{
  "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": 53792
    }
  },
  "results": [
    {
      "safetyreportversion": "3",
      "safetyreportid": "10003419",
      "primarysourcecountry": "US",
      "occurcountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20151125",
      "reporttype": "1",
      "serious": "2",
      "receivedateformat": "102",
      "receivedate": "20140312",
      "receiptdateformat": "102",
      "receiptdate": "20150812",
      "fulfillexpeditecriteria": "2",
      "companynumb": "US-GILEAD-2012-0062200",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "GILEAD",
        "duplicatenumb": "US-GILEAD-2012-0062200"
      },
      "primarysource": {
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        "qualification": "3"
      },
      "sender": {
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        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
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        "receiverorganization": "FDA"
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      "patient": {
        "patientonsetage": "75",
        "patientonsetageunit": "801",
        "patientagegroup": "6",
        "patientsex": "2",
        "reaction": [
          {
            "reactionmeddraversionpt": "18.1",
            "reactionmeddrapt": "Anaemia",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "18.1",
            "reactionmeddrapt": "Fatigue",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "18.1",
            "reactionmeddrapt": "Fibrosis",
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          },
          {
            "reactionmeddraversionpt": "18.1",
            "reactionmeddrapt": "Dyspnoea",
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          {
            "reactionmeddraversionpt": "18.1",
            "reactionmeddrapt": "Weight decreased",
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        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "LETAIRIS",
            "drugbatchnumb": "GKZV",
            "drugauthorizationnumb": "022081",
            "drugstructuredosagenumb": "10",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
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            "drugindication": "PULMONARY ARTERIAL HYPERTENSION",
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            "drugstartdate": "20110112",
            "actiondrug": "4",
            "activesubstance": {
              "activesubstancename": "AMBRISENTAN"
            },
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              "application_number": [
                "NDA022081"
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              "brand_name": [
                "LETAIRIS"
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              "generic_name": [
                "AMBRISENTAN"
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              "manufacturer_name": [
                "Gilead Sciences, Inc."
              ],
              "product_ndc": [
                "61958-0801",
                "61958-0802"
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              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
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              "substance_name": [
                "AMBRISENTAN"
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                "722122",
                "722124"
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              ],
              "spl_set_id": [
                "725d4e73-6c83-477a-adc6-0ae4a133a844"
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              "package_ndc": [
                "61958-0801-2",
                "61958-0801-3",
                "61958-0801-1",
                "61958-0801-5",
                "61958-0801-4",
                "61958-0801-6",
                "61958-0802-2",
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                "61958-0802-5"
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                "N0000175364"
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                "Endothelin Receptor Antagonist [EPC]"
              ],
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                "Endothelin Receptor Antagonists [MoA]"
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              "unii": [
                "HW6NV07QEC"
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          {
            "drugcharacterization": "2",
            "medicinalproduct": "REVATIO",
            "activesubstance": {
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            },
            "openfda": {
              "application_number": [
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                "NDA203109",
                "NDA022473"
              ],
              "brand_name": [
                "REVATIO"
              ],
              "generic_name": [
                "SILDENAFIL CITRATE"
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                "PFIZER LABORATORIES DIV PFIZER INC",
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                "0069-0336",
                "58151-385",
                "58151-402",
                "58151-395"
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              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
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              "route": [
                "ORAL",
                "INTRAVENOUS"
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              "substance_name": [
                "SILDENAFIL CITRATE"
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              "package_ndc": [
                "0069-4190-68",
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                "0069-0336-21",
                "58151-402-77",
                "58151-395-31",
                "58151-385-35"
              ],
              "unii": [
                "BW9B0ZE037"
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        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 201206"
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      }
    }
  ]
}