{
  "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": "16641206",
      "primarysourcecountry": "US",
      "occurcountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20191004",
      "reporttype": "1",
      "serious": "2",
      "receivedateformat": "102",
      "receivedate": "20190729",
      "receiptdateformat": "102",
      "receiptdate": "20190729",
      "fulfillexpeditecriteria": "1",
      "companynumb": "US-KYOWAKIRIN-2019BKK011821",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "KYOWA",
        "duplicatenumb": "US-KYOWAKIRIN-2019BKK011821"
      },
      "primarysource": {
        "reportercountry": "US",
        "qualification": "3"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "reaction": [
          {
            "reactionmeddraversionpt": "22.0",
            "reactionmeddrapt": "Drug ineffective",
            "reactionoutcome": "6"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "SANCUSO",
            "drugbatchnumb": "180095",
            "drugauthorizationnumb": "022198",
            "drugdosagetext": "UNKNOWN",
            "drugdosageform": "TRANSDERMAL PATCH",
            "drugadministrationroute": "061",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "drugstartdateformat": "102",
            "drugstartdate": "20190226",
            "actiondrug": "4",
            "activesubstance": {
              "activesubstancename": "GRANISETRON"
            },
            "openfda": {
              "application_number": [
                "NDA022198"
              ],
              "brand_name": [
                "SANCUSO"
              ],
              "generic_name": [
                "GRANISETRON"
              ],
              "manufacturer_name": [
                "Cumberland Pharmaceuticals Inc."
              ],
              "product_ndc": [
                "66220-637"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "TRANSDERMAL"
              ],
              "substance_name": [
                "GRANISETRON"
              ],
              "rxcui": [
                "825003",
                "825005"
              ],
              "spl_id": [
                "c78db5de-683f-41bd-8f25-700b9d0e2e46"
              ],
              "spl_set_id": [
                "7379369a-03df-4ec3-8f2e-66645cc736d8"
              ],
              "package_ndc": [
                "66220-637-31",
                "66220-637-72"
              ],
              "nui": [
                "N0000175817",
                "N0000175818"
              ],
              "pharm_class_moa": [
                "Serotonin 3 Receptor Antagonists [MoA]"
              ],
              "pharm_class_epc": [
                "Serotonin-3 Receptor Antagonist [EPC]"
              ],
              "unii": [
                "WZG3J2MCOL"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "SYNDROS",
            "drugdosagetext": "UNKNOWN",
            "drugadministrationroute": "065",
            "drugindication": "NAUSEA",
            "actiondrug": "5",
            "drugadditional": "3",
            "activesubstance": {
              "activesubstancename": "DRONABINOL"
            },
            "openfda": {
              "application_number": [
                "NDA205525"
              ],
              "brand_name": [
                "SYNDROS"
              ],
              "generic_name": [
                "DRONABINOL"
              ],
              "manufacturer_name": [
                "Wellhouse Pharma, LLC",
                "Benuvia Operations, LLC"
              ],
              "product_ndc": [
                "85776-201",
                "78613-201"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "DRONABINOL"
              ],
              "spl_id": [
                "dcc02ae3-f1fa-431e-81bb-c52d35b81c66",
                "3e1cbbb1-291c-41bb-b209-93c1fb08313a"
              ],
              "spl_set_id": [
                "3cdcb4f5-5af9-4ff7-b535-2a5cf4c6da89",
                "a7801c70-995d-46a2-91ee-141ef427c6b5"
              ],
              "package_ndc": [
                "85776-201-30",
                "78613-201-30"
              ],
              "nui": [
                "N0000175782",
                "M0003267"
              ],
              "pharm_class_epc": [
                "Cannabinoid [EPC]"
              ],
              "pharm_class_cs": [
                "Cannabinoids [CS]"
              ],
              "unii": [
                "7J8897W37S"
              ],
              "rxcui": [
                "1928948",
                "1928954"
              ]
            }
          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 20190719"
        }
      }
    }
  ]
}