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OpenAPI Spec (JSON)

{
  "info": {
    "description": "Consolidated OpenAPI spec for all openFDA Drug endpoints: adverse event, labeling, NDC directory, Drugs@FDA, enforcement, shortages.",
    "title": "openFDA Drug API",
    "version": "1.0.0",
    "x-bionic-slug": "openfda"
  },
  "openapi": "3.0.1",
  "paths": {
    "/drugsfda.json": {
      "get": {
        "description": "Returns approval history, sponsors, products, submission data for Drugs@FDA dataset.",
        "operationId": "getDrugsFDA",
        "parameters": [
          {
            "description": "Filter, e.g. sponsor_name:\"Pfizer\"",
            "in": "query",
            "name": "search",
            "schema": {
              "type": "string"
            }
          },
          {
            "description": "Max records",
            "in": "query",
            "name": "limit",
            "schema": {
              "maximum": 99,
              "type": "integer"
            }
          },
          {
            "description": "Offset",
            "in": "query",
            "name": "skip",
            "schema": {
              "type": "integer"
            }
          },
          {
            "description": "API key",
            "in": "query",
            "name": "api_key",
            "schema": {
              "type": "string"
            }
          }
        ],
        "responses": {
          "200": {
            "content": {
              "application/json": {
                "schema": {
                  "type": "object"
                }
              }
            },
            "description": "Drugs@FDA data"
          }
        },
        "summary": "Retrieve FDA‑approved drug application & product history"
      }
    },
    "/drugshortages.json": {
      "get": {
        "description": "Fetch current and historical drug shortages data provided by manufacturers and FDA.",
        "operationId": "getDrugShortages",
        "parameters": [
          {
            "description": "Filter e.g. product_name:\"hydrocortisone\"",
            "in": "query",
            "name": "search",
            "schema": {
              "type": "string"
            }
          },
          {
            "description": "Max records",
            "in": "query",
            "name": "limit",
            "schema": {
              "maximum": 100,
              "type": "integer"
            }
          },
          {
            "description": "Offset",
            "in": "query",
            "name": "skip",
            "schema": {
              "type": "integer"
            }
          },
          {
            "description": "API key",
            "in": "query",
            "name": "api_key",
            "schema": {
              "type": "string"
            }
          }
        ],
        "responses": {
          "200": {
            "content": {
              "application/json": {
                "schema": {
                  "type": "object"
                }
              }
            },
            "description": "Drug shortage status records"
          }
        },
        "summary": "Retrieve drug shortage status records"
      }
    },
    "/enforcement.json": {
      "get": {
        "description": "Provides recall enforcement data from FDA’s RES database (recalls classification, reason, dates, firm, product).",
        "operationId": "getDrugEnforcement",
        "parameters": [
          {
            "description": "Filter, e.g. classification:\"Class I\"",
            "in": "query",
            "name": "search",
            "schema": {
              "type": "string"
            }
          },
          {
            "description": "Max records",
            "in": "query",
            "name": "limit",
            "schema": {
              "maximum": 100,
              "type": "integer"
            }
          },
          {
            "description": "Offset",
            "in": "query",
            "name": "skip",
            "schema": {
              "type": "integer"
            }
          },
          {
            "description": "API key",
            "in": "query",
            "name": "api_key",
            "schema": {
              "type": "string"
            }
          }
        ],
        "responses": {
          "200": {
            "content": {
              "application/json": {
                "schema": {
                  "type": "object"
                }
              }
            },
            "description": "Recall enforcement results"
          }
        },
        "summary": "Retrieve drug recall enforcement reports"
      }
    },
    "/event.json": {
      "get": {
        "description": "Returns public adverse event and medication error reports from FDA’s FAERS database.",
        "operationId": "getDrugAdverseEvent",
        "parameters": [
          {
            "description": "Elasticsearch‐style filter, e.g. reactionmeddrapt:\"headache\"",
            "in": "query",
            "name": "search",
            "required": false,
            "schema": {
              "type": "string"
            }
          },
          {
            "description": "Max number of records to return (default 1)",
            "in": "query",
            "name": "limit",
            "required": false,
            "schema": {
              "maximum": 1000,
              "type": "integer"
            }
          },
          {
            "description": "Number of records to skip",
            "in": "query",
            "name": "skip",
            "required": false,
            "schema": {
              "type": "integer"
            }
          },
          {
            "description": "Your API key for higher rate limits",
            "in": "query",
            "name": "api_key",
            "required": false,
            "schema": {
              "type": "string"
            }
          }
        ],
        "responses": {
          "200": {
            "content": {
              "application/json": {
                "schema": {
                  "properties": {
                    "meta": {
                      "description": "Metadata about the response",
                      "properties": {
                        "disclaimer": {
                          "type": "string"
                        },
                        "last_updated": {
                          "format": "date",
                          "type": "string"
                        },
                        "license": {
                          "type": "string"
                        },
                        "results": {
                          "properties": {
                            "limit": {
                              "type": "integer"
                            },
                            "skip": {
                              "type": "integer"
                            },
                            "total": {
                              "type": "integer"
                            }
                          },
                          "type": "object"
                        }
                      },
                      "type": "object"
                    },
                    "results": {
                      "description": "List of adverse event reports",
                      "items": {
                        "properties": {
                          "patient": {
                            "properties": {
                              "death": {
                                "properties": {
                                  "patientdeathdate": {
                                    "type": "string"
                                  }
                                },
                                "type": "object"
                              },
                              "drug": {
                                "items": {
                                  "properties": {
                                    "drugadministrationroute": {
                                      "type": "string"
                                    },
                                    "drugcharacterization": {
                                      "type": "string"
                                    },
                                    "drugindication": {
                                      "type": "string"
                                    },
                                    "medicinalproduct": {
                                      "type": "string"
                                    }
                                  },
                                  "type": "object"
                                },
                                "type": "array"
                              },
                              "patientonsetage": {
                                "type": "string"
                              },
                              "patientonsetageunit": {
                                "type": "string"
                              },
                              "patientsex": {
                                "type": "string"
                              },
                              "reaction": {
                                "items": {
                                  "properties": {
                                    "reactionmeddrapt": {
                                      "type": "string"
                                    }
                                  },
                                  "type": "object"
                                },
                                "type": "array"
                              }
                            },
                            "type": "object"
                          },
                          "receivedate": {
                            "type": "string"
                          },
                          "safetyreportid": {
                            "type": "string"
                          },
                          "serious": {
                            "type": "string"
                          },
                          "transmissiondate": {
                            "type": "string"
                          }
                        },
                        "type": "object"
                      },
                      "type": "array"
                    }
                  },
                  "type": "object"
                }
              }
            },
            "description": "Search results for adverse events"
          }
        },
        "summary": "Retrieve drug adverse event reports (FAERS)"
      }
    },
    "/label.json": {
      "get": {
        "description": "Fetch structured product labeling (prescribing/OTC info, adverse reactions, indications, boxed warnings, etc.)",
        "operationId": "getDrugLabeling",
        "parameters": [
          {
            "description": "Search filter, e.g. openfda.brand_name:\"aspirin\"",
            "in": "query",
            "name": "search",
            "required": false,
            "schema": {
              "type": "string"
            }
          },
          {
            "description": "Max records",
            "in": "query",
            "name": "limit",
            "schema": {
              "maximum": 100,
              "type": "integer"
            }
          },
          {
            "description": "Skip offset",
            "in": "query",
            "name": "skip",
            "schema": {
              "type": "integer"
            }
          },
          {
            "description": "API key",
            "in": "query",
            "name": "api_key",
            "schema": {
              "type": "string"
            }
          }
        ],
        "responses": {
          "200": {
            "content": {
              "application/json": {
                "schema": {
                  "properties": {
                    "meta": {
                      "type": "object"
                    },
                    "results": {
                      "items": {
                        "properties": {
                          "adverse_reactions": {
                            "type": "string"
                          },
                          "boxed_warning": {
                            "type": "string"
                          },
                          "effective_time": {
                            "type": "string"
                          },
                          "inactive_ingredient": {
                            "items": {
                              "type": "string"
                            },
                            "type": "array"
                          },
                          "indications_and_usage": {
                            "type": "string"
                          },
                          "purpose": {
                            "items": {
                              "type": "string"
                            },
                            "type": "array"
                          }
                        },
                        "type": "object"
                      },
                      "type": "array"
                    }
                  },
                  "type": "object"
                }
              }
            },
            "description": "Labeling search results"
          }
        },
        "summary": "Retrieve drug labeling records (SPL)"
      }
    },
    "/ndc.json": {
      "get": {
        "description": "Fetch NDC Directory data: packaging, marketing status, labeler, dosage form etc.",
        "operationId": "getDrugNDC",
        "parameters": [
          {
            "description": "Filter, e.g. dosage_form:\"TABLET\"",
            "in": "query",
            "name": "search",
            "schema": {
              "type": "string"
            }
          },
          {
            "description": "Max records",
            "in": "query",
            "name": "limit",
            "schema": {
              "maximum": 100,
              "type": "integer"
            }
          },
          {
            "description": "Offset",
            "in": "query",
            "name": "skip",
            "schema": {
              "type": "integer"
            }
          },
          {
            "description": "API key",
            "in": "query",
            "name": "api_key",
            "schema": {
              "type": "string"
            }
          }
        ],
        "responses": {
          "200": {
            "content": {
              "application/json": {
                "schema": {
                  "properties": {
                    "meta": {
                      "type": "object"
                    },
                    "results": {
                      "items": {
                        "properties": {
                          "active_ingredients": {
                            "items": {
                              "properties": {
                                "name": {
                                  "type": "string"
                                },
                                "strength": {
                                  "type": "string"
                                }
                              },
                              "type": "object"
                            },
                            "type": "array"
                          },
                          "dosage_form": {
                            "type": "string"
                          },
                          "listing_expiration_date": {
                            "type": "string"
                          },
                          "marketing_start_date": {
                            "type": "string"
                          },
                          "ndc": {
                            "type": "string"
                          },
                          "packaging": {
                            "properties": {
                              "description": {
                                "type": "string"
                              }
                            },
                            "type": "object"
                          },
                          "product_type": {
                            "type": "string"
                          }
                        },
                        "type": "object"
                      },
                      "type": "array"
                    }
                  },
                  "type": "object"
                }
              }
            },
            "description": "NDC directory entries"
          }
        },
        "summary": "Retrieve National Drug Code directory entries"
      }
    }
  },
  "servers": [
    {
      "url": "https://api.fda.gov/drug"
    }
  ]
}

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