{
  "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": 22986
    }
  },
  "results": [
    {
      "safetyreportversion": "2",
      "safetyreportid": "10003641",
      "primarysourcecountry": "US",
      "occurcountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20150720",
      "reporttype": "1",
      "serious": "2",
      "receivedateformat": "102",
      "receivedate": "20140312",
      "receiptdateformat": "102",
      "receiptdate": "20150312",
      "fulfillexpeditecriteria": "2",
      "companynumb": "US-ABBVIE-13P-163-1090373-00",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "ABBVIE",
        "duplicatenumb": "US-ABBVIE-13P-163-1090373-00"
      },
      "primarysource": {
        "reportercountry": "US",
        "qualification": "5"
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      "sender": {
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        "senderorganization": "FDA-Public Use"
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      "receiver": {
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        "receiverorganization": "FDA"
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      "patient": {
        "patientonsetage": "41",
        "patientonsetageunit": "801",
        "patientweight": "118.04",
        "patientsex": "1",
        "reaction": [
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Medication residue present",
            "reactionoutcome": "3"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "DEPAKOTE",
            "drugbatchnumb": "UNKNOWN",
            "drugauthorizationnumb": "018723",
            "drugseparatedosagenumb": "3",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
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            "drugindication": "BIPOLAR DISORDER",
            "actiondrug": "4",
            "activesubstance": {
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                "NDA021168",
                "NDA018723",
                "NDA019680"
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                "DEPAKOTE ER",
                "DEPAKOTE",
                "DEPAKOTE SPRINKLES"
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              "manufacturer_name": [
                "AbbVie Inc."
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                "0074-3826",
                "0074-7126",
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                "0074-7325",
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                "0074-7327",
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                "0074-6114"
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                "HUMAN PRESCRIPTION DRUG"
              ],
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              ],
              "substance_name": [
                "DIVALPROEX SODIUM"
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                "0074-7326-13",
                "0074-6114-13",
                "0074-6114-11"
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              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "INVEGA",
            "drugindication": "BIPOLAR DISORDER",
            "activesubstance": {
              "activesubstancename": "PALIPERIDONE"
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              "application_number": [
                "NDA021999"
              ],
              "brand_name": [
                "INVEGA"
              ],
              "generic_name": [
                "PALIPERIDONE"
              ],
              "manufacturer_name": [
                "Janssen Pharmaceuticals, Inc."
              ],
              "product_ndc": [
                "50458-550",
                "50458-551",
                "50458-552",
                "50458-554"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "PALIPERIDONE"
              ],
              "rxcui": [
                "672567",
                "672569",
                "672571",
                "686441",
                "686443",
                "686445",
                "866103",
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              "spl_id": [
                "3c5e5b30-a841-4dfe-88ce-361806c9275f"
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              "spl_set_id": [
                "7b8e5b26-b9e4-4704-921b-3c3c0d159916"
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                "50458-550-01",
                "50458-550-10",
                "50458-550-98",
                "50458-551-01",
                "50458-551-10",
                "50458-551-98",
                "50458-552-01",
                "50458-552-10",
                "50458-552-98",
                "50458-554-01",
                "50458-554-10",
                "50458-554-98"
              ],
              "nui": [
                "N0000175430"
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              "pharm_class_epc": [
                "Atypical Antipsychotic [EPC]"
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              "unii": [
                "838F01T721"
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            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "METFORMIN",
            "drugindication": "DIABETES MELLITUS",
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              "application_number": [
                "ANDA200690",
                "ANDA209674",
                "ANDA209313"
              ],
              "brand_name": [
                "METFORMIN HYDROCHLORIDE",
                "METFORMIN"
              ],
              "generic_name": [
                "METFORMIN",
                "METFORMIN ER 500 MG",
                "METFORMIN ER 750 MG"
              ],
              "manufacturer_name": [
                "Mylan Pharmaceuticals Inc.",
                "Ingenus Pharmaceuticals, LLC",
                "Granules Pharmaceuticals Inc."
              ],
              "product_ndc": [
                "0378-6001",
                "0378-6002",
                "50742-633",
                "50742-634",
                "70010-491",
                "70010-492"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "METFORMIN HYDROCHLORIDE"
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              "rxcui": [
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                "1807917",
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              "spl_set_id": [
                "7e41818c-60e9-4bcf-9586-7bb8d33d5e89",
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                "6d6ee6f8-9650-ff4f-e053-2991aa0acf19"
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              "package_ndc": [
                "0378-6002-91",
                "0378-6001-91",
                "50742-633-60",
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                "50742-633-10",
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                "50742-634-60",
                "50742-634-10",
                "70010-491-01",
                "70010-491-05",
                "70010-491-10",
                "70010-491-18",
                "70010-491-19",
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                "70010-492-20",
                "70010-492-21"
              ],
              "unii": [
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          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "COGENTIN",
            "drugindication": "ADVERSE EVENT",
            "activesubstance": {
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            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "BISOPROLOL",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "activesubstance": {
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            },
            "openfda": {
              "application_number": [
                "ANDA075474"
              ],
              "brand_name": [
                "BISOPROLOL"
              ],
              "generic_name": [
                "BISOPROLOL FUMARATE"
              ],
              "manufacturer_name": [
                "TruPharma, LLC"
              ],
              "product_ndc": [
                "52817-270",
                "52817-271"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "BISOPROLOL FUMARATE"
              ],
              "rxcui": [
                "854901",
                "854905"
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              "spl_id": [
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              "spl_set_id": [
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              "package_ndc": [
                "52817-270-10",
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                "52817-271-10",
                "52817-271-30"
              ],
              "unii": [
                "UR59KN573L"
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            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "COGENTIN",
            "drugindication": "PROPHYLAXIS",
            "activesubstance": {
              "activesubstancename": "BENZTROPINE MESYLATE"
            }
          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 201304"
        }
      }
    }
  ]
}