{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-07-30", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "safetyreportversion": "18", "safetyreportid": "12482233", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20161109", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20160620", "receiptdateformat": "102", "receiptdate": "20160909", "fulfillexpeditecriteria": "1", "companynumb": "PHHO2016US007957", "duplicate": "1", "reportduplicate": { "duplicatesource": "NOVARTIS", "duplicatenumb": "PHHO2016US007957" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "70", "patientonsetageunit": "801", "patientweight": "72.9", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "19.1", "reactionmeddrapt": "Pyrexia", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "19.1", "reactionmeddrapt": "Dehydration", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "19.1", "reactionmeddrapt": "Pyrexia", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "MARINOL", "drugstructuredosagenumb": "5", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugcumulativedosagenumb": "50", "drugcumulativedosageunit": "003", "drugdosagetext": "5 MG, BID", "drugadministrationroute": "048", "drugindication": "NAUSEA", "drugstartdateformat": "102", "drugstartdate": "20160524", "drugenddateformat": "102", "drugenddate": "20160528", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "DRONABINOL" }, "openfda": { "application_number": [ "NDA018651" ], "brand_name": [ "MARINOL" ], "generic_name": [ "DRONABINOL" ], "manufacturer_name": [ "ThePharmaNetwork, LLC" ], "product_ndc": [ "53097-568", "53097-569", "53097-570", "53097-571", "53097-572", "53097-573" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DRONABINOL" ], "rxcui": [ "197634", "197635", "197636", "205641", "205642", "205645" ], "spl_id": [ "628f9609-6583-49be-be77-b64cfbc46fd7", "5ce802d5-e8ab-4cd1-9ba0-1f39f22ddd48" ], "spl_set_id": [ "628f9609-6583-49be-be77-b64cfbc46fd7", "d0efeeec-640d-43c3-8f0a-d31324a11c68" ], "package_ndc": [ "53097-568-60", "53097-569-60", "53097-570-60", "53097-571-60", "53097-572-60", "53097-573-60" ], "nui": [ "N0000175782", "M0003267" ], "pharm_class_epc": [ "Cannabinoid [EPC]" ], "pharm_class_cs": [ "Cannabinoids [CS]" ], "unii": [ "7J8897W37S" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CICLOSPORIN", "drugstructuredosagenumb": "25", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "25 MG, QD", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20160701", "drugenddateformat": "102", "drugenddate": "20160705", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "CYCLOSPORINE" } }, { "drugcharacterization": "1", "medicinalproduct": "BLINDED CSJ148", "drugdosagetext": "CODE NOT BROKEN", "drugdosageform": "SOLUTION FOR INFUSION", "drugadministrationroute": "042", "drugindication": "CYTOMEGALOVIRUS INFECTION", "drugstartdateformat": "102", "drugstartdate": "20160607", "actiondrug": "4", "activesubstance": { "activesubstancename": "INVESTIGATIONAL PRODUCT" } }, { "drugcharacterization": "2", "medicinalproduct": "ATIVAN", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "032", "drugdosagetext": "1 DF(0.05-1 MG), PRN", "drugadministrationroute": "048", "drugindication": "NAUSEA", "drugstartdateformat": "102", "drugstartdate": "20150517", "actiondrug": "4", "activesubstance": { "activesubstancename": "LORAZEPAM" }, "openfda": { "application_number": [ "NDA017794", "NDA018140" ], "brand_name": [ "ATIVAN" ], "generic_name": [ "LORAZEPAM" ], "manufacturer_name": [ "Bausch Health US LLC", "Hikma Pharmaceuticals USA Inc." ], "product_ndc": [ "0187-0063", "0187-0064", "0187-0065", "0641-6000", "0641-6003", "0641-6002", "0641-6001" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAMUSCULAR", "INTRAVENOUS" ], "substance_name": [ "LORAZEPAM" ], "rxcui": [ "104719", "197900", "197901", "197902", "206821", "206828", "206819", "206820", "238100", "238101", "1665188", "1665190", "1665326", "1665327" ], "spl_id": [ "93bdf2de-1222-44a4-b4d5-2280f9ce58d8", "209b0091-c890-4f69-a693-d0594c2606fe" ], "spl_set_id": [ "89057c93-8155-4040-acec-64e877bd2b4c", "5fc0e987-61c9-40c4-b0d5-fcea07c8733e" ], "package_ndc": [ "0187-0063-01", "0187-0063-50", "0187-0063-10", "0187-0064-01", "0187-0064-50", "0187-0064-10", "0187-0065-01", "0187-0065-50", "0187-0065-10", "0641-6003-01", "0641-6003-25", "0641-6002-01", "0641-6002-10", "0641-6001-01", "0641-6001-25", "0641-6000-01", "0641-6000-10" ], "nui": [ "N0000175694", "M0002356" ], "pharm_class_epc": [ "Benzodiazepine [EPC]" ], "pharm_class_cs": [ "Benzodiazepines [CS]" ], "unii": [ "O26FZP769L" ] } }, { "drugcharacterization": "1", "medicinalproduct": "SCOPOLAMINE", "drugstructuredosagenumb": "1.5", "drugstructuredosageunit": "003", "drugdosagetext": "1.5 MG, Q3 DAYS", "drugdosageform": "PATCH", "drugadministrationroute": "062", "drugindication": "NAUSEA", "drugstartdateformat": "102", "drugstartdate": "20160523", "drugenddateformat": "102", "drugenddate": "20160530", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "SCOPOLAMINE" }, "openfda": { "application_number": [ "ANDA203753", "ANDA217893", "ANDA215329", "ANDA212342", "ANDA208769", "NDA017874", "ANDA218384" ], "brand_name": [ "SCOPOLAMINE", "TRANSDERM SCOP" ], "generic_name": [ "SCOPOLAMINE" ], "manufacturer_name": [ "Mylan Pharmaceuticals Inc.", "Zydus Pharmaceuticals USA Inc.", "Rhodes Pharmaceuticals LLC", "Ingenus Pharmaceuticals, LLC", "Actavis Pharma, Inc.", "Zydus Lifesciences Limited", "Baxter Healthcare Corporation", "Amneal Pharmaceuticals NY LLC" ], "product_ndc": [ "0378-6470", "70710-1846", "42858-150", "50742-505", "0591-2258", "70771-1787", "10019-008", "10019-553", "69238-1662" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "TRANSDERMAL" ], "substance_name": [ "SCOPOLAMINE" ], "rxcui": [ "226552", "351875" ], "spl_id": [ "79930eea-4bac-4412-871f-5cd0933bef05", "12f01688-9740-4229-b196-f51cff21a122", "1aa687d4-9052-41b4-baaa-cc69c444e623", "3baa2417-8daa-4253-89a4-fef4be344fc1", "59f10193-3604-4f3c-a9f7-68a55004f3d0", "2bd0ca3f-183d-4af2-8c0e-962115d97fed", "b29f6fe1-c232-49ac-914b-29c31ab8c73d", "eef82f5e-a712-475a-9206-91891d462bee" ], "spl_set_id": [ "163accb7-45e6-4d97-844d-72b606677008", "62d8332e-b8d2-4d13-8071-978d57e51928", "ba5a1237-4d23-441a-808e-96b97045fbe2", "2a6f9aaf-a70a-481f-a82b-1dcaaadc185b", "800b6421-48eb-47f5-b255-c12f75e59068", "016df9f3-61d5-45e9-b1d6-791a5d2f26d5", "b877a694-a1d0-4280-937a-a06820b12a88", "48e6e53a-d904-475b-84dd-6068cc0cb36b" ], "package_ndc": [ "0378-6470-16", "0378-6470-99", "0378-6470-97", "0378-6470-44", "70710-1846-7", "70710-1846-2", "70710-1846-1", "70710-1846-4", "42858-150-40", "42858-150-14", "42858-150-70", "50742-505-04", "50742-505-10", "50742-505-24", "0591-2258-04", "0591-2258-79", "0591-2258-23", "70771-1787-2", "70771-1787-7", "70771-1787-1", "70771-1787-4", "10019-553-03", "10019-553-04", "10019-553-90", "10019-553-06", "10019-008-10", "10019-008-24", "10019-008-01", "10019-008-04", "69238-1662-9", "69238-1662-2", "69238-1662-4" ], "nui": [ "N0000175574", "N0000175370" ], "pharm_class_epc": [ "Anticholinergic [EPC]" ], "pharm_class_moa": [ "Cholinergic Antagonists [MoA]" ], "unii": [ "DL48G20X8X" ] } }, { "drugcharacterization": "2", "medicinalproduct": "COMPAZINE", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugdosagetext": "10 MG, PRN", "drugadministrationroute": "048", "drugindication": "NAUSEA", "drugstartdateformat": "102", "drugstartdate": "20160520", "actiondrug": "4", "activesubstance": { "activesubstancename": "PROCHLORPERAZINE MALEATE" } }, { "drugcharacterization": "2", "medicinalproduct": "CICLOSPORIN", "drugstructuredosagenumb": "75", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "75 MG, QD (50 MG IN AM, 25 MG IN PM)", "drugadministrationroute": "048", "drugindication": "PROPHYLAXIS", "drugstartdateformat": "102", "drugstartdate": "20160610", "drugenddateformat": "102", "drugenddate": "20160620", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "CYCLOSPORINE" } }, { "drugcharacterization": "2", "medicinalproduct": "FLOMAX", "drugstructuredosagenumb": ".4", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "0.4 MG, QD", "drugadministrationroute": "048", "drugindication": "BENIGN PROSTATIC HYPERPLASIA", "drugstartdateformat": "610", "drugstartdate": "201509", "drugenddateformat": "102", "drugenddate": "20160612", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "TAMSULOSIN HYDROCHLORIDE" } }, { "drugcharacterization": "1", "medicinalproduct": "BLINDED PLACEBO", "drugdosagetext": "CODE NOT BROKEN", "drugdosageform": "SOLUTION FOR INFUSION", "drugadministrationroute": "042", "drugindication": "CYTOMEGALOVIRUS INFECTION", "drugstartdateformat": "102", "drugstartdate": "20160607", "actiondrug": "4", "activesubstance": { "activesubstancename": "INVESTIGATIONAL PRODUCT" } }, { "drugcharacterization": "1", "medicinalproduct": "BLINDED NO TREATMENT RECEIVED", "drugdosagetext": "CODE NOT BROKEN", "drugdosageform": "SOLUTION FOR INFUSION", "drugadministrationroute": "042", "drugindication": "CYTOMEGALOVIRUS INFECTION", "drugstartdateformat": "102", "drugstartdate": "20160607", "actiondrug": "4", "activesubstance": { "activesubstancename": "INVESTIGATIONAL PRODUCT" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20160529" } } } ] }