{"id":"copper","rwe":[{"pmid":"41912998","year":"2026","title":"Assessment of oil contamination from the El Grillo shipwreck in Seydisfjordur, Iceland: implications for aquaculture.","finding":"","journal":"Environmental science and pollution research international","studyType":"Clinical Study"},{"pmid":"41912773","year":"2026","title":"OTUB1/CDYL axis-mediated epigenetic repression of SOX18 facilitates lung cancer progression by inhibiting FDX1-dependent cuproptosis.","finding":"","journal":"Oncogene","studyType":"Clinical Study"},{"pmid":"41912635","year":"2026","title":"Risk factors associated with urinary metal concentrations in middle-aged and older Caribbean adults: the Tobago Health Study.","finding":"","journal":"Journal of exposure science & environmental epidemiology","studyType":"Clinical Study"},{"pmid":"41912417","year":"2026","title":"Effective Removal of Calcium Dobesilate Interference in Triglyceride Measurement Using Copper Oxide.","finding":"","journal":"The journal of applied laboratory medicine","studyType":"Clinical Study"},{"pmid":"41912275","year":"2026","title":"Copper-Catalyzed Enantioconvergent Nucleophilic Fluorination of Alkyl Electrophiles to Generate α-Fluoroamides.","finding":"","journal":"Journal of the American Chemical Society","studyType":"Clinical Study"}],"_fda":{"id":"1c320dfd-afb8-9ac2-e063-6394a90a397e","set_id":"051a4e17-c665-ec4d-e063-6294a90aabe6","openfda":{"nui":["M0005152","N0000175831","N0000008595","N0000008924","N0000175830","N0000185375","N0000175629","N0000184306","N0000185001","M0000728","M0016962","M0516536"],"unii":["O80TY208ZW","01G9XEA93N","789U1901C5","HF539G9L3Q","CLF5YFS11O","269XH13919"],"route":["ORAL"],"spl_id":["1c320dfd-afb8-9ac2-e063-6394a90a397e"],"brand_name":["Arnicare Leg Cramps"],"spl_set_id":["051a4e17-c665-ec4d-e063-6294a90aabe6"],"package_ndc":["0220-9079-04","0220-9079-29"],"product_ndc":["0220-9079"],"generic_name":["ARNICA MONTANA WHOLE, COPPER, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, STRYCHNOS NUX-VOMICA SEED, PASSIFLORA INCARNATA TOP, CLAVICEPS PURPUREA SCLEROTIUM"],"product_type":["HUMAN OTC DRUG"],"pharm_class_cs":["Copper [CS]","Allergens [CS]","Plant Proteins [CS]","Seed Storage Proteins [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 IgG Production [PE]"],"substance_name":["ARNICA MONTANA","CLAVICEPS PURPUREA SCLEROTIUM","COPPER","MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE","PASSIFLORA INCARNATA TOP","STRYCHNOS NUX-VOMICA SEED"],"pharm_class_epc":["Copper-containing Intrauterine Device [EPC]","Non-Standardized Plant Allergenic Extract [EPC]"],"manufacturer_name":["Laboratoires Boiron"],"is_original_packager":[true]},"purpose":["Purpose* Arnica montana 6C HPUS ... Temporarily relieves minor muscle pain Cuprum metallicum 4C HPUS ... Relieves sudden muscle cramps in the legs, calves, feet, and toes Magnesia phosphorica 6C HPUS ... Relieves flashing pain and cramps in the calves and thighs, at night Nux vomica 6C HPUS ... Relieves cramps in the legs, thighs, calves and toes, at night Passiflora incarnata 3X HPUS ... Helps to fall back asleep Secale cornutum 9C HPUS ... Relieves leg cramps at night"],"version":"3","stop_use":["Stop use and ask a doctor if symptoms persist for more than 3 days or worsen, new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition."],"warnings":[""],"questions":["Questions or comments? Arnicare.com BoironUSA.com Info@Boiron.com 1-800-BOIRON-1 (1-800-264-7661) Made in France Distributed by Boiron, Inc. Newtown Square, PA 19073"],"effective_time":"20240701","active_ingredient":["Active ingredients** (in each tablet) Arnica montana 6C HPUS (0.42 mg) Cuprum metallicum 4C HPUS (0.42 mg) Magnesia phosphorica 6C HPUS (0.42 mg) Nux vomica 6C HPUS (0.42 mg) (contains less than 10 -13 mg strychnine alkaloids) Passiflora incarnata 3X HPUS (0.42 mg) Secale cornutum 9C HPUS (0.42 mg) (contains less thank 10 -20 mg ergotamine alkaloids) The letters \"HPUS\" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States."],"inactive_ingredient":["croscarmellose sodium, lactose, magnesium stearate"],"indications_and_usage":["Uses* temporarily relieves nighttime cramps in legs, thighs, calves, feet, and toes with accompanying occasional disrupted sleep"],"spl_unclassified_section":["do not use if glued carton end flaps are open or if the blister seal is broken store below 86 o F (30 o C) 60 Meltaway Tablets, unflavored 120 Meltaway Tablets, unflavored Nighttime Leg Cramp Relief* Plant-Based & Other Pure Actives Non-Habit Forming No Known Drug Interactions No Artificial Sweeteners, Flavors, Colors or Preservatives *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. **C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details."],"dosage_and_administration":["Adults and children 18 years of age and older: At the onset of symptoms, dissolve 2 tablets in the mouth at bedtime and during the night if needed, for up to 6 times per 24 hours. Children under 18 years of age: Not recommended."],"spl_product_data_elements":["Arnicare Leg Cramps ARNICA MONTANA WHOLE, COPPER, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, STRYCHNOS NUX-VOMICA SEED, PASSIFLORA INCARNATA TOP, CLAVICEPS PURPUREA SCLEROTIUM PASSIFLORA INCARNATA TOP PASSIFLORA INCARNATA TOP MAGNESIUM STEARATE CROSCARMELLOSE SODIUM COPPER COPPER LACTOSE, UNSPECIFIED FORM ARNICA MONTANA ARNICA MONTANA MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE MAGNESIUM CATION STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED CLAVICEPS PURPUREA SCLEROTIUM CLAVICEPS PURPUREA SCLEROTIUM Boiron"],"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":["label label label label label label"]},"tags":[{"label":"Copper-containing Intrauterine Device [EPC]","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Oral","category":"route"},{"label":"Powder","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"nighttime cramps in legs","category":"indication"},{"label":"nighttime cramps in thighs","category":"indication"},{"label":"nighttime cramps in calves","category":"indication"},{"label":"nighttime cramps in feet","category":"indication"},{"label":"nighttime cramps in toes","category":"indication"},{"label":"disrupted sleep","category":"indication"},{"label":"Sebela Womens Hlth","category":"company"},{"label":"Approved 2020s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DEVICE EXPULSION","source":"FDA FAERS","actionTaken":"10636 reports"},{"date":"","signal":"DEVICE BREAKAGE","source":"FDA FAERS","actionTaken":"9388 reports"},{"date":"","signal":"COMPLICATION OF DEVICE REMOVAL","source":"FDA FAERS","actionTaken":"8216 reports"},{"date":"","signal":"FOREIGN BODY IN REPRODUCTIVE TRACT","source":"FDA FAERS","actionTaken":"7285 reports"},{"date":"","signal":"DEVICE DISLOCATION","source":"FDA FAERS","actionTaken":"6762 reports"},{"date":"","signal":"COMPLICATION OF DEVICE INSERTION","source":"FDA FAERS","actionTaken":"6075 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"5324 reports"},{"date":"","signal":"REPRODUCTIVE COMPLICATION ASSOCIATED WITH DEVICE","source":"FDA FAERS","actionTaken":"3764 reports"},{"date":"","signal":"EMBEDDED DEVICE","source":"FDA FAERS","actionTaken":"3603 reports"},{"date":"","signal":"INJURY ASSOCIATED WITH DEVICE","source":"FDA FAERS","actionTaken":"2852 reports"}]},"trials":[],"aliases":[],"company":"Sebela Womens Hlth","patents":[{"type":"Formulation","number":"10398588","applicant":"SEBELA WOMENS HEALTH INC","territory":"US","tradeName":"MIUDELLA","expiryDate":"2034-02-24"},{"type":"Method of Use","number":"9610191","applicant":"SEBELA WOMENS HEALTH INC","territory":"US","tradeName":"MIUDELLA","expiryDate":"2034-02-24"},{"type":"Method of Use","number":"9265652","applicant":"SEBELA WOMENS HEALTH INC","territory":"US","tradeName":"MIUDELLA","expiryDate":"2034-04-28"},{"type":"Formulation","number":"9427351","applicant":"SEBELA WOMENS HEALTH INC","territory":"US","tradeName":"MIUDELLA","expiryDate":"2032-08-14"},{"type":"Formulation","number":"11850181","applicant":"SEBELA WOMENS HEALTH INC","territory":"US","tradeName":"MIUDELLA","expiryDate":"2032-08-14"},{"type":"Formulation","number":"10918516","applicant":"SEBELA WOMENS HEALTH 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boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:11:52.658366+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":"2026-04-20T00:12:07.928809+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL55643/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:12:07.140985+00:00"}},"allNames":"arnicare leg cramps","offLabel":[],"synonyms":["Arnicare Leg Cramps","ARNICA MONTANA"],"timeline":[{"date":"1984-11-15","type":"positive","source":"FDA Orange Book","milestone":"Paragard T 380A approved — 309MG/COPPER"},{"date":"2025-02-24","type":"positive","source":"FDA Orange Book","milestone":"Miudella approved — N/A"},{"date":"2026-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from Sentynl Theraps Inc to Sebela Womens Hlth"},{"date":"20260112","type":"positive","source":"OpenFDA","milestone":"FDA approval (Sentynl Theraps Inc)"}],"approvals":[{"date":"20260112","orphan":false,"company":"SENTYNL THERAPS INC","regulator":"FDA"}],"brandName":"Arnicare Leg Cramps","ecosystem":[],"mechanism":{"modality":"Small Molecule","drugClass":"Copper-containing Intrauterine Device [EPC]","explanation":"","oneSentence":"","technicalDetail":"Arnicare Leg Cramps contains a copper-containing intrauterine device that releases copper ions, which interact with voltage-gated calcium channels in the body, reducing the frequency and severity of muscle contractions."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Copper","title":"Copper","extract":"Copper is a chemical element; it has symbol Cu and atomic number 29. It is a soft, malleable, and ductile metal with very high thermal and electrical conductivity. A freshly exposed surface of pure copper has a pinkish-orange color. Copper is used as a conductor of heat and electricity, as a building material, and as a constituent of various metal alloys, such as sterling silver used in jewelry, cupronickel used to make marine hardware and coins, and constantan used in strain gauges and thermocouples for temperature measurement.","wiki_history":"==History==\n===Prehistoric===\n====Copper Age====\n \n\nCopper occurs naturally as native metallic copper and was known to some of the oldest civilizations on record. The history of native copper use dates to 9000 BC in the Middle East; a native copper pendant was found in northern Iraq that dates to 8700 BC. Evidence suggests that gold and meteoric iron (but not smelted iron) were the only metals used by humans before copper. The history of copper metallurgy is thought to follow this sequence: first, cold working of native copper, then annealing, smelting, and, finally, casting. The earliest archaeological support of smelting (hot metallurgy) in Eurasia is found in the Balkans and Carpathian Mountains, as evidenced by findings of copper objects made by metal casting and smelting dated to around  with the invention of copper metallurgy.\n\nProduction of cold worked non-smelted copper in the Old Copper Complex in Michigan and Wisconsin is dated between 6500 and 3000 BC. A copper spearpoint found in Wisconsin has been dated to 6500 BC. Indigenous peoples of North America around the Great Lakes may have also been mining copper during this time, making it one of the oldest known examples of copper extraction in the world. There is evidence from prehistoric lead pollution from lakes in Michigan that people in the region began mining copper .\n\nThe earliest evidence of lost-wax casting copper comes from an amulet found in Mehrgarh, Pakistan, and is dated to 4000 BC. Investment casting was invented in 4500–4000 BC in Southeast Asia Carbon dating has established mining at Alderley Edge in Cheshire, UK, at 2280 to 1890 BC.\n\nthumb|upright=.5|Replica of [[Ötzi's copper axe from the Chalcolithic Era]]\nÖtzi the Iceman, a male dated from 3300 to 3200 BC, was found with an axe with a copper head 99.7% pure; high levels of arsenic in his hair suggest an involvement in copper smelting. Experience with copper has assisted the development of other meta"},"commercial":{"launchDate":"2026","_launchSource":"OpenFDA (20260112, SENTYNL THERAPS INC)"},"references":[{"id":1,"url":"https://api.fda.gov/drug/label.json?search=openfda.generic_name:\"COPPER\"","fields":["mechanism","indications","adverse_reactions","contraindications","warnings","dosage"],"source":"OpenFDA Label"},{"id":2,"url":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:\"COPPER\"","fields":["approvals","company"],"source":"OpenFDA Drugs@FDA"},{"id":3,"url":"https://clinicaltrials.gov/search?intr=copper","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":4,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=copper","fields":["publications"],"source":"PubMed/NCBI"},{"id":5,"url":"https://en.wikipedia.org/wiki/Copper","fields":["history","overview"],"source":"Wikipedia"},{"id":6,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-31T10:22:12.526120","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:12:09.242538+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"copper","indications":{"approved":[{"name":"nighttime cramps in legs","source":"OpenFDA Label","regulator":"FDA"},{"name":"nighttime cramps in thighs","source":"OpenFDA Label","regulator":"FDA"},{"name":"nighttime cramps in calves","source":"OpenFDA 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