{"id":"caffeine-citrate-oral-solution","safety":{"commonSideEffects":[{"rate":null,"effect":"Tachycardia"},{"rate":null,"effect":"Jitteriness"},{"rate":null,"effect":"Irritability"},{"rate":null,"effect":"Feeding intolerance"},{"rate":null,"effect":"Necrotizing enterocolitis (rare)"}]},"_chembl":null,"_dailymed":{"setId":"2bd238d4-4657-4341-9c28-1b468b8f3bf8","title":"CAFFEINE CITRATE ORAL SOLUTION (CAFFEINE CITRATE) SOLUTION [ARMAS PHARMACEUTICALS INC.]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Caffeine competitively inhibits adenosine receptors (A1 and A2A) in the brain and spinal cord, preventing adenosine's inhibitory effects on neuronal activity. This leads to increased alertness, improved respiratory drive, and enhanced metabolic activity. In neonates, it is primarily used to stimulate respiration and reduce apnea episodes by increasing central nervous system excitability.","oneSentence":"Caffeine citrate is a nonselective adenosine receptor antagonist that blocks adenosine-mediated central nervous system depression, promoting wakefulness and respiratory stimulation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:29:33.941Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Apnea of prematurity in preterm infants"},{"name":"Neonatal respiratory depression"}]},"trialDetails":[{"nctId":"NCT06821698","phase":"PHASE1","title":"To Determine the Effect of KP-001 on Rosuvastatin, Caffeine PK and the Effect of Fluvoxamine on KP-001 PK in Volunteers","status":"COMPLETED","sponsor":"Kaken Pharmaceutical","startDate":"2025-02-13","conditions":"Healty Volunteers","enrollment":38},{"nctId":"NCT06855108","phase":"PHASE3","title":"Caffeine for Hypoxic Ischemic Encephalopathy","status":"NOT_YET_RECRUITING","sponsor":"NICHD Global Network for Women's and Children's Health","startDate":"2025-06","conditions":"Hypoxic Ischemic Encephalopathy (HIE)","enrollment":830},{"nctId":"NCT05232734","phase":"PHASE2","title":"CaffeinICU Study - A Study on Oral Caffeine in ICU Patients With Coma","status":"SUSPENDED","sponsor":"Singapore General Hospital","startDate":"2022-11-24","conditions":"Depressed GCS","enrollment":10},{"nctId":"NCT06051175","phase":"NA","title":"Study of the Neurophysiological Response to Foodstuffs","status":"COMPLETED","sponsor":"Egas Moniz - Cooperativa de Ensino Superior, CRL","startDate":"2023-03-01","conditions":"Healthy Nutrition","enrollment":30},{"nctId":"NCT04869176","phase":"NA","title":"Effect of Caffeine on Heart Rate Variability in Newborns","status":"COMPLETED","sponsor":"University of Ljubljana","startDate":"2017-11-17","conditions":"Caffeine, Heart Rate Variability, Apnoea of Newborn","enrollment":25},{"nctId":"NCT02098785","phase":"PHASE1","title":"Inhibition of VAP-1 by Caffeine in Healthy Human Volunteers Study","status":"WITHDRAWN","sponsor":"University of Birmingham","startDate":"2018-03","conditions":"Liver Disease","enrollment":""},{"nctId":"NCT01751724","phase":"NA","title":"Caffeine to Reduce Mechanical Ventilation in Preterm Infants","status":"TERMINATED","sponsor":"University of Miami","startDate":"2012-12","conditions":"Prematurity, Apnea, Respiratory Failure","enrollment":87},{"nctId":"NCT02390180","phase":"","title":"Sorting of Oral Sensations","status":"COMPLETED","sponsor":"Purdue University","startDate":"2014-10","conditions":"Taste Qualities, Primary Tastes","enrollment":107}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[{"date":"20191216","type":"ORIG","sponsor":"MICRO LABS","applicationNumber":"ANDA213202"}],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Caffeine","CafCit","Caffeine Ingestion","YA Kofeiinitabletti 100 mg, Yliopiston apteekki","200 mg Vivarin Tablet"],"phase":"marketed","status":"active","brandName":"Caffeine citrate oral solution","genericName":"Caffeine citrate oral solution","companyName":"NICHD Global Network for Women's and Children's Health","companyId":"nichd-global-network-for-women-s-and-children-s-health","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Caffeine citrate is a nonselective adenosine receptor antagonist that blocks adenosine-mediated central nervous system depression, promoting wakefulness and respiratory stimulation. Used for Apnea of prematurity in preterm infants, Neonatal respiratory depression.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2019-12-16T00:00:00.000Z","mah":"MICRO LABS","brand_name_local":null,"application_number":"ANDA213202"}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}