{
  "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": "2026-04-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 592884
    }
  },
  "results": [
    {
      "safetyreportversion": "1",
      "safetyreportid": "10003765",
      "primarysourcecountry": "AR",
      "occurcountry": "AR",
      "transmissiondateformat": "102",
      "transmissiondate": "20141002",
      "reporttype": "1",
      "serious": "1",
      "seriousnessother": "1",
      "receivedateformat": "102",
      "receivedate": "20140312",
      "receiptdateformat": "102",
      "receiptdate": "20140312",
      "fulfillexpeditecriteria": "1",
      "companynumb": "AR-AMGEN-ARGSP2014016868",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "AMGEN",
        "duplicatenumb": "AR-AMGEN-ARGSP2014016868"
      },
      "primarysource": {
        "reportercountry": "AR",
        "qualification": "5"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientonsetage": "69",
        "patientonsetageunit": "801",
        "patientsex": "2",
        "reaction": [
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Visual impairment",
            "reactionoutcome": "1"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "ENBREL",
            "drugauthorizationnumb": "103795",
            "drugstructuredosagenumb": "50",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "803",
            "drugdosagetext": "50 MG, WEEKLY",
            "drugdosageform": "Solution for injection in pre-filled syringe",
            "drugadministrationroute": "065",
            "drugindication": "RHEUMATOID ARTHRITIS",
            "drugstartdateformat": "102",
            "drugstartdate": "20140217",
            "actiondrug": "4",
            "openfda": {
              "application_number": [
                "BLA103795"
              ],
              "brand_name": [
                "ENBREL"
              ],
              "generic_name": [
                "ETANERCEPT"
              ],
              "manufacturer_name": [
                "Immunex Corporation"
              ],
              "product_ndc": [
                "58406-010",
                "58406-425",
                "58406-021",
                "58406-032",
                "58406-044",
                "58406-055"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "SUBCUTANEOUS"
              ],
              "substance_name": [
                "ETANERCEPT"
              ],
              "spl_id": [
                "de3ee3bd-0047-4365-a4c7-5786521a1649"
              ],
              "spl_set_id": [
                "a002b40c-097d-47a5-957f-7a7b1807af7f"
              ],
              "package_ndc": [
                "58406-425-41",
                "58406-425-34",
                "58406-424-01",
                "58406-910-01",
                "58406-021-01",
                "58406-021-04",
                "58406-021-96",
                "58406-032-01",
                "58406-032-04",
                "58406-032-96",
                "58406-032-90",
                "58406-010-01",
                "58406-010-04",
                "58406-010-96",
                "58406-044-01",
                "58406-044-04",
                "58406-044-96",
                "58406-044-24",
                "58406-044-90",
                "58406-055-01",
                "58406-055-04",
                "58406-055-96",
                "58406-055-90"
              ],
              "nui": [
                "N0000175610",
                "N0000175451"
              ],
              "pharm_class_epc": [
                "Tumor Necrosis Factor Blocker [EPC]"
              ],
              "pharm_class_moa": [
                "Tumor Necrosis Factor Receptor Blocking Activity [MoA]"
              ],
              "unii": [
                "OP401G7OJC"
              ]
            }
          }
        ]
      }
    }
  ]
}