{ "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": 3323 } }, "results": [ { "safetyreportversion": "2", "safetyreportid": "10308068", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "2", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140716", "receiptdateformat": "102", "receiptdate": "20140814", "fulfillexpeditecriteria": "1", "companynumb": "PHEH2014US013902", "duplicate": "1", "reportduplicate": { "duplicatesource": "NOVARTIS", "duplicatenumb": "PHEH2014US013902" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientweight": "58.5", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Trigeminal neuralgia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Ophthalmoplegia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Hyperreflexia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Osteonecrosis", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Multiple sclerosis relapse", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Fatigue", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Head injury", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Hypoaesthesia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Dysarthria", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Paraesthesia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Disorientation", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Detrusor sphincter dyssynergia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Gait disturbance", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Gastrooesophageal sphincter insufficiency", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Weight decreased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Contusion", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Muscle spasticity", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Apathy", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Irritable bowel syndrome", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Fall", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Central nervous system lesion", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Demyelination", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Meningioma", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Nuclear magnetic resonance imaging abnormal", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Cerebellar ataxia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Muscular weakness", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "DEPO-PROVERA", "actiondrug": "5", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "MEDROXYPROGESTERONE ACETATE" }, "openfda": { "application_number": [ "NDA020246" ], "brand_name": [ "DEPO-PROVERA" ], "generic_name": [ "MEDROXYPROGESTERONE ACETATE" ], "manufacturer_name": [ "Pharmacia & Upjohn Company LLC" ], "product_ndc": [ "0009-0746", "0009-7376" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR" ], "substance_name": [ "MEDROXYPROGESTERONE ACETATE" ], "rxcui": [ "1000126", "1000128", "1000153", "1000154" ], "spl_id": [ "048d453b-e149-464e-99a9-97b2db8582c9" ], "spl_set_id": [ "199cf13e-0859-4a73-9b45-e700d0cd1049" ], "package_ndc": [ "0009-0746-30", "0009-0746-35", "0009-7376-11" ], "unii": [ "C2QI4IOI2G" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LISINOPRIL.", "actiondrug": "5", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "LISINOPRIL" }, "openfda": { "application_number": [ "ANDA212041", "ANDA208920", "ANDA077321", "NDA208401", "ANDA076102", "ANDA076164", "ANDA075903", "ANDA076059", "ANDA075743", "ANDA203508", "NDA019777", "ANDA077622" ], "brand_name": [ "LISINOPRIL", "QBRELIS", "ZESTRIL" ], "generic_name": [ "LISINOPRIL" ], "manufacturer_name": [ "Chartwell RX, LLC", "Quallent Pharmaceuticals Health LLC", "Azurity Pharmaceuticals, Inc.", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901)", "Solco healthcare U.S., LLC", "Camber Pharmaceuticals, Inc.", "Actavis Pharma, Inc.", "Lupin Pharmaceuticals, Inc.", "XLCare Pharmaceuticals Inc.", "Exelan Pharmaceuticals, Inc", "BluePoint Laboratories", "Exelan Pharmaceuticals Inc.", "Upsher-Smith Laboratories, LLC", "Aurobindo Pharma Limited" ], "product_ndc": [ "62135-640", "62135-641", "62135-642", "62135-643", "62135-644", "62135-645", "82009-062", "82009-063", "82009-064", "82009-065", "82009-066", "52652-3001", "23155-876", "23155-877", "23155-878", "23155-879", "23155-880", "23155-881", "43547-351", "43547-352", "43547-353", "43547-354", "43547-355", "43547-356", "31722-172", "31722-176", "31722-177", "31722-178", "31722-179", "31722-180", "0591-0405", "0591-0406", "0591-0407", "0591-0408", "0591-0885", "0591-0409", "68180-512", "68180-513", "68180-517", "68180-980", "68180-981", "68180-982", "68180-979", "68180-514", "68180-515", "68180-516", "72865-208", "72865-209", "72865-210", "72865-211", "72865-212", "72865-213", "76282-728", "76282-729", "76282-730", "76282-731", "76282-732", "76282-733", "68001-332", "68001-337", "68001-333", "68001-486", "68001-334", "68001-335", "68001-336", "43547-414", "43547-415", "43547-416", "43547-417", "43547-418", "43547-419", "76282-417", "76282-418", "76282-419", "76282-420", "76282-421", "76282-422", "24979-238", "24979-239", "24979-240", "24979-241", "24979-242", "24979-243", "65862-037", "65862-038", "65862-039", "65862-040", "65862-041", "65862-042" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LISINOPRIL" ], "rxcui": [ "197884", "205326", "311353", "311354", "314076", "314077", "1806884", "1806890", "104375", "104376", "104377", "104378", "206771", "213482" ], "spl_id": [ "462a5023-e5a0-692a-e063-6294a90a7236", "d2b42923-6e5f-47a1-9b31-4d019142a102", "461e97d5-c8b3-75a7-e063-6394a90a6ec6", "cb748971-2531-4478-8dff-e01cd87dec09", "61b942b0-3ad3-49d4-8321-c3b01f0d7ce1", "cfe12692-404c-ae05-e053-2995a90aa182", "01764c1d-aebe-4a46-920c-4b5f8cca8acb", "6723a96d-02f8-40c2-95ec-89a7053a7117", "c008ecb6-970d-4ac9-9402-e21e8d9d76b2", "c3c02066-1571-4291-ae9a-fd50a43486ad", "c5fac2c4-de1f-49d3-e053-2a95a90a5285", "1ed80b02-cb3b-41c5-ab33-ff0106b8792d", "3e79fbc7-ef6e-4f2f-99a3-7ae3c1e1eec7", "7875efff-59e3-4f68-84c5-e3c9c16d6a3c", "02e12641-9edf-4791-8684-5f148f3ed574", "337644b9-adae-41c1-9a9c-8d879ab355d2" ], "spl_set_id": [ "8824e5e5-ed35-4a95-bfd6-98a2e7c4bbce", "f2e09150-22f2-4028-b214-917d686200ad", "9f6e4e57-a489-4b36-b093-b93865d3717c", "c6c55efa-36bd-4613-98ca-2eb589a31e53", "e299d477-a612-4af4-b6aa-f5addc8a736d", "8f20acd7-2635-4a9b-b732-2a84ea93dea7", "43e2c8d1-3704-4323-bcaf-f582572b81f7", "7d6c31e2-b5a4-4279-8013-a8dad37ea73b", "c008ecb6-970d-4ac9-9402-e21e8d9d76b2", "4aad4d30-3e18-489c-80ad-ccf7532bb933", "34ebeea1-6812-4697-84c4-b2ae4f39e55f", "f8d16c85-50e2-4d99-afae-6fb902734e42", "1bc69836-a659-4e3b-84a7-a00b7c4dc268", "838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8", "0e6364a4-6d66-4151-8197-d45e2a762895", "387068e7-7fb9-44f3-ae1c-e45ebc755a3e" ], "package_ndc": [ "62135-640-31", "62135-640-90", "62135-641-31", "62135-641-90", "62135-642-31", "62135-642-90", "62135-643-31", "62135-643-90", "62135-644-31", "62135-644-90", "62135-645-31", "62135-645-90", "82009-062-05", "82009-063-10", "82009-064-10", "82009-065-10", "82009-066-10", "52652-3001-1", "23155-876-01", "23155-876-05", "23155-877-01", "23155-877-10", "23155-878-01", "23155-878-10", "23155-879-01", "23155-879-10", "23155-880-01", "23155-880-05", "23155-881-01", "23155-881-10", "43547-351-50", "43547-351-10", "43547-351-03", "43547-352-11", "43547-352-10", "43547-353-11", "43547-353-10", "43547-353-03", "43547-354-11", "43547-354-10", "43547-354-03", "43547-355-11", "43547-355-10", "43547-355-03", "43547-355-50", "43547-356-11", "43547-356-10", "31722-172-01", "31722-172-05", "31722-176-01", "31722-176-10", "31722-177-01", "31722-177-10", "31722-178-01", "31722-178-10", "31722-179-01", "31722-179-05", "31722-180-01", "31722-180-10", "0591-0405-01", "0591-0405-05", "0591-0406-01", "0591-0406-10", "0591-0407-01", "0591-0407-10", "0591-0408-01", "0591-0408-10", "0591-0885-01", "0591-0409-01", "0591-0409-05", "68180-512-02", "68180-512-30", "68180-512-09", "68180-512-01", "68180-512-03", "68180-513-30", "68180-513-03", "68180-513-01", "68180-513-09", "68180-513-02", "68180-513-05", "68180-517-03", "68180-517-01", "68180-517-30", "68180-517-09", "68180-517-04", "68180-517-02", "68180-980-03", "68180-980-30", "68180-980-01", "68180-980-09", "68180-980-05", "68180-980-02", "68180-981-01", "68180-981-03", "68180-981-30", "68180-981-09", "68180-981-02", "68180-981-05", "68180-982-01", "68180-982-02", "68180-982-30", "68180-982-03", "68180-982-09", "68180-979-01", "68180-979-03", "68180-979-30", "68180-979-09", "68180-514-01", "68180-514-02", "68180-514-03", "68180-514-09", "68180-514-30", "68180-514-05", "68180-515-01", "68180-515-02", "68180-515-03", "68180-515-09", "68180-515-30", "68180-515-05", "68180-516-01", "68180-516-02", "68180-516-03", "68180-516-09", "68180-516-30", "72865-208-01", "72865-208-05", "72865-209-45", "72865-209-90", "72865-209-01", "72865-209-10", "72865-210-45", "72865-210-90", "72865-210-01", "72865-210-10", "72865-210-50", "72865-211-45", "72865-211-90", "72865-211-01", "72865-211-18", "72865-211-10", "72865-211-50", "72865-212-01", "72865-212-05", "72865-213-45", "72865-213-90", "72865-213-01", "72865-213-18", "72865-213-10", "76282-728-30", "76282-728-45", "76282-728-90", "76282-728-01", "76282-728-18", "76282-728-05", "76282-728-10", "76282-729-30", "76282-729-45", "76282-729-90", "76282-729-01", "76282-729-18", "76282-729-05", "76282-729-10", "76282-730-30", "76282-730-45", "76282-730-90", "76282-730-01", "76282-730-18", "76282-730-05", "76282-730-10", "76282-730-50", "76282-731-30", "76282-731-45", "76282-731-90", "76282-731-01", "76282-731-18", "76282-731-05", "76282-731-10", "76282-731-50", "76282-732-30", "76282-732-45", "76282-732-90", "76282-732-01", "76282-732-18", "76282-732-05", "76282-732-10", "76282-733-30", "76282-733-45", "76282-733-90", "76282-733-01", "76282-733-18", "76282-733-05", "76282-733-10", "68001-337-00", "68001-337-08", "68001-332-00", "68001-332-03", "68001-333-00", "68001-333-08", "68001-486-00", "68001-486-08", "68001-334-00", "68001-334-08", "68001-335-00", "68001-335-08", "68001-336-00", "43547-414-10", "43547-414-50", "43547-415-03", "43547-415-04", "43547-415-09", "43547-415-10", "43547-415-50", "43547-415-11", "43547-415-25", "43547-416-04", "43547-416-09", "43547-416-10", "43547-416-50", "43547-416-11", "43547-416-15", "43547-417-04", "43547-417-09", "43547-417-10", "43547-417-50", "43547-417-11", "43547-417-15", "43547-418-10", "43547-418-50", "43547-419-04", "43547-419-09", "43547-419-10", "43547-419-18", "43547-419-50", "43547-419-11", "43547-419-15", "43547-419-25", "76282-417-30", "76282-417-45", "76282-417-90", "76282-417-01", "76282-417-18", "76282-417-05", "76282-417-10", "76282-418-30", "76282-418-45", "76282-418-90", "76282-418-01", "76282-418-18", "76282-418-05", "76282-418-10", "76282-419-30", "76282-419-45", "76282-419-90", "76282-419-01", "76282-419-18", "76282-419-05", "76282-419-10", "76282-419-50", "76282-420-30", "76282-420-45", "76282-420-90", "76282-420-01", "76282-420-18", "76282-420-05", "76282-420-10", "76282-420-50", "76282-421-30", "76282-421-45", "76282-421-90", "76282-421-01", "76282-421-18", "76282-421-05", "76282-421-10", "76282-422-30", "76282-422-45", "76282-422-90", "76282-422-01", "76282-422-18", "76282-422-05", "76282-422-10", "24979-238-07", "24979-239-07", "24979-240-07", "24979-241-07", "24979-242-07", "24979-243-07", "65862-037-30", "65862-037-01", "65862-037-00", "65862-037-05", "65862-037-99", "65862-038-30", "65862-038-01", "65862-038-00", "65862-038-05", "65862-038-99", "65862-039-30", "65862-039-01", "65862-039-00", "65862-039-05", "65862-039-99", "65862-040-30", "65862-040-01", "65862-040-00", "65862-040-05", "65862-040-99", "65862-041-30", "65862-041-01", "65862-041-00", "65862-041-05", "65862-041-99", "65862-042-30", "65862-042-01", "65862-042-00", "65862-042-05", "65862-042-99", "31722-172-31", "31722-176-31", "31722-177-31", "31722-178-31", "31722-179-31", "31722-180-31" ], "unii": [ "E7199S1YWR" ] } }, { "drugcharacterization": "2", "medicinalproduct": "MULTIVITAMIN /00097801/", "actiondrug": "5", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "VITAMINS" } }, { "drugcharacterization": "1", "medicinalproduct": "GILENYA", "drugauthorizationnumb": "022527", "drugstructuredosagenumb": ".5", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "0.5 MG, QD", "drugdosageform": "CAPSULE", "drugadministrationroute": "048", "drugindication": "MULTIPLE SCLEROSIS", "drugstartdateformat": "102", "drugstartdate": "20130605", "actiondrug": "4", "activesubstance": { "activesubstancename": "FINGOLIMOD HYDROCHLORIDE" }, "openfda": { "application_number": [ "NDA022527" ], "brand_name": [ "GILENYA" ], "generic_name": [ "FINGOLIMOD HCL" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0607", "0078-0965" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "FINGOLIMOD HYDROCHLORIDE" ], "rxcui": [ "1012895", "1012899", "2045491", "2045493" ], "spl_id": [ "7b0c88c7-0bb4-44a4-9855-3156bfc63a66" ], "spl_set_id": [ "cc9e1c8c-0e2b-44e2-878b-27057f786be9" ], "package_ndc": [ "0078-0607-15", "0078-0607-51", "0078-0607-89", "0078-0965-89" ], "unii": [ "G926EC510T" ] } } ] } } ] }