{ "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": "2026-04-28", "results": { "skip": 0, "limit": 1, "total": 34175 } }, "results": [ { "safetyreportversion": "2", "safetyreportid": "10004153", "primarysourcecountry": "NL", "occurcountry": "NL", "transmissiondateformat": "102", "transmissiondate": "20150528", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20141010", "fulfillexpeditecriteria": "1", "companynumb": "PHHY2014NL029257", "duplicate": "1", "reportduplicate": { "duplicatesource": "NOVARTIS", "duplicatenumb": "PHHY2014NL029257" }, "primarysource": { "reportercountry": "COUNTRY NOT SPECIFIED", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientagegroup": "6", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Hip fracture", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Fall", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Urinary tract infection", "reactionoutcome": "2" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "SANDOSTATIN LAR DEPOT", "drugbatchnumb": "S0008", "drugauthorizationnumb": "021008", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugdosagetext": "20 MG PER 2 ML, ONCE EVERY 4 WEEKS", "drugdosageform": "SUSPENSION", "drugadministrationroute": "030", "drugstartdateformat": "102", "drugstartdate": "20140106", "actiondrug": "5", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "OCTREOTIDE ACETATE" }, "openfda": { "application_number": [ "NDA021008" ], "brand_name": [ "SANDOSTATIN LAR DEPOT" ], "generic_name": [ "OCTREOTIDE ACETATE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0811", "0078-0818", "0078-0825" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "898589", "898591", "898601", "898603", "898605", "898607" ], "spl_id": [ "2a2ad59f-21cd-4734-9c4b-0154e9db1642" ], "spl_set_id": [ "d0b7fe9e-7000-4b79-ba3b-291ce92c14f9" ], "package_ndc": [ "0078-0811-81", "0078-0790-61", "0078-0818-81", "0078-0797-61", "0078-0825-81", "0078-0804-61" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CALCIUM", "drugstructuredosagenumb": "500", "drugstructuredosageunit": "003", "drugdosagetext": "500 MG, 1DD1", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "CALCIUM" }, "openfda": { "brand_name": [ "7030 CALCIUM PREMIUM", "AG-X", "7030 CALCIUM GOLD" ], "generic_name": [ "CALCIUM" ], "manufacturer_name": [ "Apexel Co., Ltd", "APEXEL CO., LTD." ], "product_ndc": [ "55259-1112", "55259-0007", "55259-0001" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CALCIUM" ], "spl_id": [ "0fa8135f-89c9-41a2-e063-6294a90a403d", "11cc283a-fe2c-f101-e063-6294a90ad2d4", "11cc310a-d82e-be44-e063-6394a90a227c" ], "spl_set_id": [ "bdc7c833-daf7-48f9-e053-2995a90ad88e", "bdee5e24-645b-7fa0-e053-2995a90a7d25", "bdc7c088-83e3-20ce-e053-2995a90abd2f" ], "package_ndc": [ "55259-1112-1", "55259-0007-1", "55259-0001-1" ], "nui": [ "M0003153", "N0000175901" ], "pharm_class_cs": [ "Calcium [CS]" ], "pharm_class_epc": [ "Calcium [EPC]" ], "unii": [ "SY7Q814VUP" ] } }, { "drugcharacterization": "1", "medicinalproduct": "SANDOSTATIN LAR DEPOT", "drugbatchnumb": "S0010/344618", "drugauthorizationnumb": "021008", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugdosagetext": "20 MG PER 2 ML, ONCE EVERY 4 WEEKS", "drugdosageform": "SUSPENSION", "drugadministrationroute": "030", "drugstartdateformat": "102", "drugstartdate": "20140307", "actiondrug": "5", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "OCTREOTIDE ACETATE" }, "openfda": { "application_number": [ "NDA021008" ], "brand_name": [ "SANDOSTATIN LAR DEPOT" ], "generic_name": [ "OCTREOTIDE ACETATE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0811", "0078-0818", "0078-0825" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "898589", "898591", "898601", "898603", "898605", "898607" ], "spl_id": [ "2a2ad59f-21cd-4734-9c4b-0154e9db1642" ], "spl_set_id": [ "d0b7fe9e-7000-4b79-ba3b-291ce92c14f9" ], "package_ndc": [ "0078-0811-81", "0078-0790-61", "0078-0818-81", "0078-0797-61", "0078-0825-81", "0078-0804-61" ] } }, { "drugcharacterization": "2", "medicinalproduct": "THYRAX", "drugstructuredosagenumb": ".025", "drugstructuredosageunit": "003", 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"c62d424c-7630-413c-be2c-3932831c3f1d", "353fcb30-2fa7-4ff1-8a18-26f3ec279d00", "c6eb489d-2946-4c14-839f-d4af761ead31", "beaaf383-730f-4411-b5e7-15c32b53a338", "20a60231-64f0-4751-aa81-6c0e64334179", "c3658bc8-1524-43db-930e-66f9ac01b808", "e1a907a7-fad9-a860-8639-4c6136c85734", "29bddc43-2809-4e1f-ae35-2865e15e9bb6" ], "package_ndc": [ "65862-867-30", "65862-867-10", "65862-867-03", "65862-868-30", "65862-868-10", "65862-868-03", "65862-869-30", "65862-869-10", "65862-869-03", "46708-608-10", "46708-608-30", "46708-608-91", "46708-609-10", "46708-609-30", "46708-609-91", "46708-610-10", "46708-610-30", "46708-610-91", "72241-015-16", "72241-015-18", "72241-015-22", "72241-015-04", "72241-015-05", "72241-015-10", "72241-015-11", "72241-016-16", "72241-016-18", "72241-016-22", "72241-016-04", "72241-016-05", "72241-016-10", "72241-016-11", "72241-017-16", "72241-017-18", "72241-017-22", "72241-017-04", "72241-017-05", "72241-017-10", "72241-017-11", "53746-291-30", "53746-292-30", "53746-293-30", "0597-0039-37", "0597-0040-37", "0597-0041-37", "33342-118-10", "33342-118-07", "33342-119-10", "33342-119-07", "33342-120-10", "33342-120-07", "65841-804-06", "65841-804-16", "65841-804-01", "65841-804-05", "65841-804-10", "65841-804-30", "65841-804-78", "65841-805-06", "65841-805-16", "65841-805-01", "65841-805-05", "65841-805-10", "65841-805-30", "65841-805-78", "65841-806-06", "65841-806-16", "65841-806-01", "65841-806-05", "65841-806-10", "65841-806-30", "65841-806-78", "43547-283-03", "43547-283-09", "43547-283-50", "43547-284-03", "43547-284-09", "43547-284-50", "43547-285-03", "43547-285-09", "43547-285-50", "70756-312-30", "70756-312-01", "70756-312-99", "70756-313-30", "70756-313-01", "70756-313-80", "70756-314-30", "70756-314-01", "70756-314-80", "68382-471-30", "68382-471-78", "68382-471-06", "68382-471-16", "68382-471-01", "68382-471-05", "68382-471-10", "68382-472-30", "68382-472-78", "68382-472-16", "68382-472-01", "68382-472-05", "68382-472-10", "68382-472-06", "68382-473-30", "68382-473-78", "68382-473-06", "68382-473-16", "68382-473-01", "68382-473-05", "68382-473-10", "42291-790-30", "42291-791-30", "42291-792-30", "42571-226-30", "42571-226-90", "42571-226-05", "42571-226-10", "42571-226-32", "42571-226-11", "42571-226-41", "42571-227-30", "42571-227-90", "42571-227-05", "42571-227-10", "42571-227-32", "42571-227-11", "42571-227-41", "42571-228-30", "42571-228-90", "42571-228-05", "42571-228-10", "42571-228-32", "42571-228-11", "42571-228-41", "72603-831-01", "72603-832-01", "72603-833-01", "62332-087-10", "62332-087-30", "62332-087-91", "62332-088-10", "62332-088-30", "62332-088-91", "62332-089-10", "62332-089-30", "62332-089-91", "71209-049-16", "71209-049-18", "71209-049-01", "71209-049-04", "71209-049-05", "71209-049-10", "71209-049-11", "71209-050-16", "71209-050-18", "71209-050-01", "71209-050-04", "71209-050-05", "71209-050-10", "71209-050-11", "71209-051-16", "71209-051-18", "71209-051-01", "71209-051-04", "71209-051-05", "71209-051-10", "71209-051-11", "68462-199-30", "68462-199-01", "68462-199-13", "68462-199-96", "68462-199-90", "68462-200-30", "68462-200-01", "68462-200-13", "68462-200-82", "68462-200-90", "68462-201-30", "68462-201-01", "68462-201-13", "68462-201-78", "68462-201-90", "62135-535-30", "62135-536-30", "62135-537-30", "65162-291-03", "65162-291-09", "65162-291-50", "65162-291-63", "65162-292-03", "65162-292-09", "65162-292-50", "65162-292-11", "65162-292-63", "65162-293-03", "65162-293-09", "65162-293-50", "65162-293-11", "65162-293-63", "0378-2920-93", "0378-2920-77", "0378-2921-93", "0378-2921-77", "0378-2922-93", "0378-2922-77", "59746-439-12", "59746-439-32", "59746-440-12", "59746-440-32", "59746-441-12", "59746-441-32", "67877-482-30", "67877-482-90", "67877-482-05", "67877-483-30", "67877-483-90", "67877-483-05", "67877-484-30", "67877-484-90", "67877-484-05" ], "nui": [ "N0000000070", "N0000175561" ], "pharm_class_moa": [ "Angiotensin 2 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Angiotensin 2 Receptor Blocker [EPC]" ], "unii": [ "U5SYW473RQ" ] } }, { "drugcharacterization": "1", "medicinalproduct": "SANDOSTATIN LAR DEPOT", "drugauthorizationnumb": "021008", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugdosagetext": "20 MG PER 2 ML, ONCE EVERY 4 WEEKS", "drugdosageform": "SUSPENSION", "drugadministrationroute": "030", "drugindication": "NEUROENDOCRINE TUMOUR", "actiondrug": "5", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "OCTREOTIDE ACETATE" }, "openfda": { "application_number": [ "NDA021008" ], "brand_name": [ "SANDOSTATIN LAR DEPOT" ], "generic_name": [ "OCTREOTIDE ACETATE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0811", "0078-0818", "0078-0825" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "898589", "898591", "898601", "898603", "898605", "898607" ], "spl_id": [ "2a2ad59f-21cd-4734-9c4b-0154e9db1642" ], "spl_set_id": [ "d0b7fe9e-7000-4b79-ba3b-291ce92c14f9" ], "package_ndc": [ "0078-0811-81", "0078-0790-61", "0078-0818-81", "0078-0797-61", "0078-0825-81", "0078-0804-61" ] } }, { "drugcharacterization": "1", "medicinalproduct": "SANDOSTATIN LAR DEPOT", "drugbatchnumb": "S0007/344384", "drugauthorizationnumb": "021008", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugdosagetext": "20 MG PER 2 ML, ONCE EVERY 4 WEEKS", "drugdosageform": "SUSPENSION", "drugadministrationroute": "030", "drugstartdateformat": "102", "drugstartdate": "20140206", "actiondrug": "5", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "OCTREOTIDE ACETATE" }, "openfda": { "application_number": [ "NDA021008" ], "brand_name": [ "SANDOSTATIN LAR DEPOT" ], "generic_name": [ "OCTREOTIDE ACETATE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0811", "0078-0818", "0078-0825" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "898589", "898591", "898601", "898603", "898605", "898607" ], "spl_id": [ "2a2ad59f-21cd-4734-9c4b-0154e9db1642" ], "spl_set_id": [ "d0b7fe9e-7000-4b79-ba3b-291ce92c14f9" ], "package_ndc": [ "0078-0811-81", "0078-0790-61", "0078-0818-81", "0078-0797-61", "0078-0825-81", "0078-0804-61" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ACENOCOUMAROL", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "003", "drugdosagetext": "1 MG, UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "ACENOCOUMAROL" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140214" } } } ] }