{"id":"prometa","rwe":[],"tags":[],"safety":{"boxedWarnings":["WARNING Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B 12 is deficient. Precautions Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission "],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Gastrointestinal disturbances","drugRate":"","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"","severity":"common","organSystem":""},{"effect":"Constipation","drugRate":"","severity":"common","organSystem":""},{"effect":"Anorexia","drugRate":"","severity":"common","organSystem":""},{"effect":"Gastrointestinal intolerance","drugRate":"","severity":"common","organSystem":""}],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"Allergic sensitizations","drugRate":"","severity":"serious"},{"effect":"Allergic reactions","drugRate":"","severity":"serious"},{"effect":"Idiosyncratic reactions","drugRate":"","severity":"serious"}]},"trials":[],"_chembl":null,"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"_dailymed":{"setId":"b364551b-2ccc-4db3-e053-2995a90afbbf","title":"PROMETA (FERROUS FUMARATE, FOLIC ACID) TABLET PRENATRYL (FERROUS FUMARATE, FOLIC ACID) TABLET [PURETEK CORPORATION]"},"ecosystem":[],"mechanism":{},"_scrapedAt":"2026-03-28T02:06:27.310Z","_scrapedBy":"cloudflare-swarm","_wikipedia":{"url":"https://en.wikipedia.org/wiki/Gabasync","title":"Gabasync","extract":"\nGabasync is an ineffective treatment promoted for methamphetamine addiction, although it had also been claimed to be effective for dependence on alcohol or cocaine. It was marketed as PROMETA. The treatment, based loosely on research of a Spanish psychologist, involved a combination of three medications as well as therapy. While the individual drugs had been approved by the FDA, their off-label use for addiction treatment has not. Gabasync was marketed by Hythiam, Inc. which is owned by Terren Peizer, a former junk bond salesman who has since been indicted for securities fraud relative to another company. Hythiam has sought to patent the protocol and charges up to $15,000 per patient to license its use. Lower rates are offered to the criminal justice system, where it has been used in drug court pilot programs."},"references":[],"biosimilars":[],"competitors":[],"dataSources":[],"indications":{"approved":[],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06810739","phase":"NA","title":"The Women's Screening and Self-Testing Program (PROMETA) Study","status":"NOT_YET_RECRUITING","sponsor":"Tulane University","startDate":"2026-01-01","conditions":"Human Papilloma Virus Related Cervical Carcinoma","enrollment":8445},{"nctId":"NCT00262639","phase":"PHASE2, PHASE3","title":"Prometa Protocol for Alcohol Dependence","status":"COMPLETED","sponsor":"Medical University of South Carolina","startDate":"2005-12","conditions":"Alcohol Dependence","enrollment":60},{"nctId":"NCT00260481","phase":"PHASE2, PHASE3","title":"Prometa Pharmacotherapy for Methamphetamine Dependence","status":"COMPLETED","sponsor":"University of California, Los Angeles","startDate":"2006-01","conditions":"Drug Abuse, Drug Dependence","enrollment":120},{"nctId":"NCT00570388","phase":"NA","title":"Neurocognitive Functioning Following The PROMETA® Treatment Protocol In Subjects With Alcohol Dependence","status":"UNKNOWN","sponsor":"Institute of Addiction Medicine","startDate":"2007-03","conditions":"Alcohol Dependence","enrollment":120}],"_emaApprovals":[],"_faersSignals":[{"count":2,"reaction":"DIARRHOEA"},{"count":1,"reaction":"ALCOHOL ABUSE"},{"count":1,"reaction":"ALOPECIA"},{"count":1,"reaction":"ARTHRALGIA"},{"count":1,"reaction":"ATRIAL FIBRILLATION"},{"count":1,"reaction":"CATARACT"},{"count":1,"reaction":"CONTUSION"},{"count":1,"reaction":"CYTOMEGALOVIRUS INFECTION"},{"count":1,"reaction":"DEATH"},{"count":1,"reaction":"DEPRESSION"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":32,"therapeuticAreas":["Other"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Prometa","genericName":"Prometa","companyName":"University of California, Los Angeles","companyId":"university-of-california-los-angeles","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":2,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":false,"safety":true,"trials":true,"score":2}}