{
  "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": 22916
    }
  },
  "results": [
    {
      "safetyreportversion": "1",
      "safetyreportid": "10006160",
      "primarysourcecountry": "US",
      "occurcountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20141002",
      "reporttype": "2",
      "serious": "1",
      "seriousnessother": "1",
      "receivedateformat": "102",
      "receivedate": "20140313",
      "receiptdateformat": "102",
      "receiptdate": "20140313",
      "fulfillexpeditecriteria": "1",
      "companynumb": "US-ASTELLAS-2014US002478",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "ASTELLAS",
        "duplicatenumb": "US-ASTELLAS-2014US002478"
      },
      "primarysource": {
        "reportercountry": "US",
        "qualification": "5"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientsex": "1",
        "reaction": [
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Dyspepsia",
            "reactionoutcome": "6"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "ERLOTINIB TABLET",
            "drugauthorizationnumb": "021743",
            "drugstructuredosagenumb": "100",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugdosagetext": "100 MG, UID/QD",
            "drugdosageform": "TABLET",
            "drugadministrationroute": "048",
            "drugindication": "NEOPLASM MALIGNANT",
            "actiondrug": "4"
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "PANTOPRAZOLE",
            "drugstructuredosagenumb": "20",
            "drugstructuredosageunit": "003",
            "drugdosagetext": "20 MG, UNKNOWN/D",
            "drugadministrationroute": "065",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "openfda": {
              "application_number": [
                "ANDA202882",
                "ANDA205119",
                "ANDA077619"
              ],
              "brand_name": [
                "PANTOPRAZOLE SODIUM",
                "PANTOPRAZOLE"
              ],
              "generic_name": [
                "PANTOPRAZOLE"
              ],
              "manufacturer_name": [
                "XLCare Pharmaceuticals Inc.",
                "Quallent Pharmaceuticals Health LLC",
                "Amneal Pharmaceuticals LLC",
                "Camber Pharmaceuticals, Inc.",
                "NorthStar RxLLC",
                "Dr.Reddy's Laboratories Limited"
              ],
              "product_ndc": [
                "72865-229",
                "72865-230",
                "82009-010",
                "82009-011",
                "65162-636",
                "65162-637",
                "31722-712",
                "31722-713",
                "72603-177",
                "72603-178",
                "55111-332",
                "55111-333"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "PANTOPRAZOLE SODIUM"
              ],
              "rxcui": [
                "251872",
                "314200"
              ],
              "spl_id": [
                "f26fc428-a419-1008-e053-2a95a90a83fc",
                "48430767-cec0-15e0-e063-6394a90ac032",
                "774b587f-7d77-4d2e-97f6-2b19d8cec56a",
                "48f42a12-2eac-e5dd-e063-6294a90aa92d",
                "57338853-6995-de1e-62ca-be5505c8d656",
                "c0575fc6-20c4-12a6-10b7-1af65cac1ee0"
              ],
              "spl_set_id": [
                "17468dbf-84b6-4c53-9ad5-341350d2cfab",
                "643eb498-d916-4fb7-9281-32895575ab36",
                "f3ded82a-cf0d-4844-944a-75f9f9215ff0",
                "9daa1483-5a36-44db-9e0d-904d100da262",
                "82f0103a-2b97-d210-6d7d-c627d60ad694",
                "564709e8-358f-c185-4ecb-b3849c3fe59c"
              ],
              "package_ndc": [
                "72865-229-90",
                "72865-230-90",
                "72865-230-10",
                "82009-010-90",
                "82009-011-90",
                "82009-011-10",
                "65162-636-03",
                "65162-636-09",
                "65162-637-03",
                "65162-637-09",
                "65162-637-50",
                "65162-637-11",
                "31722-712-90",
                "31722-712-32",
                "31722-712-31",
                "31722-713-90",
                "31722-713-32",
                "31722-713-31",
                "31722-713-10",
                "72603-177-01",
                "72603-178-01",
                "55111-332-30",
                "55111-332-90",
                "55111-332-01",
                "55111-332-05",
                "55111-332-10",
                "55111-332-79",
                "55111-332-81",
                "55111-332-78",
                "55111-333-30",
                "55111-333-90",
                "55111-333-01",
                "55111-333-05",
                "55111-333-10",
                "55111-333-79",
                "55111-333-81",
                "55111-333-78"
              ],
              "unii": [
                "6871619Q5X"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "CREON",
            "drugstructuredosagenumb": "20",
            "drugstructuredosageunit": "032",
            "drugdosagetext": "20 DF, UNKNOWN/D",
            "drugadministrationroute": "065",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "openfda": {
              "application_number": [
                "BLA020725"
              ],
              "brand_name": [
                "CREON"
              ],
              "generic_name": [
                "PANCRELIPASE"
              ],
              "manufacturer_name": [
                "AbbVie Inc."
              ],
              "product_ndc": [
                "0032-0045",
                "0032-1203",
                "0032-1206",
                "0032-1212",
                "0032-1224",
                "0032-3016",
                "0032-0046",
                "0032-0047",
                "0032-2636",
                "0032-2637"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "PANCRELIPASE AMYLASE",
                "PANCRELIPASE LIPASE",
                "PANCRELIPASE PROTEASE"
              ],
              "rxcui": [
                "855495",
                "855499",
                "855503",
                "863829",
                "863836",
                "863841",
                "1113042",
                "1113046",
                "1373325",
                "1373327"
              ],
              "spl_id": [
                "94463229-9296-4640-854f-41d76386d312"
              ],
              "spl_set_id": [
                "073201aa-556d-4a70-918e-84e9616fd88d"
              ],
              "package_ndc": [
                "0032-1203-70",
                "0032-1203-64",
                "0032-1206-07",
                "0032-1206-01",
                "0032-1206-56",
                "0032-1212-07",
                "0032-1212-01",
                "0032-1212-46",
                "0032-1212-13",
                "0032-1224-07",
                "0032-1224-01",
                "0032-1224-46",
                "0032-3016-28",
                "0032-3016-13",
                "0032-3016-50",
                "0032-3016-12",
                "0032-0045-70",
                "0032-0045-30",
                "0032-0046-30",
                "0032-0046-70",
                "0032-0047-30",
                "0032-0047-70",
                "0032-2636-70",
                "0032-2636-01",
                "0032-2636-30",
                "0032-2637-70",
                "0032-2637-01",
                "0032-2637-30"
              ],
              "unii": [
                "3560D81V50",
                "YOJ58O116E",
                "8MYC33932O"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "LASIX                              /00032601/",
            "drugstructuredosagenumb": "40",
            "drugstructuredosageunit": "003",
            "drugdosagetext": "40 MG, UNKNOWN/D",
            "drugadministrationroute": "065",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION"
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "AMARYL",
            "drugstructuredosagenumb": "1",
            "drugstructuredosageunit": "003",
            "drugdosagetext": "1 MG, UNKNOWN/D",
            "drugadministrationroute": "065",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION"
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "OXYCODONE AND ACETAMINOPHEN",
            "drugdosagetext": "5/500 MG",
            "drugadministrationroute": "065",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "openfda": {
              "application_number": [
                "ANDA211708",
                "ANDA087463",
                "ANDA040545",
                "ANDA040330",
                "ANDA207419",
                "ANDA201278",
                "ANDA201972",
                "ANDA210644",
                "ANDA040608",
                "ANDA204407",
                "ANDA203864",
                "ANDA211499",
                "ANDA040778",
                "ANDA040777",
                "ANDA207510",
                "ANDA202677"
              ],
              "brand_name": [
                "OXYCODONE AND ACETAMINOPHEN",
                "ENDOCET",
                "PROLATE",
                "NALOCET"
              ],
              "generic_name": [
                "OXYCODONE AND ACETAMINOPHEN",
                "OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN",
                "OXYCODONE AND ACETAMINOPHEN TABLETS"
              ],
              "manufacturer_name": [
                "Granules Pharmaceuticals Inc.",
                "SpecGx LLC",
                "Par Health USA, LLC",
                "Camber Pharmaceuticals, Inc.",
                "Rhodes Pharmaceuticals LLC",
                "Aurolife Pharma, LLC",
                "KVK-Tech, Inc.",
                "FH2 Pharma LLC",
                "Lupin Pharmaceuticals,Inc.",
                "Forte Bio-Pharma LLC",
                "Epic Pharma, LLC",
                "XLCare Pharmaceuticals, Inc.",
                "Amneal Pharmaceuticals of New York LLC",
                "Eywa Pharma Inc",
                "Amneal Pharmaceuticals LLC",
                "Alvogen, Inc."
              ],
              "product_ndc": [
                "70010-667",
                "70010-668",
                "70010-669",
                "70010-670",
                "0406-0512",
                "0406-0522",
                "0406-0523",
                "60951-602",
                "60951-700",
                "60951-712",
                "60951-701",
                "31722-948",
                "31722-949",
                "31722-950",
                "31722-951",
                "42858-102",
                "42858-103",
                "42858-104",
                "13107-043",
                "13107-044",
                "13107-045",
                "13107-046",
                "10702-184",
                "10702-185",
                "10702-186",
                "10702-187",
                "72887-193",
                "72887-683",
                "72887-681",
                "72887-682",
                "43386-490",
                "43386-491",
                "43386-492",
                "43386-493",
                "31722-191",
                "31722-192",
                "31722-193",
                "31722-194",
                "72245-681",
                "72245-682",
                "72245-683",
                "42806-114",
                "42806-115",
                "42806-116",
                "72865-113",
                "72865-114",
                "72865-115",
                "72865-116",
                "10702-238",
                "53746-204",
                "72245-193",
                "53746-203",
                "71930-045",
                "71930-046",
                "71930-047",
                "65162-207",
                "47781-196",
                "47781-229",
                "47781-230"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "ACETAMINOPHEN",
                "OXYCODONE HYDROCHLORIDE",
                "OXYCODONE"
              ],
              "rxcui": [
                "1049214",
                "1049221",
                "1049225",
                "1049635",
                "1049216",
                "1049223",
                "1049227",
                "1487288",
                "1014599",
                "1014615",
                "1014632",
                "1037259",
                "2279510",
                "2279512",
                "2279514",
                "1049580",
                "2045500"
              ],
              "spl_id": [
                "4221a53d-0185-7219-e063-6394a90a7ff7",
                "38cc2423-8e75-4007-b224-75aa920582d7",
                "097fa5e7-7122-439a-8ac9-c85766003509",
                "77cf0bd6-7b1c-41ec-825b-0ffd86032537",
                "5a4985b5-92c6-42a6-9279-25601ef4d009",
                "c86ebd1a-f32c-4a67-9a1b-ff0a3861c124",
                "5104be8c-6b64-f19a-e063-6294a90ac130",
                "4d2337f3-a324-e04a-e063-6394a90a0a35",
                "5e566e5f-2fef-4d70-8cfe-c24b13659b8e",
                "560e8cac-91f2-47dc-ac17-4d511598c49a",
                "4c0a051e-78a7-de5f-e063-6294a90a90c9",
                "5418fa2c-3b31-4aec-ad48-6ee7bff4dd27",
                "9194f464-1cd1-44ac-8758-ae96b6643d5e",
                "483734fe-f7da-e43c-e063-6294a90a8191",
                "be8f26ed-3ee9-4a9f-b300-8c7654a84ceb",
                "502384f0-4ffd-5d16-e063-6394a90ad304",
                "bb27c9aa-111e-4598-8aa6-3073e42d2e3f",
                "51a144da-2ebd-45df-b57d-4cd346fb647e",
                "34daf86b-3616-4e9e-a43e-56666cf95fa4",
                "61dc641a-41f6-5a0e-dc3a-8a957328a9c1"
              ],
              "spl_set_id": [
                "cc966d57-7cdc-4de3-bbcf-718e2fce9cb7",
                "f2137f1a-b49a-40bd-97ac-cd6b36e295f4",
                "944d3e60-7eee-11de-a413-0002a5d5c51b",
                "42777191-0454-4ccb-8fc3-8b18b0ee43f7",
                "5999f3c3-3225-4d24-82cd-0b8d7a309587",
                "69df20d9-b1d5-47dc-9ff0-29987284f8c7",
                "f9cf218c-af5e-4249-aa3b-a8555ed02278",
                "88d97caf-bcf5-3cde-e053-2995a90acf4a",
                "916ff456-a27e-49dc-a312-274126a8c30c",
                "2a49ee34-6f1d-4ed3-8daa-343723d2a2be",
                "9cbbfa94-37b9-9652-e053-2995a90a736b",
                "700a229f-dc2d-7086-e053-2991aa0aec91",
                "7f3c6dd7-6bc8-450e-aded-997f9cf63a8f",
                "9986aa04-c976-4654-8ad7-b97d2eecea93",
                "d61e0ff4-e04b-4dc6-b818-6a8f46e99b5e",
                "f5f7dfca-a5c7-4445-8a5e-9ec62f33f5be",
                "683d563f-0686-4964-8183-cf08758cae71",
                "1da85ac1-46a2-4081-b533-4890ec9e0482",
                "c5cc2e88-aa00-46bd-91dc-901c3a7c899c",
                "900ec197-720e-5428-b526-055b7756aa4a"
              ],
              "package_ndc": [
                "70010-667-01",
                "70010-667-05",
                "70010-668-01",
                "70010-668-05",
                "70010-669-01",
                "70010-669-05",
                "70010-670-01",
                "70010-670-05",
                "0406-0512-01",
                "0406-0512-05",
                "0406-0512-62",
                "0406-0512-23",
                "0406-0512-91",
                "0406-0522-01",
                "0406-0522-62",
                "0406-0522-05",
                "0406-0522-23",
                "0406-0523-01",
                "0406-0523-62",
                "0406-0523-05",
                "0406-0523-23",
                "60951-602-70",
                "60951-602-85",
                "60951-700-70",
                "60951-712-70",
                "60951-701-70",
                "31722-948-01",
                "31722-948-05",
                "31722-949-01",
                "31722-949-05",
                "31722-950-01",
                "31722-950-05",
                "31722-951-01",
                "31722-951-05",
                "42858-102-01",
                "42858-102-50",
                "42858-102-10",
                "42858-103-01",
                "42858-103-50",
                "42858-103-10",
                "42858-104-01",
                "42858-104-50",
                "42858-104-10",
                "13107-043-30",
                "13107-043-01",
                "13107-043-05",
                "13107-043-99",
                "13107-044-30",
                "13107-044-01",
                "13107-044-05",
                "13107-044-99",
                "13107-045-30",
                "13107-045-01",
                "13107-045-05",
                "13107-045-99",
                "13107-046-30",
                "13107-046-01",
                "13107-046-05",
                "13107-046-99",
                "10702-184-01",
                "10702-184-50",
                "10702-184-10",
                "10702-185-01",
                "10702-185-50",
                "10702-185-10",
                "10702-186-01",
                "10702-186-50",
                "10702-186-10",
                "10702-187-01",
                "10702-187-50",
                "10702-187-10",
                "72887-193-03",
                "72887-683-03",
                "72887-681-03",
                "72887-682-03",
                "43386-490-01",
                "43386-490-10",
                "43386-490-05",
                "43386-491-01",
                "43386-491-10",
                "43386-491-05",
                "43386-492-10",
                "43386-492-01",
                "43386-492-05",
                "43386-493-01",
                "43386-493-05",
                "43386-493-10",
                "31722-191-01",
                "31722-191-05",
                "31722-192-01",
                "31722-192-05",
                "31722-193-01",
                "31722-193-05",
                "31722-194-01",
                "31722-194-05",
                "72245-681-03",
                "72245-681-10",
                "72245-682-10",
                "72245-682-03",
                "72245-683-03",
                "72245-683-10",
                "42806-114-01",
                "42806-115-01",
                "42806-116-01",
                "72865-113-01",
                "72865-113-05",
                "72865-114-01",
                "72865-114-05",
                "72865-115-01",
                "72865-115-05",
                "72865-116-01",
                "72865-116-05",
                "10702-238-50",
                "53746-204-01",
                "53746-204-05",
                "72245-193-10",
                "72245-193-03",
                "53746-203-01",
                "53746-203-05",
                "71930-045-12",
                "71930-045-52",
                "71930-046-12",
                "71930-046-52",
                "71930-047-12",
                "71930-047-52",
                "65162-207-03",
                "65162-207-50",
                "65162-207-10",
                "47781-229-01",
                "47781-229-05",
                "47781-229-63",
                "47781-230-01",
                "47781-230-05",
                "47781-230-63",
                "47781-196-01",
                "47781-196-05",
                "47781-196-63"
              ],
              "unii": [
                "C1ENJ2TE6C",
                "362O9ITL9D",
                "CD35PMG570"
              ],
              "nui": [
                "N0000175684",
                "N0000175690"
              ],
              "pharm_class_moa": [
                "Full Opioid Agonists [MoA]"
              ],
              "pharm_class_epc": [
                "Opioid Agonist [EPC]"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "METFORMIN",
            "drugstructuredosagenumb": "500",
            "drugstructuredosageunit": "003",
            "drugdosagetext": "500 MG, UNKNOWN/D",
            "drugadministrationroute": "065",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "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": [
                "7c8e06cd-8ef3-4a03-b4ee-3df6899280cf",
                "3a97a225-ff03-4d81-a2fe-7f66611cc4c1",
                "451bc376-d523-ee84-e063-6394a90a4743"
              ],
              "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": "KLOR-CON",
            "drugstructuredosagenumb": "10",
            "drugstructuredosageunit": "029",
            "drugdosagetext": "10 MEQ, UNKNOWN/D",
            "drugadministrationroute": "065",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "openfda": {
              "application_number": [
                "NDA019123",
                "ANDA209662",
                "ANDA218979"
              ],
              "brand_name": [
                "KLOR-CON"
              ],
              "generic_name": [
                "POTASSIUM CHLORIDE"
              ],
              "manufacturer_name": [
                "Upsher-Smith Laboratories, LLC"
              ],
              "product_ndc": [
                "0245-5315",
                "0245-5316",
                "0245-0360",
                "0245-0835",
                "0245-0836"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "POTASSIUM CHLORIDE"
              ],
              "rxcui": [
                "312529",
                "628953",
                "628958",
                "832718",
                "1867544",
                "1867547"
              ],
              "spl_id": [
                "39e77e07-bdc8-28e9-e063-6394a90a120c",
                "39e79418-0497-2b5e-e063-6394a90a4f3a",
                "ad0ecaea-8b55-4e39-a7ae-f7df5f206258"
              ],
              "spl_set_id": [
                "1ff53330-065c-4213-9c0c-ac498621d09d",
                "e61a4522-b91d-400a-952c-6f035e4610dd",
                "4340c3f2-ecf8-44cd-9b69-217f543e24e2"
              ],
              "package_ndc": [
                "0245-5315-11",
                "0245-5315-15",
                "0245-5315-89",
                "0245-5315-01",
                "0245-5316-11",
                "0245-5316-15",
                "0245-5316-89",
                "0245-5316-01",
                "0245-0360-89",
                "0245-0360-30",
                "0245-0360-01",
                "0245-0835-11",
                "0245-0835-15",
                "0245-0836-11",
                "0245-0836-15"
              ],
              "unii": [
                "660YQ98I10"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "TAMSULOSIN",
            "drugstructuredosagenumb": ".4",
            "drugstructuredosageunit": "003",
            "drugdosagetext": "0.4 MG, UNKNOWN/D",
            "drugdosageform": "CAPSULE",
            "drugadministrationroute": "065",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION"
          }
        ]
      }
    }
  ]
}