{"id":"oxytocin","rwe":[],"_fda":{"id":"7d9af689-848b-3aea-e053-2a91aa0a70d2","set_id":"03dc86d3-575f-4c65-b06d-2613efbcd943","openfda":{"nui":["M0000499","N0000175941","N0000175945","M0021504","N0000009705","N0000175828","M0015703","N0000175949","M0021496"],"upc":["0317089349181"],"unii":["O80TY208ZW","6P669D8HQ8","L7A49804ZQ","A1ED6W905I","K0U68Q2TXA","2P299V784P","Q51BO43MG4","QH51543Y7U","817L1N4CKP","JL5DK93RCL","02R4V6T25Y","P658DCA9XD","1JQS135EYN","47E5O17Y3R","6EC706HI7F","8558G7RUTR","3T006GV98U","KU1MBT4JJB","398IYQ16YV","GV54Q19G55","N6R0856Z79","AVX3D5A4LM"],"route":["ORAL"],"spl_id":["7d9af689-848b-3aea-e053-2a91aa0a70d2"],"brand_name":["GUNA-GERIATRICS"],"spl_set_id":["03dc86d3-575f-4c65-b06d-2613efbcd943"],"package_ndc":["17089-349-18"],"product_ndc":["17089-349"],"generic_name":["1,4-BENZOQUINONE - ARNICA MONTANA - OXYTOCIN - BARIUM CARBONATE - BARIUM OXALOSUCCINATE - CORTICOTROPIN - LEAD - LEVOTHYROXINE - LUTRELIN - MALIC ACID - MELATONIN - NEUROTROPHIN-3 - NEUROTROPHIN-4 - PHENYLALANINE - PORK LIVER - PYRUVIC ACID - RINFABATE - SUS SCROFA ADRENAL GLAND - SUS SCROFA FRONTAL LOBE - SUS SCROFA HYPOTHALAMUS - THYROTROPIN ALFA - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN -"],"product_type":["HUMAN OTC DRUG"],"pharm_class_cs":["Adrenocorticotropic Hormone [CS]","Thyroxine [CS]","Oxytocin [CS]","Thyrotropin [CS]"],"pharm_class_pe":["Increased Uterine Smooth Muscle Contraction or Tone [PE]"],"substance_name":["ARNICA MONTANA","BARIUM CARBONATE","BARIUM OXALOSUCCINATE","BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN","CORTICOTROPIN","LEAD","LEVOTHYROXINE","LUTRELIN","MALIC ACID","MELATONIN","NEUROTROPHIN-3","NEUROTROPHIN-4","OXYTOCIN","PHENYLALANINE","PORK LIVER","PYRUVIC ACID","QUINONE","RINFABATE","SUS SCROFA ADRENAL GLAND","SUS SCROFA FRONTAL LOBE","SUS SCROFA HYPOTHALAMUS","THYROTROPIN ALFA"],"pharm_class_epc":["Adrenocorticotropic Hormone [EPC]","l-Thyroxine [EPC]","Oxytocic [EPC]","Thyroid Stimulating Hormone [EPC]"],"manufacturer_name":["Guna spa"],"is_original_packager":[true]},"purpose":["For the temporary relief symptoms due to aging, scuh as: poor memory impaired concentration"],"version":"2","warnings":["WARNINGS Stop use and ask doctor if symptoms persist more than 5 days. If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Contains ethyl alcohol 30%"],"questions":["QUESTIONS Questions?: info@gunainc.com, tel. 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LOBE SUS SCROFA ADRENAL GLAND SUS SCROFA ADRENAL GLAND PORK LIVER PORK LIVER SUS SCROFA HYPOTHALAMUS SUS SCROFA HYPOTHALAMUS RINFABATE RINFABATE LUTRELIN LUTRELIN MELATONIN MELATONIN NEUROTROPHIN-3 NEUROTROPHIN-3 NEUROTROPHIN-4 NEUROTROPHIN-4 OXYTOCIN OXYTOCIN PHENYLALANINE PHENYLALANINE LEAD LEAD PYRUVIC ACID PYRUVIC ACID THYROTROPIN ALFA THYROTROPIN ALFA LEVOTHYROXINE LEVOTHYROXINE"],"pregnancy_or_breast_feeding":["PREGNANCY If pregnant or breast-feeding ask a doctor before use"],"keep_out_of_reach_of_children":["WARNINGS Keep this and all medicines out of reach of children"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL 5USGER- REV06-24-05-18"]},"tags":[{"label":"Oxytocic","category":"class"},{"label":"Peptide","category":"modality"},{"label":"Oxytocin receptor","category":"target"},{"label":"OXTR","category":"gene"},{"label":"AVPR1A","category":"gene"},{"label":"AVPR1B","category":"gene"},{"label":"G02AC01","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Intramuscular","category":"route"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Incomplete miscarriage","category":"indication"},{"label":"Induction of labor","category":"indication"},{"label":"Postpartum hemorrhage","category":"indication"},{"label":"Pregnancy with abortive outcome","category":"indication"},{"label":"Fresenius Kabi Usa","category":"company"},{"label":"Approved 1980s","category":"decade"},{"label":"Oxytocics","category":"pharmacology"},{"label":"Reproductive Control Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"FOETAL EXPOSURE DURING PREGNANCY","source":"FDA FAERS","actionTaken":"429 reports"},{"date":"","signal":"MATERNAL EXPOSURE DURING PREGNANCY","source":"FDA FAERS","actionTaken":"426 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"388 reports"},{"date":"","signal":"EXPOSURE DURING PREGNANCY","source":"FDA FAERS","actionTaken":"359 reports"},{"date":"","signal":"PREMATURE BABY","source":"FDA FAERS","actionTaken":"205 reports"},{"date":"","signal":"HYPOTENSION","source":"FDA FAERS","actionTaken":"191 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"185 reports"},{"date":"","signal":"PREMATURE DELIVERY","source":"FDA FAERS","actionTaken":"159 reports"},{"date":"","signal":"DRUG EXPOSURE DURING PREGNANCY","source":"FDA FAERS","actionTaken":"143 reports"},{"date":"","signal":"POSTPARTUM HAEMORRHAGE","source":"FDA FAERS","actionTaken":"131 reports"}],"commonSideEffects":[],"contraindications":["Deliveries by cesarean","Fetal distress","Finding of malposition of fetus","Grand multipara","Hypertensive disorder","Multiple pregnancy","Placenta previa"],"specialPopulations":{"Pregnancy":"Based on the wide experience with this drug and its chemical structure and pharmacological properties, it would not be expected to present risk of fetal abnormalities when used as indicated."}},"trials":[],"aliases":[],"company":"Fresenius Kabi","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=OXYTOCIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:34:52.352927+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:34:57.407313+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:34:51.459078+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=OXYTOCIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:34:57.924892+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":"2026-04-20T00:34:47.137003+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:34:47.137037+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed 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(Novartis)"},{"date":"1985-03-29","type":"positive","source":"FDA Orange Book","milestone":"Oxytocin 10 Usp Units In Dextrose 5% approved — 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"2013-02-13","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 2 manufacturers approved"}],"aiSummary":"Oxytocin 5 Usp Units In Dextrose 5% is a medication developed by Novartis and currently owned by Fresenius Kabi USA. It is a small molecule that targets the oxytocin receptor, classified as an oxytocic drug. Oxytocin 5 Usp Units In Dextrose 5% is FDA-approved for incomplete miscarriage, induction of labor, postpartum hemorrhage, and pregnancy with abortive outcome. The medication is off-patent, with three generic manufacturers available. Key safety considerations include careful dosing and monitoring due to potential risks of uterine rupture and other complications.","approvals":[{"date":"1980-04-17","orphan":false,"company":"NOVARTIS","regulator":"FDA"}],"brandName":"Oxytocin 5 Usp Units In Dextrose 5%","ecosystem":[{"indication":"Incomplete miscarriage","otherDrugs":[{"name":"dinoprost","slug":"dinoprost","company":"Pharmacia And Upjohn"},{"name":"dinoprostone","slug":"dinoprostone","company":"Pharmacia And Upjohn"}],"globalPrevalence":null},{"indication":"Induction of labor","otherDrugs":[{"name":"dinoprost","slug":"dinoprost","company":"Pharmacia And Upjohn"},{"name":"dinoprostone","slug":"dinoprostone","company":"Pharmacia And Upjohn"}],"globalPrevalence":null},{"indication":"Postpartum hemorrhage","otherDrugs":[{"name":"carboprost","slug":"carboprost","company":"Pharmacia And Upjohn"},{"name":"methylergometrine","slug":"methylergometrine","company":"Edison Theraps Llc"},{"name":"misoprostol","slug":"misoprostol","company":"Gd Searle Llc"}],"globalPrevalence":null},{"indication":"Pregnancy with abortive outcome","otherDrugs":[{"name":"carboprost","slug":"carboprost","company":"Pharmacia And Upjohn"},{"name":"dinoprost","slug":"dinoprost","company":"Pharmacia And Upjohn"},{"name":"dinoprostone","slug":"dinoprostone","company":"Pharmacia And Upjohn"},{"name":"mifepristone","slug":"mifepristone","company":"Danco Labs Llc"}],"globalPrevalence":null}],"mechanism":{"target":"Oxytocin receptor","novelty":"Follow-on","targets":[{"gene":"OXTR","source":"DrugCentral","target":"Oxytocin receptor","protein":"Oxytocin receptor"},{"gene":"AVPR1A","source":"DrugCentral","target":"Vasopressin V1a receptor","protein":"Vasopressin V1a receptor"},{"gene":"AVPR1B","source":"DrugCentral","target":"Vasopressin V1b receptor","protein":"Vasopressin V1b receptor"},{"gene":"AVPR2","source":"DrugCentral","target":"Vasopressin V2 receptor","protein":"Vasopressin V2 receptor"},{"gene":"OXT","source":"DrugCentral","target":"Oxytocin-neurophysin 1","protein":"Oxytocin-neurophysin 1"}],"modality":"Peptide","drugClass":"Adrenocorticotropic Hormone [EPC]","explanation":"","oneSentence":"","technicalDetail":"Oxytocin 5 Usp Units In Dextrose 5% is a synthetic analogue of the naturally occurring hormone oxytocin, which binds to the oxytocin receptor (OXTR) to induce uterine contractions through a G-protein coupled receptor mechanism, ultimately leading to an increase in intracellular calcium and contraction of the uterine smooth muscle."},"commercial":{"launchDate":"1980","_launchSource":"DrugCentral (FDA 1980-04-17, NOVARTIS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2042","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=OXYTOCIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=OXYTOCIN","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 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Usa","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"methylergometrine","brandName":"methylergometrine","genericName":"methylergometrine","approvalYear":"1946","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07430228","phase":"PHASE2","title":"Efficacy of Intravenous Oxytocin to Speed Recovery After THA","status":"NOT_YET_RECRUITING","sponsor":"Wake Forest University Health Sciences","startDate":"2026-05","conditions":["Total Hip Arthroplasty"],"enrollment":80,"completionDate":"2027-06"},{"nctId":"NCT07053774","phase":"PHASE2","title":"Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain","status":"RECRUITING","sponsor":"Wake Forest University Health Sciences","startDate":"2025-11-05","conditions":["Pain, Acute"],"enrollment":24,"completionDate":"2026-06-20"},{"nctId":"NCT01113229","phase":"PHASE4","title":"Combined Use of Oxytocin and Misoprostol in the Prevention of Post 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Pain","status":"ACTIVE_NOT_RECRUITING","sponsor":"Memorial University of Newfoundland","startDate":"2022-04-01","conditions":["Chronic Pain"],"enrollment":336,"completionDate":"2026-03-31"},{"nctId":"NCT07276152","phase":"NA","title":"Plasma Oxytocin Changes in Response to Music Modified by Sonic Augmentation Technology","status":"RECRUITING","sponsor":"University Hospital, Basel, Switzerland","startDate":"2026-01-09","conditions":["Sonic Augmentation Technology"],"enrollment":22,"completionDate":"2026-08"},{"nctId":"NCT07380529","phase":"NA","title":"Comparison of the Effect of Carbetocin Versus Oxytocin in the Prevention of Postpartum Hemorrhage After Emergency Caesarean Section in Antenatal Low-risk Patients","status":"COMPLETED","sponsor":"Ankara Etlik City Hospital","startDate":"2024-10-01","conditions":["Postpartum Hemorrhage \\(PPH\\)"],"enrollment":300,"completionDate":"2025-08-04"},{"nctId":"NCT07409753","phase":"PHASE2","title":"Effects Of Intravenous Oxytocin On Peripheral 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