{
  "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": 36317
    }
  },
  "results": [
    {
      "safetyreportversion": "2",
      "safetyreportid": "10003633",
      "primarysourcecountry": "US",
      "occurcountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20141002",
      "reporttype": "1",
      "serious": "1",
      "seriousnessdeath": "1",
      "receivedateformat": "102",
      "receivedate": "20140312",
      "receiptdateformat": "102",
      "receiptdate": "20140312",
      "fulfillexpeditecriteria": "1",
      "companynumb": "US-GE HEALTHCARE MEDICAL DIAGNOSTICS-OSCN-PR-1006S-0175",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "GE HEALTHCARE",
        "duplicatenumb": "US-GE HEALTHCARE MEDICAL DIAGNOSTICS-OSCN-PR-1006S-0175"
      },
      "primarysource": {
        "reportercountry": "US",
        "qualification": "4"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientonsetage": "70",
        "patientonsetageunit": "801",
        "patientweight": "55.39",
        "patientsex": "1",
        "reaction": [
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Nephrogenic systemic fibrosis",
            "reactionoutcome": "5"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "OMNISCAN",
            "drugauthorizationnumb": "020123",
            "drugstructuredosagenumb": "40",
            "drugstructuredosageunit": "012",
            "drugdosageform": "SOLUTION FOR INJECTION",
            "drugadministrationroute": "042",
            "drugindication": "CEREBROVASCULAR ACCIDENT",
            "drugstartdateformat": "102",
            "drugstartdate": "20031122",
            "drugenddateformat": "102",
            "drugenddate": "20031122",
            "openfda": {
              "application_number": [
                "NDA020123"
              ],
              "brand_name": [
                "OMNISCAN"
              ],
              "generic_name": [
                "GADODIAMIDE"
              ],
              "manufacturer_name": [
                "GE Healthcare Inc."
              ],
              "product_ndc": [
                "0407-0690"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "INTRAVENOUS"
              ],
              "substance_name": [
                "GADODIAMIDE"
              ],
              "spl_id": [
                "dfe2f58c-7a8f-408a-9690-6300a49eda17"
              ],
              "spl_set_id": [
                "1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a"
              ],
              "package_ndc": [
                "0407-0690-05",
                "0407-0690-10",
                "0407-0690-15",
                "0407-0690-20",
                "0407-0690-12",
                "0407-0690-17",
                "0407-0690-22"
              ],
              "nui": [
                "N0000175862",
                "N0000180184"
              ],
              "pharm_class_moa": [
                "Magnetic Resonance Contrast Activity [MoA]"
              ],
              "pharm_class_epc": [
                "Paramagnetic Contrast Agent [EPC]"
              ],
              "unii": [
                "84F6U3J2R6"
              ]
            }
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "OMNISCAN",
            "drugauthorizationnumb": "020123",
            "drugstructuredosagenumb": "40",
            "drugstructuredosageunit": "012",
            "drugdosageform": "SOLUTION FOR INJECTION",
            "drugadministrationroute": "042",
            "drugindication": "HYPERTENSION",
            "drugstartdateformat": "102",
            "drugstartdate": "20031123",
            "drugenddateformat": "102",
            "drugenddate": "20031123",
            "openfda": {
              "application_number": [
                "NDA020123"
              ],
              "brand_name": [
                "OMNISCAN"
              ],
              "generic_name": [
                "GADODIAMIDE"
              ],
              "manufacturer_name": [
                "GE Healthcare Inc."
              ],
              "product_ndc": [
                "0407-0690"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "INTRAVENOUS"
              ],
              "substance_name": [
                "GADODIAMIDE"
              ],
              "spl_id": [
                "dfe2f58c-7a8f-408a-9690-6300a49eda17"
              ],
              "spl_set_id": [
                "1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a"
              ],
              "package_ndc": [
                "0407-0690-05",
                "0407-0690-10",
                "0407-0690-15",
                "0407-0690-20",
                "0407-0690-12",
                "0407-0690-17",
                "0407-0690-22"
              ],
              "nui": [
                "N0000175862",
                "N0000180184"
              ],
              "pharm_class_moa": [
                "Magnetic Resonance Contrast Activity [MoA]"
              ],
              "pharm_class_epc": [
                "Paramagnetic Contrast Agent [EPC]"
              ],
              "unii": [
                "84F6U3J2R6"
              ]
            }
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "OMNISCAN",
            "drugauthorizationnumb": "020123",
            "drugdosageform": "SOLUTION FOR INJECTION",
            "drugadministrationroute": "042",
            "drugindication": "RENAL ARTERY STENOSIS",
            "drugstartdateformat": "102",
            "drugstartdate": "20050326",
            "drugenddateformat": "102",
            "drugenddate": "20050326",
            "openfda": {
              "application_number": [
                "NDA020123"
              ],
              "brand_name": [
                "OMNISCAN"
              ],
              "generic_name": [
                "GADODIAMIDE"
              ],
              "manufacturer_name": [
                "GE Healthcare Inc."
              ],
              "product_ndc": [
                "0407-0690"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "INTRAVENOUS"
              ],
              "substance_name": [
                "GADODIAMIDE"
              ],
              "spl_id": [
                "dfe2f58c-7a8f-408a-9690-6300a49eda17"
              ],
              "spl_set_id": [
                "1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a"
              ],
              "package_ndc": [
                "0407-0690-05",
                "0407-0690-10",
                "0407-0690-15",
                "0407-0690-20",
                "0407-0690-12",
                "0407-0690-17",
                "0407-0690-22"
              ],
              "nui": [
                "N0000175862",
                "N0000180184"
              ],
              "pharm_class_moa": [
                "Magnetic Resonance Contrast Activity [MoA]"
              ],
              "pharm_class_epc": [
                "Paramagnetic Contrast Agent [EPC]"
              ],
              "unii": [
                "84F6U3J2R6"
              ]
            }
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "OMNISCAN",
            "drugauthorizationnumb": "020123",
            "drugdosageform": "SOLUTION FOR INJECTION",
            "drugadministrationroute": "042",
            "drugindication": "PAIN IN EXTREMITY",
            "drugstartdateformat": "102",
            "drugstartdate": "20050428",
            "drugenddateformat": "102",
            "drugenddate": "20050428",
            "openfda": {
              "application_number": [
                "NDA020123"
              ],
              "brand_name": [
                "OMNISCAN"
              ],
              "generic_name": [
                "GADODIAMIDE"
              ],
              "manufacturer_name": [
                "GE Healthcare Inc."
              ],
              "product_ndc": [
                "0407-0690"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "INTRAVENOUS"
              ],
              "substance_name": [
                "GADODIAMIDE"
              ],
              "spl_id": [
                "dfe2f58c-7a8f-408a-9690-6300a49eda17"
              ],
              "spl_set_id": [
                "1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a"
              ],
              "package_ndc": [
                "0407-0690-05",
                "0407-0690-10",
                "0407-0690-15",
                "0407-0690-20",
                "0407-0690-12",
                "0407-0690-17",
                "0407-0690-22"
              ],
              "nui": [
                "N0000175862",
                "N0000180184"
              ],
              "pharm_class_moa": [
                "Magnetic Resonance Contrast Activity [MoA]"
              ],
              "pharm_class_epc": [
                "Paramagnetic Contrast Agent [EPC]"
              ],
              "unii": [
                "84F6U3J2R6"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "OXYCONTIN",
            "drugindication": "PAIN",
            "openfda": {
              "application_number": [
                "NDA022272"
              ],
              "brand_name": [
                "OXYCONTIN"
              ],
              "generic_name": [
                "OXYCODONE HYDROCHLORIDE"
              ],
              "manufacturer_name": [
                "Knoa Pharma LLC"
              ],
              "product_ndc": [
                "59011-410",
                "59011-415",
                "59011-420",
                "59011-430",
                "59011-440",
                "59011-460",
                "59011-480"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "OXYCODONE HYDROCHLORIDE"
              ],
              "rxcui": [
                "1049504",
                "1049545",
                "1049565",
                "1049576",
                "1049586",
                "1049595",
                "1049601",
                "1860127",
                "1860129",
                "1860137",
                "1860148",
                "1860151",
                "1860154",
                "1860157"
              ],
              "spl_id": [
                "4a1edd18-f1f0-4609-9eaf-29067937c3c6"
              ],
              "spl_set_id": [
                "bfdfe235-d717-4855-a3c8-a13d26dadede"
              ],
              "package_ndc": [
                "59011-410-10",
                "59011-410-20",
                "59011-415-10",
                "59011-415-20",
                "59011-420-10",
                "59011-420-20",
                "59011-430-10",
                "59011-430-20",
                "59011-440-10",
                "59011-440-20",
                "59011-460-10",
                "59011-460-20",
                "59011-480-20",
                "59011-480-10"
              ],
              "unii": [
                "C1ENJ2TE6C"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "NEURONTIN",
            "openfda": {
              "application_number": [
                "NDA020882",
                "NDA020235",
                "NDA021129"
              ],
              "brand_name": [
                "NEURONTIN"
              ],
              "generic_name": [
                "GABAPENTIN"
              ],
              "manufacturer_name": [
                "Parke-Davis Div of Pfizer Inc",
                "Viatris Specialty LLC"
              ],
              "product_ndc": [
                "0071-0401",
                "0071-0803",
                "0071-0805",
                "0071-0806",
                "0071-0513",
                "0071-2012",
                "58151-281",
                "58151-282",
                "58151-283",
                "58151-284",
                "58151-285",
                "58151-290"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "GABAPENTIN"
              ],
              "rxcui": [
                "105028",
                "105029",
                "105030",
                "261280",
                "261281",
                "283523",
                "310430",
                "310431",
                "310432",
                "310433",
                "310434",
                "351973"
              ],
              "spl_id": [
                "e730d5df-d47b-4d7f-ae3b-bd449f6b1213",
                "dfbc1443-0ba8-479b-8590-32bd942732d4"
              ],
              "spl_set_id": [
                "ee9ad9ed-6d9f-4ee1-9d7f-cfad438df388",
                "97935fd9-1d4a-43b6-a5d9-de994591187b"
              ],
              "package_ndc": [
                "0071-0803-24",
                "0071-0803-40",
                "0071-0805-24",
                "0071-0805-40",
                "0071-0806-24",
                "0071-0806-40",
                "0071-0513-24",
                "0071-0401-24",
                "0071-2012-23",
                "0071-2012-44",
                "0071-2012-47",
                "58151-281-01",
                "58151-282-01",
                "58151-283-01",
                "58151-284-01",
                "58151-285-01",
                "58151-290-35"
              ],
              "nui": [
                "N0000008486"
              ],
              "pharm_class_pe": [
                "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
              ],
              "unii": [
                "6CW7F3G59X"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "THALIDOMIDE",
            "drugindication": "NEPHROGENIC SYSTEMIC FIBROSIS",
            "drugstartdateformat": "102",
            "drugstartdate": "20050823",
            "openfda": {
              "application_number": [
                "NDA020785"
              ],
              "brand_name": [
                "THALOMID"
              ],
              "generic_name": [
                "THALIDOMIDE"
              ],
              "manufacturer_name": [
                "Celgene Corporation"
              ],
              "product_ndc": [
                "59572-205",
                "59572-210",
                "59572-215",
                "59572-220"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "THALIDOMIDE"
              ],
              "rxcui": [
                "200390",
                "213360",
                "360176",
                "360177",
                "404449",
                "404450",
                "700416",
                "700418"
              ],
              "spl_id": [
                "58b287d1-24f5-4dfe-84ca-898a8a5b9302"
              ],
              "spl_set_id": [
                "2eda833b-1357-4ed4-a093-194524fcb061"
              ],
              "package_ndc": [
                "59572-205-14",
                "59572-205-94",
                "59572-205-17",
                "59572-205-97",
                "59572-210-15",
                "59572-210-95",
                "59572-215-13",
                "59572-215-93",
                "59572-220-16",
                "59572-220-96"
              ],
              "nui": [
                "N0000008663"
              ],
              "pharm_class_pe": [
                "Decreased Immunologically Active Molecule Activity [PE]"
              ],
              "unii": [
                "4Z8R6ORS6L"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "CELEXA",
            "drugindication": "PAIN",
            "openfda": {
              "application_number": [
                "NDA020822"
              ],
              "brand_name": [
                "CELEXA"
              ],
              "generic_name": [
                "CITALOPRAM"
              ],
              "manufacturer_name": [
                "Allergan, Inc."
              ],
              "product_ndc": [
                "0456-4010",
                "0456-4020",
                "0456-4040"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "CITALOPRAM HYDROBROMIDE"
              ],
              "rxcui": [
                "200371",
                "213344",
                "213345",
                "283672",
                "284591",
                "309314"
              ],
              "spl_id": [
                "0eee9751-8886-474c-a806-8003e90cb151"
              ],
              "spl_set_id": [
                "4259d9b1-de34-43a4-85a8-41dd214e9177"
              ],
              "package_ndc": [
                "0456-4010-01",
                "0456-4020-01",
                "0456-4020-11",
                "0456-4020-63",
                "0456-4040-01",
                "0456-4040-11",
                "0456-4040-63"
              ],
              "unii": [
                "I1E9D14F36"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "INTRAVENOUS IMMUNOGLOBULIN",
            "drugindication": "NEPHROGENIC SYSTEMIC FIBROSIS",
            "drugstartdateformat": "102",
            "drugstartdate": "20050808"
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "OXYCODONE",
            "drugindication": "PAIN",
            "openfda": {
              "application_number": [
                "ANDA203638",
                "NDA208090"
              ],
              "brand_name": [
                "OXYCODONE HYDROCHLORIDE",
                "XTAMPZA ER"
              ],
              "generic_name": [
                "OXYCODONE"
              ],
              "manufacturer_name": [
                "Amneal Pharmaceuticals LLC",
                "Collegium Pharmaceutical, Inc."
              ],
              "product_ndc": [
                "65162-047",
                "65162-048",
                "65162-049",
                "65162-050",
                "65162-051",
                "24510-110",
                "24510-115",
                "24510-120",
                "24510-130",
                "24510-140"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "OXYCODONE HYDROCHLORIDE",
                "OXYCODONE"
              ],
              "rxcui": [
                "1049611",
                "1049618",
                "1049621",
                "1049683",
                "1049686",
                "1790527",
                "1790533",
                "1791558",
                "1791560",
                "1791567",
                "1791569",
                "1791574",
                "1791576",
                "1791580",
                "1791582"
              ],
              "spl_id": [
                "8b9e3253-7735-44cc-a59b-3125ab573c84",
                "fda0989d-9319-4e35-af83-fca1ec66878e"
              ],
              "spl_set_id": [
                "094b64b3-cd32-4de5-afb6-ea00d9caad74",
                "b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c"
              ],
              "package_ndc": [
                "65162-047-03",
                "65162-047-10",
                "65162-047-25",
                "65162-047-50",
                "65162-048-03",
                "65162-048-10",
                "65162-048-25",
                "65162-049-03",
                "65162-049-10",
                "65162-049-25",
                "65162-049-50",
                "65162-050-03",
                "65162-050-10",
                "65162-050-25",
                "65162-051-03",
                "65162-051-10",
                "65162-051-25",
                "65162-051-50",
                "24510-110-10",
                "24510-110-20",
                "24510-115-10",
                "24510-115-20",
                "24510-120-10",
                "24510-120-20",
                "24510-130-10",
                "24510-130-20",
                "24510-140-10",
                "24510-140-20"
              ],
              "unii": [
                "C1ENJ2TE6C",
                "CD35PMG570"
              ],
              "nui": [
                "N0000175684",
                "N0000175690"
              ],
              "pharm_class_moa": [
                "Full Opioid Agonists [MoA]"
              ],
              "pharm_class_epc": [
                "Opioid Agonist [EPC]"
              ]
            }
          }
        ]
      }
    }
  ]
}