{"id":"phenylephrine","rwe":[],"_fda":{"id":"3aa48604-afd3-49a2-b0a8-ab15171c7913","set_id":"0044c53c-11dd-41a9-a5d9-622dd8b1c144","openfda":{"upc":["0032251921049"],"unii":["362O9ITL9D","9D2RTI9KYH","04JA59TNSJ"],"route":["ORAL"],"rxcui":["1113705"],"spl_id":["3aa48604-afd3-49a2-b0a8-ab15171c7913"],"brand_name":["Daytime Cold and Flu"],"spl_set_id":["0044c53c-11dd-41a9-a5d9-622dd8b1c144"],"package_ndc":["55319-960-08"],"product_ndc":["55319-960"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL"],"product_type":["HUMAN OTC DRUG"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE"],"manufacturer_name":["Family Dollar (FAMILY WELLNESS)"],"application_number":["M012"],"is_original_packager":[true]},"purpose":["Purposes Pain reliever/fever reducer Cough suppressant Nasal decongestant"],"version":"3","stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with a rash or headache that lasts. These could be signs of a serious condition."],"warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may inclide: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease heart disease diabetes high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with a rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"questions":["Questions or comments? Call 1 -877-753-3935 Monday-Friday 9AM-5PM EST"],"ask_doctor":["Ask a doctor before use if you have liver disease heart disease diabetes high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema"],"do_not_use":["Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist."],"when_using":["When using this product, do not exceed recommended dosage"],"effective_time":"20240327","active_ingredient":["Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg"],"inactive_ingredient":["Inactive ingredients acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate"],"indications_and_usage":["Uses temporarily relieves these symptoms due to a cold minor aches and pains headache nasal and sinus congestion sore throat cough due to minor throat and bronchial irritation temporarily reduces fever"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin."],"other_safety_information":["Other information each 30 mL contains : sodium 16 mg store between 20-25ºC (68-77ºF). Do not refrigerate."],"dosage_and_administration":["Directions do not take more than directed (see overdose warning ) do not take more than 6 doses (180 mL) in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL= milliliter keep dosing cup with product adults and children 12 years and over 30 mL every 4 hours chlldren under 12 years of age: do not use"],"spl_product_data_elements":["Daytime Cold and Flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM ALCOHOL ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN MALTITOL PROPYLENE GLYCOL WATER SODIUM BENZOATE TRISODIUM CITRATE DIHYDRATE"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"package_label_principal_display_panel":["Principal Display Panel COMPARE TO THE ACTIVE INGREDIENTS IN THERAFLU® EXPRESSMAX® DAYTIME SEVERE COLD & COUGH* ADULT DAYTIME SEVERE COLD & COUGH RELIEF Acetaminophen 650 mg Pain reliever; Fever reducer Dextromethorphan HBr 20 mg Cough suppressant Phenylephrine HCI 10 mg Nasal decongestion RELIEVES Cough Nasal congestion Sore throat Fever Body ache Headache Alcohol 10% For Ages 12 Years & Older BERRY FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. *This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® ExpressMax® Daytime Severe Cold & Cough. DISTRIBUTED BY: MIDWOOD BRANDS, LLC 500 VOLVO PKWY, CHESAPEAKE, VA 23320","Product Label FAMILY WELLNESS Adult Daytime Severe Cold & Cough Relief Acetaminophen 650 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg"]},"tags":[],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"22484 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"19778 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"16521 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"16115 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"16102 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"14825 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"13542 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"13103 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"12103 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"9840 reports"}],"drugInteractions":[],"commonSideEffects":[],"contraindications":["Achalasia of esophagus","Acidosis","Acute abdominal pain","Acute erosive gastritis","Acute exacerbation of asthma","Acute hepatitis","Acute nephropathy","Acute pancreatitis","Acute tuberculosis","Adrenal cortical hypofunction","Agoraphobia","Alcohol intoxication","Alcohol withdrawal delirium","Alcoholism","Anemia","Anemia due to enzyme deficiency","Angle-closure glaucoma","Anuria","Anxiety","Arterial aneurysm","Arterial thrombosis","Arteriosclerotic vascular disease","Asthenia","Atony of colon","Autonomic dysreflexia","Azotemia","Benign intracranial hypertension","Benign prostatic hyperplasia","Bladder outflow obstruction","Bleeding","Blood coagulation disorder","Body fluid retention","Bone marrow depression","Bradycardia","Brain damage","Breastfeeding (mother)","Bronchitis","Cardiovascular event risk","Central nervous system depression","Chronic disease of respiratory system","Chronic heart failure","Chronic idiopathic constipation","Chronic lung disease","Chronic myocardial ischemia","Chronic obstructive lung disease","Coma","Complete trisomy 21 syndrome","Conduction disorder of the heart","Constipation","Cor pulmonale","Coronary arteriosclerosis","Decreased respiratory function","Deficiency of glucose-6-phosphate dehydrogenase","Dehydration","Dependent drug abuse","Dermatitis herpetiformis","Diabetes mellitus","Disease of liver","Disorder of brain","Disorder of cardiovascular system","Disorder of coronary artery","Disorder of gallbladder","Disorder of the central nervous system","Disturbance of salivary secretion","Drowsy","Drug AND/OR toxin-induced diarrhea","Drug-induced psychosis","Dysfunction of sphincter of Oddi","Epilepsy","Exacerbation of asthma","Factor II deficiency","Familial hyperkalemic periodic paralysis","Gastric ulcer","Gastritis","Gastroesophageal reflux disease","Gastrointestinal hemorrhage","Gastrointestinal obstruction","Gastrointestinal ulcer","Goiter","Gout","Hashimoto thyroiditis","Heart disease","Hemophilia","Hepatic failure","Hiatal hernia","Hyperbilirubinemia","Hypercapnia","Hyperkalemia","Hypernatremia","Hypertensive disorder","Hypertensive urgency","Hyperthyroidism","Hypocalcemia","Hypocomplementemic urticarial vasculitis","Hyporeninemic hypoaldosteronism","Hypothyroidism","Hypoxia","Impaired renal function disorder","Infective otitis media","Inflammatory bowel disease","Injury of head","Insomnia","Kidney disease","Lesion of brain","Lowered convulsive threshold","Metabolic acidosis","Metabolic alkalosis","Mood swings","Morbid obesity","Myasthenia gravis","Myocardial dysfunction","Myocardial infarction","Myocardial infarction in recovery phase","Myocardial ischemia","Nasal polyp","Necrotizing enterocolitis in fetus OR newborn","Neoplasm of brain","Nervousness","Neuroleptic malignant syndrome","Obsessive-compulsive disorder","Ocular hypertension","Oliguria","Open wound","Operation on gastrointestinal tract","Panic disorder","Paralytic ileus","Partial atrioventricular block","Peptic reflux disease","Peptic ulcer","Perforation of tympanic membrane","Peripheral edema","Poisoning by acetaminophen","Porphyria","Predisposition to Glaucoma","Pregnancy, function","Primary adrenocortical insufficiency","Procedure on urinary system","Pseudomembranous enterocolitis","Psychotic disorder","Pulmonary edema","Pulmonary emphysema","Pyloric obstruction","Retention of urine","Reye's syndrome","Rhabdomyolysis","Seizure disorder","Severe chronic ulcerative colitis","Severe dehydration","Shock","Sleep apnea","Spastic paralysis","Substance abuse","Suicidal thoughts","Tachyarrhythmia","Thrombocytopenic disorder","Thrombotic thrombocytopenic purpura","Thyrotoxicosis","Toxic megacolon","Traumatic injury","Ulcerative colitis","Ultrarapid metabolizer due to cytochrome p450 CYP2D6 variant","Urethral stricture","Urinary tract obstruction","Ventricular tachycardia","Vitamin K deficiency","von Willebrand disorder"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"approved","trials":["NCT02220218","NCT02504320","NCT05293171","NCT06161636","NCT06914063","NCT02408003","NCT02252627","NCT02169479","NCT01048125","NCT05158699","NCT02177539","NCT06955754","NCT02221180","NCT07300722","NCT06151522","NCT00676442","NCT02532270","NCT02737397","NCT01393561","NCT00047580","NCT02560805","NCT06508359","NCT00783003","NCT02062203","NCT06770426","NCT02093689","NCT01660893","NCT02009007","NCT03864094","NCT00927901","NCT01365117","NCT01643889","NCT01708044","NCT01208155","NCT03248817","NCT00857571","NCT05118672","NCT02390609","NCT06433908","NCT02778113","NCT05939518","NCT02726620","NCT02214953","NCT00838695","NCT02018536","NCT02748265","NCT03047109","NCT03620942","NCT06158022","NCT01370031"],"aliases":["Sudafed PE","Neo-Synephrine"],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=phenylephrine","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:06:52.966677+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:07:03.950421+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T01:06:51.593894+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=phenylephrine","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:07:04.678714+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:06:49.924988+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:06:49.925045+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T01:07:06.573947+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Adrenergic receptor alpha-1 agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:07:05.226548+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200339/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:07:05.132007+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M012","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:06:49.925056+00:00"}},"allNames":"sudafed pe","offLabel":[],"timeline":[],"aiSummary":"Phenylephrine is a widely sold OTC decongestant, though FDA panels found oral doses ineffective for congestion. The IV form is an important vasopressor. The nasal spray is effective topically. Available generically.","brandName":"Sudafed PE","companyId":"unknown","ecosystem":[],"mechanism":{"target":"Alpha-1A adrenergic receptor, Alpha-1B adrenergic receptor, Alpha-1D adrenergic receptor","novelty":"","modality":"Small molecule","drugClass":"Alpha-1 adrenergic agonist (decongestant/vasopressor)","explanation":"","oneSentence":"","technicalDetail":""},"commercial":null,"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:07:08.281849+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"companyName":"Generic (multiple manufacturers)","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"},{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"phenylephrine","indications":{"approved":[{"name":"Allergic conjunctivitis","diseaseId":"allergic-conjunctivitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Allergic rhinitis","diseaseId":"allergic-rhinitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Common cold","diseaseId":"common-cold","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Cough","diseaseId":"cough","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Dilated pupil","diseaseId":"dilated-pupil","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Fever","diseaseId":"fever","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Headache disorder","diseaseId":"headache-disorder","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Hemorrhoids","diseaseId":"hemorrhoids","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Influenza-like symptoms","diseaseId":"influenza-like-symptoms","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Maintenance of intraoperative mydriasis","diseaseId":"maintenance-of-intraoperative-mydriasis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Nasal congestion","diseaseId":"nasal-congestion","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Nasal discharge","diseaseId":"nasal-discharge","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Postoperative ocular pain in intraocular lens replacement surgery","diseaseId":"postoperative-ocular-pain-in-intraocular-lens-replacement-surgery","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Prevention of Posterior Synechiae","diseaseId":"prevention-of-posterior-synechiae","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Prevention of intraoperative miosis","diseaseId":"prevention-of-intraoperative-miosis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Proctitis","diseaseId":"proctitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Pruritus ani","diseaseId":"pruritus-ani","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Rectal pain","diseaseId":"rectal-pain","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Red eye","diseaseId":"red-eye","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Rhinitis","diseaseId":"rhinitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Seasonal allergic rhinitis","diseaseId":"seasonal-allergic-rhinitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Sinus headache","diseaseId":"sinus-headache","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Sneezing","diseaseId":"sneezing","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Vasomotor rhinitis","diseaseId":"vasomotor-rhinitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT02220218","phase":"Phase 1","title":"A Single-Dose, Open-Label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Immedia","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","isPivotal":false,"enrollment":2,"indication":"Healthy","completionDate":"2014-10"},{"nctId":"NCT02504320","phase":"Phase 1","title":"A Phase 1, Randomized, Open-Label, Single-Dose, 4-Way Crossover Study to Assess the Relative Bioavailability of Four 80 mg Febuxostat XR Formulations","status":"COMPLETED","sponsor":"Takeda","isPivotal":false,"enrollment":78,"indication":"Healthy Volunteers","completionDate":"2015-10"},{"nctId":"NCT05293171","phase":"Phase 1","title":"A Single-Dose, Randomized, Double-Blind, Placebo-Controlled, Positive-Controlled, Four-Way Crossover Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects","status":"COMPLETED","sponsor":"BioLineRx, Ltd.","isPivotal":false,"enrollment":38,"indication":"Healthy Subjects","completionDate":"2022-08-15"},{"nctId":"NCT06161636","phase":"N/A","title":"Contribution of the Kinematic Theory in the Early Differential Diagnosis of the Parkinson's Disease","status":"RECRUITING","sponsor":"Centre hospitalier de l'Université de Montréal (CHUM)","isPivotal":false,"enrollment":90,"indication":"Parkinson Disease, Healthy","completionDate":"2028-12"},{"nctId":"NCT06914063","phase":"NA","title":"Assessing Patient Comfort, Anxiety, and Satisfaction During Cycloplegic Refraction: Comparing Conventional Drops With Rapid-Onset Cycloplegics","status":"ACTIVE_NOT_RECRUITING","sponsor":"Superior University","isPivotal":false,"enrollment":74,"indication":"Cycloplegic Paralysis of Accommodation","completionDate":"2026-02-20"},{"nctId":"NCT02408003","phase":"NA","title":"What Are the Changes in Cardiac Deformation Variables and Hemodynamic Parameters Following Changes in Cardiac Loading Conditions and After Administration of Two Different Inotropic Drugs.","status":"COMPLETED","sponsor":"Sahlgrenska University Hospital","isPivotal":false,"enrollment":30,"indication":"Heart Failure, Diastolic, Aortic Valve Stenosis","completionDate":"2017-05"},{"nctId":"NCT02252627","phase":"N/A","title":"An Observational Study to Test the Effect of the Vasoactive Drugs Phenylephrine and Ephedrine on the Stroke Volume and Microvascular Blood Flow of Healthy Volunteers","status":"UNKNOWN","sponsor":"University of Nottingham","isPivotal":false,"enrollment":8,"indication":"Healthy Volunteers","completionDate":"2015-08"},{"nctId":"NCT02169479","phase":"Phase 1","title":"Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa: a Doubleblind, Randomized, F","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","isPivotal":false,"enrollment":16,"indication":"Parkinson's Disease (PD)","completionDate":"2008-12"},{"nctId":"NCT01048125","phase":"NA","title":"Characterization of Sympathetic Nerve Activity in Stress Cardiomyopathy","status":"TERMINATED","sponsor":"University of Missouri-Columbia","isPivotal":false,"enrollment":2,"indication":"Cardiomyopathy","completionDate":"2012-07"},{"nctId":"NCT05158699","phase":"Phase 3","title":"The ESCRS EPICAT Study: Effectiveness of Periocular Drug Injection in CATaract Surgery","status":"TERMINATED","sponsor":"Luigi Rondas","isPivotal":true,"enrollment":628,"indication":"Macular Edema, Cystoid Macular Edema","completionDate":"2024-08-13"},{"nctId":"NCT02177539","phase":"Phase 4","title":"A New More Efficient Cycloplegia Scheme","status":"UNKNOWN","sponsor":"Pontificia Universidad Catolica de Chile","isPivotal":false,"enrollment":30,"indication":"Refractive Errors","completionDate":"2014-09"},{"nctId":"NCT06955754","phase":"Phase 1","title":"Relative Bioavailability of Three Different Oral Formulations of BI 764198 Including the Investigation of Food Effect on the Tablet Formulation in Healthy Male and Female Subjects (an Open-label, Rand","status":"COMPLETED","sponsor":"Boehringer Ingelheim","isPivotal":false,"enrollment":16,"indication":"Healthy","completionDate":"2025-07-14"},{"nctId":"NCT02221180","phase":"Phase 1","title":"A Single-Dose, Open-Label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Immedia","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","isPivotal":false,"enrollment":2,"indication":"Bioequivalence","completionDate":"2014-11"},{"nctId":"NCT07300722","phase":"NA","title":"Impact of \"SI Kumbang\" Gymnastic Exercise on Physical Performance and Immunity in the Elderly","status":"COMPLETED","sponsor":"Umi Sjarqiah","isPivotal":false,"enrollment":66,"indication":"Healthy","completionDate":"2025-09-30"},{"nctId":"NCT06151522","phase":"NA","title":"90% Effective Dose of Phenylephrine Infusions for Preventing Postspinal Anesthesia Hypotension Under Intensive and Standard Treatment During Cesarean Section","status":"UNKNOWN","sponsor":"General Hospital of Ningxia Medical University","isPivotal":false,"enrollment":80,"indication":"Adverse Effect","completionDate":"2025-06-30"},{"nctId":"NCT00676442","phase":"Phase 1","title":"An Open-Label, Randomized, Four-Way Crossover Study to Evaluate the Effect of Food on the Bioavailability of Naproxen and Esomeprazole From a PN 400 Tablet in Healthy Subjects","status":"COMPLETED","sponsor":"POZEN","isPivotal":false,"enrollment":24,"indication":"Arthritis","completionDate":"2008-06"},{"nctId":"NCT02532270","phase":"NA","title":"Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring During Spinal Anaesthesia for Cesarean Section:A Prospective,Randomized, Controlled Study","status":"UNKNOWN","sponsor":"Fudan University","isPivotal":false,"enrollment":100,"indication":"Hypotension","completionDate":"2016-06"},{"nctId":"NCT02737397","phase":"Phase 2","title":"A Double-blind Placebo-controlled 4-Way Crossover Study to Evaluate the Efficacy of JMI-001 (an Over-the-counter Pain Medicine and an Antihistamine) in the Prophylaxis of Veisalgia in Healthy Voluntee","status":"COMPLETED","sponsor":"Sen-Jam Pharmaceutical","isPivotal":false,"enrollment":13,"indication":"Veisalgia","completionDate":"2016-05"},{"nctId":"NCT01393561","phase":"Phase 3","title":"Multicenter Clinical Trial, Phase III, Randomized, Double-blind, Placebo Controlled, Comparative for Evaluate the Efficacy and Safety of Fixed Dose Combination of Brompheniramine Maleate + Phenylephri","status":"COMPLETED","sponsor":"Ache Laboratorios Farmaceuticos S.A.","isPivotal":true,"enrollment":167,"indication":"Nasal Congestion and Inflammations, Rhinitis","completionDate":"2014-12"},{"nctId":"NCT00047580","phase":"Phase 3","title":"A Multicenter, Open-Label, Randomized, 4-Way Crossover Trial of the Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex (Tizanidine Hydrochloride) Tablets Taken Under Fed and Fast","status":"COMPLETED","sponsor":"Elan Pharmaceuticals","isPivotal":true,"enrollment":120,"indication":"Multiple Sclerosis, Muscle Spasticity","completionDate":"2002-09"},{"nctId":"NCT02560805","phase":"Phase 2","title":"Post-Traumatic Stress Disorder and Cardiovascular Disease Risk: Role of Sympathetic Overactivity and Angiotensin II","status":"SUSPENDED","sponsor":"Emory University","isPivotal":false,"enrollment":134,"indication":"Stress Disorders, Post-Traumatic","completionDate":"2026-02"},{"nctId":"NCT06508359","phase":"NA","title":"Prophylactic vs Rescue Norepinephrine and Phenylephrine for Spinal Anesthesia-induced Hypotension on Neonatal Outcomes During Cesarean Section: A Multicenter, Single-blind, Crossover, Factorial Cluste","status":"NOT_YET_RECRUITING","sponsor":"General Hospital of Ningxia Medical University","isPivotal":false,"enrollment":2000,"indication":"Outcome","completionDate":"2027-02-28"},{"nctId":"NCT00783003","phase":"Phase 1","title":"A Single Centre, Randomised, Placebo-controlled, Four-way Cross Over Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of GSK233705 and GW642444 a","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":false,"enrollment":16,"indication":"Pulmonary Disease, Chronic Obstructive","completionDate":"2009-02-06"},{"nctId":"NCT02062203","phase":"Phase 1","title":"A Phase 1, Single-Center, Partially Double-Blinded, Active and Placebo Controlled, Randomized 4-Way Crossover Study to Evaluate the Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Vo","status":"COMPLETED","sponsor":"Akebia Therapeutics","isPivotal":false,"enrollment":50,"indication":"Healthy Volunteers","completionDate":"2014-04"},{"nctId":"NCT06770426","phase":"Phase 3","title":"CompARing Between CO2 Phenylephrine and Phenylephrine Only Treatment in Patients With proGrEssing Cerebral infarctioN(CARBOGEN Trial)","status":"NOT_YET_RECRUITING","sponsor":"Yonsei University","isPivotal":true,"enrollment":40,"indication":"Acute Ischemic Stroke","completionDate":"2027-12"},{"nctId":"NCT02093689","phase":"Phase 3","title":"A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study of the Effect of OMS302 on Intraoperative Pupil Diameter in Subjects at High Risk of Intraoperative Floppy Iris Syndrome Undergoing Intrao","status":"TERMINATED","sponsor":"Omeros Corporation","isPivotal":true,"enrollment":18,"indication":"Intraocular Lens Replacement, Intraoperative Floppy Iris Syndrome","completionDate":"2014-08"},{"nctId":"NCT01660893","phase":"Phase 3","title":"A Phase III, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing the Efficacy and Safety of Intranasally Administered Kovacaine Mist to Tetracaine Alone and to Placebo for","status":"TERMINATED","sponsor":"St. Renatus, LLC","isPivotal":true,"enrollment":26,"indication":"Anesthesia","completionDate":"2012-09"},{"nctId":"NCT02009007","phase":"Phase 1","title":"Effect of Phenylephrine or Dopamine Infusion on Cerebral Oxygen Saturation in Thoracic Surgery Patients","status":"UNKNOWN","sponsor":"Samsung Medical Center","isPivotal":false,"enrollment":50,"indication":"Hypoxia, Hypotension","completionDate":"2014-12"},{"nctId":"NCT03864094","phase":"Phase 4","title":"\"Haemodynamic Stability During Induction of General Anesthesia With Propofol and Remifentanil: A Randomized, Controlled, Double-blind Study Comparing Equipotent Prophylactic Doses of Ephedrine, Phenyl","status":"COMPLETED","sponsor":"Helse Fonna","isPivotal":false,"enrollment":128,"indication":"Hemodynamic Instability, Anesthesia, General","completionDate":"2023-12-14"},{"nctId":"NCT00927901","phase":"Phase 2","title":"A Multi-centre, Randomized, Double-blind, Placebo-controlled, Multiple-dose, 4-way Crossover Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Orally Inhaled Indacaterol Sa","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","isPivotal":false,"enrollment":30,"indication":"Asthma","completionDate":"2009-11"},{"nctId":"NCT01365117","phase":"Phase 1","title":"Phase 1, Single-center, Open-label, Randomized, Crossover Design Clinical Trial in Healthy Normal Volunteers to Evaluate Insulin Exposure and Dose-proportionality Following Inhalation of Technosphere®","status":"COMPLETED","sponsor":"Mannkind Corporation","isPivotal":false,"enrollment":50,"indication":"Healthy Volunteers","completionDate":"2011-04"},{"nctId":"NCT01643889","phase":"Phase 1","title":"A Randomized, Double-Blind, Placebo- and Positive-Controlled, Single- and Multiple-Dose, 4-Way Crossover Study to Evaluate the Effects of Domperidone on Cardiac Repolarization in Healthy Subjects","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","isPivotal":false,"enrollment":44,"indication":"Healthy","completionDate":"2012-11"},{"nctId":"NCT01708044","phase":"Phase 1","title":"A Phase 1, Randomized, Placebo-Controlled Single-Blind, Dose-Ranging, 4-Way Crossover Study to Evaluate the Effect of Different Fixed Pramlintide: Insulin Dose Ratios on Postprandial Glycemic Control ","status":"COMPLETED","sponsor":"AstraZeneca","isPivotal":false,"enrollment":32,"indication":"Type 1 Diabetes","completionDate":"2013-09"},{"nctId":"NCT01208155","phase":"Phase 1","title":"An Open-label, Randomized, Four-way Crossover Study in Healthy Male Subjects to Assess the Relative Bioavailability of 4 Different Fostamatinib Tablets","status":"COMPLETED","sponsor":"AstraZeneca","isPivotal":false,"enrollment":24,"indication":"Bioavailability, Pharmacokinetics","completionDate":"2010-11"},{"nctId":"NCT03248817","phase":"Phase 4","title":"Comparison of Different Protocols of Phenylephrine Infusion for Prophylaxis Against Post-spinal Hypotension During Cesarean Delivery","status":"UNKNOWN","sponsor":"Cairo University","isPivotal":false,"enrollment":255,"indication":"Cesarean Section Complications, Spinal Anesthesia","completionDate":"2020-05-25"},{"nctId":"NCT00857571","phase":"Phase 1","title":"An Open-Label Randomized Incomplete Block Four-Way Crossover Study To Evaluate The Dose Response Of PF-02413873 Tablets And PF-02413873 Suspension.","status":"TERMINATED","sponsor":"Pfizer","isPivotal":false,"enrollment":12,"indication":"Healthy","completionDate":"2009-05"},{"nctId":"NCT05118672","phase":"Phase 3","title":"A Multicenter, Randomized, Parallel-group, Double-blind, Comparative Trial of the Superiority of Paracetamol 500mg/Fexofenadine 60mg/Phenylephrine 20mg Fixed-dose Combination Versus Placebo in the Sym","status":"COMPLETED","sponsor":"Eurofarma Laboratorios S.A.","isPivotal":true,"enrollment":567,"indication":"Cold, Flu Symptom","completionDate":"2025-08-26"},{"nctId":"NCT02390609","phase":"Phase 1","title":"Open-Label, Randomized, Parallel Group, 3- or 4-Way Crossover Bioavailability Study of Ibrutinib Suspension and Sprinkle Formulations Compared to Capsules in Healthy Adults","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","isPivotal":false,"enrollment":40,"indication":"Healthy","completionDate":"2015-11"},{"nctId":"NCT06433908","phase":"Phase 1","title":"A Phase 1, Randomized, Open-label, Single Dose, 2-treatment Arm (200 μg and 800 μg), 4-way Crossover Study in Healthy Participants Aged 18 to 55 to Compare the Pharmacokinetics of Salbutamol Administe","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":false,"enrollment":60,"indication":"Asthma, Healthy Participants","completionDate":"2024-10-22"},{"nctId":"NCT02778113","phase":"Phase 1","title":"A Single Site, Randomized, Four-Way, Four-Period PK/PD Crossover Phase 1 Clinical Study in 16 Fasted Healthy Adult Volunteers Receiving 3 Dose Levels of Intranasally Administered Glucagon and One Dose","status":"COMPLETED","sponsor":"Eli Lilly and Company","isPivotal":false,"enrollment":16,"indication":"Healthy","completionDate":"2011-11"},{"nctId":"NCT05939518","phase":"NA","title":"The Contribution of Liberal Fluid Therapy to Glycocalyx Shedding, Interstitial Edema and Fluid Accumulation During Moderate Surgery","status":"COMPLETED","sponsor":"Hadassah Medical Organization","isPivotal":false,"enrollment":51,"indication":"Abdominoplasty","completionDate":"2023-08-03"},{"nctId":"NCT02726620","phase":"NA","title":"Decision Support for Intraoperative Low Blood Pressure","status":"COMPLETED","sponsor":"Vanderbilt University Medical Center","isPivotal":false,"enrollment":22435,"indication":"Hypotension","completionDate":"2018-12-29"},{"nctId":"NCT02214953","phase":"Phase 1","title":"An Open, Randomised, Single-dose, Four-way Cross-over Formulation Finding Study of the Oral Bioavailability of Four Prototype Extended Release Formulations With 25 mg BI 11634, and Intra-individual Co","status":"COMPLETED","sponsor":"Boehringer Ingelheim","isPivotal":false,"enrollment":17,"indication":"Healthy","completionDate":""},{"nctId":"NCT00838695","phase":"NA","title":"Variability in Adrenergic Response","status":"COMPLETED","sponsor":"Vanderbilt University","isPivotal":false,"enrollment":106,"indication":"Vascular Reaction to Medications","completionDate":"2011-12"},{"nctId":"NCT02018536","phase":"Phase 1","title":"A Phase 1, Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GSK2336805 (Part 1), Followed by an Open-label, Ra","status":"COMPLETED","sponsor":"Janssen R&D Ireland","isPivotal":false,"enrollment":48,"indication":"Healthy","completionDate":"2014-03"},{"nctId":"NCT02748265","phase":"Phase 4","title":"A Pilot Study of the Effects of Nebulized Epoprostenol (Flolan) and Systemic Phenylephrine on Arterial Oxygenation During One Lung Ventilation","status":"COMPLETED","sponsor":"University Health Network, Toronto","isPivotal":false,"enrollment":8,"indication":"Oxygenation During One Lung Ventilation","completionDate":"2018-12-31"},{"nctId":"NCT03047109","phase":"Phase 2","title":"Ephedrine Versus Phenylephrine Infusion for Prevention of Spinal Hypotension During Cesarean Section: Effect on Maternal Cardiodynamics and Fetal Circulation: Randomized Double-blind Study","status":"COMPLETED","sponsor":"Assiut University","isPivotal":true,"enrollment":60,"indication":"Spinal Hypotension","completionDate":"2020-03-30"},{"nctId":"NCT03620942","phase":"NA","title":"Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System With Improved Hemodynamic Trend Control During Spinal Anaesthesia for Caesarean Section","status":"ACTIVE_NOT_RECRUITING","sponsor":"KK Women's and Children's Hospital","isPivotal":false,"enrollment":173,"indication":"Hypotension, Anesthesia","completionDate":"2026-12-31"},{"nctId":"NCT06158022","phase":"NA","title":"Determination of ED90s of Phenylephrine and Norepinephrine Infusion for Strict Blood Pressure Management Targets in Preeclamptic Patients Undergoing Cesarean Section: A Randomized Sequential Allocatio","status":"COMPLETED","sponsor":"General Hospital of Ningxia Medical University","isPivotal":false,"enrollment":60,"indication":"Adverse Effect","completionDate":"2025-05-20"},{"nctId":"NCT01370031","phase":"Phase 2","title":"Pilot, Open-Label, Randomized, Repeated Dose, 4-Way Cross-Over, Clinical Pharmacology Study of Beclomethasone Dipropionate (Clenil® Modulite®) 250 µg HFA pMDI Using the Aerochamber Plus™ Spacer Device","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","isPivotal":false,"enrollment":16,"indication":"Asthma","completionDate":"2011-06"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"Oral","frequency":"Every 4 hours (oral)","formulation":"Tablet, Liquid, Nasal spray, Eye drops, Injectable"},"crossReferences":{"chemblId":"CHEMBL1200339"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":20728,"therapeuticAreas":["Infectious Disease"],"biosimilarFilings":[],"firstApprovalDate":"1976-01-01","companionDiagnostics":[],"firstApprovalCountry":"United States","genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1996-12-24T00:00:00.000Z","mah":"ALCON LABS INC","brand_name_local":null,"application_number":"ANDA084300"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2012-12-20T00:00:00.000Z","mah":"HIKMA","brand_name_local":null,"application_number":"NDA203826"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2016-01-15T00:00:00.000Z","mah":"RAYNER SURGICAL","brand_name_local":null,"application_number":"NDA205388"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2020-06-11T00:00:00.000Z","mah":"CAPLIN","brand_name_local":null,"application_number":"ANDA213318"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2022-08-30T00:00:00.000Z","mah":"MANKIND PHARMA","brand_name_local":null,"application_number":"ANDA217069"},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":4,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:07:08.281849+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}