{
  "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": 433189
    }
  },
  "results": [
    {
      "safetyreportversion": "6",
      "safetyreportid": "10003336",
      "primarysourcecountry": "US",
      "occurcountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20150528",
      "reporttype": "1",
      "serious": "1",
      "seriousnessdeath": "1",
      "seriousnesshospitalization": "1",
      "seriousnessother": "1",
      "receivedateformat": "102",
      "receivedate": "20140312",
      "receiptdateformat": "102",
      "receiptdate": "20141105",
      "fulfillexpeditecriteria": "1",
      "companynumb": "US-MERCK-1403USA005334",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "MERCK",
        "duplicatenumb": "US-MERCK-1403USA005334"
      },
      "primarysource": {
        "reportercountry": "US",
        "qualification": "5"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientweight": "97.96",
        "patientsex": "1",
        "reaction": [
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Metastases to spine",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Anxiety",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Renal cyst",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Metastases to thorax",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Metastases to retroperitoneum",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Emotional disorder",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Pancreatic carcinoma metastatic",
            "reactionoutcome": "5"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Metastases to liver",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Metastases to lung",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Emotional distress",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Lymphadenopathy",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Prostate cancer",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Peripheral venous disease",
            "reactionoutcome": "6"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "JANUMET",
            "drugauthorizationnumb": "022044",
            "drugdosagetext": "50/1000 MG",
            "drugdosageform": "FILM-COATED TABLET",
            "drugadministrationroute": "048",
            "drugindication": "TYPE 2 DIABETES MELLITUS",
            "drugstartdateformat": "610",
            "drugstartdate": "201107",
            "drugenddateformat": "102",
            "drugenddate": "20120808",
            "actiondrug": "4",
            "activesubstance": {
              "activesubstancename": "METFORMIN HYDROCHLORIDE\\SITAGLIPTIN PHOSPHATE"
            },
            "openfda": {
              "application_number": [
                "NDA022044",
                "NDA202270"
              ],
              "brand_name": [
                "JANUMET",
                "JANUMET XR"
              ],
              "generic_name": [
                "SITAGLIPTIN AND METFORMIN HYDROCHLORIDE"
              ],
              "manufacturer_name": [
                "Merck Sharp & Dohme LLC"
              ],
              "product_ndc": [
                "0006-0575",
                "0006-0577",
                "0006-0078",
                "0006-0080",
                "0006-0081"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "METFORMIN HYDROCHLORIDE",
                "SITAGLIPTIN PHOSPHATE"
              ],
              "rxcui": [
                "861771",
                "861821",
                "2709488",
                "2709491",
                "1243833",
                "1243843",
                "1243848",
                "2709470",
                "2709477",
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              "spl_id": [
                "601dfad8-02f7-4696-9fe2-548610338dc9",
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              "spl_set_id": [
                "d19c7ed0-ad5c-426e-b2df-722508f97d67",
                "64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50"
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              "package_ndc": [
                "0006-0575-82",
                "0006-0575-61",
                "0006-0575-62",
                "0006-0575-01",
                "0006-0575-52",
                "0006-0575-56",
                "0006-0575-02",
                "0006-0575-03",
                "0006-0577-61",
                "0006-0577-62",
                "0006-0577-82",
                "0006-0577-01",
                "0006-0577-52",
                "0006-0577-56",
                "0006-0577-02",
                "0006-0577-03",
                "0006-0078-61",
                "0006-0078-62",
                "0006-0078-82",
                "0006-0078-14",
                "0006-0078-28",
                "0006-0080-61",
                "0006-0080-62",
                "0006-0080-82",
                "0006-0080-14",
                "0006-0080-28",
                "0006-0081-31",
                "0006-0081-54",
                "0006-0081-82",
                "0006-0081-07",
                "0006-0081-14"
              ],
              "unii": [
                "786Z46389E",
                "TS63EW8X6F"
              ]
            }
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "JANUVIA",
            "drugdosagetext": "UNK",
            "drugdosageform": "FILM-COATED TABLET",
            "drugadministrationroute": "048",
            "drugstartdateformat": "610",
            "drugstartdate": "201107",
            "drugenddateformat": "610",
            "drugenddate": "201207",
            "actiondrug": "4",
            "activesubstance": {
              "activesubstancename": "SITAGLIPTIN PHOSPHATE"
            },
            "openfda": {
              "application_number": [
                "NDA021995"
              ],
              "brand_name": [
                "JANUVIA"
              ],
              "generic_name": [
                "SITAGLIPTIN"
              ],
              "manufacturer_name": [
                "Merck Sharp & Dohme LLC"
              ],
              "product_ndc": [
                "0006-0112",
                "0006-0221",
                "0006-0277"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "SITAGLIPTIN PHOSPHATE"
              ],
              "rxcui": [
                "665036",
                "665040",
                "665044",
                "2709603",
                "2709608",
                "2709612"
              ],
              "spl_id": [
                "71d449de-955b-4711-9a44-1e1f66e2e9eb"
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              "spl_set_id": [
                "f85a48d0-0407-4c50-b0fa-7673a160bf01"
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              "package_ndc": [
                "0006-0221-01",
                "0006-0221-28",
                "0006-0221-31",
                "0006-0221-54",
                "0006-0112-01",
                "0006-0112-28",
                "0006-0112-31",
                "0006-0112-54",
                "0006-0277-01",
                "0006-0277-28",
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                "0006-0277-54",
                "0006-0277-02",
                "0006-0277-33",
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                "0006-0277-30"
              ],
              "unii": [
                "TS63EW8X6F"
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            }
          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 201112"
        }
      }
    }
  ]
}