{
  "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": 13710
    }
  },
  "results": [
    {
      "safetyreportversion": "1",
      "safetyreportid": "12083898",
      "primarysourcecountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20160526",
      "reporttype": "1",
      "serious": "2",
      "receivedateformat": "102",
      "receivedate": "20160216",
      "receiptdateformat": "102",
      "receiptdate": "20160216",
      "fulfillexpeditecriteria": "2",
      "primarysource": {
        "reportercountry": "US",
        "qualification": "2"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientonsetage": "65",
        "patientonsetageunit": "801",
        "patientsex": "1",
        "reaction": [
          {
            "reactionmeddraversionpt": "19.0",
            "reactionmeddrapt": "Peripheral swelling"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "VELTASSA",
            "drugstructuredosagenumb": "8.4",
            "drugstructuredosageunit": "002",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugadministrationroute": "048",
            "drugindication": "HYPERKALAEMIA",
            "activesubstance": {
              "activesubstancename": "PATIROMER"
            },
            "openfda": {
              "application_number": [
                "NDA205739"
              ],
              "brand_name": [
                "VELTASSA"
              ],
              "generic_name": [
                "PATIROMER"
              ],
              "manufacturer_name": [
                "Vifor Pharma, Inc."
              ],
              "product_ndc": [
                "53436-010",
                "53436-084",
                "53436-168",
                "53436-252"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "PATIROMER"
              ],
              "rxcui": [
                "1716209",
                "1716215",
                "1716217",
                "1716219",
                "1716221",
                "1716223",
                "2692050",
                "2692052"
              ],
              "spl_id": [
                "3e4b6452-1c7c-4f58-aee4-12fb185aaa83"
              ],
              "spl_set_id": [
                "bf002984-d6c9-46df-aecb-a07733f763c1"
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              "package_ndc": [
                "53436-084-01",
                "53436-084-04",
                "53436-084-30",
                "53436-084-91",
                "53436-084-92",
                "53436-168-01",
                "53436-168-30",
                "53436-252-01",
                "53436-252-30",
                "53436-010-01",
                "53436-010-60"
              ],
              "nui": [
                "N0000178378",
                "N0000178377"
              ],
              "pharm_class_epc": [
                "Potassium Binder [EPC]"
              ],
              "pharm_class_moa": [
                "Potassium Ion Binding Activity [MoA]"
              ],
              "unii": [
                "1FQ2RY5YHH"
              ]
            }
          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 20160212"
        }
      }
    }
  ]
}