{ "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": "1", "safetyreportid": "15487186", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20190205", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20181011", "receiptdateformat": "102", "receiptdate": "20181011", "fulfillexpeditecriteria": "2", "companynumb": "US-CELGENEUS-USA-20181002957", "duplicate": "1", "reportduplicate": { "duplicatesource": "CELGENE", "duplicatenumb": "US-CELGENEUS-USA-20181002957" }, "primarysource": { "reportercountry": "US", "qualification": "2" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Alopecia", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Rash", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "OTEZLA", "drugbatchnumb": "F2270A", "drugauthorizationnumb": "205437", "drugdosageform": "TABLETS", "drugadministrationroute": "048", "drugindication": "PSORIASIS", "drugstartdateformat": "610", "drugstartdate": "201807", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "APREMILAST" }, "openfda": { "application_number": [ "NDA205437", "NDA210745" ], "brand_name": [ "OTEZLA" ], "generic_name": [ "APREMILAST" ], "manufacturer_name": [ "Amgen, Inc" ], "product_ndc": [ "55513-137", "55513-369", "55513-485", "55513-497", "55513-508", "55513-996", "55513-519", "55513-516" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "APREMILAST" ], "spl_id": [ "8d1d49ca-6dc1-4580-b2d5-f69ccb4f1c8e" ], "spl_set_id": [ "f6b1f516-4972-4d82-bced-113e47b41cc5" ], "package_ndc": [ "55513-137-60", "55513-137-95", "55513-369-55", "55513-485-95", "55513-485-96", "55513-497-60", "55513-508-55", "55513-518-04", "55513-497-51", "55513-996-96", "55513-996-95", "55513-497-23", "55513-519-30", "55513-516-41", "55513-517-04", "55513-523-04", "55513-521-19", "55513-522-14" ], "nui": [ "N0000182961", "N0000182960" ], "pharm_class_epc": [ "Phosphodiesterase 4 Inhibitor [EPC]" ], "pharm_class_moa": [ "Phosphodiesterase 4 Inhibitors [MoA]" ], "unii": [ "UP7QBP99PN" ] } }, { "drugcharacterization": "1", "medicinalproduct": "OTEZLA", "drugbatchnumb": "F2270A", "drugauthorizationnumb": "205437", "drugstructuredosagenumb": "30", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "60 MILLIGRAM", "drugdosageform": "TABLETS", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20180907", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "APREMILAST" }, "openfda": { "application_number": [ "NDA205437", "NDA210745" ], "brand_name": [ "OTEZLA" ], "generic_name": [ "APREMILAST" ], "manufacturer_name": [ "Amgen, Inc" ], "product_ndc": [ "55513-137", "55513-369", "55513-485", "55513-497", "55513-508", "55513-996", "55513-519", "55513-516" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "APREMILAST" ], "spl_id": [ "8d1d49ca-6dc1-4580-b2d5-f69ccb4f1c8e" ], "spl_set_id": [ "f6b1f516-4972-4d82-bced-113e47b41cc5" ], "package_ndc": [ "55513-137-60", "55513-137-95", "55513-369-55", "55513-485-95", "55513-485-96", "55513-497-60", "55513-508-55", "55513-518-04", "55513-497-51", "55513-996-96", "55513-996-95", "55513-497-23", "55513-519-30", "55513-516-41", "55513-517-04", "55513-523-04", "55513-521-19", "55513-522-14" ], "nui": [ "N0000182961", "N0000182960" ], "pharm_class_epc": [ "Phosphodiesterase 4 Inhibitor [EPC]" ], "pharm_class_moa": [ "Phosphodiesterase 4 Inhibitors [MoA]" ], "unii": [ "UP7QBP99PN" ] } }, { "drugcharacterization": "2", "medicinalproduct": "AMLODIPINE", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "AMLODIPINE BESYLATE" }, "openfda": { "application_number": [ "NDA219531", "NDA214439", "NDA211340" ], "brand_name": [ "SDAMLO", "NORLIQVA", "KATERZIA" ], "generic_name": [ "AMLODIPINE" ], "manufacturer_name": [ "Pangea Pharmaceuticals, LLC", "CMP Pharma, Inc.", "Azurity Pharmaceuticals, Inc." ], "product_ndc": [ "81279-133", "81279-134", "81279-135", "46287-035", "46287-037", "52652-5001" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AMLODIPINE BESYLATE", "AMLODIPINE", "AMLODIPINE BENZOATE" ], "rxcui": [ "2726058", "2726064", "2726065", "2726067", "2726068", "2726070", "2599173", "2599179", "2184120", "2184126" ], "spl_id": [ "4b0523be-cded-6306-e063-6394a90a8a12", "63a6bb49-fb68-4351-be5f-a6b6e8f6b540", "4fee8eba-2fa2-4a9c-884a-ccec171e1977", "461e8d10-1805-e107-e063-6294a90aa288" ], "spl_set_id": [ "886a7f97-60a4-4206-a6c7-5206069ed487", "c1730a51-4383-4c61-a9a1-7e1326bd0abe", "614d974f-51c7-4b18-8171-39eb6e8d4c03", "df673a4d-acb8-444c-a472-c87ab8cbd366" ], "package_ndc": [ "81279-133-10", "81279-134-10", "81279-135-10", "46287-035-15", "46287-037-01", "52652-5001-1" ], "unii": [ "864V2Q084H", "1J444QC288", "XD75TQ8A2P" ], "nui": [ "N0000000069", "N0000175421", "N0000175566", "M0006414", "N0000190114" ], "pharm_class_moa": [ "Calcium Channel Antagonists [MoA]", "Cytochrome P450 3A Inhibitors [MoA]" ], "pharm_class_epc": [ "Dihydropyridine Calcium Channel Blocker [EPC]", "Calcium Channel Blocker [EPC]" ], "pharm_class_cs": [ "Dihydropyridines [CS]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "MARINOL", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "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": "MORPHINE", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "MORPHINE" }, "openfda": { "brand_name": [ "OPIUM TINCTURE DEODORIZED", "OPIUM" ], "generic_name": [ "MORPHINE" ], "manufacturer_name": [ "Edenbridge Pharmaceuticals, LLC", "Genus Lifesciences Inc." ], "product_ndc": [ "42799-217", "64950-258" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "MORPHINE" ], "rxcui": [ "830196" ], "spl_id": [ "46e15fdb-940a-7018-e063-6294a90a9cc1", "b937d1d0-9ed8-4aa3-9e4a-cce02870e7e9" ], "spl_set_id": [ "e2a5697a-cc41-4cf1-b3a8-59b0268740d7", "8a77894b-2137-4f46-8dff-5c7b773d4d16" ], "package_ndc": [ "42799-217-01", "42799-217-02", "64950-258-11" ], "nui": [ "N0000175684", "N0000175690" ], "pharm_class_moa": [ "Full Opioid Agonists [MoA]" ], "pharm_class_epc": [ "Opioid Agonist [EPC]" ], "unii": [ "76I7G6D29C" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 2018" } } } ] }