{
  "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": "15860889",
      "primarysourcecountry": "US",
      "occurcountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20190417",
      "reporttype": "1",
      "serious": "2",
      "receivedateformat": "102",
      "receivedate": "20190124",
      "receiptdateformat": "102",
      "receiptdate": "20190124",
      "fulfillexpeditecriteria": "2",
      "companynumb": "US-INSYS THERAPEUTICS, INC-INS201810-000390",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "INSYS",
        "duplicatenumb": "US-INSYS THERAPEUTICS, INC-INS201810-000390"
      },
      "primarysource": {
        "reportercountry": "US",
        "qualification": "2"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientonsetage": "60",
        "patientonsetageunit": "801",
        "patientsex": "2",
        "reaction": [
          {
            "reactionmeddraversionpt": "21.1",
            "reactionmeddrapt": "Oral discomfort",
            "reactionoutcome": "1"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "SYNDROS",
            "drugbatchnumb": "160697R",
            "drugauthorizationnumb": "205525",
            "drugstructuredosagenumb": "1.2",
            "drugstructuredosageunit": "012",
            "drugdosagetext": "ONE TO THREE HOURS BEFORE CHEMOTHERAPY AND THEN EVERY TWO TO FOUR HOURS AFTER CHEMOTHERAPY",
            "drugdosageform": "ORAL SOLUTION",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "drugstartdateformat": "610",
            "drugstartdate": "201809",
            "actiondrug": "6",
            "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: 201809"
        }
      }
    }
  ]
}