{
  "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": "13618468",
      "primarysourcecountry": "US",
      "occurcountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20170830",
      "reporttype": "1",
      "serious": "2",
      "receivedateformat": "102",
      "receivedate": "20170606",
      "receiptdateformat": "102",
      "receiptdate": "20170606",
      "fulfillexpeditecriteria": "2",
      "companynumb": "US-ABBVIE-16P-163-1754056-00",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "ABBVIE",
        "duplicatenumb": "US-ABBVIE-16P-163-1754056-00"
      },
      "primarysource": {
        "reportercountry": "US",
        "qualification": "5"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientweight": "80.81",
        "patientsex": "1",
        "reaction": [
          {
            "reactionmeddraversionpt": "20.0",
            "reactionmeddrapt": "Drug ineffective",
            "reactionoutcome": "6"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "2",
            "medicinalproduct": "METOPROLOL.",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "activesubstance": {
              "activesubstancename": "METOPROLOL"
            },
            "openfda": {
              "application_number": [
                "ANDA078950",
                "ANDA091045",
                "ANDA202871",
                "ANDA090317"
              ],
              "brand_name": [
                "METOPROLOL",
                "METOPROLOL TARTRATE"
              ],
              "generic_name": [
                "METOPROLOL TARTRATE",
                "METOPROLOL",
                "METOPROLOL TARTRATE INJECTION"
              ],
              "manufacturer_name": [
                "Baxter Healthcare Corporation",
                "Fresenius Kabi USA, LLC",
                "Alembic Pharmaceuticals Inc.",
                "Oneosource Specialty Pharma Limited",
                "Alembic Pharmaceuticals Limited"
              ],
              "product_ndc": [
                "36000-033",
                "63323-660",
                "62332-112",
                "62332-113",
                "62332-114",
                "65219-665",
                "83270-177",
                "46708-290",
                "46708-291",
                "46708-292"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "INTRAVENOUS",
                "ORAL"
              ],
              "substance_name": [
                "METOPROLOL TARTRATE"
              ],
              "rxcui": [
                "866508",
                "866511",
                "866514",
                "866924"
              ],
              "spl_id": [
                "5d975af3-d078-4130-9448-ed77123f1aac",
                "4066607a-15cb-42ac-999e-5254907dda5a",
                "c7738f42-299e-4bea-af50-778e069352f0",
                "ccb1a15e-c943-4042-ae46-550bdabfc96b",
                "571d8a14-0118-d00c-e063-6394a90a2769",
                "f31d2aef-f902-4984-803c-5bdb015e9253"
              ],
              "spl_set_id": [
                "09566368-f91d-43a3-b683-30c844fb125a",
                "be1c686e-37a5-4a53-945b-68a6ead35134",
                "24837d82-0f3f-4482-9af0-31e5f675c30f",
                "ccb1a15e-c943-4042-ae46-550bdabfc96b",
                "05946833-9d66-4832-a0d8-b91b1ff01b8b",
                "cb76a73f-549a-4170-b96a-f93ed7e09464"
              ],
              "package_ndc": [
                "36000-033-10",
                "63323-660-01",
                "63323-660-05",
                "62332-112-30",
                "62332-112-31",
                "62332-112-91",
                "62332-113-30",
                "62332-113-31",
                "62332-113-91",
                "62332-114-30",
                "62332-114-31",
                "62332-114-91",
                "65219-665-01",
                "65219-665-05",
                "83270-177-01",
                "83270-177-10",
                "46708-290-30",
                "46708-290-31",
                "46708-290-91",
                "46708-290-10",
                "46708-290-71",
                "46708-291-30",
                "46708-291-31",
                "46708-291-91",
                "46708-291-10",
                "46708-292-30",
                "46708-292-31",
                "46708-292-91",
                "46708-292-10"
              ],
              "unii": [
                "W5S57Y3A5L"
              ]
            }
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "MARINOL",
            "drugbatchnumb": "UNKNOWN",
            "drugauthorizationnumb": "018651",
            "drugadministrationroute": "065",
            "drugindication": "DYSGEUSIA",
            "actiondrug": "1",
            "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": "BABY ASPIRIN",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "activesubstance": {
              "activesubstancename": "ASPIRIN"
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "LISINOPROL",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "activesubstance": {
              "activesubstancename": "LISINOPRIL"
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "SUTENT",
            "drugstructuredosagenumb": "37.5",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "drugstartdateformat": "102",
            "drugstartdate": "20160816",
            "activesubstance": {
              "activesubstancename": "SUNITINIB MALATE"
            },
            "openfda": {
              "application_number": [
                "NDA021938"
              ],
              "brand_name": [
                "SUTENT"
              ],
              "generic_name": [
                "SUNITINIB MALATE"
              ],
              "manufacturer_name": [
                "Pfizer Laboratories Div Pfizer Inc"
              ],
              "product_ndc": [
                "0069-0550",
                "0069-0770",
                "0069-0980",
                "0069-0830"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "SUNITINIB MALATE"
              ],
              "rxcui": [
                "616279",
                "616283",
                "616285",
                "616287",
                "616289",
                "616292",
                "1541890",
                "1541928"
              ],
              "spl_id": [
                "530eef58-b5ab-49f1-8d73-a2dae0356f24"
              ],
              "spl_set_id": [
                "43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c"
              ],
              "package_ndc": [
                "0069-0550-38",
                "0069-0770-38",
                "0069-0980-38",
                "0069-0830-38"
              ],
              "unii": [
                "LVX8N1UT73"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "GLIPIZIDE.",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "activesubstance": {
              "activesubstancename": "GLIPIZIDE"
            },
            "openfda": {
              "application_number": [
                "NDA020329",
                "ANDA214874",
                "ANDA074497",
                "ANDA203499",
                "ANDA074378",
                "ANDA206928",
                "ANDA204720",
                "ANDA075795",
                "ANDA074223"
              ],
              "brand_name": [
                "GLUCOTROL XL",
                "GLIPIZIDE"
              ],
              "generic_name": [
                "GLIPIZIDE"
              ],
              "manufacturer_name": [
                "Roerig",
                "Advagen Pharma Limited",
                "ANI Pharmaceuticals, Inc.",
                "Northstar Rx LLC.",
                "Oxford Pharmaceuticals, LLC",
                "Aurobindo Pharma Limited",
                "Rising Pharma Holdings, Inc.",
                "TruPharma LLC",
                "Apotex Corp.",
                "Actavis Pharma, Inc."
              ],
              "product_ndc": [
                "0049-0174",
                "0049-0170",
                "0049-0178",
                "72888-115",
                "72888-116",
                "72888-117",
                "72888-231",
                "62559-315",
                "62559-316",
                "16714-894",
                "16714-895",
                "16714-896",
                "69584-309",
                "69584-310",
                "59651-780",
                "59651-781",
                "59651-782",
                "64980-279",
                "64980-280",
                "64980-281",
                "52817-385",
                "60505-0141",
                "60505-0142",
                "0591-0460",
                "0591-0461"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "GLIPIZIDE"
              ],
              "rxcui": [
                "310489",
                "314006",
                "315107",
                "865568",
                "865571",
                "865573",
                "310488",
                "310490",
                "379804",
                "2737151"
              ],
              "spl_id": [
                "c98a3ab5-faeb-4d79-8bcd-05f37c2b50bf",
                "4c5799dd-65b6-d94e-e063-6294a90a066b",
                "fa36cf30-4c93-4df7-a6f2-309d55abda20",
                "26f0c341-a482-4dc1-aaef-f0a92a84937c",
                "496b39ed-3ca0-4265-a401-674fe6d4a0d1",
                "7d29a701-73cf-42ce-9068-b9a5153fdb56",
                "efa05b41-c609-4076-adf4-75071cd5f5f0",
                "076b74ec-ead5-781c-e063-6394a90ab362",
                "f1793ea0-b041-708c-ff9e-c711affdba6e",
                "72fa43ff-7f68-4fcf-9008-dc0ab36cf5d2"
              ],
              "spl_set_id": [
                "eed99b60-d043-4249-9b2a-f05e46fb588d",
                "e954afb8-52eb-416a-8f1b-14b0fcb3bac2",
                "252ba4e0-8dc3-43e3-be00-32570dc095bd",
                "915636a4-092e-4e2e-9bc0-0d387d996977",
                "87cd4930-ba68-4acf-bf74-619c477b557d",
                "84794a52-b717-488c-8533-6425c83d405f",
                "0ffe361a-c99b-4f68-a7e2-a67a71c0c496",
                "95ea4c96-84b9-4515-9494-a93d26820f70",
                "dcf426b8-bcdc-8214-a1b6-6388bd3399a0",
                "ad55dfd7-ffb5-478a-aa84-1009fa921e22"
              ],
              "package_ndc": [
                "0049-0170-01",
                "0049-0174-02",
                "0049-0174-03",
                "0049-0178-07",
                "0049-0178-08",
                "72888-115-30",
                "72888-115-01",
                "72888-115-05",
                "72888-115-00",
                "72888-116-30",
                "72888-116-01",
                "72888-116-05",
                "72888-116-00",
                "72888-117-30",
                "72888-117-01",
                "72888-117-05",
                "72888-117-00",
                "72888-231-01",
                "72888-231-05",
                "72888-231-00",
                "62559-315-10",
                "62559-316-10",
                "16714-894-01",
                "16714-895-01",
                "16714-895-02",
                "16714-896-01",
                "16714-896-02",
                "69584-309-10",
                "69584-309-50",
                "69584-309-90",
                "69584-310-10",
                "69584-310-50",
                "69584-310-90",
                "59651-780-30",
                "59651-781-30",
                "59651-781-01",
                "59651-781-05",
                "59651-782-30",
                "59651-782-01",
                "59651-782-05",
                "59651-782-99",
                "64980-279-03",
                "64980-280-01",
                "64980-280-05",
                "64980-280-10",
                "64980-281-01",
                "64980-281-05",
                "64980-281-10",
                "52817-385-10",
                "52817-385-50",
                "60505-0141-0",
                "60505-0141-2",
                "60505-0141-1",
                "60505-0141-8",
                "60505-0142-0",
                "60505-0142-2",
                "60505-0142-1",
                "60505-0142-4",
                "0591-0460-01",
                "0591-0460-05",
                "0591-0460-10",
                "0591-0461-01",
                "0591-0461-05",
                "0591-0461-10"
              ],
              "nui": [
                "N0000175608",
                "M0020795"
              ],
              "pharm_class_epc": [
                "Sulfonylurea [EPC]"
              ],
              "pharm_class_cs": [
                "Sulfonylurea Compounds [CS]"
              ],
              "unii": [
                "X7WDT95N5C"
              ]
            }
          }
        ]
      }
    }
  ]
}