{
  "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": 13446
    }
  },
  "results": [
    {
      "safetyreportversion": "2",
      "safetyreportid": "10004053",
      "primarysourcecountry": "CH",
      "occurcountry": "CH",
      "transmissiondateformat": "102",
      "transmissiondate": "20150326",
      "reporttype": "1",
      "serious": "1",
      "seriousnessother": "1",
      "receivedateformat": "102",
      "receivedate": "20140312",
      "receiptdateformat": "102",
      "receiptdate": "20140804",
      "fulfillexpeditecriteria": "1",
      "companynumb": "CH-ABBVIE-14P-151-1210162-00",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "ABBVIE",
        "duplicatenumb": "CH-ABBVIE-14P-151-1210162-00"
      },
      "primarysource": {
        "reportercountry": "CH",
        "qualification": "5"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientsex": "1",
        "reaction": [
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Fat redistribution",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Lipodystrophy acquired",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "CD4 lymphocytes decreased",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Unevaluable event",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Multifocal motor neuropathy",
            "reactionoutcome": "2"
          },
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Muscle atrophy",
            "reactionoutcome": "6"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "ZERIT",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "drugstartdateformat": "602",
            "drugstartdate": "1997",
            "drugenddateformat": "602",
            "drugenddate": "2012",
            "activesubstance": {
              "activesubstancename": "STAVUDINE"
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "ZIAGEN",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "activesubstance": {
              "activesubstancename": "ABACAVIR SULFATE"
            },
            "openfda": {
              "application_number": [
                "NDA020978"
              ],
              "brand_name": [
                "ZIAGEN"
              ],
              "generic_name": [
                "ABACAVIR SULFATE"
              ],
              "manufacturer_name": [
                "ViiV Healthcare Company"
              ],
              "product_ndc": [
                "49702-222"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "ABACAVIR SULFATE"
              ],
              "rxcui": [
                "213461",
                "242680"
              ],
              "spl_id": [
                "b0a93ca3-a511-4567-8875-24abb03dd28c"
              ],
              "spl_set_id": [
                "ca73b519-015a-436d-aa3c-af53492825a1"
              ],
              "package_ndc": [
                "49702-222-48"
              ],
              "unii": [
                "J220T4J9Q2"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "3TC",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "activesubstance": {
              "activesubstancename": "LAMIVUDINE"
            }
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "KALETRA",
            "drugbatchnumb": "UNKNOWN",
            "drugauthorizationnumb": "021906",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "actiondrug": "4",
            "activesubstance": {
              "activesubstancename": "LOPINAVIR\\RITONAVIR"
            },
            "openfda": {
              "application_number": [
                "NDA021906",
                "NDA021251"
              ],
              "brand_name": [
                "KALETRA"
              ],
              "generic_name": [
                "LOPINAVIR AND RITONAVIR"
              ],
              "manufacturer_name": [
                "AbbVie Inc."
              ],
              "product_ndc": [
                "0074-0522",
                "0074-3956",
                "0074-6799",
                "0074-4014",
                "0074-3008",
                "0074-2605",
                "0074-1575"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "LOPINAVIR",
                "RITONAVIR"
              ],
              "rxcui": [
                "311369",
                "597730",
                "746645",
                "847741",
                "847745",
                "847749"
              ],
              "spl_id": [
                "a0e519cd-694a-44de-9a89-eac59fce76c9"
              ],
              "spl_set_id": [
                "8290add3-4449-4e58-6c97-8fe1eec972e3"
              ],
              "package_ndc": [
                "0074-0522-60",
                "0074-3956-46",
                "0074-6799-22",
                "0074-6799-30",
                "0074-4014-12",
                "0074-3008-60",
                "0074-2605-21",
                "0074-1575-21"
              ],
              "nui": [
                "N0000000246",
                "N0000191001",
                "N0000175889",
                "N0000190114",
                "N0000182137",
                "N0000185607",
                "N0000190118",
                "N0000185503",
                "N0000190113",
                "N0000182141",
                "N0000191266",
                "N0000185507",
                "N0000187064",
                "N0000190117",
                "N0000190107"
              ],
              "pharm_class_moa": [
                "HIV Protease Inhibitors [MoA]",
                "Cytochrome P450 3A Inhibitors [MoA]",
                "Cytochrome P450 2D6 Inhibitors [MoA]",
                "Cytochrome P450 2C19 Inducers [MoA]",
                "Cytochrome P450 3A Inducers [MoA]",
                "P-Glycoprotein Inhibitors [MoA]",
                "Breast Cancer Resistance Protein Inhibitors [MoA]",
                "Cytochrome P450 3A4 Inhibitors [MoA]",
                "Cytochrome P450 1A2 Inducers [MoA]",
                "Cytochrome P450 2C9 Inducers [MoA]",
                "Cytochrome P450 2B6 Inducers [MoA]",
                "UDP Glucuronosyltransferases Inducers [MoA]",
                "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]"
              ],
              "pharm_class_epc": [
                "Cytochrome P450 3A Inhibitor [EPC]",
                "Protease Inhibitor [EPC]"
              ],
              "unii": [
                "O3J8G9O825",
                "2494G1JF75"
              ]
            }
          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 20140306"
        }
      }
    }
  ]
}