{
  "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": 24599
    }
  },
  "results": [
    {
      "safetyreportversion": "1",
      "safetyreportid": "13613166",
      "primarysourcecountry": "US",
      "occurcountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20170830",
      "reporttype": "4",
      "serious": "1",
      "seriousnessother": "1",
      "receivedateformat": "102",
      "receivedate": "20170605",
      "receiptdateformat": "102",
      "receiptdate": "20170605",
      "fulfillexpeditecriteria": "1",
      "companynumb": "US-NEUROCRINE BIOSCIENCES INC.-2017NBI00246",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "NEUROCRINE BIOSCIENCES",
        "duplicatenumb": "US-NEUROCRINE BIOSCIENCES INC.-2017NBI00246"
      },
      "primarysource": {
        "reportercountry": "COUNTRY NOT SPECIFIED"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientonsetage": "42",
        "patientonsetageunit": "801",
        "patientsex": "2",
        "reaction": [
          {
            "reactionmeddraversionpt": "20.0",
            "reactionmeddrapt": "Facial paralysis",
            "reactionoutcome": "6"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "INGREZZA",
            "drugbatchnumb": "1490843",
            "drugauthorizationnumb": "209241",
            "drugstructuredosagenumb": "40",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugdosageform": "CAPSULE",
            "drugadministrationroute": "048",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "actiondrug": "5",
            "drugrecurreadministration": "3",
            "drugadditional": "3",
            "activesubstance": {
              "activesubstancename": "VALBENAZINE"
            },
            "openfda": {
              "application_number": [
                "NDA209241"
              ],
              "brand_name": [
                "INGREZZA"
              ],
              "generic_name": [
                "VALBENAZINE"
              ],
              "manufacturer_name": [
                "Neurocrine Biosciences, Inc."
              ],
              "product_ndc": [
                "70370-1060",
                "70370-2040",
                "70370-1080",
                "70370-2048",
                "70370-2046",
                "70370-4040",
                "70370-4060",
                "70370-4080"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "VALBENAZINE TOSYLATE"
              ],
              "rxcui": [
                "1918224",
                "1918230",
                "1986329",
                "1986331",
                "2054268",
                "2054269",
                "2541511",
                "2541513",
                "2665627",
                "2665628",
                "2680779",
                "2680780",
                "2680781",
                "2680782",
                "2680783",
                "2680784"
              ],
              "spl_id": [
                "bbfcd3d3-5b8b-411d-9cb6-3521a4e36e6b"
              ],
              "spl_set_id": [
                "4c970164-cafb-421f-9eb5-c226ef0a3417"
              ],
              "package_ndc": [
                "70370-2040-1",
                "70370-1060-1",
                "70370-1080-1",
                "70370-2048-6",
                "70370-2046-1",
                "70370-4040-1",
                "70370-4060-1",
                "70370-4080-1"
              ],
              "unii": [
                "5SML1T733B"
              ]
            }
          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 20170526"
        }
      }
    }
  ]
}