{ "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": 10, "total": 23188 } }, "results": [ { "safetyreportversion": "2", "safetyreportid": "10003641", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150720", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20150312", "fulfillexpeditecriteria": "2", "companynumb": "US-ABBVIE-13P-163-1090373-00", "duplicate": "1", "reportduplicate": { "duplicatesource": "ABBVIE", "duplicatenumb": "US-ABBVIE-13P-163-1090373-00" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "41", "patientonsetageunit": "801", "patientweight": "118.04", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Medication residue present", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "DEPAKOTE", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "018723", "drugseparatedosagenumb": "3", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "ONE IN AM AND TWO IN PM", "drugadministrationroute": "048", "drugindication": "BIPOLAR DISORDER", "actiondrug": "4", "activesubstance": { "activesubstancename": "DIVALPROEX SODIUM" }, "openfda": { "application_number": [ "NDA021168", "NDA018723", "NDA019680" ], "brand_name": [ "DEPAKOTE ER", "DEPAKOTE", "DEPAKOTE SPRINKLES" ], "generic_name": [ "DIVALPROEX SODIUM" ], "manufacturer_name": [ "AbbVie Inc." ], "product_ndc": [ "0074-7401", "0074-3826", "0074-7126", "0074-7402", 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"medicinalproduct": "INVEGA", "drugindication": "BIPOLAR DISORDER", "activesubstance": { "activesubstancename": "PALIPERIDONE" }, "openfda": { "application_number": [ "NDA021999" ], "brand_name": [ "INVEGA" ], "generic_name": [ "PALIPERIDONE" ], "manufacturer_name": [ "Janssen Pharmaceuticals, Inc." ], "product_ndc": [ "50458-550", "50458-551", "50458-552", "50458-554" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PALIPERIDONE" ], "rxcui": [ "672567", "672569", "672571", "686441", "686443", "686445", "866103", "866105" ], "spl_id": [ "3c5e5b30-a841-4dfe-88ce-361806c9275f" ], "spl_set_id": [ "7b8e5b26-b9e4-4704-921b-3c3c0d159916" ], "package_ndc": [ "50458-550-01", "50458-550-10", "50458-550-98", "50458-551-01", "50458-551-10", "50458-551-98", "50458-552-01", "50458-552-10", "50458-552-98", "50458-554-01", "50458-554-10", "50458-554-98" ], "nui": [ "N0000175430" ], "pharm_class_epc": [ "Atypical Antipsychotic [EPC]" ], "unii": [ "838F01T721" ] } }, { "drugcharacterization": "2", "medicinalproduct": "METFORMIN", "drugindication": "DIABETES MELLITUS", "activesubstance": { "activesubstancename": "METFORMIN HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA200690", "ANDA209674", "ANDA209313" ], "brand_name": [ "METFORMIN HYDROCHLORIDE", "METFORMIN" ], "generic_name": [ "METFORMIN", "METFORMIN ER 500 MG", "METFORMIN ER 750 MG" ], "manufacturer_name": [ "Mylan Pharmaceuticals Inc.", "Ingenus Pharmaceuticals, LLC", "Granules Pharmaceuticals Inc." ], "product_ndc": [ "0378-6001", "0378-6002", "50742-633", "50742-634", "70010-491", "70010-492" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "METFORMIN HYDROCHLORIDE" ], "rxcui": [ "1807894", "1807917", "860975", "860981" ], "spl_id": [ "2a0bac1b-3575-4b62-a74b-07f54ba064af", "3a97a225-ff03-4d81-a2fe-7f66611cc4c1", "537f5fd2-89a1-d029-e063-6394a90a9d0e" ], "spl_set_id": [ "7e41818c-60e9-4bcf-9586-7bb8d33d5e89", "49a0b5c2-ebaf-4c4c-905f-dfd1962ac647", "6d6ee6f8-9650-ff4f-e053-2991aa0acf19" ], "package_ndc": [ "0378-6002-91", "0378-6001-91", "50742-633-60", "50742-633-90", "50742-633-10", "50742-634-30", "50742-634-60", "50742-634-10", "70010-491-01", "70010-491-05", "70010-491-10", "70010-491-18", "70010-491-19", "70010-491-09", "70010-492-01", "70010-492-05", "70010-492-20", "70010-492-21" ], "unii": [ "786Z46389E" ] } }, { "drugcharacterization": "2", "medicinalproduct": "COGENTIN", "drugindication": "ADVERSE EVENT", "activesubstance": { "activesubstancename": "BENZTROPINE MESYLATE" } }, { "drugcharacterization": "2", "medicinalproduct": "BISOPROLOL", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "BISOPROLOL" }, "openfda": { "application_number": [ "ANDA218303", "ANDA075474" ], "brand_name": [ "BISOPROLOL" ], "generic_name": [ "BISOPROLOL FUMARATE" ], "manufacturer_name": [ "Micro Labs Limited", "TruPharma, LLC" ], "product_ndc": [ "42571-470", "42571-471", "52817-270", "52817-271" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "BISOPROLOL FUMARATE" ], "rxcui": [ "854901", "854905" ], "spl_id": [ "4cbe74e3-3af3-2b98-e063-6294a90a1c2b", "2a9e4180-cb1c-f924-e063-6394a90a60c6" ], "spl_set_id": [ "c3ee566c-74c4-45f4-a947-526a7313e326", "bba0bc2b-602f-4df1-a761-85bd3c80c7de" ], "package_ndc": [ "42571-470-30", "42571-470-01", "42571-470-05", "42571-471-30", "42571-471-01", "42571-471-05", "52817-270-10", "52817-270-30", "52817-271-10", "52817-271-30" ], "unii": [ "UR59KN573L" ] } }, { "drugcharacterization": "2", "medicinalproduct": "COGENTIN", "drugindication": "PROPHYLAXIS", "activesubstance": { "activesubstancename": "BENZTROPINE MESYLATE" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 201304" } } }, { "safetyreportversion": "1", "safetyreportid": "10004213", "primarysourcecountry": "SE", "occurcountry": "SE", "transmissiondateformat": "102", 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"reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Tremor", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Galactorrhoea", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Blood prolactin increased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Palpitations", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Dyskinesia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Dysuria", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Swelling", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Muscle spasms", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Breast enlargement", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Fatigue", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Muscular weakness", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Agitation", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Aggression", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Hyperhidrosis", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "OMEPRAZOLE", "drugauthorizationnumb": "019810", "drugadministrationroute": "048", "actiondrug": "5", "openfda": { "application_number": [ "NDA022032", "ANDA079182", "ANDA210593", "ANDA207891", "ANDA075410", "ANDA206877", "ANDA075757", "NDA209400", "ANDA206582", "ANDA075576", "ANDA216096", "ANDA091352", "ANDA203481", "ANDA207740", "ANDA076515", 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"58602-729-03" ], "nui": [ "N0000175525", "N0000000147", "N0000182140" ], "pharm_class_epc": [ "Proton Pump Inhibitor [EPC]" ], "pharm_class_moa": [ "Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]" ], "unii": [ "KG60484QX9", "8MDF5V39QO", "426QFE7XLK" ] } }, { "drugcharacterization": "1", "medicinalproduct": "OMEPRAZOLE", "drugbatchnumb": "UNKNOWN", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "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. Perrigo Company", "WinCo Foods, LLC", "Aurohealth LLC", "Amazon.com Services LLC", "Meijer Distribution Inc.", "Meijer Distribution Inc", "CVS Pharmacy", "H E B", "Quallent Pharmaceuticals Health LLC", "Target Corporation", "Fred's, Inc.", "Wal-Mart Stores Inc", "THE KROGER COMPANY", "HyVee Inc", "Meijer, Inc.", "Dolgencorp, LLC", "Topco Associates LLC", "Dolgencorp Inc", "Zydus Lifesciences Limited", "NORTHEAST PHARMA", "Rite Aid Corporation", "P & L Development, LLC", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "Retail Business Services, LLC", "Walgreen Company", "United Natural Foods, Inc. dba UNFI", "Little Pharma, Inc.", "American Sales Company", "Golden State Medical Supply, Inc.", "Padagis Israel Pharmaceuticals Ltd", "AMERISOURCE BERGEN", "BluePoint Laboratories", "Cardinal Health 110, LLC. dba Leader", "Twin Med LLC", "Sun Pharmaceutical Industries, Inc.", "Zydus Pharmaceuticals USA Inc.", "Walmart Inc.", "Apotex Corp", "Strategic Sourcing Services", "Rite Aid", "CHAIN DRUG MARKETING ASSOCIATION, INC.", "Rugby Laboratories", "VALU MERCHANDISERS COMPANY", "WALMART INC. (see also Equate)", "Camber Pharmaceuticals, Inc.", "H-E-B", "KROGER COMPANY", "Living Better Brands LLC", "Safeway", "Publix Super Markets Inc", "Sam's West Inc", "Camber Consumer Care Inc", "Glenmark Pharmaceuticals Inc., USA", "Family Dollar (FAMILY WELLNESS)", "Allegiant Health", "Dr. Reddy's Laboratories Limited", "Kroger Company", "NorthStar Rx LLC", "BI-MART", "Family Dollar Stores, LLC", "Chain Drug Marketing Association INC", "AMERISOURCEBERGEN DRUG CORPORATION", "CVS Pharamacy, Inc", "Bi-Mart", "Dr. Reddys Laboratories Inc", "Aurobindo Pharma Limited", "UP & UP", "Winco Foods, LLC.", "Xiromed, LLC", "WALMART INC.", "7-Eleven", "Army & Air Force Exchange Service", "Best Choice", "Rising Pharma Holdings, Inc.", "Walgreens", "Wal-Mart Stores, Inc." ], "product_ndc": [ "46122-281", "64380-182", "64380-183", "63981-915", "57483-740", "51660-029", "70677-1275", "70677-1098", "57896-659", "62175-114", "62175-118", "62175-136", "0363-1008", "0781-2785", "0781-2790", "70000-0521", 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"CARDIOVASCULAR DISORDER", "drugstartdateformat": "602", "drugstartdate": "2011", "openfda": { "application_number": [ "M013", "M013.50", "part343", "M" ], "brand_name": [ "BAYER GENUINE ASPIRIN", "ASPIRIN", "ENTERIC ASPIRIN", "ADULT LOW DOSE ASPIRIN", "CHEWABLE ASPIRIN", "DRUG MART EFFERVESCENT PAIN RELIEF", "ASPIRIN LOW DOSE", "ASPIRIN ENTERIC COATED", "ASPIRIN 81", "ADULT CHEWABLE ASPIRIN", "ASPIRIN 81MG", "ADULT LOW DOSE ENTERIC COATED ASPIRIN", "ASPIRIN LOW DOSE SAFETY COATED", "GERITREX ASPIRIN", "BUFFERED ASPIRIN", "ENTERIC COATED ASPIRIN", "BUFFERIN REGULAR STRENGTH PAIN RELIEF", "WISPIRIN", "EQUATE ASPIRIN", "LOW DOSE ASPIRIN", "HEB EFFERVESCENT PAIN RELIEF", "PAIN RELIEF ASPIRIN LOW DOSE", "ASPIRIN 81 MG LOW DOSE", "ASPIRIN EXTRA STRENGTH", "BAYER CHEWABLE - ASPIRIN REGIMEN LOW DOSE ASPIRIN CHERRY FLAVORED", "TRAVEL SAVVY ASPIRIN", "CHEWABLE ASPIRIN 81 MG", "TOPCARE ASPIRIN", "RAPIDOL ASPIRIN", "CAREALL ASPIRIN", "ASPIRIN REGULAR STRENGTH", "REGULAR STRENGTH ASPIRIN", "LOW 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