{
  "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": 19429
    }
  },
  "results": [
    {
      "safetyreportversion": "4",
      "safetyreportid": "10004384",
      "primarysourcecountry": "DK",
      "occurcountry": "DK",
      "transmissiondateformat": "102",
      "transmissiondate": "20150326",
      "reporttype": "1",
      "serious": "1",
      "seriousnessother": "1",
      "receivedateformat": "102",
      "receivedate": "20140312",
      "receiptdateformat": "102",
      "receiptdate": "20140926",
      "fulfillexpeditecriteria": "1",
      "authoritynumb": "DK-DKMA-EFO7901",
      "companynumb": "PHHY2014DK029550",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "NOVARTIS",
        "duplicatenumb": "PHHY2014DK029550"
      },
      "primarysource": {
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        "qualification": "3"
      },
      "sender": {
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        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
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        "receiverorganization": "FDA"
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      "patient": {
        "patientweight": "27",
        "patientsex": "1",
        "reaction": [
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Palpitations",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Decreased appetite",
            "reactionoutcome": "3"
          },
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Atrial fibrillation",
            "reactionoutcome": "1"
          },
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Insomnia",
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          },
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Painful erection",
            "reactionoutcome": "1"
          },
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Chest pain",
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          },
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Tic",
            "reactionoutcome": "3"
          },
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Dyspnoea",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Abdominal pain upper",
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          }
        ],
        "drug": [
          {
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            "medicinalproduct": "CONCERTA",
            "drugstructuredosagenumb": "36",
            "drugstructuredosageunit": "032",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
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            "drugindication": "ATTENTION DEFICIT/HYPERACTIVITY DISORDER",
            "drugstartdateformat": "602",
            "drugstartdate": "2003",
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            "drugrecurreadministration": "3",
            "activesubstance": {
              "activesubstancename": "METHYLPHENIDATE HYDROCHLORIDE"
            },
            "openfda": {
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              ],
              "brand_name": [
                "CONCERTA"
              ],
              "generic_name": [
                "METHYLPHENIDATE HYDROCHLORIDE"
              ],
              "manufacturer_name": [
                "Janssen Pharmaceuticals, Inc."
              ],
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                "50458-585",
                "50458-588",
                "50458-586",
                "50458-587"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
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                "50458-585-01",
                "50458-588-01",
                "50458-586-01",
                "50458-587-01"
              ],
              "unii": [
                "4B3SC438HI"
              ]
            }
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "RITALIN",
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            "drugstructuredosagenumb": "10",
            "drugstructuredosageunit": "003",
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            "drugdosagetext": "10 MG, QD",
            "drugindication": "ATTENTION DEFICIT/HYPERACTIVITY DISORDER",
            "drugstartdateformat": "602",
            "drugstartdate": "2004",
            "actiondrug": "5",
            "drugrecurreadministration": "3",
            "activesubstance": {
              "activesubstancename": "METHYLPHENIDATE HYDROCHLORIDE"
            },
            "openfda": {
              "application_number": [
                "NDA010187",
                "NDA021284"
              ],
              "brand_name": [
                "RITALIN",
                "RITALIN LA"
              ],
              "generic_name": [
                "METHYLPHENIDATE HYDROCHLORIDE"
              ],
              "manufacturer_name": [
                "Novartis Pharmaceuticals Corporation",
                "Sandoz Inc"
              ],
              "product_ndc": [
                "0078-0439",
                "0078-0440",
                "0078-0441",
                "66758-273",
                "66758-274",
                "66758-275",
                "0078-0370",
                "0078-0371",
                "0078-0372",
                "0078-0424"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "METHYLPHENIDATE HYDROCHLORIDE"
              ],
              "rxcui": [
                "1091150",
                "1091379",
                "1091392",
                "1091395",
                "1091497",
                "1091500",
                "1091143",
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                "1091182",
                "1091197",
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                "1806183",
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              ],
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                "00db4d6e-410b-43a1-ab5e-7047f525e68d",
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              ],
              "package_ndc": [
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                "0078-0441-05",
                "66758-273-01",
                "66758-274-01",
                "66758-275-01",
                "0078-0370-05",
                "0078-0371-05",
                "0078-0372-05",
                "0078-0424-05"
              ],
              "unii": [
                "4B3SC438HI"
              ]
            }
          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 2008"
        }
      }
    }
  ]
}