{"id":"hydroxocobalamin","rwe":[{"pmid":"41888059","year":"2026","title":"Exploratory Laparotomy After Routine Cardiac Surgery: Results From 17,000 Patients.","finding":"","journal":"World journal of surgery","studyType":"Clinical Study"},{"pmid":"41822598","year":"2026","title":"Survival After Massive Potassium Cyanide Ingestion Without Antidote in a Tertiary Care Setting.","finding":"","journal":"Cureus","studyType":"Clinical Study"},{"pmid":"41806320","year":"2026","title":"Metabolic Enzyme MeHNL11 Regulates MeCAS1b Transcription for Cyanide Reutilization in Response to Nitrate Deficiency in Cassava.","finding":"","journal":"Plant biotechnology journal","studyType":"Clinical Study"},{"pmid":"41805397","year":"2026","title":"A two-center comparison of the efficacy of methylene blue and hydroxocobalamin for the treatment of refractory shock.","finding":"","journal":"Perfusion","studyType":"Clinical Study"},{"pmid":"41799837","year":"2026","title":"Intravenous Hydroxocobalamin for Cyanide Poisoning From Smoke Inhalation: A Comprehensive Scoping Review.","finding":"","journal":"Journal of the American College of Emergency Physicians open","studyType":"Clinical Study"}],"_fda":{"id":"c47477bf-6413-4699-ab77-c5441a9d1557","set_id":"a3087a39-f218-4f16-a1e7-17c39bb2eb69","openfda":{"unii":["S535M27N3Q"],"route":["INTRAMUSCULAR"],"rxcui":["317106"],"spl_id":["c47477bf-6413-4699-ab77-c5441a9d1557"],"brand_name":["Hydroxocobalamin"],"spl_set_id":["a3087a39-f218-4f16-a1e7-17c39bb2eb69"],"package_ndc":["0591-2888-30"],"product_ndc":["0591-2888"],"generic_name":["HYDROXOCOBALAMIN"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["HYDROXOCOBALAMIN ACETATE"],"manufacturer_name":["Actavis Pharma, Inc."],"application_number":["ANDA085998"],"is_original_packager":[true]},"version":"5","warnings":["WARNINGS Avoid the intravenous route. Folic acid is not a substitute for vitamin B 12 although it may improve vitamin B 12 deficient megaloblastic anemia. Exclusive use of folic acid in treating vitamin B 12 deficient megaloblastic anemia could result in progressive and irreversible neurologic damage. Blunted or impeded therapeutic response to vitamin B 12 may be due to such conditions as infection, uremia, drugs having bone marrow suppressant properties such as chloramphenicol, and concurrent iron or folic acid deficiency."],"pregnancy":["Pregnancy Teratogenic Effects: Pregnancy Category C: Animal reproduction studies have not been conducted with hydroxocobalamin. It is also not known whether hydroxocobalamin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hydroxocobalamin should be given to a pregnant woman only if clearly needed."],"overdosage":["OVERDOSAGE The intravenous LD 50 of hydroxocobalamin in mice is greater than 50 mL/kg."],"description":["DESCRIPTION Hydroxocobalamin injection is a sterile solution of hydroxocobalamin for intramuscular administration. Each mL contains: Hydroxocobalamin Acetate equivalent to 1000 mcg Hydroxocobalamin, Sodium Acetate Anhydrous 0.2 mg, Glacial Acetic Acid 0.442 mg, Sodium Chloride 8.2 mg, with Methylparaben 1.5 mg and Propylparaben 0.2 mg as preservatives, in Water for Injection q.s. Additional Glacial Acetic Acid and/or Sodium Acetate may have been used to adjust pH. pH range is 3.5 to 5.0. Hydroxocobalamin appears as dark red orthorhombic needles or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and moderately soluble in water. It has a molecular weight of 1346.37. The vitamin B 12 coenzymes are very unstable in light. Hydroxocobalamin shares the cobalamin molecular structure with cyanocobalamin. The chemical name is α-(5,6-dimethylbenzimidazoly) hydroxocobamide. The empirical formula is C 62 H 89 CoN 13 O 15 P and its structural formula is: The cobalt content is 4.34%. Hydroxocobalamin Structural Formula"],"precautions":["PRECAUTIONS General The validity of diagnostic vitamin B 12 or folic acid blood assays could be compromised by medications, and this should be considered before relying on such tests for therapy. Vitamin B 12 is not a substitute for folic acid and since it might improve folic acid deficient megaloblastic anemia, indiscriminate use of vitamin B 12 could mask the true diagnosis. Hypokalemia and thrombocytosis could occur upon conversion of severe megaloblastic to normal erythropoiesis with B 12 therapy. Therefore, serum potassium levels and the platelet count should be monitored carefully during therapy. Vitamin B 12 deficiency may suppress the signs of polycythemia vera. Treatment with vitamin B 12 may unmask this condition. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies of carcinogenicity, mutagenesis, or impairment of fertility have not been performed with hydroxocobalamin. Pregnancy Teratogenic Effects: Pregnancy Category C: Animal reproduction studies have not been conducted with hydroxocobalamin. It is also not known whether hydroxocobalamin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hydroxocobalamin should be given to a pregnant woman only if clearly needed."],"how_supplied":["HOW SUPPLIED Hydroxocobalamin Injection USP, 1000 mcg/mL is available in a 30 mL multiple dose vial, individually boxed. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] PROTECT FROM LIGHT. Literature revised: January 2017 Manufactured by: Hikma Farmaceutica (Portugal) S.A. 2705-906 Terrugem SNT, Portugal Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA PIN229-WAT/2"],"effective_time":"20170131","adverse_reactions":["ADVERSE REACTIONS Mild transient diarrhea, itching, transitory exanthema, feeling of swelling of entire body, and anaphylaxis. A few patients may experience pain after injection of hydroxocobalamin. To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions."],"contraindications":["CONTRAINDICATION Hypersensitivity to any component of this medication."],"general_precautions":["General The validity of diagnostic vitamin B 12 or folic acid blood assays could be compromised by medications, and this should be considered before relying on such tests for therapy. Vitamin B 12 is not a substitute for folic acid and since it might improve folic acid deficient megaloblastic anemia, indiscriminate use of vitamin B 12 could mask the true diagnosis. Hypokalemia and thrombocytosis could occur upon conversion of severe megaloblastic to normal erythropoiesis with B 12 therapy. Therefore, serum potassium levels and the platelet count should be monitored carefully during therapy. Vitamin B 12 deficiency may suppress the signs of polycythemia vera. Treatment with vitamin B 12 may unmask this condition."],"storage_and_handling":["Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] PROTECT FROM LIGHT. Literature revised: January 2017 Manufactured by: Hikma Farmaceutica (Portugal) S.A. 2705-906 Terrugem SNT, Portugal Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA PIN229-WAT/2"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Vitamin B 12 is essential to growth, cell reproduction, hematopoiesis, nucleoprotein and myelin synthesis. Fifty percent of the administered dose of hydroxocobalamin disappears from the injection site in 2.5 hours. Hydroxocobalamin is bound to plasma proteins and stored in the liver. It is excreted in the bile and undergoes some enterohepatic recycling. Within 72 hours after injection of 500 to 1000 mcg of hydroxocobalamin, 16 to 66 percent of the injected dose may appear in the urine. The major portion is excreted within the first 24 hours."],"indications_and_usage":["INDICATIONS AND USAGE Pernicious anemia, both uncomplicated and accompanied by nervous system involvement. Dietary deficiency of Vitamin B 12 , occurring in strict vegetarians and in their breast-fed infants. (Isolated vitamin B 12 deficiency is very rare). Malabsorption of vitamin B 12 , resulting from structural or functional damage to the stomach, where intrinsic factor is secreted or to the ileum, where intrinsic factor facilitates vitamin B 12 absorption. These conditions include tropical sprue, and nontropical sprue (idiopathic steatorrhea, gluten-induced enteropathy). Folate deficiency in these patients is usually more severe than vitamin B 12 deficiency. Inadequate secretion of intrinsic factor, resulting from lesions that destroy the gastric mucosa (ingestion of corrosives, extensive neoplasia), and a number of conditions associated with a variable degree of gastric atrophy (such as multiple sclerosis, certain endocrine disorders, iron deficiency, and subtotal gastrectomy). Total gastrectomy always produces vitamin B 12 deficiency. Structural lesions leading to vitamin B 12 deficiency include regional ileitis, ileal resections, malignancies, etc. Competition for Vitamin B 12 by intestinal parasites or bacteria. The fish tapeworm (Diphyllobothrium latum) absorbs huge quantities of vitamin B 12 and infested patients often have associated gastric atrophy. The blind-loop syndrome may produce deficiency of Vitamin B 12 or folate. Inadequate utilization of vitamin B 12 . This may occur if antimetabolites for the vitamin are employed in the treatment of neoplasia. For the Schilling Test."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Protect from light. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Hydroxocobalamin injection should be given only intramuscularly. In patients with Addisonian Pernicious Anemia, parenteral therapy with vitamin B 12 is the recommended method of treatment and will be required for the remainder of the patient’s life. Oral therapy is not dependable. In other patients with vitamin B 12 deficiency, the duration of therapy and route of administration will depend upon the cause and whether or not it is reversible. Confirmatory diagnostic studies should be performed prior to initiating therapy, if possible, and the patient should be followed with appropriate studies to demonstrate hematologic improvement (Hgb, hematocrit, RBC, reticulocyte count). A diagnostic trial utilizing physiologic doses of vitamin B 12 (1 mcg daily) and observing daily reticulocyte counts after establishing a baseline may also be performed. The observation of reticulocytosis which usually occurs between the third and tenth day of therapy confirms the diagnosis of vitamin B 12 deficiency. In seriously ill patients it may be advisable to administer both vitamin B 12 and folic acid while awaiting the results of distinguishing laboratory studies. It is not necessary to withhold vitamin B 12 therapy until the precise cause of B 12 deficiency is established since absorption studies can be performed at any time. Serum potassium should be closely observed the first 48 hours and potassium should be administered if necessary. Treatment of Vitamin B 12 Deficiency Thirty mcg daily for 5 to 10 days followed by 100 to 200 mcg monthly injected intramuscularly. If the patient is critically ill, or has neurologic disease, an infectious disease or hyperthyroidism, considerably higher doses may be indicated. However, current data indicate that the optimum obtainable neurologic response may be expected with a dosage of vitamin B 12 sufficient to produce good hematologic response. Children may be given a total of 1 to 5 mg over a period of 2 or more weeks in doses of 100 mcg, then 30 to 50 mcg every 4 weeks for maintenance. Patients who have normal intestinal absorption may be treated with an oral therapeutic multivitamin preparation, containing 15 mcg vitamin B 12 daily. Schilling Test The flushing dose is 1000 mcg."],"spl_product_data_elements":["Hydroxocobalamin Hydroxocobalamin HYDROXOCOBALAMIN ACETATE HYDROXOCOBALAMIN SODIUM ACETATE ANHYDROUS ACETIC ACID SODIUM CHLORIDE METHYLPARABEN PROPYLPARABEN WATER"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 0591-2888-30 30 mL Sterile Multiple Dose Vial Hydroxocobalamin Injection USP 30,000 mcg/30 mL (1,000 mcg/mL) FOR INTRAMUSCULAR USE ONLY Actavis Rx only NDC 0591-2888-30"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility Studies of carcinogenicity, mutagenesis, or impairment of fertility have not been performed with hydroxocobalamin."]},"tags":[{"label":"Antidote","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"B03BA03","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Cobalamin deficiency","category":"indication"},{"label":"Pernicious anemia","category":"indication"},{"label":"Prevention of Vitamin B12 Deficiency","category":"indication"},{"label":"Toxic effect of cyanide","category":"indication"},{"label":"Btg Intl","category":"company"},{"label":"Approved 1970s","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":[{"llr":140.159,"date":"","count":123,"signal":"Hyponatraemia","source":"DrugCentral FAERS","actionTaken":"Reported 123 times (LLR=140)"},{"llr":125.234,"date":"","count":196,"signal":"Acute kidney injury","source":"DrugCentral FAERS","actionTaken":"Reported 196 times (LLR=125)"},{"llr":93.838,"date":"","count":48,"signal":"Chromaturia","source":"DrugCentral FAERS","actionTaken":"Reported 48 times (LLR=94)"},{"llr":72.678,"date":"","count":41,"signal":"Neutropenic sepsis","source":"DrugCentral FAERS","actionTaken":"Reported 41 times (LLR=73)"},{"llr":66.487,"date":"","count":54,"signal":"Pneumonia aspiration","source":"DrugCentral FAERS","actionTaken":"Reported 54 times (LLR=66)"},{"llr":53.273,"date":"","count":44,"signal":"Orthostatic hypotension","source":"DrugCentral FAERS","actionTaken":"Reported 44 times (LLR=53)"},{"llr":45.199,"date":"","count":100,"signal":"Confusional state","source":"DrugCentral FAERS","actionTaken":"Reported 100 times (LLR=45)"},{"llr":40.389,"date":"","count":8,"signal":"Forceps delivery","source":"DrugCentral FAERS","actionTaken":"Reported 8 times (LLR=40)"},{"llr":40.206,"date":"","count":49,"signal":"Coma","source":"DrugCentral FAERS","actionTaken":"Reported 49 times (LLR=40)"},{"llr":39.476,"date":"","count":47,"signal":"Hallucination","source":"DrugCentral FAERS","actionTaken":"Reported 47 times (LLR=39)"},{"llr":37.183,"date":"","count":41,"signal":"Swelling face","source":"DrugCentral FAERS","actionTaken":"Reported 41 times (LLR=37)"},{"llr":36.319,"date":"","count":79,"signal":"Somnolence","source":"DrugCentral FAERS","actionTaken":"Reported 79 times (LLR=36)"},{"llr":35.242,"date":"","count":9,"signal":"Food refusal","source":"DrugCentral FAERS","actionTaken":"Reported 9 times (LLR=35)"},{"llr":34.205,"date":"","count":30,"signal":"Lip swelling","source":"DrugCentral FAERS","actionTaken":"Reported 30 times (LLR=34)"},{"llr":32.549,"date":"","count":37,"signal":"Liver function test abnormal","source":"DrugCentral FAERS","actionTaken":"Reported 37 times (LLR=33)"}],"commonSideEffects":[{"effect":"Chromaturia (red colored urine)","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Erythema","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Oxalate crystals in urine","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Rash","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Blood pressure increased","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Nausea","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Headache","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Infusion site reaction","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Lymphocyte percent decreased","drugRate":"8%","severity":"mild","_validated":true},{"effect":"Ventricular extrasystoles","drugRate":"reported","severity":"unknown"},{"effect":"Electrocardiogram repolarization abnormality","drugRate":"reported","severity":"unknown"},{"effect":"Heart rate increased","drugRate":"reported","severity":"unknown"},{"effect":"Pleural effusion","drugRate":"reported","severity":"unknown"},{"effect":"Acute renal failure with acute tubular necrosis","drugRate":"reported","severity":"unknown"},{"effect":"Renal impairment","drugRate":"reported","severity":"unknown"},{"effect":"Urine calcium oxalate crystals","drugRate":"reported","severity":"unknown"},{"effect":"Swelling","drugRate":"reported","severity":"unknown"},{"effect":"Irritation","drugRate":"reported","severity":"unknown"},{"effect":"Redness","drugRate":"reported","severity":"unknown"},{"effect":"Dysphagia","drugRate":"reported","severity":"unknown"},{"effect":"Abdominal discomfort","drugRate":"reported","severity":"unknown"},{"effect":"Vomiting","drugRate":"reported","severity":"unknown"},{"effect":"Diarrhea","drugRate":"reported","severity":"unknown"},{"effect":"Dyspepsia","drugRate":"reported","severity":"unknown"},{"effect":"Hematochezia","drugRate":"reported","severity":"unknown"},{"effect":"Peripheral edema","drugRate":"reported","severity":"unknown"},{"effect":"Chest discomfort","drugRate":"reported","severity":"unknown"},{"effect":"Allergic reaction","drugRate":"reported","severity":"unknown"},{"effect":"Memory impairment","drugRate":"reported","severity":"unknown"},{"effect":"Dizziness","drugRate":"reported","severity":"unknown"}],"contraindications":["Hypertensive disorder"],"specialPopulations":{"Lactation":"Breastfeeding is not recommended during treatment with CYANOKIT. There are no data to determine when breastfeeding may be safely restarted following administration of CYANOKIT.","Pregnancy":"Based on animal studies, may cause fetal harm; however, CYANOKIT administration for cyanide poisoning may be lifesaving for the pregnant woman and fetus. Treatment should not be withheld due to pregnancy. Available data from cases reported in the published literature and postmarketing surveillance with CYANOKIT use in pregnant women are insufficient to identify drug-associated risk for major birth defects, miscarriage, or adverse maternal and fetal outcomes.","Geriatric use":"Approximately 50 known or suspected cyanide poisoning victims aged 65 or older received hydroxocobalamin in clinical studies. In general, the safety and effectiveness of hydroxocobalamin in these patients was similar to that of younger patients. No adjustment of dose is required in elderly patients.","Paediatric use":"Safety and effectiveness of CYANOKIT have not been established in this population. In non-US marketing experience, dose of 70 mg/kg has been used to treat pediatric patients."}},"trials":[],"aliases":[],"company":"Btg Intl","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-11-20","unitCost":"$0.7961/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$287","description":"HYDROXOCOBALAMIN 1,000 MCG/ML","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=HYDROXOCOBALAMIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:18:31.278373+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:18:36.590333+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T03:18:30.474413+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=HYDROXOCOBALAMIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:18:37.042317+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:18:27.645067+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:18:27.645099+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Cyanide sequestering agent","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:18:38.245272+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2103737/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:18:37.909385+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA085998","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:18:27.645104+00:00"}},"allNames":"cyanokit","offLabel":[],"synonyms":["hydroxocobalamin","hydrocobalamin","hydroxocobalamine","hydroxocobemine","Hydroxy vitamin B12","hydroxycobalamin","hydroxycobalamine","Cyanokit"],"timeline":[{"date":"1978-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from WATSON LABS to Btg Intl"},{"date":"1978-08-16","type":"positive","source":"DrugCentral","milestone":"FDA approval (Watson Labs)"}],"aiSummary":"Cyanokit (HYDROXOCOBALAMIN) is an antidote medication originally developed by WATSON LABS and currently owned by Btg Intl. It is a small molecule drug classified as an antidote, approved by the FDA in 1978 for indications including cobalamin deficiency, pernicious anemia, prevention of vitamin B12 deficiency, and toxic effects of cyanide. The medication is off-patent, with multiple generic manufacturers available. Key safety considerations include the potential for allergic reactions and interactions with other medications. Cyanokit is used to treat cyanide poisoning by binding to the cyanide ion and forming a stable complex.","approvals":[{"date":"1978-08-16","orphan":false,"company":"WATSON LABS","regulator":"FDA"}],"brandName":"Cyanokit","ecosystem":[{"indication":"Cobalamin deficiency","otherDrugs":[{"name":"cobalamin","slug":"cobalamin","company":""},{"name":"cyanocobalamin","slug":"cyanocobalamin","company":""},{"name":"thiamine","slug":"thiamine","company":"Hospira"}],"globalPrevalence":null},{"indication":"Pernicious anemia","otherDrugs":[{"name":"cobalamin","slug":"cobalamin","company":""},{"name":"cyanocobalamin","slug":"cyanocobalamin","company":""},{"name":"thiamine","slug":"thiamine","company":"Hospira"}],"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":"folic acid","slug":"folic-acid","company":"Lederle"}],"globalPrevalence":null},{"indication":"Toxic effect of cyanide","otherDrugs":[{"name":"amyl nitrite","slug":"amyl-nitrite","company":""},{"name":"cobalamin","slug":"cobalamin","company":""},{"name":"sodium nitrite","slug":"sodium-nitrite","company":"Hope Pharms"},{"name":"sodium thiosulfate","slug":"sodium-thiosulfate","company":"Us Army"}],"globalPrevalence":null}],"mechanism":{"novelty":"Follow-on","modality":"Small Molecule","drugClass":"Antidote","explanation":"","oneSentence":"","technicalDetail":"Cyanokit (hydroxocobalamin) acts as a cyanide ion trap, forming a stable cyanocobalamin complex that is excreted by the kidneys, thereby preventing cyanide from binding to cytochrome c oxidase and disrupting cellular respiration."},"commercial":{"launchDate":"1978","_launchSource":"DrugCentral (FDA 1978-08-16, WATSON LABS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4309","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=HYDROXOCOBALAMIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=HYDROXOCOBALAMIN","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":"2026-03-30T11:57:42.398279","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:18:40.643828+00:00","fieldsConflicting":9,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"cyanocobalamin","drugSlug":"cyanocobalamin","fdaApproval":"1949-09-15","genericCount":32,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"cobamamide","drugSlug":"cobamamide","fdaApproval":"","relationship":"same-class"},{"drugName":"mecobalamin","drugSlug":"mecobalamin","fdaApproval":"","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":"hydroxocobalamin","indications":{"approved":[{"name":"Cobalamin deficiency","source":"DrugCentral","snomedId":190634004,"regulator":"FDA","eligibility":"No information available"},{"name":"Pernicious anemia","source":"DrugCentral","snomedId":84027009,"regulator":"FDA","eligibility":"No information available"},{"name":"Prevention of Vitamin B12 Deficiency","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"No information available"},{"name":"Toxic effect of cyanide","source":"DrugCentral","snomedId":66207005,"regulator":"FDA","eligibility":"Known or suspected cyanide poisoning"}],"offLabel":[{"name":"Methylmalonic acidemia","source":"DrugCentral","drugName":"HYDROXOCOBALAMIN","evidenceCount":58,"evidenceLevel":"strong"}],"pipeline":[]},"currentOwner":"Btg Intl","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"cyanocobalamin","brandName":"cyanocobalamin","genericName":"cyanocobalamin","approvalYear":"1949","relationship":"same-class"},{"drugId":"cobamamide","brandName":"cobamamide","genericName":"cobamamide","approvalYear":"","relationship":"same-class"},{"drugId":"mecobalamin","brandName":"mecobalamin","genericName":"mecobalamin","approvalYear":"","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT05385042","phase":"NA","title":"Iron and Immune Response to Vaccine (IRONMUM)","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2022-06-18","conditions":["Pregnancy Related"],"enrollment":171,"completionDate":"2025-07-22"},{"nctId":"NCT00078078","phase":"","title":"Clinical and Laboratory Study of Methylmalonic Acidemia","status":"RECRUITING","sponsor":"National Human Genome Research Institute (NHGRI)","startDate":"2004-06-07","conditions":["Organic Acidemia","Methylmalonic Acidemia","Inborn Errors of Metabolism"],"enrollment":2275,"completionDate":""},{"nctId":"NCT07487610","phase":"","title":"Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older","status":"RECRUITING","sponsor":"Sultan 1. 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