{"id":"acetylcystein","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Stomatitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Fever","drugRate":"","severity":"common","organSystem":""},{"effect":"Rhinorrhea","drugRate":"","severity":"common","organSystem":""},{"effect":"Drowsiness","drugRate":"","severity":"common","organSystem":""},{"effect":"Clamminess","drugRate":"","severity":"common","organSystem":""},{"effect":"Chest tightness","drugRate":"","severity":"common","organSystem":""},{"effect":"Irritation to tracheal and bronchial tracts","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Acute exacerbation of asthma","Bronchospasm","Decreased respiratory function","Esophageal varices","Low blood pressure","Peptic ulcer"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"Bronchoconstriction","drugRate":"","severity":"serious"},{"effect":"Bronchospasm","drugRate":"","severity":"serious"},{"effect":"Hemoptysis","drugRate":"","severity":"serious"},{"effect":"Acquired sensitization to acetylcysteine","drugRate":"","severity":"serious"},{"effect":"Dermal eruptions","drugRate":"","severity":"serious"}]},"trials":[],"_chembl":{"chemblId":"CHEMBL3706516","moleculeType":"Small molecule","molecularWeight":"303.38"},"aliases":["Acetylcystein group"],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Acetylcystein","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:37:36.048908+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:37:42.589240+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Acetylcystein","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:37:42.983154+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3706516/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:37:43.771532+00:00"}},"offLabel":[],"timeline":[],"_dailymed":{"setId":"9d305722-e74f-4f48-8d2c-0daa99144749","title":"ACETYLCYSTEINE INJECTION [PADAGIS US LLC]"},"ecosystem":[],"mechanism":{"target":"Cystine/glutamate transporter, Cytochrome c, Glutathione synthetase"},"_scrapedAt":"2026-03-28T00:44:01.748Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:37:45.404139+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"indications":{"approved":[{"name":"Amyloidosis","diseaseId":"amyloidosis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Atelectasis due to Mucous Obstruction","diseaseId":"atelectasis-due-to-mucous-obstruction","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Bronchiectasis","diseaseId":"bronchiectasis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Bronchitis","diseaseId":"bronchitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Contrast Media-Induced Nephrotoxicity Prevention","diseaseId":"contrast-media-induced-nephrotoxicity-prevention","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Cystic fibrosis of the lung","diseaseId":"cystic-fibrosis-of-the-lung","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"General anesthesia","diseaseId":"general-anesthesia","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Poisoning by acetaminophen","diseaseId":"poisoning-by-acetaminophen","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Support of pincer nail correction","diseaseId":"support-of-pincer-nail-correction","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Thick Bronchial Secretions","diseaseId":"thick-bronchial-secretions","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06187220","phase":"","title":"Plasma Exchange for Amanita Toxin-induced Acute Liver Failure","status":"COMPLETED","sponsor":"Hannover Medical School","startDate":"2024-01-01","conditions":"Acute Liver Failure","enrollment":111},{"nctId":"NCT06297369","phase":"PHASE2","title":"Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients","status":"UNKNOWN","sponsor":"Ain Shams University","startDate":"2024-02-01","conditions":"Cisplatin Adverse Reaction, Cisplatin Nephrotoxicity, Cisplatin Induced Peripheral Neuropathy","enrollment":60},{"nctId":"NCT05777733","phase":"PHASE1","title":"NAC Effect on Iron Overload and Blood Transfusion in β-thalassemia Major","status":"UNKNOWN","sponsor":"Assiut University","startDate":"2024-03-23","conditions":"Thalassemia Major","enrollment":100},{"nctId":"NCT01098032","phase":"PHASE3","title":"RenalGuard System and Contrast Media","status":"COMPLETED","sponsor":"Clinica Mediterranea","startDate":"2009-01","conditions":"Chronic Kidney Disease","enrollment":294},{"nctId":"NCT01537926","phase":"PHASE1","title":"Hypertrophic Regression With N-Acetylcysteine in HCM","status":"COMPLETED","sponsor":"The University of Texas Health Science Center, Houston","startDate":"2012-01","conditions":"Hypertrophic Cardiomyopathy","enrollment":42},{"nctId":"NCT01439828","phase":"PHASE2","title":"Clinical Trial of N-acetylcysteine Versus Placebo Efficacy in the Cannabis Withdrawal","status":"TERMINATED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2012-02","conditions":"Cannabis Dependence, Cannabis Abuse","enrollment":6},{"nctId":"NCT04668469","phase":"NA","title":"Efficacy and Safety of Ivermectin for Treatment and Prophylaxis of COVID-19 Pandemic","status":"COMPLETED","sponsor":"Benha University","startDate":"2020-06-08","conditions":"Covid19","enrollment":600},{"nctId":"NCT04641455","phase":"NA","title":"Use of Mucolytic Solution Before Upper Endoscopy","status":"UNKNOWN","sponsor":"Vitkovice Hospital","startDate":"2020-12-01","conditions":"Gastric Cancer, Gastroscopy","enrollment":120},{"nctId":"NCT02511691","phase":"PHASE2","title":"PET/MRI Imaging of Glutamate Release in the Brain","status":"TERMINATED","sponsor":"University of Zurich","startDate":"2015-07","conditions":"Healthy","enrollment":10},{"nctId":"NCT00614679","phase":"PHASE1","title":"A Novel Catheter Lock Solution for Treatment of Tunneled Hemodialysis Catheter-Associated Bacteremia","status":"COMPLETED","sponsor":"University of California, San Diego","startDate":"2006-10","conditions":"End-Stage Renal Disease, Hemodialysis Catheter-associated Infection","enrollment":18},{"nctId":"NCT03879356","phase":"PHASE4","title":"Supportive Measures in Treatment of Aluminum Phosphide Poisoning","status":"COMPLETED","sponsor":"Assiut University","startDate":"2016-01-01","conditions":"Detection of Different Prognostic Factors and Their Relation With the Outcome, Using New Protocol to Prove the Role of N-acetyl Cysteine and Adequate Supportive Measures in Aluminum Phosphide Poisoning","enrollment":44},{"nctId":"NCT03838822","phase":"EARLY_PHASE1","title":"Kinetics of Metabolic Cofactors in NAFLD","status":"COMPLETED","sponsor":"Sahlgrenska University Hospital","startDate":"2018-09-01","conditions":"Healthy","enrollment":10},{"nctId":"NCT03440268","phase":"PHASE4","title":"Prevention of Acute Kidney Injury by N-Acetylcystein in Patients Undergone Cardiac Valve Replacement","status":"UNKNOWN","sponsor":"University of Sao Paulo General Hospital","startDate":"2018-03-15","conditions":"Surgery--Complications, Cardiac Valve Disease, Acute Kidney Injury","enrollment":154},{"nctId":"NCT00205647","phase":"PHASE2","title":"Study of Expectorant Activity of Oral N-acetylcystein (NAC) in Patients With Stable Chronic Bronchitis","status":"COMPLETED","sponsor":"Wake Forest University","startDate":"1997-01","conditions":"Chronic Bronchitis","enrollment":240},{"nctId":"NCT03322488","phase":"NA","title":"Fistulodesis Pilot Study for Closure of Perianal Fistulae","status":"UNKNOWN","sponsor":"University of Zurich","startDate":"2017-06-20","conditions":"Perianal Fistula, Crohn Disease","enrollment":40},{"nctId":"NCT02626494","phase":"PHASE4","title":"Neurobiological Adaptations and Pharmacological Interventions in Cocaine Addiction","status":"COMPLETED","sponsor":"Psychiatric University Hospital, Zurich","startDate":"2015-03","conditions":"Cocaine Addiction","enrollment":71},{"nctId":"NCT02967094","phase":"NA","title":"Mucolytic Solution Before Upper Endoscopy","status":"UNKNOWN","sponsor":"Vitkovice Hospital","startDate":"2016-11","conditions":"Gastroscopy; Gastric Cancer","enrollment":150},{"nctId":"NCT02294591","phase":"PHASE2","title":"NACOS - The Effect of N-acetylcystein for Depressive Symptoms in Patients Suffering From Bipolar Depression","status":"COMPLETED","sponsor":"Region Syddanmark","startDate":"2014-11","conditions":"Bipolar Disorder","enrollment":80},{"nctId":"NCT02882477","phase":"PHASE2, PHASE3","title":"Treatment of Wolfram Syndrome Type 2 With the Chelator Deferiprone and Incretin Based Therapy","status":"UNKNOWN","sponsor":"Hadassah Medical Organization","startDate":"2016-12","conditions":"Diabetes Mellitus, Iron Metabolism Disorders, Gastroduodenal Ulcer","enrollment":20},{"nctId":"NCT01012726","phase":"NA","title":"Study About the Effect of Doxycycline and Acetylcystein in the Treatment of CD-associated Fistulae","status":"TERMINATED","sponsor":"Gerhard Rogler","startDate":"2009-11","conditions":"Crohn's Disease","enrollment":20},{"nctId":"NCT01327625","phase":"NA","title":"Efficacy Study of Azithromycin-based Therapy for Bronchiolitis Obliterans","status":"TERMINATED","sponsor":"Asan Medical Center","startDate":"2011-03","conditions":"Graft vs Host Disease, Bronchiolitis Obliterans","enrollment":6},{"nctId":"NCT01727492","phase":"NA","title":"Prevention of Noise-induced Damage by Use of Antioxidants","status":"UNKNOWN","sponsor":"University Hospital, Antwerp","startDate":"2012-11","conditions":"Noise-induced Tinnitus, Noise-induced Hearing Loss","enrollment":30},{"nctId":"NCT00525551","phase":"PHASE4","title":"Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis","status":"COMPLETED","sponsor":"Karolinska University Hospital","startDate":"2007-09","conditions":"Otosclerosis","enrollment":152},{"nctId":"NCT01753752","phase":"PHASE2","title":"Evaluation of the Corneal Residence Time of Chitosan-N-acetylcysteine Eye Drops in Patients With Dry Eye Syndrome After Single and Multiple Instillation","status":"COMPLETED","sponsor":"Gerhard Garhofer","startDate":"2012-09","conditions":"Dry Eye Syndrome","enrollment":32},{"nctId":"NCT01160627","phase":"NA","title":"Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction","status":"COMPLETED","sponsor":"Odense University Hospital","startDate":"2010-04","conditions":"Contrast Induced Nephropathy","enrollment":720},{"nctId":"NCT01394497","phase":"PHASE2","title":"Use of N-Acetylcysteine During Liver Procurement","status":"COMPLETED","sponsor":"Azienda Ospedaliera di Padova","startDate":"2006-12","conditions":"Liver Failure, Liver Failure, Acute, Liver Diseases","enrollment":140},{"nctId":"NCT01771978","phase":"PHASE3","title":"Ischaemia-réperfusion During the Coronary Surgery With Beating Heart","status":"UNKNOWN","sponsor":"University Hospital, Strasbourg, France","startDate":"2002-06","conditions":"Ischaemia-reperfusion Injury","enrollment":120},{"nctId":"NCT01741207","phase":"PHASE3","title":"Effect of N-acetylcystein in Myocardial Infarction","status":"UNKNOWN","sponsor":"Tehran University of Medical Sciences","startDate":"2011-01","conditions":"Acute Myocardial Infarction","enrollment":100},{"nctId":"NCT00337038","phase":"EARLY_PHASE1","title":"Endothelial Function as a Marker for Blood Pressure Control Among Hypertensive Diabetic Patients","status":"COMPLETED","sponsor":"Soroka University Medical Center","startDate":"2006-06","conditions":"Hypertension, Diabetes Mellitus Type 2","enrollment":50},{"nctId":"NCT01572597","phase":"PHASE4","title":"Increased Re-eradication Rate of Helicobacter Pylori by Adding N-acetylcystein or Metronidazole to the Triple Therapy","status":"UNKNOWN","sponsor":"Buddhist Tzu Chi General Hospital","startDate":"2011-06","conditions":"Bacterial Infection Due to Helicobacter Pylori (H. Pylori)","enrollment":120},{"nctId":"NCT01571687","phase":"NA","title":"Pik Lenin High Altitude Research Expedition 2009","status":"COMPLETED","sponsor":"Insel Gruppe AG, University Hospital Bern","startDate":"2009-04","conditions":"Oxidative Stress, Cell-derived Microparticles","enrollment":30},{"nctId":"NCT00463749","phase":"PHASE3","title":"Myocardial Salvage and Contrast Dye Induced Nephropathy Reduction by N-Acetylcystein","status":"COMPLETED","sponsor":"University of Leipzig","startDate":"2006-12","conditions":"Myocardial Infarction","enrollment":251},{"nctId":"NCT00476736","phase":"PHASE4","title":"The Effect of N-Acetylcystein on Quality of Life and Air Trapping During Rest and After Exercise","status":"UNKNOWN","sponsor":"Assaf-Harofeh Medical Center","startDate":"2007-05","conditions":"Quality of Life, Exercise","enrollment":30},{"nctId":"NCT00356954","phase":"PHASE4","title":"NASPI: N-Acetylcysteine vs. Ascorbic Acid for Prevention of Contrast Induced Nephropathy in Renal Insufficiency Undergoing Coronary Catheterization","status":"COMPLETED","sponsor":"Seoul National University Hospital","startDate":"2005-02","conditions":"Kidney Failure","enrollment":250}],"_emaApprovals":[],"_faersSignals":[{"count":44,"reaction":"DYSPNOEA"},{"count":30,"reaction":"GENERAL PHYSICAL HEALTH DETERIORATION"},{"count":25,"reaction":"ANAEMIA"},{"count":25,"reaction":"FATIGUE"},{"count":25,"reaction":"VOMITING"},{"count":24,"reaction":"PYREXIA"},{"count":23,"reaction":"DIZZINESS"},{"count":22,"reaction":"NAUSEA"},{"count":19,"reaction":"COUGH"},{"count":18,"reaction":"ABDOMINAL PAIN"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"crossReferences":{"chemblId":"CHEMBL3706516"},"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":217,"therapeuticAreas":["Respiratory"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Acetylcystein","genericName":"Acetylcystein","companyName":"University Hospital, Strasbourg, France","companyId":"university-hospital-strasbourg-france","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:37:45.404139+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}