki","startDate":"2018-09-13","conditions":["Postpartum Anaemia"],"enrollment":290,"completionDate":"2019-02-20"},{"nctId":"NCT07084298","phase":"EARLY_PHASE1","title":"Effects of Iron Supplementation on Skeletal Muscle Properties in Females With Suboptimal Iron Storage","status":"NOT_YET_RECRUITING","sponsor":"University of Calgary","startDate":"2025-08","conditions":["Iron Deficiency"],"enrollment":36,"completionDate":"2026-06"},{"nctId":"NCT03493048","phase":"PHASE2","title":"Cetuximab Plus FOLFOXIRI vs Cetuximab Plus FOLFOX For CRCLM","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2018-04-15","conditions":["Colorectal Cancer","Liver Metastases"],"enrollment":146,"completionDate":"2026-06"},{"nctId":"NCT07095244","phase":"NA","title":"Pediatric Outcomes and Recovery With Peri-Operative Iron Supplement Evaluation","status":"NOT_YET_RECRUITING","sponsor":"University of British Columbia","startDate":"2025-09-01","conditions":["Varus-Derotation Osteotomy Surgery","Iron-deficiency Anemia","Pelvic Osteotomy Surgery","Cerebral Palsy"],"enrollment":180,"completionDate":"2027-12-31"},{"nctId":"NCT06508827","phase":"PHASE2","title":"Intravenous Iron in Combination With Standard of Care Immunotherapy in Melanoma","status":"WITHDRAWN","sponsor":"Indiana University","startDate":"2025-05","conditions":["Anemia, Iron Deficiency","Melanoma"],"enrollment":0,"completionDate":"2026-06"},{"nctId":"NCT02543268","phase":"PHASE3","title":"A Study to Evaluate the 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Irvine","startDate":"2023-01-09","conditions":["Osteoarthritis"],"enrollment":69,"completionDate":"2024-06-30"},{"nctId":"NCT04228783","phase":"PHASE3","title":"A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants","status":"COMPLETED","sponsor":"Janssen Vaccines & Prevention B.V.","startDate":"2020-02-18","conditions":["Ebola"],"enrollment":974,"completionDate":"2022-04-25"},{"nctId":"NCT06624709","phase":"NA","title":"The Benefit in Terms of Improvement in Haemoglobin Level at 6 Months in Premature Babies Receiving Alternate Iron Substitution 4 Times a Week Compared to a Daily Substitution","status":"RECRUITING","sponsor":"Riccardo Pfister","startDate":"2024-11-02","conditions":["Premature Birth"],"enrollment":160,"completionDate":"2027-05"},{"nctId":"NCT03929757","phase":"PHASE2","title":"A Study of 2-dose Vaccination Regimen of Ad26.ZEBOV and MVA-BN-Filo in Infants","status":"COMPLETED","sponsor":"Janssen Vaccines & 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Modified Radical Hysterectomy","Uterine Skeletonization"],"enrollment":75,"completionDate":"2024-09-17"},{"nctId":"NCT06778655","phase":"NA","title":"Propolis in Primary Herpetic Gingivostomatitis","status":"COMPLETED","sponsor":"Fayoum University","startDate":"2024-10-10","conditions":["Herpetic Gingivostomatitis"],"enrollment":60,"completionDate":"2025-01-15"},{"nctId":"NCT03495960","phase":"PHASE2","title":"Study on Tailored Treatment in Elderly Patients With Newly Diagnosed Primary Lymphoma of Central Nervous System","status":"COMPLETED","sponsor":"International Extranodal Lymphoma Study Group (IELSG)","startDate":"2019-06-15","conditions":["Primary Central Nervous System Lymphoma"],"enrollment":72,"completionDate":"2024-12-12"},{"nctId":"NCT02259855","phase":"PHASE1","title":"Pharmacokinetics (PK) of Tipranavir/Ritonavir, Ribavirin, Pegylated Interferon (Peg INF) in Hepatitis C (HCV) Subjects With Mild Hepatic Impairment and in HCV, Hepatitis B (HBV), Hepatitis D Infected Subjects or Alcoholic Cirrhosis With Moderate Hepatic Impairment","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2006-01-01","conditions":["Hepatic Insufficiency"],"enrollment":36,"completionDate":""},{"nctId":"NCT04497012","phase":"PHASE4","title":"Iron Supplementation and Intestinal Health","status":"UNKNOWN","sponsor":"University of South Florida","startDate":"2020-11-17","conditions":["Anemia of Prematurity","Very Low Birth Weight Infant"],"enrollment":183,"completionDate":"2025-07-31"},{"nctId":"NCT05989984","phase":"NA","title":"Efficacy Evaluation of an ODF Iron Supplement Vs an Iron Supplement in Capsules in Subjects with Mild Anemia","status":"COMPLETED","sponsor":"IBSA Farmaceutici Italia Srl","startDate":"2023-07-29","conditions":["Iron Deficiencies"],"enrollment":23,"completionDate":"2024-08-08"},{"nctId":"NCT05904106","phase":"PHASE2","title":"Venetoclax Plus Azacitidine Versus Intensive Chemotherapy for Fit Patients With Newly Diagnosed NPM1 Mutated 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