{
  "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": "3",
      "safetyreportid": "16195499",
      "primarysourcecountry": "US",
      "occurcountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20190711",
      "reporttype": "1",
      "serious": "2",
      "receivedateformat": "102",
      "receivedate": "20190415",
      "receiptdateformat": "102",
      "receiptdate": "20190618",
      "fulfillexpeditecriteria": "2",
      "companynumb": "US-GW PHARMA-201902USGW0240",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "G AND W LAB",
        "duplicatenumb": "US-GW PHARMA-201902USGW0240"
      },
      "primarysource": {
        "reportercountry": "US",
        "qualification": "5"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "reaction": [
          {
            "reactionmeddraversionpt": "22.0",
            "reactionmeddrapt": "Drug interaction",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "22.0",
            "reactionmeddrapt": "Somnolence",
            "reactionoutcome": "6"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "ONFI",
            "drugdosagetext": "DECREASING DOSE OF ONFI TO 1 DAILY",
            "drugadministrationroute": "065",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "actiondrug": "1",
            "activesubstance": {
              "activesubstancename": "CLOBAZAM"
            },
            "openfda": {
              "application_number": [
                "NDA203993",
                "NDA202067"
              ],
              "brand_name": [
                "ONFI"
              ],
              "generic_name": [
                "CLOBAZAM"
              ],
              "manufacturer_name": [
                "Lundbeck Pharmaceuticals LLC"
              ],
              "product_ndc": [
                "67386-313",
                "67386-314",
                "67386-315"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "CLOBAZAM"
              ],
              "rxcui": [
                "199450",
                "246172",
                "1191056",
                "1191058",
                "1366192",
                "1366196"
              ],
              "spl_id": [
                "68dbe31c-2dbe-49ad-8b2e-2cf1b8521167"
              ],
              "spl_set_id": [
                "de03bd69-2dca-459c-93b4-541fd3e9571c"
              ],
              "package_ndc": [
                "67386-314-01",
                "67386-315-01",
                "67386-313-21"
              ],
              "nui": [
                "N0000175694",
                "M0002356",
                "N0000182137",
                "N0000185506"
              ],
              "pharm_class_epc": [
                "Benzodiazepine [EPC]"
              ],
              "pharm_class_cs": [
                "Benzodiazepines [CS]"
              ],
              "pharm_class_moa": [
                "Cytochrome P450 2D6 Inhibitors [MoA]",
                "Cytochrome P450 3A4 Inducers [MoA]"
              ],
              "unii": [
                "2MRO291B4U"
              ]
            }
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "EPIDIOLEX",
            "drugbatchnumb": "W002331",
            "drugdosagetext": "100 MILLIGRAM",
            "drugdosageform": "ORAL SOLUTION",
            "drugadministrationroute": "048",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "drugstartdateformat": "610",
            "drugstartdate": "201901",
            "actiondrug": "5",
            "drugadditional": "3",
            "activesubstance": {
              "activesubstancename": "CANNABIDIOL"
            },
            "openfda": {
              "application_number": [
                "NDA210365"
              ],
              "brand_name": [
                "EPIDIOLEX"
              ],
              "generic_name": [
                "CANNABIDIOL"
              ],
              "manufacturer_name": [
                "Jazz Pharmaceuticals, Inc."
              ],
              "product_ndc": [
                "70127-100"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "CANNABIDIOL"
              ],
              "rxcui": [
                "2058900",
                "2058906"
              ],
              "spl_id": [
                "1eb7ac65-8df5-4a4a-9156-802cfaa92b06"
              ],
              "spl_set_id": [
                "8bf27097-4870-43fb-94f0-f3d0871d1eec"
              ],
              "package_ndc": [
                "70127-100-01",
                "70127-100-10",
                "70127-100-06",
                "70127-100-60"
              ],
              "nui": [
                "M0003267",
                "N0000187062",
                "N0000185504",
                "N0000182140",
                "N0000191278",
                "N0000191273",
                "N0000182138",
                "N0000182139",
                "N0000187064"
              ],
              "pharm_class_cs": [
                "Cannabinoids [CS]"
              ],
              "pharm_class_moa": [
                "Cytochrome P450 2C8 Inhibitors [MoA]",
                "Cytochrome P450 2C9 Inhibitors [MoA]",
                "Cytochrome P450 2C19 Inhibitors [MoA]",
                "UGT1A9 Inhibitors [MoA]",
                "UGT2B7 Inhibitors [MoA]",
                "Cytochrome P450 1A2 Inhibitors [MoA]",
                "Cytochrome P450 2B6 Inhibitors [MoA]",
                "Cytochrome P450 2B6 Inducers [MoA]"
              ],
              "unii": [
                "19GBJ60SN5"
              ]
            }
          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 2019"
        }
      }
    }
  ]
}