{ "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": 197 } }, "results": [ { "safetyreportversion": "3", "safetyreportid": "10229394", "primarysourcecountry": "CN", "occurcountry": "CN", "transmissiondateformat": "102", "transmissiondate": "20160525", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140611", "receiptdateformat": "102", "receiptdate": "20160329", "fulfillexpeditecriteria": "1", "companynumb": "CN-ROCHE-1413869", "duplicate": "1", "reportduplicate": { "duplicatesource": "ROCHE", "duplicatenumb": "CN-ROCHE-1413869" }, "primarysource": { "reportercountry": "CN", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "54", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "19.0", "reactionmeddrapt": "Pulmonary fibrosis", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "OMEPRAZOLE.", "drugadministrationroute": "065", "drugindication": "PROPHYLAXIS", "drugstartdateformat": "102", "drugstartdate": "20140526", "drugenddateformat": "102", "drugenddate": "20140604", "activesubstance": { "activesubstancename": "OMEPRAZOLE" }, "openfda": { "application_number": [ "NDA022032", "ANDA079182", "ANDA210593", "ANDA207891", "ANDA075410", "ANDA206877", "ANDA075757", "NDA209400", "ANDA206582", "ANDA075576", "ANDA216096", "ANDA091352", "ANDA203481", "ANDA207740", "ANDA076515", "ANDA076048", "ANDA211732", "ANDA204012", "ANDA218829", "ANDA091672", "ANDA213201", "ANDA078490", "ANDA212977", "ANDA203270" ], "brand_name": [ "GOOD NEIGHBOR PHARMACY OMEPRAZOLE", "OMEPRAZOLE/SODIUM BICARBONATE", "KIRKLAND SIGNATURE OMEPRAZOLE", "OMEPRAZOLE", "FOSTER AND THRIVE OMEPRAZOLE", "ACID REDUCER", "BERKLEY AND JENSEN OMEPRAZOLE", "GOOD NOW OMEPRAZOLE", "GOOD SENSE OMEPRAZOLE", "BASIC CARE OMEPRAZOLE", "UP AND UP OMEPRAZOLE", "EQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER", "DG HEALTH OMEPRAZOLE", "TOPCARE OMEPRAZOLE", "CAREONE OMEPRAZOLE", "EQUALINE OMEPRAZOLE", "LEADER OMEPRAZOLE", "EQUATE OMEPRAZOLE", "DG HEALTH OMPERAZOLE", "OMEPRAZOLE DELAYED-RELEASE", "SIGNATURE CARE OMEPRAZOLE", "MEMBERS MARK OMEPRAZOLE", "AMAZON BASIC CARE OMEPRAZOLE", "RUGBY OMEPRAZOLE", "TOPCARE OMEPRAZOLE DELAYED RELEASE", "24 HR OMEPRAZOLE", "CARE ONE OMEPRAZOLE", "EXCHANGE SELECT OMEPRAZOLE", "GOOD SENSE OMEPRAZOLE DELAYED RELEASE" ], "generic_name": [ "OMEPRAZOLE", "OMEPRAZOLE MAGNESIUM" ], "manufacturer_name": [ "Amerisource Bergen", "Strides Pharma Science Limited", "Costco Wholesale Company", "INNOVUS PHARMACEUTICALS, INC.", "OHM LABORATORIES INC.", "Strategic Sourcing Services LLC", "STRATEGIC SOURCING SERVICES LLC", "GERI-CARE PHARMACEUTICALS, CORP", "Lannett Company, Inc.", "WALGREEN CO.", "Sandoz Inc", "Cardinal Health", "Chartwell RX, LLC", "BJWC", "CVS Pharmacy, Inc.", "HARRIS TEETER", "PLD Acquisitions LLC DBA Avma Pharma Solutions", "RELIABLE 1 LABORATORIES LLC", "DISCOUNT DRUG MART", "Gobrands, Inc", "L. 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Co., Ltd.", "Baxter Healthcare Company", "Hikma Pharmaceuticals USA Inc.", "NorthStar Rx LLC", "Sagent Pharmaceuticals", "BluePoint Laboratories", "Roerig", "Slate Run Pharmaceuticals", "Radha Pharmaceuticals Inc", "ANI Pharmaceuticals, Inc.", "Zydus Pharmaceuticals (USA) Inc.", "Mylan Pharmaceuticals Inc.", "Aurobindo Pharma Limited" ], "product_ndc": [ "70771-1063", "70771-1064", "70771-1065", "70771-1066", "55111-143", "55111-144", "55111-145", "55111-146", "62135-130", "62135-131", "62135-132", "62135-133", "0409-3435", "0409-4321", "57237-003", "57237-004", "57237-005", "57237-006", "68462-101", "68462-102", "68462-103", "68462-119", "68462-104", "72673-091", "0338-6045", "0338-6046", "0143-9899", "0143-9669", "0143-9668", "0143-9667", "0143-9666", "16714-691", "16714-694", "16714-692", "16714-693", "25021-184", "57237-149", "57237-150", "16714-695", "16714-696", "68001-251", "68001-253", "68001-254", "68001-252", "0049-3450", "0049-3410", "0049-3420", "0049-3500", "0049-3430", 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"02f74fe7-0649-46c5-a06a-0700cd265773", "ccbe0991-27a1-4ddb-bfc7-1b3422e53390", "afde17e7-b95b-4cd5-97eb-e361724014bd", "83bcb8fc-53f1-4d7b-b083-0905b52c6c7e", "f694c617-3383-416c-91b6-b94fda371204", "13804efd-7cb3-431f-a6a7-bd6d1da5889e", "c041227b-dab6-4c29-ab59-d31993d524b2", "4616c7ad-be61-7ac0-e063-6394a90ab9ed", "8f90f169-6a72-4c33-a2af-0bc943602bc2", "d1364455-1537-46d4-b093-38cca3be778f", "737e0fac-a2d2-4053-a0d7-edbfb6248f69", "bf588f7e-89de-4b4e-8d33-c1ff2be1b34e", "6ebf24fd-41cd-4b3c-8176-a1436253ba2d" ], "package_ndc": [ "70771-1063-3", "70771-1063-1", "70771-1063-5", "70771-1063-4", "70771-1064-3", "70771-1064-1", "70771-1064-5", "70771-1064-4", "70771-1065-3", "70771-1065-1", "70771-1065-5", "70771-1065-7", "70771-1065-8", "70771-1066-3", "70771-1066-1", "70771-1066-5", "70771-1066-4", "55111-143-30", "55111-143-01", "55111-143-05", "55111-143-79", "55111-143-78", "55111-144-30", "55111-144-01", "55111-144-05", "55111-144-79", "55111-144-78", "55111-145-71", "55111-145-12", "55111-146-30", "55111-146-01", "55111-146-05", "55111-146-79", "55111-146-78", "62135-130-30", "62135-131-30", "62135-132-77", "62135-133-30", "0409-3435-01", "0409-3435-24", "0409-4321-01", "0409-4321-24", "57237-003-30", "57237-004-30", "57237-005-11", "57237-006-30", "57237-006-01", "68462-101-30", "68462-101-10", "68462-102-30", "68462-102-10", "68462-103-40", "68462-119-40", "68462-119-44", "68462-104-30", "68462-104-10", "72673-091-14", "0338-6046-48", "0338-6045-37", "0143-9899-01", "0143-9899-91", "0143-9669-01", "0143-9669-10", "0143-9668-01", "0143-9668-10", "0143-9667-01", "0143-9667-06", "0143-9666-01", "0143-9666-06", "16714-694-01", "16714-691-01", "16714-691-02", "16714-692-10", "16714-692-11", "16714-693-01", "16714-693-02", "25021-184-82", "25021-184-87", "57237-149-35", "57237-150-35", "16714-695-01", "16714-696-01", "68001-253-21", "68001-253-20", "68001-253-44", "68001-253-17", "68001-254-04", "68001-251-04", "68001-252-04", "0049-3410-30", "0049-3420-30", "0049-3420-41", "0049-3500-79", "0049-3430-30", "0049-3430-41", "0049-3440-19", "0049-3450-19", "70436-227-48", "25021-184-66", "25021-184-67", "77771-396-30", "77771-397-30", "77771-397-01", "77771-398-13", "77771-398-11", "77771-399-30", "77771-399-01", "62559-990-30", "62559-991-30", "62559-992-12", "62559-993-30", "70710-1137-1", "70710-1137-5", "70710-1137-4", "70710-1137-3", "70710-1138-3", "70710-1138-1", "70710-1138-5", "70710-1138-4", "70710-1139-3", "70710-1139-1", "70710-1139-5", "70710-1139-7", "70710-1139-8", "70710-1140-3", "70710-1140-1", "70710-1140-5", "70710-1140-4", "59762-5015-1", "59762-5016-1", "59762-5017-1", "59762-5018-1", "59762-5029-1", "59762-5030-1", "65862-299-35", "65862-300-35", "65862-058-30", "65862-059-30", "65862-059-01", "65862-059-05", "65862-060-11", "65862-061-30", "65862-061-01", "65862-061-05" ], "nui": [ "N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504" ], "pharm_class_epc": [ "Azole Antifungal [EPC]" ], "pharm_class_cs": [ "Azoles [CS]" ], "pharm_class_moa": [ "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]" ], "unii": [ "8VZV102JFY" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140603" } } } ] }