{
  "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": "15499380",
      "primarysourcecountry": "US",
      "occurcountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20190205",
      "reporttype": "1",
      "serious": "2",
      "receivedateformat": "102",
      "receivedate": "20181015",
      "receiptdateformat": "102",
      "receiptdate": "20181015",
      "fulfillexpeditecriteria": "2",
      "reportduplicate": {
        "duplicatesource": "FDA-CTU"
      },
      "primarysource": {
        "reportercountry": "US",
        "qualification": "2"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientonsetage": "60",
        "patientonsetageunit": "801",
        "patientweight": "52.74",
        "patientsex": "2",
        "reaction": [
          {
            "reactionmeddraversionpt": "21.1",
            "reactionmeddrapt": "Oral discomfort"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "SYNDROS",
            "drugbatchnumb": "160697R",
            "drugstructuredosagenumb": "1.2",
            "drugstructuredosageunit": "012",
            "drugdosagetext": "?          OTHER FREQUENCY:EVERY 2 TO 4 HOURS;?",
            "drugadministrationroute": "048",
            "drugindication": "RECTAL CANCER",
            "drugstartdateformat": "102",
            "drugstartdate": "20180905",
            "drugenddateformat": "102",
            "drugenddate": "20180911",
            "drugadditional": "1",
            "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: 20180907"
        }
      }
    }
  ]
}