{"id":"arsenic-trioxide","rwe":[],"_fda":{"id":"b071dd55-090c-4989-ba4c-869c5f0f6a0b","set_id":"02661e24-1270-4b5b-9a62-ca156015f33c","openfda":{"unii":["S7V92P67HO","396421SP9F","Q28R5GF371","VSW71SS07I","R03O05RB0P","11E6VI8VEG","K93UPA2CNQ","70FD1KFU70","46PYZ1F82M"],"route":["ORAL"],"spl_id":["b071dd55-090c-4989-ba4c-869c5f0f6a0b"],"brand_name":["Hevert Detox Lymph"],"spl_set_id":["02661e24-1270-4b5b-9a62-ca156015f33c"],"package_ndc":["54532-0034-5"],"product_ndc":["54532-0034"],"generic_name":["ARSENIC TRIOXIDE, CLEMATIS RECTA FLOWERING TOP, CONIUM MACULATUM FLOWERING TOP, LACHESIS MUTA VENOM, MERCURIC IODIDE, PHYTOLACCA AMERICANA ROOT, TOXICODENDRON PUBESCENS SHOOT, SCROPHULARIA NODOSA LEAF WITH STEM, AND SULFUR"],"product_type":["HUMAN OTC DRUG"],"substance_name":["ARSENIC TRIOXIDE","CLEMATIS RECTA FLOWERING TOP","CONIUM MACULATUM FLOWERING TOP","LACHESIS MUTA VENOM","MERCURIC IODIDE","PHYTOLACCA AMERICANA ROOT","SCROPHULARIA NODOSA LEAF WITH STEM","SULFUR","TOXICODENDRON PUBESCENS SHOOT"],"manufacturer_name":["Hevert Arzneimittel GmbH & Co KG"],"is_original_packager":[true]},"purpose":["Active ingredients Purpose \"X\" indicates a homeopathic dilution. For more information visit: www.hevertusa.com Arsenicum album 6X Relief of discomfort associated with lymphatic swelling and edema Clematis 4X Conium 6X Lachesis 8X Mercurius bijodatus 8X Phytolacca 4X Rhus toxicodendron 6X Scrophularia nodosa, herba 3X Sulfur 4X"],"version":"3","stop_use":["Stop use and ask a doctor if you suffer from thyroid disease or symptoms persist for more than 7 days, worsen or new symptoms occur."],"warnings":["Warnings For oral use only. Chronically enlarged lymph nodes can be the sign of different diseases. Therefore, consult a doctor in order to clarify the underlying disease before using this medicine. Also consult a doctor promptly in case of acute signs of inflammation (redness, heat, swelling, pain and dysfunction) and fever or enlargement of the lymph nodes during treatment. Do not use if you are allergic to Rhus toxicodendron or other plants from the cashew family Stop use and ask a doctor if you suffer from thyroid disease or symptoms persist for more than 7 days, worsen or new symptoms occur. 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."],"questions":["Questions? 1-855-387-6466"],"ask_doctor":["Chronically enlarged lymph nodes can be the sign of different diseases. Therefore, consult a doctor in order to clarify the underlying disease before using this medicine. Also consult a doctor promptly in case of acute signs of inflammation (redness, heat, swelling, pain and dysfunction) and fever or enlargement of the lymph nodes during treatment."],"do_not_use":["Do not use if you are allergic to Rhus toxicodendron or other plants from the cashew family"],"purpose_table":["
Active ingredientsPurpose
"X" indicates a homeopathic dilution. For more information visit: www.hevertusa.com
Arsenicum album 6XRelief of discomfort associated with lymphatic swelling and edema
Clematis 4X
Conium 6X
Lachesis 8X
Mercurius bijodatus 8X
Phytolacca 4X
Rhus toxicodendron 6X
Scrophularia nodosa, herba 3X
Sulfur 4X
"],"effective_time":"20221220","active_ingredient":["Active ingredients Purpose \"X\" indicates a homeopathic dilution. For more information visit: www.hevertusa.com Arsenicum album 6X Relief of discomfort associated with lymphatic swelling and edema Clematis 4X Conium 6X Lachesis 8X Mercurius bijodatus 8X Phytolacca 4X Rhus toxicodendron 6X Scrophularia nodosa, herba 3X Sulfur 4X"],"inactive_ingredient":["Inactive ingredients 46 % ethanol V/V, purified water"],"storage_and_handling":["Other information Store at 68 to 77 °F. Tamper Evident: Do not use if tamper evident strip is broken or missing from base of bottle cap. To report serious adverse events, call 1-855-387-6466."],"indications_and_usage":["Uses For temporary relief of discomfort associated with lymphatic swelling and edema. Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."],"active_ingredient_table":["
Active ingredientsPurpose
"X" indicates a homeopathic dilution. For more information visit: www.hevertusa.com
Arsenicum album 6XRelief of discomfort associated with lymphatic swelling and edema
Clematis 4X
Conium 6X
Lachesis 8X
Mercurius bijodatus 8X
Phytolacca 4X
Rhus toxicodendron 6X
Scrophularia nodosa, herba 3X
Sulfur 4X
"],"spl_unclassified_section":["Drug Facts","Distributed by: Hevert Pharmaceuticals, LLC Boulder, CO 80303"],"dosage_and_administration":["Directions Adults and children over 12 years of age: Take 20 drops in water 3 times daily. Consult a physician for use in children under 12 years of age. Do not use for children under 1 year of age."],"spl_product_data_elements":["Hevert Detox Lymph Arsenic Trioxide, Clematis Recta Flowering top, Conium Maculatum Flowering Top, Lachesis Muta Venom, Mercuric Iodide, Phytolacca Americana Root, Toxicodendron Pubescens shoot, Scrophularia Nodosa leaf with stem, and Sulfur Arsenic Trioxide Arsenic Cation (3+) Clematis Recta Flowering top Clematis Recta Flowering top Conium Maculatum Flowering Top Conium Maculatum Flowering Top Lachesis Muta Venom Lachesis Muta Venom Mercuric Iodide Mercuric Iodide Phytolacca Americana Root Phytolacca Americana Root Toxicodendron Pubescens shoot Toxicodendron Pubescens shoot Scrophularia Nodosa leaf with stem Scrophularia Nodosa leaf with stem Sulfur Sulfur ALCOHOL WATER"],"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. In case of overdose, get medical help or contact a Poison Control Center right away."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton NDC 54532-0034-5 HEVERT ® DETOX LYMPH Homeopathic Medicine For the lymphatic system 1.7 fl oz (50 ml) 46 % alcohol V/V Oral drops Made in Germany hEVERT Principal Display Panel - 50 ml Bottle Carton"]},"tags":[{"label":"High Risk QT Prolonging Agents","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Potassium voltage-gated channel subfamily H member 2","category":"target"},{"label":"KCNH2","category":"gene"},{"label":"TXNRD1","category":"gene"},{"label":"L01XX27","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Oral","category":"route"},{"label":"Injection","category":"form"},{"label":"Liquid","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Acute myelomonocytic leukemia, FAB M4","category":"indication"},{"label":"Acute promyelocytic leukemia, FAB M3","category":"indication"},{"label":"Cephalon","category":"company"},{"label":"Approved 2000s","category":"decade"},{"label":"Antineoplastic Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"292 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"275 reports"},{"date":"","signal":"ELECTROCARDIOGRAM QT PROLONGED","source":"FDA FAERS","actionTaken":"258 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"239 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"232 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"225 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"218 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"217 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"211 reports"},{"date":"","signal":"DIFFERENTIATION SYNDROME","source":"FDA FAERS","actionTaken":"210 reports"}],"drugInteractions":[{"url":"/drug/high-risk-qt-prolonging-agents","drug":"High Risk QT Prolonging Agents","action":"Avoid combination","effect":"Highest Risk QTc-Prolonging Agents may enhance the QTc-prolonging effect of other Highest Risk QTc-Prolonging Agents","source":"DrugCentral","drugSlug":"high-risk-qt-prolonging-agents"},{"url":"/drug/ziprasidone","drug":"ziprasidone","action":"Avoid combination","effect":"May interact with Ziprasidone","source":"DrugCentral","drugSlug":"ziprasidone"}],"commonSideEffects":[{"effect":"Nausea","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Cough","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Pyrexia","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Abdominal pain","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Tachycardia","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Dyspnea","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Hypokalemia","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Leukocytosis","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Hyperglycemia","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Hypomagnesemia","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Insomnia","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Dermatitis","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Edema","drugRate":"30%","severity":"common","organSystem":""},{"effect":"QTc prolongation","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Rigors","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Sore throat","drugRate":"30%","severity":"common","organSystem":""}],"contraindications":["Breastfeeding (mother)","Chronic heart failure","Complete atrioventricular block","Congenital long QT syndrome","Disease of liver","Hyperkalemia","Hypokalemia","Hypomagnesemia","Kidney disease","Pregnancy, function","Prolonged QT interval","Torsades de pointes"],"specialPopulations":{"Pregnancy":"Arsenic trioxide can cause fetal harm when administered to pregnant woman. Arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day at dose approximately 10 times the recommended human daily dose on mg/m2 basis.","Geriatric use":"Use of arsenic trioxide injection as monotherapy in patients with relapsed or refractory APL is supported by the open-label, single-arm trial that included patients aged 65 and older (range: 65 to 73 years).","Paediatric use":"The safety and efficacy of arsenic trioxide injection as single agent for treatment of pediatric patients with relapsed or refractory APL is supported by the pivotal phase study in 40 patients with relapsed or refractory APL.","Renal impairment":"Monitor patients with severe renal impairment (creatinine clearance less than 30 mL/min) for toxicity when treated with Arsenic Trioxide Injection; dose reduction may be warranted.","Hepatic impairment":"Monitor patients with severe hepatic impairment (Child-Pugh Class C) for toxicity when treated with Arsenic Trioxide Injection."},"seriousAdverseEvents":[{"effect":"Thrombocytopenia > 15 days (Grade 3-4)","drugRate":"58%","severity":"serious"},{"effect":"Hepatic toxicity (Grade 3-4)","drugRate":"40%","severity":"serious"},{"effect":"Neutropenia > 15 days (Grade 3-4)","drugRate":"48%","severity":"serious"},{"effect":"Infection and fever of unknown origin","drugRate":"23%","severity":"serious"},{"effect":"Hypertriglyceridemia","drugRate":"22%","severity":"serious"},{"effect":"QT prolongation","drugRate":"9%","severity":"serious"},{"effect":"Differentiation syndrome","drugRate":"2%","severity":"serious"},{"effect":"Pneumonia","drugRate":"2%","severity":"serious"},{"effect":"Abnormal liver tests","drugRate":"2%","severity":"serious"}]},"trials":[],"aliases":[],"company":"Cephalon","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ARSENIC TRIOXIDE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:42:26.026071+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:42:32.194486+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T00:42:26.098030+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:42:25.146188+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ARSENIC TRIOXIDE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:42:32.512116+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:42:23.799346+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:42:23.799370+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":"2026-04-20T00:42:34.091018+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Thioredoxin reductase 1 inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:42:33.562545+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL5483015/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:42:33.224222+00:00"}},"allNames":"trisenox","offLabel":[],"synonyms":["trisenox","arsenic trioxide","arsenic oxide","arsenious oxide","arsenious trioxide","white arsenic"],"timeline":[{"date":"2000-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from CEPHALON to Cephalon"},{"date":"2000-09-25","type":"positive","source":"DrugCentral","milestone":"FDA approval (Cephalon)"},{"date":"2019-11-14","type":"positive","source":"DrugCentral","milestone":"EMA approval (Accord Healthcare Slu)"},{"date":"2023-04-20","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 11 manufacturers approved"}],"aiSummary":"Trisenox is a small molecule inhibitor of thioredoxin reductase 1, used in the treatment of Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) and Adult Acute Promyelocytic Leukemia (M3).","brandName":"Trisenox","ecosystem":[{"indication":"Acute myelomonocytic leukemia, FAB M4","otherDrugs":[],"globalPrevalence":null},{"indication":"Acute promyelocytic leukemia, FAB M3","otherDrugs":[{"name":"cytarabine","slug":"cytarabine","company":""},{"name":"daunorubicin","slug":"daunorubicin","company":""},{"name":"idarubicin","slug":"idarubicin","company":""},{"name":"mercaptopurine","slug":"mercaptopurine","company":"Stason Pharms"}],"globalPrevalence":null}],"mechanism":{"target":"Potassium voltage-gated channel subfamily H member 2","novelty":"Follow-on","targets":[{"gene":"KCNH2","source":"DrugCentral","target":"Potassium voltage-gated channel subfamily H member 2","protein":"Potassium voltage-gated channel subfamily H member 2"},{"gene":"TXNRD1","source":"DrugCentral","target":"Thioredoxin reductase 1, cytoplasmic","protein":"Thioredoxin reductase 1, cytoplasmic"}],"modality":"Small Molecule","drugClass":"High Risk QT Prolonging Agents","explanation":"","oneSentence":"","technicalDetail":"Trisenox binds to the Kv11.1 potassium channel, leading to the inhibition of potassium efflux and subsequent depolarization of the cell membrane, which triggers a series of downstream events resulting in apoptosis."},"commercial":{"launchDate":"2000","_launchSource":"DrugCentral (FDA 2000-09-25, CEPHALON)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/244","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ARSENIC%20TRIOXIDE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ARSENIC 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2026","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"eribulin","drugSlug":"eribulin","fdaApproval":"2010-11-15","patentExpiry":"Jul 8, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"aflibercept","drugSlug":"aflibercept","fdaApproval":"2011-11-18","relationship":"same-class"},{"drugName":"venetoclax","drugSlug":"venetoclax","fdaApproval":"2016-04-11","patentExpiry":"Sep 6, 2033","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"enasidenib","drugSlug":"enasidenib","fdaApproval":"2017-08-01","patentExpiry":"Sep 16, 2034","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"ivosidenib","drugSlug":"ivosidenib","fdaApproval":"2018-07-20","patentExpiry":"Oct 18, 2036","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"selinexor","drugSlug":"selinexor","fdaApproval":"2019-07-03","patentExpiry":"Jul 3, 2033","patentStatus":"Patent 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TRIOXIDE","evidenceCount":0,"evidenceLevel":"emerging"}],"pipeline":[]},"currentOwner":"Cephalon","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"asparaginase","brandName":"asparaginase","genericName":"asparaginase","approvalYear":"1994","relationship":"same-class"},{"drugId":"altretamine","brandName":"altretamine","genericName":"altretamine","approvalYear":"1990","relationship":"same-class"},{"drugId":"hydroxycarbamide","brandName":"hydroxycarbamide","genericName":"hydroxycarbamide","approvalYear":"1967","relationship":"same-class"},{"drugId":"pentostatin","brandName":"pentostatin","genericName":"pentostatin","approvalYear":"1991","relationship":"same-class"},{"drugId":"masoprocol","brandName":"masoprocol","genericName":"masoprocol","approvalYear":"1992","relationship":"same-class"},{"drugId":"mitotane","brandName":"mitotane","genericName":"mitotane","approvalYear":"1970","relationship":"same-class"},{"drugId":"pegaspargase","brandName":"pegaspargase","genericName":"pegaspargase","approvalYear":"1994","relationship":"same-class"},{"drugId":"denileukin-diftitox","brandName":"denileukin 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Breadner","startDate":"2026-02-15","conditions":["Advanced Pancreatic Ductal Adenocarcinoma"],"enrollment":10,"completionDate":"2027-03"},{"nctId":"NCT04336644","phase":"NA","title":"Continuous Versus Intermittent cARdiac Electrical moNitorinG","status":"RECRUITING","sponsor":"Washington University School of Medicine","startDate":"2023-11-21","conditions":["Torsades de Pointe Caused by Drug","Long QT Syndrome"],"enrollment":60,"completionDate":"2026-12-31"},{"nctId":"NCT07296445","phase":"PHASE3","title":"A Trial to Investigate Whether Oral Arsenic Trioxide Is Similar to Intravenous Arsenic Trioxide in Pharmacokinetics, Safety, and Efficacy (LATITUDE/SDKARS-301)","status":"NOT_YET_RECRUITING","sponsor":"SDK Therapeutics, Inc.","startDate":"2026-01","conditions":["Acute Promyelocytic Leukemia (APL)","Acute Promyelocytic Leukaemia","Acute Promyelocytic Leukemia With PML-RARA","Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA","APL","Acute Promyelocytic Leukemia","Leukaemia","Leukemia Acute Promyelocytic Leukemia (APL)","Leukemia, Acute"],"enrollment":120,"completionDate":"2029-01"},{"nctId":"NCT01409161","phase":"PHASE2","title":"Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2011-10-05","conditions":["Acute Promyelocytic Leukemia With PML-RARA"],"enrollment":151,"completionDate":"2027-12-18"},{"nctId":"NCT06882031","phase":"PHASE1","title":"Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia","status":"COMPLETED","sponsor":"SDK Therapeutics, Inc.","startDate":"2025-03-11","conditions":["Acute Promyelocytic Leukemia (APL)"],"enrollment":12,"completionDate":"2025-06-30"},{"nctId":"NCT07187505","phase":"NA","title":"Venetoclax Combined With ATRA 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