{
  "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": [
    {
      "safetyreportid": "5578523-1",
      "transmissiondateformat": "102",
      "transmissiondate": "20080405",
      "serious": "1",
      "seriousnessother": "1",
      "receivedateformat": "102",
      "receivedate": "20071227",
      "receiptdateformat": "102",
      "receiptdate": "20061004",
      "fulfillexpeditecriteria": "1",
      "companynumb": "2006VX001647",
      "primarysource": {
        "reportercountry": "CANADA",
        "qualification": "3"
      },
      "sender": {
        "senderorganization": "FDA-Public Use"
      },
      "receiver": null,
      "patient": {
        "patientonsetage": "78",
        "patientonsetageunit": "801",
        "patientweight": "73",
        "patientsex": "2",
        "reaction": [
          {
            "reactionmeddrapt": "CONDITION AGGRAVATED"
          },
          {
            "reactionmeddrapt": "CONFUSIONAL STATE"
          },
          {
            "reactionmeddrapt": "GAIT DISTURBANCE"
          },
          {
            "reactionmeddrapt": "PAIN"
          },
          {
            "reactionmeddrapt": "SPINAL CORD COMPRESSION"
          },
          {
            "reactionmeddrapt": "TACHYCARDIA"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "CESAMET",
            "drugauthorizationnumb": "18677",
            "openfda": {
              "application_number": [
                "NDA018677"
              ],
              "brand_name": [
                "CESAMET"
              ],
              "generic_name": [
                "NABILONE"
              ],
              "manufacturer_name": [
                "Bausch Health US LLC"
              ],
              "product_ndc": [
                "0187-1231"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "NABILONE"
              ],
              "rxcui": [
                "104885",
                "311891"
              ],
              "spl_id": [
                "c8ba6520-445a-4934-85f4-6f706cb21585"
              ],
              "spl_set_id": [
                "83c7ac15-ece9-47de-b83c-d575544fa449"
              ],
              "package_ndc": [
                "0187-1231-50"
              ],
              "nui": [
                "N0000175782",
                "M0003267"
              ],
              "pharm_class_epc": [
                "Cannabinoid [EPC]"
              ],
              "pharm_class_cs": [
                "Cannabinoids [CS]"
              ],
              "unii": [
                "2N4O9L084N"
              ]
            }
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "REMICADE",
            "drugdosagetext": "300 MG; 8 YEARLY; IV",
            "drugadministrationroute": "042",
            "openfda": {
              "application_number": [
                "BLA103772"
              ],
              "brand_name": [
                "REMICADE"
              ],
              "generic_name": [
                "INFLIXIMAB"
              ],
              "manufacturer_name": [
                "Janssen Biotech, Inc."
              ],
              "product_ndc": [
                "57894-030"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "INTRAVENOUS"
              ],
              "substance_name": [
                "INFLIXIMAB"
              ],
              "rxcui": [
                "213361",
                "310994"
              ],
              "spl_id": [
                "36afec96-dd29-9328-e063-6294a90af8e4"
              ],
              "spl_set_id": [
                "a0a046c1-056d-45a9-bfd9-13b47c24f257"
              ],
              "package_ndc": [
                "57894-030-01"
              ],
              "nui": [
                "N0000175610",
                "N0000175451"
              ],
              "pharm_class_epc": [
                "Tumor Necrosis Factor Blocker [EPC]"
              ],
              "pharm_class_moa": [
                "Tumor Necrosis Factor Receptor Blocking Activity [MoA]"
              ],
              "unii": [
                "B72HH48FLU"
              ]
            }
          }
        ]
      }
    }
  ]
}