{"id":"pamidronic-acid","rwe":[],"tags":[{"label":"Bisphosphonate","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Farnesyl pyrophosphate synthase","category":"target"},{"label":"FDPS","category":"gene"},{"label":"M05BA03","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Active","category":"status"},{"label":"Humoral hypercalcemia of malignancy","category":"indication"},{"label":"Osteitis deformans","category":"indication"},{"label":"Osteolytic Bone Metastases of Breast Cancer","category":"indication"},{"label":"Osteolytic Lesions of Multiple Myeloma","category":"indication"},{"label":"Approved 1990s","category":"decade"},{"label":"Bone Density Conservation Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":1360.873,"date":"","count":447,"signal":"Osteonecrosis","source":"DrugCentral FAERS","actionTaken":"Reported 447 times (LLR=1361)"},{"llr":1154.939,"date":"","count":424,"signal":"Osteonecrosis of jaw","source":"DrugCentral FAERS","actionTaken":"Reported 424 times (LLR=1155)"},{"llr":394.982,"date":"","count":164,"signal":"Bone disorder","source":"DrugCentral FAERS","actionTaken":"Reported 164 times (LLR=395)"},{"llr":383.392,"date":"","count":136,"signal":"Tooth extraction","source":"DrugCentral FAERS","actionTaken":"Reported 136 times (LLR=383)"},{"llr":320.945,"date":"","count":197,"signal":"Plasma cell myeloma","source":"DrugCentral FAERS","actionTaken":"Reported 197 times (LLR=321)"},{"llr":261.593,"date":"","count":81,"signal":"Atypical femur fracture","source":"DrugCentral FAERS","actionTaken":"Reported 81 times (LLR=262)"},{"llr":238.747,"date":"","count":47,"signal":"Bone debridement","source":"DrugCentral FAERS","actionTaken":"Reported 47 times (LLR=239)"},{"llr":235.984,"date":"","count":53,"signal":"Sequestrectomy","source":"DrugCentral FAERS","actionTaken":"Reported 53 times (LLR=236)"},{"llr":187.83,"date":"","count":59,"signal":"Exposed bone in jaw","source":"DrugCentral FAERS","actionTaken":"Reported 59 times (LLR=188)"},{"llr":185.172,"date":"","count":50,"signal":"Debridement","source":"DrugCentral FAERS","actionTaken":"Reported 50 times (LLR=185)"},{"llr":166.531,"date":"","count":116,"signal":"Pain in jaw","source":"DrugCentral FAERS","actionTaken":"Reported 116 times (LLR=167)"},{"llr":157.451,"date":"","count":108,"signal":"Femur fracture","source":"DrugCentral FAERS","actionTaken":"Reported 108 times (LLR=157)"},{"llr":152.091,"date":"","count":40,"signal":"Actinomycosis","source":"DrugCentral FAERS","actionTaken":"Reported 40 times (LLR=152)"},{"llr":150.328,"date":"","count":98,"signal":"Osteomyelitis","source":"DrugCentral FAERS","actionTaken":"Reported 98 times (LLR=150)"},{"llr":140.296,"date":"","count":86,"signal":"Metastases to bone","source":"DrugCentral FAERS","actionTaken":"Reported 86 times (LLR=140)"}],"commonSideEffects":[],"contraindications":["Aseptic necrosis of bone of jaw","Dehydration","Hypocalcemia","Hypokalemia","Hypomagnesemia","Hypophosphatemia","Hypovolemia","Invasive Dental Procedure","Kidney disease","Periodontitis","Pregnancy, function","Thyroid Surgery"],"specialPopulations":{"Pregnancy":"Pamidronate disodium may cause fetal harm when administered to pregnant woman. In reproductive studies in rats and rabbits, pamidronate doses equivalent to 0.6 to 8.3 times the highest human recommended dose resulted in maternal toxicity and embryo/fetal effects. There are no adequate and well-controlled studies of pamidronate disodium in pregnant women.","Geriatric use":"Of the total number of subjects in clinical studies of pamidronate disodium, approximately 20% were 65 and over, while approximately 15% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased renal function and concomitant disease or other drug therapy in this population.","Paediatric use":"Safety and effectiveness of pamidronate disodium in pediatric patients have not been established."}},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=PAMIDRONIC ACID","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:56:57.765022+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:57:04.528812+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=PAMIDRONIC ACID","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:57:05.453736+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL834/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:57:06.364652+00:00"}},"allNames":"aredia","offLabel":[],"synonyms":["pamidronic acid","pamidronate disodium","pamidronate","pamidronate disodium hydrate"],"timeline":[{"date":"1991-10-31","type":"positive","source":"DrugCentral","milestone":"FDA approval"}],"approvals":[{"date":"1991-10-31","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Aredia","ecosystem":[{"indication":"Humoral hypercalcemia of malignancy","otherDrugs":[{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone acetate","slug":"betamethasone-acetate","company":""},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""}],"globalPrevalence":null},{"indication":"Osteitis deformans","otherDrugs":[{"name":"alendronic acid","slug":"alendronic-acid","company":"Merck And Co Inc"},{"name":"calcitonin (salmon synthetic)","slug":"calcitonin-(salmon-synthetic)","company":"Sanofi Aventis Us"},{"name":"etidronic acid","slug":"etidronic-acid","company":"Procter And Gamble"},{"name":"risedronic acid","slug":"risedronic-acid","company":"Warner Chilcott Llc"}],"globalPrevalence":null},{"indication":"Osteolytic Bone Metastases of Breast Cancer","otherDrugs":[],"globalPrevalence":null},{"indication":"Osteolytic Lesions of Multiple Myeloma","otherDrugs":[{"name":"zoledronic acid","slug":"zoledronic-acid","company":"Novartis"}],"globalPrevalence":176000}],"mechanism":{"target":"Farnesyl pyrophosphate synthase","novelty":"Follow-on","targets":[{"gene":"FDPS","source":"DrugCentral","target":"Farnesyl pyrophosphate synthase","protein":"Farnesyl pyrophosphate synthase"}],"modality":"Small Molecule","drugClass":"Bisphosphonate","explanation":"","oneSentence":"","technicalDetail":"Aredia binds to hydroxyapatite in bone through its bisphosphonate moiety, inhibiting the mevalonate pathway and subsequently reducing the production of farnesyl pyrophosphate, a critical intermediate in the prenylation of small GTPases, which are essential for osteoclast function and survival."},"commercial":{"launchDate":"1991","_launchSource":"DrugCentral (FDA 1991-10-31, )"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2048","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=PAMIDRONIC%20ACID","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=PAMIDRONIC ACID","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T15:13:03.567342","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:57:08.511964+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"etidronic acid","drugSlug":"etidronic-acid","fdaApproval":"1977-09-01","relationship":"same-class"},{"drugName":"alendronic acid","drugSlug":"alendronic-acid","fdaApproval":"1995-09-29","relationship":"same-class"},{"drugName":"tiludronic acid","drugSlug":"tiludronic-acid","fdaApproval":"1997-03-07","relationship":"same-class"},{"drugName":"ibandronic acid","drugSlug":"ibandronic-acid","fdaApproval":"2003-05-16","relationship":"same-class"},{"drugName":"risedronic acid","drugSlug":"risedronic-acid","fdaApproval":"1998-03-27","relationship":"same-class"},{"drugName":"zoledronic acid","drugSlug":"zoledronic-acid","fdaApproval":"2001-08-20","patentExpiry":"Feb 5, 2028","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"pamidronic acid","indications":{"approved":[{"name":"Humoral hypercalcemia of malignancy","source":"DrugCentral","snomedId":47709007,"regulator":"FDA"},{"name":"Osteitis deformans","source":"DrugCentral","snomedId":2089002,"regulator":"FDA"},{"name":"Osteolytic Bone Metastases of Breast Cancer","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Patients with breast cancer, receiving standard antineoplastic therapy, with or without hormonal therapy."},{"name":"Osteolytic Lesions of Multiple Myeloma","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Patients with multiple myeloma, receiving standard antineoplastic therapy.","usPrevalence":35000,"globalPrevalence":176000,"prevalenceMethod":"curated","prevalenceSource":"IARC GLOBOCAN, 2022"}],"offLabel":[{"name":"Bone Metastases","source":"DrugCentral","drugName":"PAMIDRONIC ACID","evidenceCount":509,"evidenceLevel":"strong"},{"name":"Drug-induced osteoporosis","source":"DrugCentral","drugName":"PAMIDRONIC ACID","evidenceCount":3,"evidenceLevel":"emerging"},{"name":"Prevention of Glucocorticoid-Induced Osteoporosis","source":"DrugCentral","drugName":"PAMIDRONIC ACID","evidenceCount":14,"evidenceLevel":"moderate"}],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"etidronic-acid","brandName":"etidronic acid","genericName":"etidronic acid","approvalYear":"1977","relationship":"same-class"},{"drugId":"alendronic-acid","brandName":"alendronic acid","genericName":"alendronic acid","approvalYear":"1995","relationship":"same-class"},{"drugId":"tiludronic-acid","brandName":"tiludronic acid","genericName":"tiludronic acid","approvalYear":"1997","relationship":"same-class"},{"drugId":"ibandronic-acid","brandName":"ibandronic acid","genericName":"ibandronic 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L/kg"},"publicationCount":57,"therapeuticAreas":["Oncology"],"atcClassification":{"source":"DrugCentral","atcCode":"M05BA03","allCodes":["M05BA03"]},"biosimilarFilings":[],"recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"approved","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"1991","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1991-10-31T00:00:00.000Z","mah":"","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health 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