{"id":"betaine","rwe":[],"_fda":{"id":"ed80e4f1-5ff1-5d2f-e053-2995a90afc23","set_id":"10e46b39-7903-4390-b72d-865291245b4c","openfda":{"nui":["N0000175804","N0000175805","M0005152","N0000175831","N0000008595","N0000008924","N0000175830","N0000185508","N0000175629","N0000184306","M0000728","N0000009705","N0000175828","M0015703","N0000175949","M0021496"],"upc":["0317089350187"],"unii":["3SCV180C9W","A1ED6W905I","Q59QU6N72Q","H0G9379FGK","Y0C99N5TMZ","YEA9P21S8N","8406EY2OQA","789U1901C5","935E97BOY8","79Y1949PYO","E1UOL152H7","VSW71SS07I","JL5DK93RCL","81AH48963U","02R4V6T25Y","P658DCA9XD","1JQS135EYN","ETJ7Z6XBU4","GV54Q19G55","490XI1KB4S","AVX3D5A4LM","EJ27X76M46","00J9J9XKDE","J41CSQ7QDS"],"route":["ORAL"],"spl_id":["ed80e4f1-5ff1-5d2f-e053-2995a90afc23"],"brand_name":["GUNA-AWARENESS"],"spl_set_id":["10e46b39-7903-4390-b72d-865291245b4c"],"package_ndc":["17089-350-18"],"product_ndc":["17089-350"],"generic_name":["BETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN -"],"product_type":["HUMAN OTC DRUG"],"pharm_class_cs":["Copper [CS]","Allergens [CS]","Oxytocin [CS]","Thyrotropin [CS]"],"pharm_class_pe":["Decreased Embryonic Implantation [PE]","Decreased Sperm Motility [PE]","Inhibit Ovum Fertilization [PE]","Increased Histamine Release [PE]","Cell-mediated Immunity [PE]","Increased Uterine Smooth Muscle Contraction or Tone [PE]"],"substance_name":["BETAINE","BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN","BUFO BUFO CUTANEOUS GLAND","CALCIUM CARBONATE","CHROMIC SULFATE","CICUTA VIROSA ROOT","COBALAMIN","COPPER","FOLIC ACID","GOLD","IRON","LACHESIS MUTA VENOM","MELATONIN","MOLYBDENUM","NEUROTROPHIN-3","NEUROTROPHIN-4","OXYTOCIN","SILICON DIOXIDE","SUS SCROFA FRONTAL LOBE","SUS SCROFA TEMPORAL LOBE","THYROTROPIN ALFA","UBIDECARENONE","VANADIUM","ZINC"],"pharm_class_epc":["Methylating Agent [EPC]","Copper-containing Intrauterine Device [EPC]","Standardized Chemical Allergen [EPC]","Oxytocic [EPC]","Thyroid Stimulating Hormone [EPC]"],"pharm_class_moa":["Methylating Activity [MoA]"],"manufacturer_name":["Guna spa"],"is_original_packager":[true]},"purpose":["USES Temporary relief of symptoms related to: Difficulty concentrating Difficulty falling asleep Irritability"],"version":"5","warnings":["WARNINGS Stop use and ask doctor if symptoms persist more than 5 days or worsen. If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away. Contains ethyl alcohol 30%"],"questions":["QUESTIONS Questions?: info@gunainc.com, tel. (484) 223-3500"],"effective_time":"20221115","active_ingredient":["ACTIVE INGREDIENTS/PURPOSE AURUM METALLICUM 12X ANTIDEPRESSANT BRAIN DERIVED NEUROTROPHIC FACTOR 4C HELPS MENTAL ACTIVITY BUFO RANA 12X HELPS MENTAL ACTIVITY CALCAREA CARBONICA 3X IMMUNE STRENGTHENING CHROMIUM SULPHURICUM 3X DETOXIFICATION CICUTA VIROSA 12X ANTISPASTIC COBALAMIN 3X ANTIOXIDANT COENZYME Q 3X ANTIOXIDANT CUPRUM METALLICUM 12X ANTISPASTIC FERRUM METALLICUM 3X ANTIOXIDANT FOLIC ACID 3X ANTIOXIDANT FRONTAL LOBE 6X SUPPORTS COORDINATING BEHAVIOR LACHESIS MUTUS 12X ANTI-INFLAMMATORY MELATONIN 4C ANTISTRESS MOLYBDENUM METALLICUM 3X ANTIAGING NEUROTROPHIN 3 4C SUPPORTS MENTAL ACTIVITY NEUROTROPHIN 4 4C SUPPORTS MENTAL ACTIVITY OXYTOCIN 6X STIMULATES ADRENAL CORTEX SILICEA 12X IMMUNE STRENGTHENING TEMPORAL LOBE 6X SUPPORTS AUDITORY PROCESSING THYROTROPIN-RELEASING HORMONE 3X HELPS MENTAL ACTIVITY TRIMETHYLGLYCINE 3X DETOXIFICATION VANADIUM METALLICUM 6X ANTIOXIDANT ZINCUM METALLICUM 3X ANTISTRESS"],"inactive_ingredient":["Inactive ingredient : Ethyl alcohol 30%."],"indications_and_usage":["Take 15 minutes before meals"],"dosage_and_administration":["DIRECTIONS Take 15 minutes before meals Adults and children 12 years and older 20 drops in a little water, 2 times per day Children between 12 years and 6 years of age 10 drops in a little water, 2 times per day Children under 6 years 5 drops in a glass of water, 2 times per day"],"spl_product_data_elements":["GUNA-AWARENESS BETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN - ALCOHOL GOLD GOLD BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN BUFO BUFO CUTANEOUS GLAND BUFO BUFO CUTANEOUS GLAND CALCIUM CARBONATE CALCIUM CATION CHROMIC SULFATE CHROMIC CATION CICUTA VIROSA ROOT CICUTA VIROSA ROOT COBALAMIN COBALAMIN UBIDECARENONE UBIDECARENONE COPPER COPPER IRON IRON FOLIC ACID FOLIC ACID SUS SCROFA FRONTAL LOBE SUS SCROFA FRONTAL LOBE LACHESIS MUTA VENOM LACHESIS MUTA VENOM MELATONIN MELATONIN MOLYBDENUM MOLYBDENUM NEUROTROPHIN-3 NEUROTROPHIN-3 NEUROTROPHIN-4 NEUROTROPHIN-4 OXYTOCIN OXYTOCIN SILICON DIOXIDE SILICON DIOXIDE SUS SCROFA TEMPORAL LOBE SUS SCROFA TEMPORAL LOBE THYROTROPIN ALFA THYROTROPIN ALFA BETAINE BETAINE VANADIUM VANADIUM ZINC ZINC"],"pregnancy_or_breast_feeding":["PREGNANCY If pregnant or breast-feeding ask a doctor before use"],"keep_out_of_reach_of_children":["WARNINGS Keep out of reach of children"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL 5USAWA GUNA AWARENESS-Rev04-24-05-18"]},"tags":[{"label":"Methylating Agent","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"A09AB02","category":"atc"},{"label":"Topical","category":"route"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Cream","category":"form"},{"label":"For Solution","category":"form"},{"label":"Liquid","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Bacterial urinary infection","category":"indication"},{"label":"Complicated Proteus UTI","category":"indication"},{"label":"Complicated UTI with Pseudomonas Aeruginosa","category":"indication"},{"label":"Cystitis","category":"indication"},{"label":"E. Coli Pyelonephritis","category":"indication"},{"label":"Enterococcus Complicated UTI","category":"indication"},{"label":"Recordati Rare","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Antimetabolites","category":"pharmacology"},{"label":"Gastrointestinal Agents","category":"pharmacology"},{"label":"Hypolipidemic Agents","category":"pharmacology"},{"label":"Lipid Regulating Agents","category":"pharmacology"},{"label":"Lipotropic Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"153 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"95 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"92 reports"},{"date":"","signal":"OVERDOSE","source":"FDA FAERS","actionTaken":"89 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"73 reports"},{"date":"","signal":"PRODUCT DOSE OMISSION","source":"FDA FAERS","actionTaken":"63 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"57 reports"},{"date":"","signal":"PRODUCT DOSE OMISSION ISSUE","source":"FDA FAERS","actionTaken":"54 reports"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"50 reports"},{"date":"","signal":"SEIZURE","source":"FDA FAERS","actionTaken":"48 reports"}],"commonSideEffects":[{"effect":"Mild transient diarrhea","drugRate":"","severity":"common","organSystem":""},{"effect":"Itching","drugRate":"","severity":"common","organSystem":""},{"effect":"Transitory exanthema","drugRate":"","severity":"common","organSystem":""},{"effect":"Feeling of swelling of entire body","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Achilles tendinitis","Acute pancreatitis","Cerebral edema","Congenital long QT syndrome","Crohn's disease","Epilepsy","Gastrointestinal obstruction","Hypermethioninemia","Hypokalemia","Kidney disease","Lowered convulsive threshold","Meconium ileus","Myasthenia gravis","Operation on gastrointestinal tract","Peripheral nerve disease","Prolonged QT interval","Pseudomembranous enterocolitis","Short bowel syndrome","Shoulder Tendonitis","Tendinitis","Torsades de pointes","Transplant of kidney","Transplant of lung","Transplantation of heart","Traumatic rupture of tendon"],"specialPopulations":{"Pregnancy":"Animal reproduction studies have not been conducted with Cystadane. Use only if clearly needed. Available data from limited number of published case reports and post marketing experience with Betaine Anhydrous for Oral Solution use in pregnancy have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.","Nursing women":"It is not known whether Cystadane is excreted in human milk. Use only if clearly needed. There are no data on the presence of betaine in human or animal milk, the effects on the breastfed child, or the effects on milk production.","Paediatric use":"Pediatric patients ranging in age from 24 days to 17 years have been treated with Cystadane. Children younger than years of age may benefit from dose titration. The safety and effectiveness of Betaine Anhydrous for Oral Solution have been established in pediatric patients."},"seriousAdverseEvents":[{"effect":"Polycythemia vera","drugRate":"","severity":"serious"},{"effect":"Allergic sensitization","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Recordati","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BETAINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:06:37.196347+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:06:43.690384+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T01:06:37.267509+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T01:06:36.325655+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:06:35.163520+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:06:35.163550+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:06:35.163556+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":"2026-04-20T01:06:45.382749+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Betaine-homocysteine S-methyltransferase substrate","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:06:44.972350+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL95889/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:06:44.637828+00:00"}},"allNames":"cystadane","offLabel":[],"synonyms":["betaine","oxyneurine","betafin","glycine betaine","betaine anhydrous","betaine hydrochloride","betaine chloride","cystadane","betaine HCl"],"timeline":[{"date":"1996-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from RARE DIS THERAP to Recordati Rare"},{"date":"1996-10-25","type":"positive","source":"DrugCentral","milestone":"FDA approval (Rare Dis Therap)"},{"date":"2007-02-14","type":"positive","source":"DrugCentral","milestone":"EMA approval (Orphan Europe S.A.R.L.)"},{"date":"2022-01-28","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 2 manufacturers approved"}],"brandName":"Cystadane","ecosystem":[{"indication":"Bacterial urinary infection","otherDrugs":[{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"avibactam","slug":"avibactam","company":"Cerexa Inc"}],"globalPrevalence":null},{"indication":"Complicated Proteus UTI","otherDrugs":[{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"cefepime","slug":"cefepime","company":"Hospira Inc"},{"name":"ceftazidime","slug":"ceftazidime","company":"Covis Injectables"},{"name":"ciprofloxacin","slug":"ciprofloxacin","company":"Bayer Hlthcare"}],"globalPrevalence":null},{"indication":"Complicated UTI with Pseudomonas Aeruginosa","otherDrugs":[{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"ceftazidime","slug":"ceftazidime","company":"Covis Injectables"},{"name":"ciprofloxacin","slug":"ciprofloxacin","company":"Bayer Hlthcare"},{"name":"gentamicin","slug":"gentamicin","company":"Schering"}],"globalPrevalence":null},{"indication":"Cystitis","otherDrugs":[{"name":"ciprofloxacin","slug":"ciprofloxacin","company":"Bayer Hlthcare"},{"name":"norfloxacin","slug":"norfloxacin","company":""},{"name":"ofloxacin","slug":"ofloxacin","company":""}],"globalPrevalence":null},{"indication":"E. Coli Pyelonephritis","otherDrugs":[{"name":"cefepime","slug":"cefepime","company":"Hospira Inc"},{"name":"ciprofloxacin","slug":"ciprofloxacin","company":"Bayer Hlthcare"},{"name":"ertapenem","slug":"ertapenem","company":"Merck Sharp Dohme"},{"name":"gatifloxacin","slug":"gatifloxacin","company":"Allergan"}],"globalPrevalence":null},{"indication":"Enterococcus Complicated UTI","otherDrugs":[{"name":"ciprofloxacin","slug":"ciprofloxacin","company":"Bayer Hlthcare"},{"name":"norfloxacin","slug":"norfloxacin","company":""},{"name":"ofloxacin","slug":"ofloxacin","company":""},{"name":"piperacillin","slug":"piperacillin","company":""}],"globalPrevalence":null},{"indication":"Escherichia coli urinary tract infection","otherDrugs":[{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"aztreonam","slug":"aztreonam","company":"Bristol Myers Squibb"},{"name":"carbenicillin","slug":"carbenicillin","company":"Roerig"}],"globalPrevalence":null},{"indication":"Homocystinuria","otherDrugs":[],"globalPrevalence":132000}],"mechanism":{"novelty":"Follow-on","moaClass":"Methylating Activity","modality":"Small Molecule","drugClass":"Methylating Agent [EPC]","explanation":"","oneSentence":"","technicalDetail":"Cystadane (BETAINE) acts as a methyl donor, facilitating the conversion of homocysteine to methionine via the enzyme methionine synthase, which requires vitamin B12 as a cofactor."},"commercial":{"launchDate":"1996","_launchSource":"DrugCentral (FDA 1996-10-25, RARE DIS THERAP)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/347","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BETAINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BETAINE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T08:58:42.421289","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:06:46.686387+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"glutamic acid","drugSlug":"glutamic-acid","fdaApproval":"","relationship":"same-class"},{"drugName":"citric acid","drugSlug":"citric-acid","fdaApproval":"1982-06-22","relationship":"same-class"}],"genericName":"betaine","indications":{"approved":[{"name":"Bacterial urinary infection","source":"DrugCentral","snomedId":312124009,"regulator":"FDA","eligibility":"no information available"},{"name":"Complicated Proteus UTI","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"no information available"},{"name":"Complicated UTI with Pseudomonas Aeruginosa","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"no information available"},{"name":"Cystitis","source":"DrugCentral","snomedId":38822007,"regulator":"FDA","eligibility":"no information available"},{"name":"E. 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