Drug Safety & FDA Brief

{
  "type": "json",
  "example": {
    "items": [
      {
        "drug": "ozempic",
        "note": "FAERS adverse-event reports are voluntary and do NOT establish that the drug caused the event; counts reflect reporting, not incidence or causation. Verify against the FDA label and source before any clinical or investment decision.",
        "found": true,
        "label": {
          "labelFound": true,
          "hasBoxedWarning": true,
          "boxedWarningExcerpt": "WARNING: RISK OF THYROID C-CELL TUMORS • In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether RYBELSUS and OZEMPIC tablets cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC),"
        },
        "source": "openFDA (api.fda.gov): drugsfda, event (FAERS), enforcement, label",
        "recalls": {
          "total": 1,
          "recent": [
            {
              "date": "2021-03-15",
              "firm": "Cardinal Health Inc.",
              "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
              "status": "Terminated",
              "classification": "Class II"
            }
          ]
        },
        "approval": {
          "routes": [
            "ORAL"
          ],
          "sponsors": [
            "NOVO"
          ],
          "matchedBy": "openfda.brand_name",
          "brandNames": [
            "OZEMPIC",
            "RYBELSUS"
          ],
          "dosageForms": [
            "TABLET"
          ],
          "applications": [
            "NDA213051"
          ],
          "genericNames": [
            "ORAL SEMAGLUTIDE"
          ],
          "marketingStatus": [
            "Prescription"
          ]
        },
        "capturedAt": "2026-10-23T11:32:18+00:00",
        "adverseEvents": {
          "matchedBy": "patient.drug.medicinalproduct",
          "deathReports": 1114,
          "topReactions": [
            {
              "count": 9751,
              "reaction": "Nausea"
            },
            {
              "count": 6949,
              "reaction": "Off Label Use"
            },
            {
              "count": 6341,
              "reaction": "Vomiting"
            },
            {
              "count": 5980,
              "reaction": "Diarrhoea"
            },
            {
              "count": 4507,
              "reaction": "Decreased Appetite"
            },
            {
              "count": 4406,
              "reaction": "Constipation"
            },
            {
              "count": 4157,
              "reaction": "Weight Decreased"
            },
            {
              "count": 3431,
              "reaction": "Impaired Gastric Emptying"
            },
            {
              "count": 3294,
              "reaction": "Product Use In Unapproved Indication"
            },
            {
              "count": 2962,
              "reaction": "Blood Glucose Increased"
            }
          ],
          "totalReports": 66161,
          "seriousReports": 32483
        }
      }
    ]
  }
}