{
  "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": 70807
    }
  },
  "results": [
    {
      "safetyreportversion": "2",
      "safetyreportid": "10003941",
      "primarysourcecountry": "BE",
      "occurcountry": "BE",
      "transmissiondateformat": "102",
      "transmissiondate": "20141002",
      "reporttype": "1",
      "serious": "1",
      "seriousnesslifethreatening": "1",
      "seriousnesshospitalization": "1",
      "seriousnessother": "1",
      "receivedateformat": "102",
      "receivedate": "20140312",
      "receiptdateformat": "102",
      "receiptdate": "20140312",
      "fulfillexpeditecriteria": "1",
      "companynumb": "PHHY2014BE023370",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "NOVARTIS",
        "duplicatenumb": "PHHY2014BE023370"
      },
      "primarysource": {
        "reportercountry": "BE",
        "qualification": "3"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientonsetage": "65",
        "patientonsetageunit": "801",
        "patientsex": "1",
        "reaction": [
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Interstitial lung disease",
            "reactionoutcome": "1"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Dyspnoea",
            "reactionoutcome": "1"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "General physical health deterioration",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Pleural effusion",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Oedema",
            "reactionoutcome": "1"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Aphthous stomatitis",
            "reactionoutcome": "1"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "CERTICAN",
            "drugauthorizationnumb": "021560",
            "drugstructuredosagenumb": "1",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "2",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugdosagetext": "1 MG, BID",
            "drugadministrationroute": "048",
            "drugindication": "RENAL TRANSPLANT",
            "drugstartdateformat": "610",
            "drugstartdate": "201401",
            "drugenddateformat": "102",
            "drugenddate": "20140203",
            "actiondrug": "1",
            "drugrecurreadministration": "3"
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "MYFORTIC",
            "drugstructuredosagenumb": "720",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "2",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugdosagetext": "720 MG, BID",
            "drugadministrationroute": "048",
            "drugindication": "RENAL TRANSPLANT",
            "actiondrug": "5",
            "drugrecurreadministration": "3",
            "openfda": {
              "application_number": [
                "NDA050791"
              ],
              "brand_name": [
                "MYFORTIC"
              ],
              "generic_name": [
                "MYCOPHENOLIC ACID"
              ],
              "manufacturer_name": [
                "Novartis Pharmaceuticals Corporation"
              ],
              "product_ndc": [
                "0078-0385",
                "0078-0386"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "MYCOPHENOLATE SODIUM"
              ],
              "rxcui": [
                "485020",
                "485023",
                "616449",
                "616450"
              ],
              "spl_id": [
                "c5665f04-bf64-4cc7-b98b-171a8f57155b"
              ],
              "spl_set_id": [
                "eed26501-890d-4ff6-88e7-6dbea4726e53"
              ],
              "package_ndc": [
                "0078-0386-66",
                "0078-0385-66"
              ],
              "unii": [
                "WX877SQI1G"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "EMCONCOR",
            "drugstructuredosagenumb": "5",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugdosagetext": "5 MG, QD",
            "drugadministrationroute": "048",
            "actiondrug": "5",
            "drugrecurreadministration": "3"
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "MAREVAN",
            "drugdosagetext": "UNK UKN, UNK",
            "drugadministrationroute": "048",
            "actiondrug": "5",
            "drugrecurreadministration": "3"
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "SIMVASTATIN",
            "drugstructuredosagenumb": "20",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugdosagetext": "20 MG, QD",
            "drugadministrationroute": "048",
            "actiondrug": "5",
            "drugrecurreadministration": "3",
            "openfda": {
              "application_number": [
                "ANDA078155",
                "ANDA077691",
                "ANDA078103",
                "ANDA090383",
                "ANDA200895",
                "ANDA078034",
                "ANDA211394",
                "NDA019766"
              ],
              "brand_name": [
                "SIMVASTATIN",
                "ZOCOR"
              ],
              "generic_name": [
                "SIMVASTATIN"
              ],
              "manufacturer_name": [
                "Accord Healthcare, Inc.",
                "NorthStar Rx LLC",
                "Lupin Pharmaceuticals, Inc.",
                "Micro Labs Limited",
                "XLCare Pharmaceuticals Inc.",
                "Biocon Pharma Inc,",
                "Aurobindo Pharma Limited",
                "Westminster Pharmaceuticals, LLC",
                "Quallent Pharmaceuticals Health LLC",
                "Organon LLC",
                "Camber Pharmaceuticals, Inc."
              ],
              "product_ndc": [
                "16729-004",
                "16729-005",
                "16729-006",
                "16729-007",
                "16729-156",
                "16714-681",
                "16714-682",
                "16714-683",
                "16714-684",
                "16714-685",
                "68180-464",
                "68180-482",
                "68180-478",
                "68180-479",
                "68180-480",
                "68180-481",
                "68180-465",
                "42571-005",
                "42571-010",
                "42571-020",
                "42571-040",
                "42571-080",
                "72865-305",
                "72865-306",
                "72865-307",
                "72865-308",
                "72865-309",
                "70377-001",
                "70377-002",
                "70377-003",
                "70377-004",
                "70377-005",
                "65862-050",
                "65862-051",
                "65862-052",
                "65862-053",
                "65862-054",
                "69367-374",
                "69367-375",
                "69367-376",
                "69367-377",
                "82009-013",
                "82009-012",
                "82009-014",
                "82009-015",
                "82009-016",
                "78206-180",
                "78206-182",
                "78206-181",
                "31722-510",
                "31722-511",
                "31722-512",
                "31722-513",
                "31722-514"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "SIMVASTATIN"
              ],
              "rxcui": [
                "198211",
                "200345",
                "312961",
                "312962",
                "314231",
                "104490",
                "104491",
                "152923"
              ],
              "spl_id": [
                "43910ff2-6a21-bf9e-e063-6294a90a3f5c",
                "6c353eba-27f3-43cc-b954-ec659881872f",
                "b78d4e8a-2261-43c6-9321-ac2539bdfd2f",
                "0369d423-9ef2-0191-e063-6294a90a55e7",
                "48bd010d-6429-906e-e063-6394a90ae8b7",
                "4d832ba0-8b5c-de5a-246a-a5f30e884bb4",
                "854ac8f7-cca5-434c-a611-9c1752260d4a",
                "5bcccfd7-0ae8-4fad-a535-5efa7b327550",
                "1de47781-9000-0fc1-e063-6294a90a8139",
                "11256523-425c-48e8-afe1-e3a4e28c892e",
                "1553d57f-414d-2c66-e063-6294a90af8e0"
              ],
              "spl_set_id": [
                "871251c0-36a1-4a32-9eab-ff6c1e925ca9",
                "0376351b-f1a0-43e5-a0b4-533072c49f39",
                "3e48217f-8175-4e9b-9fd0-909be4bbba95",
                "5c1c694c-4b08-469e-b538-08e69df06146",
                "433f8a86-5ad3-43db-8e62-c0812dd3d723",
                "7b325108-6940-50a7-96b4-822a5206e568",
                "4724dbb4-3613-4e6a-948f-a43d34f97f06",
                "acaaab63-c9ff-44c9-8fde-9a4ea6454dd7",
                "2b4255a7-f9f5-4235-8dbb-b0f03acbd624",
                "8f55d5de-5a4f-4a39-8c84-c53976dd6af9",
                "751b79c6-bba8-4d29-b69c-a2ac6453fec8"
              ],
              "package_ndc": [
                "16729-005-10",
                "16729-005-12",
                "16729-005-15",
                "16729-005-17",
                "16729-006-10",
                "16729-006-12",
                "16729-006-15",
                "16729-006-17",
                "16729-007-10",
                "16729-007-12",
                "16729-007-15",
                "16729-007-17",
                "16729-156-10",
                "16729-156-15",
                "16729-156-17",
                "16729-004-10",
                "16729-004-12",
                "16729-004-15",
                "16729-004-17",
                "16714-681-01",
                "16714-681-02",
                "16714-682-01",
                "16714-682-02",
                "16714-682-03",
                "16714-683-01",
                "16714-683-02",
                "16714-683-03",
                "16714-684-01",
                "16714-684-02",
                "16714-684-03",
                "16714-685-01",
                "16714-685-02",
                "16714-685-03",
                "68180-482-09",
                "68180-482-06",
                "68180-482-03",
                "68180-482-11",
                "68180-478-02",
                "68180-478-03",
                "68180-478-01",
                "68180-479-02",
                "68180-479-03",
                "68180-479-01",
                "68180-480-01",
                "68180-480-02",
                "68180-480-03",
                "68180-481-01",
                "68180-481-03",
                "68180-481-02",
                "68180-464-06",
                "68180-464-09",
                "68180-464-03",
                "68180-465-06",
                "68180-465-09",
                "68180-465-03",
                "42571-010-30",
                "42571-010-60",
                "42571-010-90",
                "42571-010-05",
                "42571-010-10",
                "42571-005-30",
                "42571-005-60",
                "42571-005-90",
                "42571-005-05",
                "42571-005-10",
                "42571-020-30",
                "42571-020-60",
                "42571-020-90",
                "42571-020-05",
                "42571-020-10",
                "42571-040-30",
                "42571-040-60",
                "42571-040-90",
                "42571-040-05",
                "42571-040-10",
                "42571-080-30",
                "42571-080-60",
                "42571-080-90",
                "42571-080-05",
                "42571-080-10",
                "72865-305-30",
                "72865-305-01",
                "72865-305-10",
                "72865-305-90",
                "72865-306-30",
                "72865-306-01",
                "72865-306-10",
                "72865-306-90",
                "72865-307-30",
                "72865-307-01",
                "72865-307-10",
                "72865-307-90",
                "72865-307-45",
                "72865-308-30",
                "72865-308-01",
                "72865-308-10",
                "72865-308-90",
                "72865-308-45",
                "72865-309-30",
                "72865-309-01",
                "72865-309-05",
                "72865-309-90",
                "72865-309-45",
                "72865-309-10",
                "70377-001-13",
                "70377-001-14",
                "70377-001-15",
                "70377-001-12",
                "70377-002-12",
                "70377-002-13",
                "70377-002-14",
                "70377-002-15",
                "70377-003-12",
                "70377-003-13",
                "70377-003-14",
                "70377-003-15",
                "70377-004-12",
                "70377-004-13",
                "70377-004-14",
                "70377-004-15",
                "70377-005-12",
                "70377-005-13",
                "70377-005-14",
                "70377-005-15",
                "65862-050-30",
                "65862-050-45",
                "65862-050-90",
                "65862-050-01",
                "65862-050-00",
                "65862-050-99",
                "65862-050-26",
                "65862-051-30",
                "65862-051-45",
                "65862-051-90",
                "65862-051-01",
                "65862-051-00",
                "65862-051-99",
                "65862-051-26",
                "65862-052-30",
                "65862-052-45",
                "65862-052-90",
                "65862-052-01",
                "65862-052-00",
                "65862-052-99",
                "65862-052-26",
                "65862-053-30",
                "65862-053-45",
                "65862-053-90",
                "65862-053-01",
                "65862-053-00",
                "65862-053-99",
                "65862-053-22",
                "65862-054-30",
                "65862-054-45",
                "65862-054-90",
                "65862-054-00",
                "65862-054-99",
                "65862-054-39",
                "69367-374-09",
                "69367-374-10",
                "69367-375-09",
                "69367-375-10",
                "69367-376-09",
                "69367-376-10",
                "69367-377-09",
                "69367-377-10",
                "82009-013-10",
                "82009-012-10",
                "82009-014-10",
                "82009-015-10",
                "82009-016-05",
                "78206-182-01",
                "78206-182-02",
                "78206-181-02",
                "78206-181-01",
                "78206-180-01",
                "78206-180-02",
                "31722-510-30",
                "31722-510-01",
                "31722-510-10",
                "31722-510-90",
                "31722-511-30",
                "31722-511-01",
                "31722-511-10",
                "31722-511-90",
                "31722-512-30",
                "31722-512-01",
                "31722-512-10",
                "31722-512-90",
                "31722-513-30",
                "31722-513-01",
                "31722-513-10",
                "31722-513-90",
                "31722-514-30",
                "31722-514-01",
                "31722-514-05",
                "31722-514-90"
              ],
              "nui": [
                "N0000175589",
                "N0000000121"
              ],
              "pharm_class_epc": [
                "HMG-CoA Reductase Inhibitor [EPC]"
              ],
              "pharm_class_moa": [
                "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"
              ],
              "unii": [
                "AGG2FN16EV"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "D-CURE",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "2",
            "drugintervaldosagedefinition": "803",
            "drugdosagetext": "UNK UKN, BIW",
            "drugdosageform": "Ampoule",
            "actiondrug": "5",
            "drugrecurreadministration": "3"
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "MOXONIDINE",
            "drugstructuredosagenumb": ".4",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugdosagetext": "0.4 MG, QD",
            "drugadministrationroute": "048",
            "actiondrug": "5",
            "drugrecurreadministration": "3"
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "TERAZOSABB",
            "drugstructuredosagenumb": "7",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugdosagetext": "7 MG, QD",
            "drugadministrationroute": "048",
            "actiondrug": "5",
            "drugrecurreadministration": "3"
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "LANOXIN",
            "drugstructuredosagenumb": ".125",
            "drugstructuredosageunit": "003",
            "drugdosagetext": "0.125 MG, QW5",
            "drugadministrationroute": "048",
            "actiondrug": "5",
            "drugrecurreadministration": "3",
            "openfda": {
              "application_number": [
                "NDA009330",
                "NDA020405"
              ],
              "brand_name": [
                "LANOXIN"
              ],
              "generic_name": [
                "DIGOXIN"
              ],
              "manufacturer_name": [
                "Covis Pharma US, Inc",
                "Advanz Pharma (US) Corp."
              ],
              "product_ndc": [
                "70515-260",
                "70515-261",
                "70515-262",
                "70515-263",
                "59212-240",
                "59212-242",
                "59212-249",
                "59212-245"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "INTRAMUSCULAR",
                "INTRAVENOUS",
                "ORAL"
              ],
              "substance_name": [
                "DIGOXIN"
              ],
              "rxcui": [
                "104208",
                "204504",
                "208135",
                "208137",
                "104206",
                "197604",
                "197606",
                "245273",
                "309888",
                "309889",
                "1441565",
                "1441567"
              ],
              "spl_id": [
                "415f97e2-9ce0-b282-e063-6394a90ab0a8",
                "3a39029f-2e63-4894-8a0d-45e122f5047b"
              ],
              "spl_set_id": [
                "9ec84cac-6ecc-43dc-8006-6ccc029e2707",
                "d91e3646-4c63-4512-ab22-db39c085c4dc"
              ],
              "package_ndc": [
                "70515-260-10",
                "70515-261-10",
                "70515-262-10",
                "70515-263-10",
                "59212-242-55",
                "59212-242-56",
                "59212-242-75",
                "59212-249-55",
                "59212-249-56",
                "59212-249-75",
                "59212-240-55",
                "59212-245-55",
                "59212-245-75"
              ],
              "nui": [
                "N0000175568",
                "M0003451"
              ],
              "pharm_class_epc": [
                "Cardiac Glycoside [EPC]"
              ],
              "pharm_class_cs": [
                "Cardiac Glycosides [CS]"
              ],
              "unii": [
                "73K4184T59"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "ZYLORIC",
            "drugstructuredosagenumb": "300",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugdosagetext": "300 MG, QD",
            "drugadministrationroute": "048",
            "actiondrug": "5",
            "drugrecurreadministration": "3"
          }
        ]
      }
    }
  ]
}