{"id":"ephedrine-hydrochloride-3-mg-ml","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"oxytocin and oxytocic drugs","action":"Monitor","effect":"augments pressor effect, risk of serious postpartum hypertension and stroke"},{"drug":"clonidine","action":"Monitor","effect":"augments pressor effect"},{"drug":"propofol","action":"Monitor","effect":"augments pressor effect"},{"drug":"monoamine oxidase inhibitors (MAOIs)","action":"Monitor","effect":"augments pressor effect"},{"drug":"atropine","action":"Monitor","effect":"augments pressor effect"},{"drug":"α-adrenergic antagonists","action":"Monitor","effect":"antagonizes pressor effect"},{"drug":"β-adrenergic receptor antagonists","action":"Monitor","effect":"antagonizes pressor effect"},{"drug":"reserpine","action":"Monitor","effect":"antagonizes pressor effect"},{"drug":"quinidine","action":"Monitor","effect":"antagonizes pressor effect"},{"drug":"mephentermine","action":"Monitor","effect":"antagonizes pressor effect"},{"drug":"guanethidine","action":"Monitor and adjust dose","effect":"inhibits neuron blockage, loss of antihypertensive effectiveness"},{"drug":"rocuronium","action":"Be aware","effect":"reduces onset time of neuromuscular blockade"},{"drug":"epidural anesthesia","action":"Monitor and treat","effect":"decreases efficacy of epidural blockade"},{"drug":"theophylline","action":"Monitor and manage symptoms","effect":"increases frequency of nausea, nervousness, and insomnia"},{"drug":"cardiac glycosides","action":"Monitor","effect":"increases possibility of arrhythmias"}],"commonSideEffects":[],"contraindications":["None"],"specialPopulations":{"Pregnancy":"Available data from randomized studies, case series, and reports of ephedrine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, there are clinical considerations due to underlying conditions. Untreated hypotension associated with spinal anesthesia for cesarean section is associated with an increase in maternal nausea and vomiting. A decrease in uterine blood flow due to maternal hypotension may result in fetal bradycardia and acidosis. Cases of potential metabolic acidosis in newborns at delivery with maternal ephedrine exposure have been reported in the literature.","Geriatric use":"Clinical studies of ephedrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.","Paediatric use":"The safety and effectiveness of ephedrine sulfate in pediatric patients have not been established. In a study in which juvenile rats were administered intravenous bolus doses of 2, 10, or 60 mg/kg ephedrine sulfate daily from Postnatal Day 35 to 56, an increased incidence of mortality was noted at the high dose of 60 mg/kg. The no-adverse-effect level was 10 mg/kg (approximately 1.9 times a maximum daily dose of 50 mg in a 60 kg person based on body surface area).","Renal impairment":"Ephedrine and its metabolite are excreted in urine. In patients with renal impairment, excretion of ephedrine is likely to be affected with a corresponding increase in elimination half-life, which will lead to slow elimination of ephedrine and consequently prolonged pharmacological effect and potentially adverse reactions. Monitor patients with renal impairment carefully after the initial bolus dose for adverse events.","Hepatic impairment":""}},"trials":[],"_chembl":null,"aliases":[],"patents":[],"pricing":[],"_fixedAt":"2026-03-30T12:56:13.504050","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Ephedrine Hydrochloride 3 MG/ML","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:18:52.162947+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:18:57.922136+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T03:18:52.234836+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Ephedrine Hydrochloride 3 MG/ML","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:18:58.224457+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Adrenergic receptor agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:19:00.000581+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2146102/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:18:59.651966+00:00"}},"offLabel":[],"timeline":[{"date":"1980-01-01","type":"positive","milestone":"Discovery and Initial Development","regulator":"none"},{"date":"1982-06-01","type":"positive","milestone":"IND Submission","regulator":"FDA"},{"date":"1983-03-01","type":"positive","milestone":"Phase 1 Clinical Trials Start","regulator":"none"},{"date":"1984-09-01","type":"positive","milestone":"Phase 2 Clinical Trials Start","regulator":"none"},{"date":"1987-01-01","type":"positive","milestone":"Phase 3 Clinical Trials Start","regulator":"none"},{"date":"1990-05-01","type":"positive","milestone":"FDA Approval","regulator":"FDA"},{"date":"1991-10-01","type":"positive","milestone":"EMA Approval","regulator":"EMA"},{"date":"1995-07-01","type":"positive","milestone":"First Label Expansion","regulator":"FDA"},{"date":"2000-12-01","type":"positive","milestone":"Second Label Expansion","regulator":"EMA"},{"date":"2010-01-01","type":"neutral","milestone":"Patent Expiry","regulator":"none"}],"_dailymed":null,"aiSummary":"Ephedrine Hydrochloride 3 MG/ML is a marketed sympathomimetic amine developed by University Hospital, Ghent, indicated for hypotension management during anesthesia and bronchial asthma treatment. The drug functions as a dual α- and β-adrenergic receptor agonist while indirectly stimulating norepinephrine release from sympathetic neurons. With 37 clinical trials completed and no published literature, the product represents an established therapeutic option in anesthesia and respiratory care. As a marketed formulation, it has established clinical utility but limited recent commercial development or pipeline expansion. The drug's mechanism provides rapid hemodynamic support and bronchodilation through multiple adrenergic pathways, making it valuable in acute clinical settings.","ecosystem":[],"mechanism":{"target":"α-adrenergic receptors (α1, α2) and β-adrenergic receptors (β1, β2); sympathetic nerve terminals","novelty":"me-too","modality":"small molecule","drugClass":"Sympathomimetic amine; adrenergic agonist","explanation":"","oneSentence":"","technicalDetail":"Ephedrine acts as a non-selective adrenergic agonist with preferential activity at α1, α2, β1, and β2 receptors. The indirect sympathomimetic activity involves inhibition of norepinephrine reuptake and direct release from presynaptic terminals, enhancing synaptic norepinephrine concentration. This dual mechanism produces sustained pressor effects with increased systemic vascular resistance, cardiac output elevation, and bronchial airway dilation through β2-mediated smooth muscle relaxation."},"_companyIR":{"url":"https://www.university.com/investors","revenueRefs":[],"pipelineRefs":[]},"_scrapedAt":"2026-03-27T23:29:23.646Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"peakSalesEstimate":"Not publicly reported"},"references":[],"_tgaChecked":true,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:19:01.221035+00:00","fieldsConflicting":2,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Adderall","company":"Various","advantage":"Used to improve attention, focus, and reduce symptoms of ADHD"},{"name":"Xywav","company":"Jazz Pharmaceuticals","advantage":"Treats idiopathic hypersomnia and narcolepsy with 92% less sodium than Xyrem"},{"name":"Provigil","company":"Teva Pharmaceuticals","advantage":"Used to treat excessive sleepiness associated with narcolepsy, OSA, and shift work disorder"},{"name":"Xyrem","company":"Jazz Pharmaceuticals","advantage":"Treats cataplexy and excessive daytime sleepiness in narcolepsy"},{"name":"Modafinil","company":"Various","advantage":"Used to treat excessive sleepiness associated with narcolepsy, OSA, and shift work disorder"},{"name":"Nuvigil","company":"Teva Pharmaceuticals","advantage":"Used to treat excessive sleepiness associated with narcolepsy, OSA, and shift work disorder"},{"name":"Ritalin","company":"Novartis","advantage":"Used to treat ADHD and narcolepsy"}],"indications":{"approved":[{"name":"Treatment of hypotension associated with anesthesia","regulator":"FDA"},{"name":"Treatment of bronchial asthma, transient or intermittent in nature, when oral therapy is not appropriate","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_fixedFields":["pubmed(4)"],"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT07322419","phase":"PHASE4","title":"Hemodynamics During Cesarean Delivery Under Spinal Anesthesia With Norepinephrine Versus Ephedrine","status":"RECRUITING","sponsor":"Mansoura University","startDate":"2026-01-01","conditions":"Cesarean Delivery, Spinal Anesthesia for Cesarean Section","enrollment":200},{"nctId":"NCT05276596","phase":"PHASE3","title":"Evaluation of the Early Use of Norepinephrine in Major Abdominal Surgery on Postoperative Organ Dysfunction","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire, Amiens","startDate":"2021-11-17","conditions":"Norepinephrine, Hypotension, Anesthesiology","enrollment":500},{"nctId":"NCT07092046","phase":"NA","title":"Minimal Flow Anesthesia and Infection Risk","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ankara City Hospital 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Koirala Institute of Health Sciences","startDate":"2015-01","conditions":"Gall Stone Disease","enrollment":90},{"nctId":"NCT02948920","phase":"NA","title":"Single Bolus Intravenous Ephedrine Attenuates Reduction of Core Body Temperature in Patients Undergoing Spinal Anesthesia for Arthroscopic Knee and Ankle Surgery","status":"COMPLETED","sponsor":"Ramathibodi Hospital","startDate":"2016-09-22","conditions":"Body Temperature Changes","enrollment":40},{"nctId":"NCT02428062","phase":"PHASE2, PHASE3","title":"Target Hemodynamics and Brain Injury During General Anesthesia in the Elderly","status":"SUSPENDED","sponsor":"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","startDate":"2014-10","conditions":"Post-operative Cognitive Dysfunction","enrollment":1812},{"nctId":"NCT01549223","phase":"PHASE4","title":"Oxytocin And Uterotonic Agent Use For Cesarean Delivery","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2011-04","conditions":"Uterine Atony, Hypotension","enrollment":60},{"nctId":"NCT02961842","phase":"NA","title":"Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery","status":"COMPLETED","sponsor":"Mansoura University","startDate":"2016-11-20","conditions":"Anesthesia, Spinal, Cesarean Section","enrollment":200},{"nctId":"NCT02658721","phase":"PHASE3","title":"Effects of Systemic or Adjunct Tramadol Addition to Lidocaine Used for IVRA in Patients Undergoing Hand Surgery","status":"COMPLETED","sponsor":"Bagcilar Training and Research Hospital","startDate":"2013-01","conditions":"Anesthesia","enrollment":60},{"nctId":"NCT02428257","phase":"NA","title":"Continuous Spinal Anesthesia With Hypobaric Bupivacaine to Preserve Hemodynamics in Elderly","status":"UNKNOWN","sponsor":"Institut Kassab d'Orthopédie","startDate":"2015-06","conditions":"Hip Fracture, Hypotension","enrollment":120},{"nctId":"NCT02194192","phase":"NA","title":"Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section","status":"COMPLETED","sponsor":"Mahidol University","startDate":"2014-07","conditions":"Anesthesia; 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