{
  "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": "6",
      "safetyreportid": "9150464",
      "primarysourcecountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20140711",
      "reporttype": "1",
      "serious": "1",
      "seriousnesshospitalization": "1",
      "receivedateformat": "102",
      "receivedate": "20130227",
      "receiptdateformat": "102",
      "receiptdate": "20131030",
      "fulfillexpeditecriteria": "1",
      "companynumb": "2013US001127",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "ARIAD",
        "duplicatenumb": "2013US001127"
      },
      "primarysource": {
        "reportercountry": "US",
        "qualification": "1"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientonsetage": "62",
        "patientonsetageunit": "801",
        "patientweight": "72",
        "patientsex": "1",
        "reaction": [
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Neuropathy peripheral"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Condition aggravated"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Pain threshold decreased"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Refusal of treatment by patient"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Blood pressure systolic increased"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Blood glucose increased"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Haemoglobin decreased"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Prothrombin time prolonged"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Electrocardiogram T wave abnormal"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Affective disorder"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Peripheral vascular disorder"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Bone pain"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Neuralgia"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Pulse absent"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Thrombocytopenia"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Bone marrow failure"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Blood pressure increased"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Blood glucose increased"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Pain"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Paraesthesia"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Electrocardiogram ST segment depression"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Coronary artery disease"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Abdominal pain"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Splenic infarction"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Hallucination, visual"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Myocardial ischaemia"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Atelectasis"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Cholelithiasis"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Decreased appetite"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Skin ulcer"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Hypophagia"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Leukocytosis"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Nausea"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Vomiting"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Paranoid personality disorder"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Adjustment disorder"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Chronic myeloid leukaemia"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Malignant neoplasm progression"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Disease progression"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "PONATINIB",
            "drugbatchnumb": "4000620",
            "drugauthorizationnumb": "203469",
            "drugstructuredosagenumb": "45",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugdosageform": "TABLET",
            "drugadministrationroute": "048",
            "drugindication": "CHRONIC MYELOID LEUKAEMIA",
            "drugstartdateformat": "102",
            "drugstartdate": "20110608",
            "drugenddateformat": "102",
            "drugenddate": "20120928",
            "drugrecurreadministration": "1",
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          },
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            }
          },
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          },
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            "drugcharacterization": "2",
            "medicinalproduct": "OXYCODONE (OXYCODONE)"
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "OXYCODONE HCL CONTROLLED RELEASE (OXYCODONE HYDROCHLORIDE)"
          },
          {
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            "medicinalproduct": "AMITRIPTYLINE (AMITRIPTYLINE)"
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          {
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            "medicinalproduct": "METOPROLOL (METOPROLOL TARTRATE)"
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                "SENNOSIDES",
                "SENNA LEAF",
                "SENNA"
              ],
              "manufacturer_name": [
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                "American Health Packaging",
                "Family Dollar Services Inc",
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                "H E B",
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                "AmerisourceBergen (Good Neighbor Pharmacy) 46122",
                "QUALITY CHOICE (Chain Drug Marketing Association)",
                "Pharbest Pharmaceuticals, Inc.",
                "Reliable 1 Laboratories LLC",
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                "Akron Pharma Inc.",
                "Rugby Laboratories",
                "AARNA USA INC.",
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              ],
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                "SENNOSIDES A AND B"
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                "69618-064-01",
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                "71399-1017-2",
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                "82568-0024-8",
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              ],
              "unii": [
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              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "CIPRO (CIPROFLOXACIN)"
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "VANCOMYCIN (VANCOMYCIN)"
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "METRONIDAZOLE (METRONIDAZOLE)"
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "CLOPIDOGREL (CLOPIDOGREL)"
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "LORAZEPAM (LORAZEPAM)"
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "DILAUDID (HYDROMORPHONE HYDROCHLORIDE)"
          }
        ]
      }
    }
  ]
}