{
  "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": 61516
    }
  },
  "results": [
    {
      "safetyreportversion": "2",
      "safetyreportid": "10004007",
      "primarysourcecountry": "DE",
      "occurcountry": "DE",
      "transmissiondateformat": "102",
      "transmissiondate": "20141002",
      "reporttype": "1",
      "serious": "1",
      "seriousnessother": "1",
      "receivedateformat": "102",
      "receivedate": "20140312",
      "receiptdateformat": "102",
      "receiptdate": "20140320",
      "fulfillexpeditecriteria": "1",
      "companynumb": "DE-GILEAD-2014-0096484",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "GILEAD",
        "duplicatenumb": "DE-GILEAD-2014-0096484"
      },
      "primarysource": {
        "reportercountry": "DE",
        "qualification": "1"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientonsetage": "81",
        "patientonsetageunit": "801",
        "patientsex": "2",
        "reaction": [
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Cardiac disorder",
            "reactionoutcome": "6"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "AMBRISENTAN",
            "drugauthorizationnumb": "022081",
            "drugdosageform": "TABLET",
            "drugadministrationroute": "048",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "actiondrug": "5",
            "openfda": {
              "application_number": [
                "ANDA208252",
                "ANDA210058",
                "NDA022081",
                "ANDA208441",
                "ANDA216531",
                "ANDA210701",
                "ANDA208354",
                "ANDA210715",
                "ANDA210784"
              ],
              "brand_name": [
                "AMBRISENTAN",
                "LETAIRIS"
              ],
              "generic_name": [
                "AMBRISENTAN"
              ],
              "manufacturer_name": [
                "Actavis Pharma, Inc.",
                "Zydus Lifesciences Limited",
                "Gilead Sciences, Inc.",
                "Mylan Pharmaceuticals Inc.",
                "Aurobindo Pharma Limited",
                "Apotex Corp.",
                "Zydus Pharmaceuticals USA Inc.",
                "Quallent Pharmaceuticals Health LLC",
                "Sigmapharm Laboratories, LLC",
                "Cipla USA Inc.",
                "Sun Pharmaceutical Industries, Inc."
              ],
              "product_ndc": [
                "0591-2405",
                "0591-2406",
                "70771-1363",
                "70771-1364",
                "61958-0801",
                "61958-0802",
                "0378-4270",
                "0378-4271",
                "59651-494",
                "59651-495",
                "60505-4552",
                "60505-4553",
                "70710-1179",
                "70710-1180",
                "82009-141",
                "82009-142",
                "42794-051",
                "42794-052",
                "69097-386",
                "69097-387",
                "47335-236",
                "47335-237"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "AMBRISENTAN"
              ],
              "spl_id": [
                "67758125-7c3e-4b62-8cb3-e17d7f079322",
                "14a85c38-61bf-4621-8e3a-34ab57a15758",
                "273ba426-0edb-47a2-b5d3-883cd1b9369a",
                "e6cdba8a-c9be-460b-918a-f72bd6310bce",
                "a6d48e99-4411-4724-8372-b01692a5dff7",
                "9ea6cb4f-0099-f884-4d51-8335310bf1b9",
                "4ad0e26d-a3b2-47d1-89a0-6e7e0697d5e4",
                "64a9be1d-a83b-40aa-942f-18c6a9382dfa",
                "f1f20771-a78f-74cf-e053-2995a90a6adf",
                "7921a3aa-6e99-4f28-a5d3-a3047b1ec3cc",
                "294580cb-5622-4f48-89a8-99000a7a2964"
              ],
              "spl_set_id": [
                "32549c43-f8ff-422c-b42d-ca0877e661cf",
                "0e3e3320-27ac-404f-9f01-3d82696e768a",
                "725d4e73-6c83-477a-adc6-0ae4a133a844",
                "8080b009-361b-4505-b09a-0d91a0e4a2c0",
                "82e51c75-fb78-4ad3-8bce-5e0581d60014",
                "291a782a-77e1-8a8e-e1c8-2626f305c2b7",
                "37af3191-0ed3-4783-8747-065f1462f2d2",
                "6fc6032f-94dc-4067-8b24-01990ec99db0",
                "e20ab2fe-bc9f-48a3-b15a-e4bc9532c2ac",
                "0e418384-cae1-47ae-ac5e-afc845d694f6",
                "a4978a54-1799-43d6-85dd-05fa9de0a5d7"
              ],
              "package_ndc": [
                "0591-2405-30",
                "0591-2406-30",
                "70771-1363-3",
                "70771-1363-9",
                "70771-1363-1",
                "70771-1363-8",
                "70771-1363-7",
                "70771-1364-3",
                "70771-1364-9",
                "70771-1364-1",
                "70771-1364-8",
                "70771-1364-7",
                "61958-0801-2",
                "61958-0801-3",
                "61958-0801-1",
                "61958-0801-5",
                "61958-0801-4",
                "61958-0801-6",
                "61958-0802-2",
                "61958-0802-3",
                "61958-0802-1",
                "61958-0802-5",
                "0378-4270-93",
                "0378-4271-93",
                "59651-494-30",
                "59651-495-30",
                "60505-4552-1",
                "60505-4552-0",
                "60505-4552-3",
                "60505-4553-1",
                "60505-4553-0",
                "60505-4553-3",
                "70710-1179-3",
                "70710-1179-9",
                "70710-1179-1",
                "70710-1179-8",
                "70710-1179-7",
                "70710-1180-3",
                "70710-1180-9",
                "70710-1180-1",
                "70710-1180-8",
                "70710-1180-7",
                "82009-141-30",
                "82009-142-30",
                "42794-051-08",
                "42794-051-22",
                "42794-052-08",
                "42794-052-22",
                "69097-386-19",
                "69097-386-02",
                "69097-387-02",
                "69097-387-19",
                "47335-236-83",
                "47335-236-60",
                "47335-236-66",
                "47335-236-64",
                "47335-236-85",
                "47335-237-83",
                "47335-237-60",
                "47335-237-66",
                "47335-237-64",
                "47335-237-85"
              ],
              "nui": [
                "N0000175581",
                "N0000175364"
              ],
              "pharm_class_epc": [
                "Endothelin Receptor Antagonist [EPC]"
              ],
              "pharm_class_moa": [
                "Endothelin Receptor Antagonists [MoA]"
              ],
              "unii": [
                "HW6NV07QEC"
              ],
              "rxcui": [
                "722116",
                "722122",
                "722120",
                "722124"
              ]
            }
          }
        ]
      }
    }
  ]
}