{
  "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": 8540
    }
  },
  "results": [
    {
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      "occurcountry": "IT",
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      "seriousnesshospitalization": "1",
      "receivedateformat": "102",
      "receivedate": "20140313",
      "receiptdateformat": "102",
      "receiptdate": "20140722",
      "fulfillexpeditecriteria": "1",
      "authoritynumb": "IT-MINISAL02-239944",
      "companynumb": "IT-MYLANLABS-2014S1004856",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "MYLAN",
        "duplicatenumb": "IT-MYLANLABS-2014S1004856"
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      "primarysource": {
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        "qualification": "1"
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        "senderorganization": "FDA-Public Use"
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      "receiver": {
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      "patient": {
        "patientonsetage": "57",
        "patientonsetageunit": "801",
        "patientagegroup": "5",
        "patientsex": "2",
        "reaction": [
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Urticaria",
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          {
            "reactionmeddraversionpt": "17.1",
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            "openfda": {
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                "NDA020692"
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                "SEREVENT DISKUS"
              ],
              "generic_name": [
                "SALMETEROL XINAFOATE"
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                "RESPIRATORY (INHALATION)"
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              "brand_name": [
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              "manufacturer_name": [
                "Lupin Pharmaceuticals, Inc.",
                "Zydus Lifesciences Limited",
                "Hikma Pharmaceuticals USA Inc.",
                "Zydus Pharmaceuticals USA Inc.",
                "GSMS, Incorporated",
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              ],
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              "substance_name": [
                "RAMIPRIL"
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                "b7e49f05-6d4f-465a-b0d7-f704466a2e52"
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                "68180-589-09",
                "68180-589-10",
                "68180-589-01",
                "68180-589-02",
                "68180-590-09",
                "68180-590-10",
                "68180-590-01",
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                "68180-591-09",
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                "0054-0106-25",
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                "0054-0108-20",
                "0054-0109-25",
                "0054-0109-29",
                "68382-144-06",
                "68382-144-16",
                "68382-144-01",
                "68382-144-05",
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                "68382-144-77",
                "68382-145-06",
                "68382-145-16",
                "68382-145-01",
                "68382-145-05",
                "68382-145-30",
                "68382-145-77",
                "68382-146-06",
                "68382-146-16",
                "68382-146-01",
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                "68382-146-77",
                "68382-147-06",
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                "68382-147-01",
                "68382-147-05",
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                "68382-147-77",
                "51407-707-01",
                "51407-708-01",
                "51407-709-01",
                "57237-222-30",
                "57237-222-01",
                "57237-223-01",
                "57237-223-05",
                "57237-224-01",
                "57237-224-05",
                "57237-225-01",
                "57237-225-05",
                "76282-670-01",
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                "76282-671-05",
                "76282-672-01",
                "76282-672-05",
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                "76282-673-05",
                "65862-474-30",
                "65862-474-01",
                "65862-474-99",
                "65862-474-10",
                "65862-475-30",
                "65862-475-01",
                "65862-475-05",
                "65862-475-99",
                "65862-475-10",
                "65862-476-30",
                "65862-476-01",
                "65862-476-05",
                "65862-476-99",
                "65862-476-10",
                "65862-477-30",
                "65862-477-01",
                "65862-477-05",
                "65862-477-99",
                "65862-477-10",
                "68001-428-00",
                "68001-429-00",
                "68001-430-00",
                "68001-430-03",
                "68001-431-00",
                "68001-431-03",
                "62135-271-30",
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                "62135-271-01",
                "62135-272-90",
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                "62135-273-01",
                "62135-273-05",
                "62135-274-90",
                "62135-274-01",
                "62135-274-05"
              ],
              "nui": [
                "N0000175562",
                "N0000000181"
              ],
              "pharm_class_epc": [
                "Angiotensin Converting Enzyme Inhibitor [EPC]"
              ],
              "pharm_class_moa": [
                "Angiotensin-converting Enzyme Inhibitors [MoA]"
              ],
              "unii": [
                "L35JN3I7SJ"
              ]
            }
          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 20131010"
        }
      }
    }
  ]
}