{
  "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": 2355
    }
  },
  "results": [
    {
      "safetyreportversion": "1",
      "safetyreportid": "10013803",
      "primarysourcecountry": "US",
      "occurcountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20141002",
      "reporttype": "1",
      "serious": "1",
      "seriousnesshospitalization": "1",
      "receivedateformat": "102",
      "receivedate": "20140316",
      "receiptdateformat": "102",
      "receiptdate": "20140316",
      "fulfillexpeditecriteria": "1",
      "companynumb": "US-US-EMD SERONO, INC.-7275416",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "EMD SERONO INC",
        "duplicatenumb": "US-US-EMD SERONO, INC.-7275416"
      },
      "primarysource": {
        "reportercountry": "US",
        "qualification": "5"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientsex": "2",
        "reaction": [
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Premature labour",
            "reactionoutcome": "1"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "GONAL-F",
            "drugauthorizationnumb": "020378",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "drugstartdateformat": "602",
            "drugstartdate": "2012",
            "actiondrug": "5",
            "openfda": {
              "application_number": [
                "BLA020378"
              ],
              "brand_name": [
                "GONAL-F"
              ],
              "generic_name": [
                "FOLLITROPIN ALFA"
              ],
              "manufacturer_name": [
                "EMD Serono, Inc."
              ],
              "product_ndc": [
                "44087-9030",
                "44087-9070"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "SUBCUTANEOUS"
              ],
              "rxcui": [
                "351125",
                "351993"
              ],
              "spl_id": [
                "cce3fe26-e11c-4cc9-9cf9-5841913db5ba"
              ],
              "spl_set_id": [
                "ae85b9c3-e7eb-4981-a5d9-346050e8f189"
              ],
              "package_ndc": [
                "44087-9030-1",
                "44087-9070-1"
              ]
            }
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "CETROTIDE (CETRORELIX ACETATE FOR INJECTION)",
            "drugauthorizationnumb": "021197",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "drugstartdateformat": "602",
            "drugstartdate": "2012",
            "actiondrug": "5"
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "OVIDREL",
            "drugauthorizationnumb": "021149",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "drugstartdateformat": "602",
            "drugstartdate": "2012",
            "actiondrug": "5",
            "openfda": {
              "application_number": [
                "BLA021149"
              ],
              "brand_name": [
                "OVIDREL"
              ],
              "generic_name": [
                "CHORIOGONADOTROPIN ALFA"
              ],
              "manufacturer_name": [
                "EMD Serono, Inc."
              ],
              "product_ndc": [
                "44087-1150"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "SUBCUTANEOUS"
              ],
              "substance_name": [
                "CHORIOGONADOTROPIN ALFA"
              ],
              "rxcui": [
                "727505",
                "727507"
              ],
              "spl_id": [
                "59d39f88-54fb-480a-979b-4d3d2c7c2cd4"
              ],
              "spl_set_id": [
                "a683e58a-63ea-44b8-a326-1a99a537bcf2"
              ],
              "package_ndc": [
                "44087-1150-1"
              ],
              "nui": [
                "N0000175838",
                "M0009540"
              ],
              "pharm_class_epc": [
                "Gonadotropin [EPC]"
              ],
              "pharm_class_cs": [
                "Gonadotropins [CS]"
              ],
              "unii": [
                "6413W06WR3"
              ]
            }
          }
        ]
      }
    }
  ]
}