{
  "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,
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    }
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      "safetyreportversion": "3",
      "safetyreportid": "10004060",
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      "receivedate": "20140312",
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      "receiptdate": "20150327",
      "fulfillexpeditecriteria": "2",
      "companynumb": "US-BAYER-2014-036236",
      "duplicate": "1",
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        "qualification": "4"
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        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
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        "patientonsetageunit": "801",
        "patientagegroup": "5",
        "patientweight": "68.27",
        "patientsex": "2",
        "reaction": [
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Pulmonary embolism",
            "reactionoutcome": "2"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "General physical health deterioration",
            "reactionoutcome": "2"
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          {
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          {
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            "reactionmeddrapt": "Injury",
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          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Abdominal pain"
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                "NDA021098"
              ],
              "brand_name": [
                "YASMIN"
              ],
              "generic_name": [
                "DROSPIRENONE AND ETHINYL ESTRADIOL"
              ],
              "manufacturer_name": [
                "Bayer HealthCare Pharmaceuticals Inc."
              ],
              "product_ndc": [
                "50419-402"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "rxcui": [
                "284207",
                "748797",
                "748800",
                "748857"
              ],
              "spl_id": [
                "84c4a6e5-8157-4f6d-a51f-3665e8568a3c"
              ],
              "spl_set_id": [
                "d7ea6a60-5a56-4f81-b206-9b27b7e58875"
              ],
              "package_ndc": [
                "50419-402-03"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "LEXAPRO",
            "drugstructuredosagenumb": "20",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugdosagetext": "20 MG, QD",
            "drugadministrationroute": "048",
            "activesubstance": {
              "activesubstancename": "ESCITALOPRAM OXALATE"
            },
            "openfda": {
              "application_number": [
                "NDA021323"
              ],
              "brand_name": [
                "LEXAPRO"
              ],
              "generic_name": [
                "ESCITALOPRAM"
              ],
              "manufacturer_name": [
                "Allergan, Inc."
              ],
              "product_ndc": [
                "0456-2005",
                "0456-2010",
                "0456-2020",
                "0456-2101"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "ESCITALOPRAM OXALATE"
              ],
              "rxcui": [
                "349332",
                "351249",
                "351250",
                "351285",
                "352272",
                "352273",
                "404408",
                "404420"
              ],
              "spl_id": [
                "9ff46a66-0f97-4a78-9d18-ec576f63bae7"
              ],
              "spl_set_id": [
                "13bb8267-1cab-43e5-acae-55a4d957630a"
              ],
              "package_ndc": [
                "0456-2005-01",
                "0456-2010-01",
                "0456-2010-11",
                "0456-2010-63",
                "0456-2020-01",
                "0456-2020-11",
                "0456-2020-63",
                "0456-2101-08"
              ],
              "unii": [
                "5U85DBW7LO"
              ]
            }
          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 200801"
        }
      }
    }
  ]
}