{
  "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": "2026-07-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "safetyreportversion": "1",
      "safetyreportid": "15539642",
      "primarysourcecountry": "US",
      "occurcountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20190205",
      "reporttype": "1",
      "serious": "2",
      "receivedateformat": "102",
      "receivedate": "20181023",
      "receiptdateformat": "102",
      "receiptdate": "20181023",
      "fulfillexpeditecriteria": "2",
      "companynumb": "US-INSYS THERAPEUTICS, INC-INS201808-000283",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "INSYS",
        "duplicatenumb": "US-INSYS THERAPEUTICS, INC-INS201808-000283"
      },
      "primarysource": {
        "reportercountry": "US",
        "qualification": "5"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientonsetage": "47",
        "patientonsetageunit": "801",
        "patientweight": "59",
        "patientsex": "1",
        "reaction": [
          {
            "reactionmeddraversionpt": "21.1",
            "reactionmeddrapt": "Product taste abnormal",
            "reactionoutcome": "3"
          },
          {
            "reactionmeddraversionpt": "21.1",
            "reactionmeddrapt": "Vomiting",
            "reactionoutcome": "6"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "2",
            "medicinalproduct": "BIKTARVY",
            "activesubstance": {
              "activesubstancename": "BICTEGRAVIR SODIUM\\EMTRICITABINE\\TENOFOVIR ALAFENAMIDE FUMARATE"
            },
            "openfda": {
              "application_number": [
                "NDA210251"
              ],
              "brand_name": [
                "BIKTARVY"
              ],
              "generic_name": [
                "BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE"
              ],
              "manufacturer_name": [
                "Gilead Sciences, Inc."
              ],
              "product_ndc": [
                "61958-2501",
                "61958-2505",
                "61958-2506"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "BICTEGRAVIR SODIUM",
                "EMTRICITABINE",
                "TENOFOVIR ALAFENAMIDE FUMARATE"
              ],
              "rxcui": [
                "1999667",
                "1999673",
                "2584354",
                "2584356"
              ],
              "spl_id": [
                "250704ed-23f6-4ac2-8f0a-31c6d7d95821"
              ],
              "spl_set_id": [
                "664cb8f0-1f65-441b-b0d9-ba3d798be309"
              ],
              "package_ndc": [
                "61958-2501-1",
                "61958-2501-2",
                "61958-2501-3",
                "61958-2501-5",
                "61958-2505-1",
                "61958-2506-1"
              ],
              "nui": [
                "N0000175462",
                "M0015066",
                "N0000009947"
              ],
              "pharm_class_epc": [
                "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"
              ],
              "pharm_class_cs": [
                "Nucleosides [CS]"
              ],
              "pharm_class_moa": [
                "Nucleoside Reverse Transcriptase Inhibitors [MoA]"
              ],
              "unii": [
                "FWF6Q91TZO",
                "4L5MP1Y7W7",
                "G70B4ETF4S"
              ]
            }
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "SYNDROS",
            "drugauthorizationnumb": "205525",
            "drugstructuredosagenumb": "4.2",
            "drugstructuredosageunit": "012",
            "drugdosageform": "ORAL SOLUTION",
            "drugindication": "DECREASED APPETITE",
            "drugstartdateformat": "610",
            "drugstartdate": "201806",
            "actiondrug": "4",
            "activesubstance": {
              "activesubstancename": "DRONABINOL"
            },
            "openfda": {
              "application_number": [
                "NDA205525"
              ],
              "brand_name": [
                "SYNDROS"
              ],
              "generic_name": [
                "DRONABINOL"
              ],
              "manufacturer_name": [
                "Wellhouse Pharma, LLC",
                "Benuvia Operations, LLC"
              ],
              "product_ndc": [
                "85776-201",
                "78613-201"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "DRONABINOL"
              ],
              "rxcui": [
                "1928948",
                "1928954"
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              "spl_id": [
                "dcc02ae3-f1fa-431e-81bb-c52d35b81c66",
                "3e1cbbb1-291c-41bb-b209-93c1fb08313a"
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              "spl_set_id": [
                "3cdcb4f5-5af9-4ff7-b535-2a5cf4c6da89",
                "a7801c70-995d-46a2-91ee-141ef427c6b5"
              ],
              "package_ndc": [
                "85776-201-30",
                "78613-201-30"
              ],
              "nui": [
                "N0000175782",
                "M0003267"
              ],
              "pharm_class_epc": [
                "Cannabinoid [EPC]"
              ],
              "pharm_class_cs": [
                "Cannabinoids [CS]"
              ],
              "unii": [
                "7J8897W37S"
              ]
            }
          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 201806"
        }
      }
    }
  ]
}