{
  "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": "22661573",
      "occurcountry": "IL",
      "transmissiondateformat": "102",
      "transmissiondate": "20230721",
      "reporttype": "1",
      "serious": "2",
      "seriousnessdeath": "2",
      "seriousnesslifethreatening": "2",
      "seriousnesshospitalization": "2",
      "seriousnessdisabling": "2",
      "seriousnesscongenitalanomali": "2",
      "seriousnessother": "2",
      "receivedateformat": "102",
      "receivedate": "20230630",
      "receiptdateformat": "102",
      "receiptdate": "20230630",
      "fulfillexpeditecriteria": "2",
      "companynumb": "IL-JAZZ-2022-IL-038781",
      "primarysource": {
        "reportercountry": "CO",
        "qualification": "5"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientonsetage": "8",
        "patientonsetageunit": "801",
        "patientsex": "2",
        "reaction": [
          {
            "reactionmeddraversionpt": "26.0",
            "reactionmeddrapt": "Seizure",
            "reactionoutcome": "1"
          },
          {
            "reactionmeddraversionpt": "26.0",
            "reactionmeddrapt": "Product colour issue",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "26.0",
            "reactionmeddrapt": "Poor quality product administered",
            "reactionoutcome": "6"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "EPIDIOLEX",
            "drugbatchnumb": "066788",
            "drugdosagetext": "90MG IN THE MORNING + 170MG IN THE EVENING",
            "drugdosageform": "Oral solution",
            "drugindication": "Severe myoclonic epilepsy of infancy",
            "drugstartdateformat": "602",
            "drugstartdate": "2019",
            "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"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "SULTHIAME",
            "drugdosagetext": "UNK",
            "drugindication": "Seizure",
            "activesubstance": {
              "activesubstancename": "SULTHIAME"
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "STIRIPENTOL",
            "drugdosagetext": "UNK",
            "drugindication": "Seizure",
            "activesubstance": {
              "activesubstancename": "STIRIPENTOL"
            },
            "openfda": {
              "application_number": [
                "NDA206709",
                "NDA207223"
              ],
              "brand_name": [
                "DIACOMIT"
              ],
              "generic_name": [
                "STIRIPENTOL"
              ],
              "manufacturer_name": [
                "BIOCODEX, INC."
              ],
              "product_ndc": [
                "68418-7939",
                "68418-7940",
                "68418-7941",
                "68418-7942"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "STIRIPENTOL"
              ],
              "rxcui": [
                "2054973",
                "2054979",
                "2054981",
                "2054983",
                "2055011",
                "2055014",
                "2055015",
                "2055016"
              ],
              "spl_id": [
                "7c968964-991e-4ec2-bc03-ef062b5bb0f9"
              ],
              "spl_set_id": [
                "58304ba8-9779-4658-811e-94ffe08c3f16"
              ],
              "package_ndc": [
                "68418-7939-6",
                "68418-7940-6",
                "68418-7941-6",
                "68418-7942-6"
              ],
              "unii": [
                "R02XOT8V8I"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "RIVOTRIL",
            "drugdosagetext": "UNK",
            "drugindication": "Seizure",
            "activesubstance": {
              "activesubstancename": "CLONAZEPAM"
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "RIVOTRIL",
            "drugindication": "Seizure",
            "activesubstance": {
              "activesubstancename": "CLONAZEPAM"
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "PHENYTOIN",
            "drugdosagetext": "UNK",
            "drugindication": "Seizure",
            "activesubstance": {
              "activesubstancename": "PHENYTOIN"
            },
            "openfda": {
              "application_number": [
                "ANDA200691",
                "ANDA040521",
                "ANDA084427",
                "NDA008762",
                "ANDA200565"
              ],
              "brand_name": [
                "PHENYTOIN",
                "PHENYTOIN INFATABS",
                "DILANTIN-125",
                "DILANTIN INFATABS"
              ],
              "generic_name": [
                "PHENYTOIN"
              ],
              "manufacturer_name": [
                "Rising Pharma Holdings, Inc.",
                "Sun Pharmaceutical Industries, Inc.",
                "Prasco Laboratories",
                "Viatris Specialty LLC",
                "Parke-Davis Div of Pfizer Inc",
                "Mylan Pharmaceuticals Inc."
              ],
              "product_ndc": [
                "64980-573",
                "51672-4069",
                "66993-372",
                "58151-115",
                "0071-0007",
                "51672-4146",
                "59762-0531"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "PHENYTOIN"
              ],
              "rxcui": [
                "1313885",
                "1313112",
                "1313884",
                "1313887"
              ],
              "spl_id": [
                "14ec4c18-fa7a-46e6-ac18-a7c23253e51c",
                "3cbd8a0c-6cfb-e0dd-e063-6394a90a8a26",
                "7cdde2aa-57b2-49e4-8563-bbe86f67cd39",
                "f339f9e4-b289-4efe-82b9-46c57d1dc277",
                "80f0cff3-357e-4328-860e-bbd525d80e6b",
                "4e03fb7d-d33a-2472-e063-6394a90a9b81",
                "212141a3-fffd-49e0-96d5-57cc921a99d1"
              ],
              "spl_set_id": [
                "e95cad66-b5f9-4802-a35f-fed340bf09ab",
                "093fd736-5971-47af-b4ef-08c1696cebe8",
                "3580e6a8-f7c3-44a0-a1eb-2a84ae589d21",
                "f339f9e4-b289-4efe-82b9-46c57d1dc277",
                "ca119a89-2394-4d34-8078-cd1fa4e8e2f1",
                "78b38e7b-1460-4adc-b738-320ffa6259c2",
                "37943ec1-a8d2-42df-967e-6f96f84c017b"
              ],
              "package_ndc": [
                "64980-573-01",
                "51672-4069-1",
                "51672-4069-2",
                "66993-372-02",
                "58151-115-35",
                "0071-0007-40",
                "0071-0007-24",
                "51672-4146-6",
                "51672-4146-1",
                "51672-4146-3",
                "59762-0531-2"
              ],
              "nui": [
                "N0000175753",
                "N0000008486",
                "N0000191266",
                "N0000187064",
                "N0000187063",
                "N0000185607",
                "N0000191267",
                "N0000190118",
                "N0000185507"
              ],
              "pharm_class_epc": [
                "Anti-epileptic Agent [EPC]"
              ],
              "pharm_class_pe": [
                "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
              ],
              "pharm_class_moa": [
                "Cytochrome P450 1A2 Inducers [MoA]",
                "Cytochrome P450 2B6 Inducers [MoA]",
                "Cytochrome P450 2C8 Inducers [MoA]",
                "Cytochrome P450 2C19 Inducers [MoA]",
                "Cytochrome P450 2D6 Inducers [MoA]",
                "Cytochrome P450 3A Inducers [MoA]",
                "Cytochrome P450 2C9 Inducers [MoA]"
              ],
              "unii": [
                "6158TKW0C5"
              ]
            }
          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 20220101"
        }
      }
    }
  ]
}