{"id":"l-cysteine","rwe":[],"_fda":{"id":"f35466c4-1e95-4c90-8342-84acc52a124e","set_id":"2061fdfd-1ceb-4c0b-b33a-10ebd30fbef5","openfda":{"unii":["K848JZ4886"],"route":["ORAL"],"spl_id":["f35466c4-1e95-4c90-8342-84acc52a124e"],"brand_name":["L-Cysteine 7403"],"spl_set_id":["2061fdfd-1ceb-4c0b-b33a-10ebd30fbef5"],"package_ndc":["63083-7403-2"],"product_ndc":["63083-7403"],"generic_name":["L-CYSTEINE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["CYSTEINE"],"manufacturer_name":["Professional Complementary Health Formulas"],"is_original_packager":[true]},"purpose":["*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."],"version":"2","warnings":["WARNINGS In case of overdose, get medical help or contact a poison control center right away. Keep out of the reach of children. If pregnant or breastfeeding, ask a healthcare professional before use."],"questions":["QUESTIONS Professional Formulas PO Box 2034 Lake Oswego, OR 97035"],"effective_time":"20260108","active_ingredient":["ACTIVE INGREDIENTS L-Cysteine 4X, 7X, 12X"],"inactive_ingredient":["INACTIVE INGREDIENTS 20% ethanol, purified water."],"indications_and_usage":["INDICATIONS For the temporary relief of nausea, diarrhea, occasional headache, dizziness or loss of balance, irritability, sneezing, mild back pain or stiffness, or feelings of discomfort or uneasiness.*"],"other_safety_information":["OTHER INFORMATION Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat."],"dosage_and_administration":["DIRECTIONS Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age."],"spl_product_data_elements":["L-Cysteine 7403 L-Cysteine CYSTEINE CYSTEINE ALCOHOL WATER"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding, ask a healthcare professional before use."],"keep_out_of_reach_of_children":["Keep out of the reach of children."],"package_label_principal_display_panel":["LABEL Est 1985 Professional Formulas Complementary Health L-Cysteine Homeopathic Remedy 2 FL. OZ. (59 mL) Label image"]},"tags":[],"safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"4 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"4 reports"},{"date":"","signal":"HYPOKALAEMIA","source":"FDA FAERS","actionTaken":"4 reports"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"3 reports"},{"date":"","signal":"CONDITION AGGRAVATED","source":"FDA FAERS","actionTaken":"3 reports"},{"date":"","signal":"DYSPEPSIA","source":"FDA FAERS","actionTaken":"3 reports"},{"date":"","signal":"GAIT DISTURBANCE","source":"FDA FAERS","actionTaken":"3 reports"},{"date":"","signal":"GLYCOSURIA","source":"FDA FAERS","actionTaken":"3 reports"},{"date":"","signal":"INSOMNIA","source":"FDA FAERS","actionTaken":"3 reports"},{"date":"","signal":"MALAISE","source":"FDA FAERS","actionTaken":"3 reports"}],"drugInteractions":[],"commonSideEffects":[{"effect":"Mild transient diarrhea","drugRate":"","severity":"mild","organSystem":""},{"effect":"Itching","drugRate":"","severity":"mild","organSystem":""},{"effect":"Transitory exanthema","drugRate":"","severity":"mild","organSystem":""},{"effect":"Feeling of swelling of entire body","drugRate":"","severity":"mild","organSystem":""}],"contraindications":["Acute exacerbation of asthma","Bronchospasm","Classical phenylketonuria","Decreased respiratory function","Esophageal varices","Gastrointestinal hemorrhage","Gastrointestinal ulcer","Low blood pressure","Peptic ulcer"],"specialPopulations":{},"seriousAdverseEvents":[{"effect":"Polycythemia vera","drugRate":"","severity":"serious"},{"effect":"Allergic sensitization","drugRate":"","severity":"serious"}]},"trials":[],"_chembl":null,"aliases":["amino acid"],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=L-cysteine","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:09:10.671148+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:09:17.023785+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=L-cysteine","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:09:17.664610+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:09:08.167226+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:09:08.167275+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":"2026-04-20T03:09:19.690936+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL863/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:09:18.624575+00:00"}},"offLabel":[],"timeline":[],"_dailymed":{"setId":"2061fdfd-1ceb-4c0b-b33a-10ebd30fbef5","title":"L-CYSTEINE 7403 (L-CYSTEINE) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]"},"aiSummary":"L-cysteine is an amino acid that has been studied for its potential to provide temporary relief for various symptoms such as nausea, diarrhea, and occasional headaches. It is not a primary treatment but can be used as a supportive measure. The drug's mechanism involves its role in antioxidant defense and detoxification processes, which may help alleviate some of these symptoms. However, it is important to note that L-cysteine is generally considered a dietary supplement rather than a pharmaceutical drug, and its use should be guided by healthcare professionals.","ecosystem":[],"mechanism":{"target":"Cystine/glutamate transporter","novelty":"Well-established amino acid with multiple physiological roles","modality":"Oral supplementation","drugClass":"Amino acid derivative","explanation":"","oneSentence":"","technicalDetail":"L-cysteine is converted into cysteine, which is then used in the synthesis of glutathione (GSH) via the enzyme gamma-glutamylcysteine synthetase. GSH is a critical component of the cellular antioxidant defense system, helping to neutralize reactive oxygen species (ROS) and maintain redox balance."},"_scrapedAt":"2026-03-28T04:30:09.870Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":null,"launchDate":null,"annualCostUS":null,"currentRevenue":null,"patientPopulation":null,"peakSalesEstimate":null},"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:09:21.773070+00:00","fieldsConflicting":2,"overallConfidence":0.8},"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":"Thick Bronchial Secretions","diseaseId":"thick-bronchial-secretions","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":["Temporary relief of nausea","Temporary relief of diarrhea","Temporary relief of occasional headache","Temporary relief of dizziness or loss of balance","Temporary relief of irritability","Temporary relief of sneezing","Temporary relief of mild back pain or stiffness","Temporary relief of feelings of discomfort or uneasiness"]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05142735","phase":"NA","title":"Effects of NAC on Symptoms of CHR Patients","status":"RECRUITING","sponsor":"Centre for Addiction and Mental Health","startDate":"2023-01-13","conditions":"Prodromal Schizophrenia","enrollment":90},{"nctId":"NCT07273071","phase":"PHASE4","title":"Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections: N-Acetylcysteine","status":"NOT_YET_RECRUITING","sponsor":"Theis S. 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