{
  "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": 42708
    }
  },
  "results": [
    {
      "safetyreportversion": "4",
      "safetyreportid": "10028729",
      "primarysourcecountry": "US",
      "occurcountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20190204",
      "reporttype": "1",
      "serious": "1",
      "seriousnessother": "1",
      "receivedateformat": "102",
      "receivedate": "20140321",
      "receiptdateformat": "102",
      "receiptdate": "20181220",
      "fulfillexpeditecriteria": "1",
      "companynumb": "US-TEVA-470236USA",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "TEVA",
        "duplicatenumb": "US-TEVA-470236USA"
      },
      "primarysource": {
        "reportercountry": "US",
        "qualification": "1"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientonsetage": "34",
        "patientonsetageunit": "801",
        "patientweight": "79.9",
        "patientsex": "2",
        "reaction": [
          {
            "reactionmeddraversionpt": "21.1",
            "reactionmeddrapt": "Drug ineffective",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "21.1",
            "reactionmeddrapt": "Maternal exposure during pregnancy",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "21.1",
            "reactionmeddrapt": "Pregnancy with contraceptive device",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "21.1",
            "reactionmeddrapt": "Device dislocation",
            "reactionoutcome": "6"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "PARAGARD T 380A",
            "drugauthorizationnumb": "018680",
            "drugadministrationroute": "015",
            "drugindication": "CONTRACEPTION",
            "drugstartdateformat": "102",
            "drugstartdate": "20070813",
            "actiondrug": "4",
            "activesubstance": {
              "activesubstancename": "COPPER"
            },
            "openfda": {
              "application_number": [
                "NDA018680"
              ],
              "brand_name": [
                "PARAGARD T 380A"
              ],
              "generic_name": [
                "COPPER"
              ],
              "manufacturer_name": [
                "CooperSurgical, Inc."
              ],
              "product_ndc": [
                "59365-5129",
                "59365-5128"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "INTRAUTERINE"
              ],
              "substance_name": [
                "COPPER"
              ],
              "rxcui": [
                "2267305",
                "2267310"
              ],
              "spl_id": [
                "898e2915-26f8-44c3-a16f-e45ab2352d06",
                "226b4d58-044f-4016-9da3-6fd6a37645dd"
              ],
              "spl_set_id": [
                "3c420b53-c95e-46af-aebd-73741be58391",
                "5ea7ce51-b87a-485e-b841-99466a07a4b2"
              ],
              "package_ndc": [
                "59365-5129-1",
                "59365-5128-1"
              ],
              "nui": [
                "M0005152",
                "N0000175831",
                "N0000008595",
                "N0000008924",
                "N0000175830"
              ],
              "pharm_class_cs": [
                "Copper [CS]"
              ],
              "pharm_class_epc": [
                "Copper-containing Intrauterine Device [EPC]"
              ],
              "pharm_class_pe": [
                "Decreased Embryonic Implantation [PE]",
                "Decreased Sperm Motility [PE]",
                "Inhibit Ovum Fertilization [PE]"
              ],
              "unii": [
                "789U1901C5"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "PHENTERMINE.",
            "drugindication": "WEIGHT DECREASED",
            "activesubstance": {
              "activesubstancename": "PHENTERMINE"
            },
            "openfda": {
              "application_number": [
                "ANDA204318"
              ],
              "brand_name": [
                "PHENTERMINE"
              ],
              "generic_name": [
                "PHENTERMINE HYDROCHLORIDE"
              ],
              "manufacturer_name": [
                "Aurolife Pharma, LLC"
              ],
              "product_ndc": [
                "13107-105",
                "13107-106"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "PHENTERMINE HYDROCHLORIDE"
              ],
              "rxcui": [
                "900038",
                "968766"
              ],
              "spl_id": [
                "53dd7857-41fb-4da1-88f7-5c68a509bfb0"
              ],
              "spl_set_id": [
                "737eef3b-9a6b-4ab3-a25c-49d84d2a0197"
              ],
              "package_ndc": [
                "13107-105-30",
                "13107-105-01",
                "13107-106-30",
                "13107-106-01"
              ],
              "unii": [
                "0K2I505OTV"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "CYTOMEL",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "activesubstance": {
              "activesubstancename": "LIOTHYRONINE SODIUM"
            },
            "openfda": {
              "application_number": [
                "NDA010379"
              ],
              "brand_name": [
                "CYTOMEL"
              ],
              "generic_name": [
                "LIOTHYRONINE SODIUM"
              ],
              "manufacturer_name": [
                "Pfizer Laboratories Div Pfizer Inc"
              ],
              "product_ndc": [
                "60793-115",
                "60793-116",
                "60793-117"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "LIOTHYRONINE SODIUM"
              ],
              "spl_id": [
                "5c1150d8-903d-4c39-aa66-5a095ee1b00a"
              ],
              "spl_set_id": [
                "51452b31-ff68-4e0c-b982-c15502ebf1d3"
              ],
              "package_ndc": [
                "60793-115-01",
                "60793-116-01",
                "60793-117-01"
              ],
              "unii": [
                "GCA9VV7D2N"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "VYVANSE",
            "drugindication": "DEPRESSION",
            "activesubstance": {
              "activesubstancename": "LISDEXAMFETAMINE DIMESYLATE"
            },
            "openfda": {
              "application_number": [
                "NDA021977",
                "NDA208510"
              ],
              "brand_name": [
                "VYVANSE"
              ],
              "generic_name": [
                "LISDEXAMFETAMINE DIMESYLATE"
              ],
              "manufacturer_name": [
                "Takeda Pharmaceuticals America, Inc."
              ],
              "product_ndc": [
                "59417-101",
                "59417-102",
                "59417-103",
                "59417-104",
                "59417-105",
                "59417-106",
                "59417-107",
                "59417-115",
                "59417-116",
                "59417-117",
                "59417-118",
                "59417-119",
                "59417-120"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "LISDEXAMFETAMINE DIMESYLATE"
              ],
              "rxcui": [
                "854830",
                "854832",
                "854834",
                "854836",
                "854838",
                "854840",
                "854842",
                "854844",
                "854846",
                "854848",
                "854850",
                "854852",
                "1593856",
                "1593858",
                "1871456",
                "1871459",
                "1871460",
                "1871461",
                "1871462",
                "1871463",
                "1871464",
                "1871465",
                "1871466",
                "1871467",
                "1871468",
                "1871469"
              ],
              "spl_id": [
                "81d087b6-4cb4-466a-9693-679edeb062e2"
              ],
              "spl_set_id": [
                "704e4378-ca83-445c-8b45-3cfa51c1ecad"
              ],
              "package_ndc": [
                "59417-101-10",
                "59417-102-10",
                "59417-103-10",
                "59417-104-10",
                "59417-105-10",
                "59417-106-10",
                "59417-107-10",
                "59417-115-01",
                "59417-116-01",
                "59417-117-01",
                "59417-118-01",
                "59417-119-01",
                "59417-120-01"
              ],
              "unii": [
                "SJT761GEGS"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "SYNTHROID",
            "drugindication": "THYROID DISORDER",
            "activesubstance": {
              "activesubstancename": "LEVOTHYROXINE SODIUM"
            },
            "openfda": {
              "application_number": [
                "NDA021402"
              ],
              "brand_name": [
                "SYNTHROID"
              ],
              "generic_name": [
                "LEVOTHYROXINE SODIUM"
              ],
              "manufacturer_name": [
                "AbbVie Inc."
              ],
              "product_ndc": [
                "0074-3727",
                "0074-4341",
                "0074-4552",
                "0074-5182",
                "0074-6594",
                "0074-6624",
                "0074-9296",
                "0074-7068",
                "0074-7069",
                "0074-7070",
                "0074-7148",
                "0074-7149"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "LEVOTHYROXINE SODIUM"
              ],
              "rxcui": [
                "892246",
                "892251",
                "892255",
                "966158",
                "966171",
                "966185",
                "966191",
                "966201",
                "966205",
                "966218",
                "966220",
                "966221",
                "966222",
                "966224",
                "966225",
                "966247",
                "966248",
                "966249",
                "966250",
                "966251",
                "966253",
                "966270",
                "966271",
                "966282"
              ],
              "spl_id": [
                "b85ab7fa-ba96-43cd-b736-44b3924e644c"
              ],
              "spl_set_id": [
                "1e11ad30-1041-4520-10b0-8f9d30d30fcc"
              ],
              "package_ndc": [
                "0074-4341-13",
                "0074-4341-90",
                "0074-4341-19",
                "0074-4341-72",
                "0074-4552-13",
                "0074-4552-90",
                "0074-4552-19",
                "0074-4552-11",
                "0074-4552-71",
                "0074-4552-72",
                "0074-5182-13",
                "0074-5182-90",
                "0074-5182-71",
                "0074-5182-19",
                "0074-5182-11",
                "0074-5182-72",
                "0074-6594-13",
                "0074-6594-90",
                "0074-6594-71",
                "0074-6594-19",
                "0074-6594-72",
                "0074-6624-13",
                "0074-6624-90",
                "0074-6624-19",
                "0074-6624-11",
                "0074-6624-71",
                "0074-6624-72",
                "0074-9296-13",
                "0074-9296-90",
                "0074-9296-19",
                "0074-9296-71",
                "0074-9296-72",
                "0074-7068-13",
                "0074-7068-90",
                "0074-7068-71",
                "0074-7068-19",
                "0074-7068-11",
                "0074-7068-72",
                "0074-3727-13",
                "0074-3727-90",
                "0074-3727-71",
                "0074-3727-19",
                "0074-3727-72",
                "0074-7069-90",
                "0074-7069-71",
                "0074-7069-19",
                "0074-7069-11",
                "0074-7069-72",
                "0074-7070-13",
                "0074-7070-90",
                "0074-7070-71",
                "0074-7070-19",
                "0074-7070-72",
                "0074-7148-90",
                "0074-7148-19",
                "0074-7148-71",
                "0074-7148-11",
                "0074-7148-72",
                "0074-7149-90",
                "0074-7149-19"
              ],
              "unii": [
                "9J765S329G"
              ]
            }
          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 20140318"
        }
      }
    }
  ]
}