{
  "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": 34371
    }
  },
  "results": [
    {
      "safetyreportversion": "2",
      "safetyreportid": "10006063",
      "primarysourcecountry": "DE",
      "occurcountry": "DE",
      "transmissiondateformat": "102",
      "transmissiondate": "20150326",
      "reporttype": "1",
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      "receivedateformat": "102",
      "receivedate": "20140313",
      "receiptdateformat": "102",
      "receiptdate": "20140909",
      "fulfillexpeditecriteria": "1",
      "companynumb": "DE-ENDO PHARMACEUTICALS INC.-AVEE20140001",
      "duplicate": "1",
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        "duplicatesource": "ENDO",
        "duplicatenumb": "DE-ENDO PHARMACEUTICALS INC.-AVEE20140001"
      },
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        "senderorganization": "FDA-Public Use"
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        "patientonsetage": "49",
        "patientonsetageunit": "801",
        "patientweight": "93",
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        "reaction": [
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Paraesthesia",
            "reactionoutcome": "1"
          },
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Dyspnoea",
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          },
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Ocular hyperaemia",
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          },
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Dyspnoea at rest",
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            "medicinalproduct": "AVEED",
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            "drugauthorizationnumb": "022219",
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              "activesubstancename": "TESTOSTERONE UNDECANOATE"
            },
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              "application_number": [
                "NDA022219"
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                "AVEED"
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                "TESTOSTERONE UNDECANOATE"
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              "manufacturer_name": [
                "Endo USA, Inc."
              ],
              "product_ndc": [
                "67979-511"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "INTRAMUSCULAR"
              ],
              "substance_name": [
                "TESTOSTERONE UNDECANOATE"
              ],
              "rxcui": [
                "1490661",
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              "spl_id": [
                "da249940-81ef-4af3-8c59-4697e0404e71"
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                "f80f025b-17d8-40af-8739-20ce07902045"
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                "67979-511-43"
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              "unii": [
                "H16A5VCT9C"
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          {
            "drugcharacterization": "1",
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            "drugauthorizationnumb": "022219",
            "drugstructuredosagenumb": "1000",
            "drugstructuredosageunit": "003",
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                "NDA022219"
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              "brand_name": [
                "AVEED"
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                "TESTOSTERONE UNDECANOATE"
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              ],
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                "67979-511"
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                "HUMAN PRESCRIPTION DRUG"
              ],
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                "INTRAMUSCULAR"
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        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 20140214"
        }
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    }
  ]
}