{
  "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": 8903
    }
  },
  "results": [
    {
      "safetyreportversion": "1",
      "safetyreportid": "11872213",
      "primarysourcecountry": "US",
      "occurcountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20160305",
      "reporttype": "1",
      "serious": "1",
      "seriousnessother": "1",
      "receivedateformat": "102",
      "receivedate": "20151228",
      "receiptdateformat": "102",
      "receiptdate": "20151228",
      "fulfillexpeditecriteria": "1",
      "companynumb": "US-PFIZER INC-2015466450",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "PFIZER",
        "duplicatenumb": "US-PFIZER INC-2015466450"
      },
      "primarysource": {
        "reportercountry": "US",
        "qualification": "5"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientonsetage": "51",
        "patientonsetageunit": "801",
        "patientweight": "90.72",
        "patientsex": "2",
        "reaction": [
          {
            "reactionmeddraversionpt": "18.1",
            "reactionmeddrapt": "Syncope",
            "reactionoutcome": "3"
          },
          {
            "reactionmeddraversionpt": "18.1",
            "reactionmeddrapt": "Feeling abnormal",
            "reactionoutcome": "3"
          },
          {
            "reactionmeddraversionpt": "18.1",
            "reactionmeddrapt": "Weight increased",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "18.1",
            "reactionmeddrapt": "Libido decreased",
            "reactionoutcome": "3"
          },
          {
            "reactionmeddraversionpt": "18.1",
            "reactionmeddrapt": "Hyperhidrosis",
            "reactionoutcome": "3"
          },
          {
            "reactionmeddraversionpt": "18.1",
            "reactionmeddrapt": "Speech disorder",
            "reactionoutcome": "3"
          },
          {
            "reactionmeddraversionpt": "18.1",
            "reactionmeddrapt": "Thinking abnormal",
            "reactionoutcome": "3"
          },
          {
            "reactionmeddraversionpt": "18.1",
            "reactionmeddrapt": "Ataxia",
            "reactionoutcome": "3"
          },
          {
            "reactionmeddraversionpt": "18.1",
            "reactionmeddrapt": "Paraesthesia",
            "reactionoutcome": "3"
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        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "CARIPRAZINE",
            "drugdosagetext": "UNK",
            "actiondrug": "1",
            "activesubstance": {
              "activesubstancename": "CARIPRAZINE"
            },
            "openfda": {
              "application_number": [
                "NDA204370"
              ],
              "brand_name": [
                "VRAYLAR"
              ],
              "generic_name": [
                "CARIPRAZINE"
              ],
              "manufacturer_name": [
                "Allergan, Inc."
              ],
              "product_ndc": [
                "61874-115",
                "61874-250",
                "61874-275",
                "61874-130",
                "61874-145",
                "61874-160",
                "61874-170"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "CARIPRAZINE"
              ],
              "rxcui": [
                "1667660",
                "1667666",
                "1667668",
                "1667670",
                "1667672",
                "1667674",
                "1667676",
                "1667678",
                "1741746",
                "1741747",
                "2729792",
                "2729794",
                "2729796",
                "2729798"
              ],
              "spl_id": [
                "db2154b0-f0c7-403c-95fd-794666e79e30"
              ],
              "spl_set_id": [
                "4b5f7c65-aa2d-452a-b3db-bc85c06ff12f"
              ],
              "package_ndc": [
                "61874-250-30",
                "61874-275-30",
                "61874-115-30",
                "61874-115-90",
                "61874-115-11",
                "61874-115-20",
                "61874-115-17",
                "61874-115-07",
                "61874-115-31",
                "61874-130-30",
                "61874-130-90",
                "61874-130-11",
                "61874-130-20",
                "61874-130-07",
                "61874-130-31",
                "61874-145-30",
                "61874-145-90",
                "61874-145-07",
                "61874-160-30",
                "61874-160-90",
                "61874-160-07",
                "61874-170-08"
              ],
              "nui": [
                "N0000175430"
              ],
              "pharm_class_epc": [
                "Atypical Antipsychotic [EPC]"
              ],
              "unii": [
                "F6RJL8B278"
              ]
            }
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "PRISTIQ EXTENDED RELEASE",
            "drugauthorizationnumb": "021992",
            "drugstructuredosagenumb": "1",
            "drugstructuredosageunit": "032",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugdosagetext": "1 DF, 1X/DAY",
            "drugdosageform": "PROLONGED-RELEASE TABLET",
            "drugindication": "DEPRESSION",
            "drugenddateformat": "102",
            "drugenddate": "20151216",
            "actiondrug": "1",
            "activesubstance": {
              "activesubstancename": "DESVENLAFAXINE SUCCINATE"
            }
          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 201512"
        }
      }
    }
  ]
}