{
  "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": "10908527",
      "primarysourcecountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20150721",
      "reporttype": "1",
      "serious": "1",
      "seriousnessdeath": "1",
      "receivedateformat": "102",
      "receivedate": "20150309",
      "receiptdateformat": "102",
      "receiptdate": "20150309",
      "fulfillexpeditecriteria": "2",
      "primarysource": {
        "reportercountry": "US",
        "qualification": "3"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientonsetage": "71",
        "patientonsetageunit": "801",
        "patientweight": "46.27",
        "patientsex": "2",
        "reaction": [
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Asthenia"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Pain"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Syncope"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Acute myeloid leukaemia"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Decreased appetite"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Lethargy"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "MARINOL",
            "drugbatchnumb": "49884-0847-02",
            "drugstructuredosagenumb": "2.5",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "3",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugadministrationroute": "048",
            "drugindication": "ACUTE MYELOID LEUKAEMIA",
            "drugstartdateformat": "102",
            "drugstartdate": "20150212",
            "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"
              ]
            }
          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 20150226"
        }
      }
    }
  ]
}