openfda-mcp-server

Openfda Drug Profile

openfda_drug_profile

Read-only

Resolve one drug name to its FDA identity, then fan out in parallel across the bounded per-drug openFDA endpoints and merge into one profile: identity, label highlights, adverse-event summary, recall history, Drugs@FDA approval, and shortage status. Replaces chaining openfda_get_drug_label, openfda_search_adverse_events, openfda_search_recalls, openfda_search_drug_approvals, and openfda_search_drug_shortages — and reconciles the identifier drift between endpoints that makes that chaining error-prone. Each section is best-effort: a miss returns null rather than failing the call. For deep dives into any one area, use the dedicated tool.

Input Schema

TableJSON Schema

Name	Required	Description	Default
`drug`	Yes	Drug name to profile — brand or generic (e.g. "metformin", "Humira", "Glucophage"). Resolved once to canonical FDA identifiers, which then key every sub-query.

Output Schema

TableJSON Schema

Name	Required	Description
`meta`	No	Request metadata.
`error`	No	Present when the call failed. Absent on success.
`label`	No	Label highlights from drug/label, or null when no label matched.
`notice`	No	Guidance when the drug could not be resolved or upstream errors degraded the profile. Absent on a fully populated profile.
`recalls`	No	Recent drug/enforcement recall actions (may be empty).
`approval`	No	Drugs@FDA approval summary, or null when no application matched.
`degraded`	No	Sub-queries that failed upstream, empty when every section resolved. A section listed here is unknown, not absent — a null section with no entry here genuinely has no FDA record.
`identity`	No	Identity resolved once and reused across every sub-query to avoid identifier drift.
`shortage`	No	Current or most-recent drug shortage status, or null when none on record.
`sectionsFound`	No	How many profile sections (label, adverse_events, recalls, approval, shortage) returned data.
`adverse_events`	No	Adverse-event summary aggregated over drug/event, or null when unavailable.

Schema Changelog

Changes observed during successful MCP inspections.

Changed3 schema fields changedOct 13, 2026

changedOutput schema / properties / adverse_events / anyOf

Previous value: -[
-  {
-    "additionalProperties": false,
-    "properties": {
-      "seriousCount": {
-        "description": "Reports flagged serious (serious=1).",
-        "type": "number"
-      },
-      "topReactions": {
-        "description": "Most-frequent reported reactions, descending.",
-        "items": {
-          "additionalProperties": false,
-          "description": "A reaction term paired with its report count.",
-          "properties": {
-            "count": {
-              "description": "Reports citing this reaction.",
-              "type": "number"
-            },
-            "term": {
-              "description": "MedDRA reaction term.",
-              "type": "string"
-            }
-          },
-          "required": [
-            "term",
-            "count"
-          ],
-          "type": "object"
-        },
-        "type": "array"
-      },
-      "total": {
-        "description": "Approximate total adverse-event reports naming this drug.",
-        "type": "number"
-      }
-    },
-    "required": [
-      "total",
-      "seriousCount",
-      "topReactions"
-    ],
-    "type": "object"
-  },
-  {
-    "type": "null"
-  }
-]New value: +[
+  {
+    "additionalProperties": false,
+    "properties": {
+      "seriousCount": {
+        "description": "Reports flagged serious (serious=1). total − seriousCount covers both non-serious reports and those with no seriousness recorded.",
+        "type": "number"
+      },
+      "topReactions": {
+        "description": "Most-frequent reported reactions, descending.",
+        "items": {
+          "additionalProperties": false,
+          "description": "A reaction term paired with its report count.",
+          "properties": {
+            "count": {
+              "description": "Reports citing this reaction.",
+              "type": "number"
+            },
+            "term": {
+              "description": "MedDRA reaction term.",
+              "type": "string"
+            }
+          },
+          "required": [
+            "term",
+            "count"
+          ],
+          "type": "object"
+        },
+        "type": "array"
+      },
+      "total": {
+        "description": "Adverse-event reports naming this drug — every matching report, including those with no seriousness recorded; equals openfda_search_adverse_events meta.total for the same medicinalproduct search.",
+        "type": "number"
+      }
+    },
+    "required": [
+      "total",
+      "seriousCount",
+      "topReactions"
+    ],
+    "type": "object"
+  },
+  {
+    "type": "null"
+  }
+]

changedOutput schema / properties / meta / properties / fanOutKey / description

Previous value: -"Canonical key the structured sub-queries (recall/enforcement, Drugs@FDA approval, shortage) ran against — the resolved generic name, falling back to a brand name, then the input term. The adverse-event sub-query instead keys off the raw input term to match heterogeneous reporter-entered values."New value: +"Canonical key the structured sub-queries (recall/enforcement, Drugs@FDA approval, shortage) ran against — the resolved generic name, falling back to a brand name, then the input term. The adverse-event sub-queries instead key off the raw input term to match heterogeneous reporter-entered values."

changedOutput schema / properties / shortage / anyOf

Previous value: -[
-  {
-    "additionalProperties": false,
-    "properties": {
-      "availability": {
-        "description": "Availability note (truncated).",
-        "type": [
-          "string",
-          "null"
-        ]
-      },
-      "status": {
-        "description": "Shortage status (Current/Resolved).",
-        "type": [
-          "string",
-          "null"
-        ]
-      }
-    },
-    "required": [
-      "status",
-      "availability"
-    ],
-    "type": "object"
-  },
-  {
-    "type": "null"
-  }
-]New value: +[
+  {
+    "additionalProperties": false,
+    "properties": {
+      "availability": {
+        "description": "Availability note (truncated).",
+        "type": [
+          "string",
+          "null"
+        ]
+      },
+      "status": {
+        "description": "Shortage status (Current, To Be Discontinued, or Resolved).",
+        "type": [
+          "string",
+          "null"
+        ]
+      }
+    },
+    "required": [
+      "status",
+      "availability"
+    ],
+    "type": "object"
+  },
+  {
+    "type": "null"
+  }
+]

Changed19 schema fields changedSep 16, 2026

changedOutput schema / properties / approval / anyOf

Previous value: -[
-  {
-    "additionalProperties": false,
-    "properties": {
-      "applicationNumber": {
-        "anyOf": [
-          {
-            "type": "string"
-          },
-          {
-            "type": "null"
-          }
-        ],
-        "description": "NDA/ANDA application number."
-      },
-      "marketingStatus": {
-        "anyOf": [
-          {
-            "type": "string"
-          },
-          {
-            "type": "null"
-          }
-        ],
-        "description": "Derived marketing/approval status."
-      },
-      "sponsor": {
-        "anyOf": [
-          {
-            "type": "string"
-          },
-          {
-            "type": "null"
-          }
-        ],
-        "description": "Sponsor/applicant name."
-      }
-    },
-    "required": [
-      "applicationNumber",
-      "sponsor",
-      "marketingStatus"
-    ],
-    "type": "object"
-  },
-  {
-    "type": "null"
-  }
-]New value: +[
+  {
+    "additionalProperties": false,
+    "properties": {
+      "applicationNumber": {
+        "description": "NDA/ANDA application number.",
+        "type": [
+          "string",
+          "null"
+        ]
+      },
+      "marketingStatus": {
+        "description": "Derived marketing/approval status.",
+        "type": [
+          "string",
+          "null"
+        ]
+      },
+      "sponsor": {
+        "description": "Sponsor/applicant name.",
+        "type": [
+          "string",
+          "null"
+        ]
+      }
+    },
+    "required": [
+      "applicationNumber",
+      "sponsor",
+      "marketingStatus"
+    ],
+    "type": "object"
+  },
+  {
+    "type": "null"
+  }
+]

removedOutput schema / properties / identity / properties / generic_name / anyOf

Removed value: -[
-  {
-    "type": "string"
-  },
-  {
-    "type": "null"
-  }
-]

addedOutput schema / properties / identity / properties / generic_name / type
```
Added value: +[
+  "string",
+  "null"
+]
```

removedOutput schema / properties / identity / properties / product_ndc / anyOf

Removed value: -[
-  {
-    "type": "string"
-  },
-  {
-    "type": "null"
-  }
-]

addedOutput schema / properties / identity / properties / product_ndc / type
```
Added value: +[
+  "string",
+  "null"
+]
```

removedOutput schema / properties / identity / properties / rxcui / anyOf

Removed value: -[
-  {
-    "type": "string"
-  },
-  {
-    "type": "null"
-  }
-]

addedOutput schema / properties / identity / properties / rxcui / type
```
Added value: +[
+  "string",
+  "null"
+]
```

removedOutput schema / properties / identity / properties / spl_set_id / anyOf

Removed value: -[
-  {
-    "type": "string"
-  },
-  {
-    "type": "null"
-  }
-]

addedOutput schema / properties / identity / properties / spl_set_id / type
```
Added value: +[
+  "string",
+  "null"
+]
```

changedOutput schema / properties / label / anyOf

Previous value: -[
-  {
-    "additionalProperties": false,
-    "properties": {
-      "dosage": {
-        "anyOf": [
-          {
-            "type": "string"
-          },
-          {
-            "type": "null"
-          }
-        ],
-        "description": "Dosage and administration (truncated)."
-      },
-      "indications": {
-        "anyOf": [
-          {
-            "type": "string"
-          },
-          {
-            "type": "null"
-          }
-        ],
-        "description": "Indications and usage (truncated)."
-      },
-      "warnings": {
-        "anyOf": [
-          {
-            "type": "string"
-          },
-          {
-            "type": "null"
-          }
-        ],
-        "description": "Warnings (truncated) — boxed warning or warnings_and_cautions for Rx labels, falling back to the OTC-monograph warnings section."
-      }
-    },
-    "required": [
-      "indications",
-      "warnings",
-      "dosage"
-    ],
-    "type": "object"
-  },
-  {
-    "type": "null"
-  }
-]New value: +[
+  {
+    "additionalProperties": false,
+    "properties": {
+      "dosage": {
+        "description": "Dosage and administration (truncated).",
+        "type": [
+          "string",
+          "null"
+        ]
+      },
+      "indications": {
+        "description": "Indications and usage (truncated).",
+        "type": [
+          "string",
+          "null"
+        ]
+      },
+      "warnings": {
+        "description": "Warnings (truncated) — boxed warning or warnings_and_cautions for Rx labels, falling back to the OTC-monograph warnings section.",
+        "type": [
+          "string",
+          "null"
+        ]
+      }
+    },
+    "required": [
+      "indications",
+      "warnings",
+      "dosage"
+    ],
+    "type": "object"
+  },
+  {
+    "type": "null"
+  }
+]

removedOutput schema / properties / recalls / items / properties / classification / anyOf
```
Removed value: -[
-  {
-    "type": "string"
-  },
-  {
-    "type": "null"
-  }
-]
```
addedOutput schema / properties / recalls / items / properties / classification / type
```
Added value: +[
+  "string",
+  "null"
+]
```

removedOutput schema / properties / recalls / items / properties / date / anyOf

Removed value: -[
-  {
-    "type": "string"
-  },
-  {
-    "type": "null"
-  }
-]

addedOutput schema / properties / recalls / items / properties / date / type
```
Added value: +[
+  "string",
+  "null"
+]
```

removedOutput schema / properties / recalls / items / properties / reason / anyOf

Removed value: -[
-  {
-    "type": "string"
-  },
-  {
-    "type": "null"
-  }
-]

addedOutput schema / properties / recalls / items / properties / reason / type
```
Added value: +[
+  "string",
+  "null"
+]
```
removedOutput schema / properties / recalls / items / properties / recalling_firm / anyOf
```
Removed value: -[
-  {
-    "type": "string"
-  },
-  {
-    "type": "null"
-  }
-]
```
addedOutput schema / properties / recalls / items / properties / recalling_firm / type
```
Added value: +[
+  "string",
+  "null"
+]
```

changedOutput schema / properties / shortage / anyOf

Previous value: -[
-  {
-    "additionalProperties": false,
-    "properties": {
-      "availability": {
-        "anyOf": [
-          {
-            "type": "string"
-          },
-          {
-            "type": "null"
-          }
-        ],
-        "description": "Availability note (truncated)."
-      },
-      "status": {
-        "anyOf": [
-          {
-            "type": "string"
-          },
-          {
-            "type": "null"
-          }
-        ],
-        "description": "Shortage status (Current/Resolved)."
-      }
-    },
-    "required": [
-      "status",
-      "availability"
-    ],
-    "type": "object"
-  },
-  {
-    "type": "null"
-  }
-]New value: +[
+  {
+    "additionalProperties": false,
+    "properties": {
+      "availability": {
+        "description": "Availability note (truncated).",
+        "type": [
+          "string",
+          "null"
+        ]
+      },
+      "status": {
+        "description": "Shortage status (Current/Resolved).",
+        "type": [
+          "string",
+          "null"
+        ]
+      }
+    },
+    "required": [
+      "status",
+      "availability"
+    ],
+    "type": "object"
+  },
+  {
+    "type": "null"
+  }
+]

Changed6 schema fields changedAug 25, 2026

changedInput schema / $schema

Previous value: -"http://json-schema.org/draft-07/schema#"New value: +"https://json-schema.org/draft/2020-12/schema"

addedInput schema / additionalProperties
```
Added value: +false
```

changedOutput schema / $schema

Previous value: -"http://json-schema.org/draft-07/schema#"New value: +"https://json-schema.org/draft/2020-12/schema"

addedOutput schema / anyOf

Added value: +[
+  {
+    "not": {
+      "required": [
+        "error"
+      ]
+    },
+    "required": [
+      "meta",
+      "identity",
+      "label",
+      "adverse_events",
+      "recalls",
+      "approval",
+      "shortage",
+      "degraded",
+      "sectionsFound"
+    ]
+  },
+  {
+    "required": [
+      "error"
+    ]
+  }
+]

addedOutput schema / properties / error

Added value: +{
+  "additionalProperties": {},
+  "description": "Present when the call failed. Absent on success.",
+  "properties": {
+    "code": {
+      "description": "JSON-RPC error code for this failure.",
+      "maximum": 9007199254740991,
+      "minimum": -9007199254740991,
+      "type": "integer"
+    },
+    "data": {
+      "additionalProperties": {},
+      "properties": {
+        "reason": {
+          "description": "Machine-readable failure mode. Declared by this tool: `blank_drug_name`: The drug name carries no searchable character — only quotes, backslashes, or whitespace. Other values are possible when a failure originates below the handler.",
+          "examples": [
+            "blank_drug_name"
+          ],
+          "type": "string"
+        },
+        "recovery": {
+          "additionalProperties": {},
+          "description": "Actionable next step for the caller.",
+          "properties": {
+            "hint": {
+              "type": "string"
+            }
+          },
+          "required": [
+            "hint"
+          ],
+          "type": "object"
+        },
+        "retryable": {
+          "description": "Whether retrying may succeed.",
+          "type": "boolean"
+        }
+      },
+      "type": "object"
+    },
+    "message": {
+      "description": "Human-readable description of what went wrong.",
+      "type": "string"
+    }
+  },
+  "required": [
+    "code",
+    "message"
+  ],
+  "type": "object"
+}

removedOutput schema / required

Removed value: -[
-  "meta",
-  "identity",
-  "label",
-  "adverse_events",
-  "recalls",
-  "approval",
-  "shortage",
-  "degraded",
-  "sectionsFound"
-]

Changed3 schema fields changedJul 26, 2026

addedInput schema / properties / drug / pattern
```
Added value: +"\\S"
```

addedOutput schema / properties / degraded

Added value: +{
+  "description": "Sub-queries that failed upstream, empty when every section resolved. A section listed here is unknown, not absent — a null section with no entry here genuinely has no FDA record.",
+  "items": {
+    "additionalProperties": false,
+    "description": "One failed sub-query and why it failed.",
+    "properties": {
+      "message": {
+        "description": "Upstream failure message for this section, truncated.",
+        "type": "string"
+      },
+      "reason": {
+        "description": "Machine-readable failure reason (e.g. rate_limited, upstream_error, query_error).",
+        "type": "string"
+      },
+      "section": {
+        "description": "Profile section whose sub-query failed.",
+        "enum": [
+          "identity",
+          "label",
+          "adverse_events",
+          "recalls",
+          "approval",
+          "shortage"
+        ],
+        "type": "string"
+      }
+    },
+    "required": [
+      "section",
+      "reason",
+      "message"
+    ],
+    "type": "object"
+  },
+  "type": "array"
+}

changedOutput schema / required

Previous value: -[
-  "meta",
-  "identity",
-  "label",
-  "adverse_events",
-  "recalls",
-  "approval",
-  "shortage",
-  "sectionsFound"
-]New value: +[
+  "meta",
+  "identity",
+  "label",
+  "adverse_events",
+  "recalls",
+  "approval",
+  "shortage",
+  "degraded",
+  "sectionsFound"
+]

Changed1 schema field changedJul 3, 2026

changedOutput schema / properties / label / anyOf

Previous value: -[
-  {
-    "additionalProperties": false,
-    "properties": {
-      "dosage": {
-        "anyOf": [
-          {
-            "type": "string"
-          },
-          {
-            "type": "null"
-          }
-        ],
-        "description": "Dosage and administration (truncated)."
-      },
-      "indications": {
-        "anyOf": [
-          {
-            "type": "string"
-          },
-          {
-            "type": "null"
-          }
-        ],
-        "description": "Indications and usage (truncated)."
-      },
-      "warnings": {
-        "anyOf": [
-          {
-            "type": "string"
-          },
-          {
-            "type": "null"
-          }
-        ],
-        "description": "Warnings (truncated)."
-      }
-    },
-    "required": [
-      "indications",
-      "warnings",
-      "dosage"
-    ],
-    "type": "object"
-  },
-  {
-    "type": "null"
-  }
-]New value: +[
+  {
+    "additionalProperties": false,
+    "properties": {
+      "dosage": {
+        "anyOf": [
+          {
+            "type": "string"
+          },
+          {
+            "type": "null"
+          }
+        ],
+        "description": "Dosage and administration (truncated)."
+      },
+      "indications": {
+        "anyOf": [
+          {
+            "type": "string"
+          },
+          {
+            "type": "null"
+          }
+        ],
+        "description": "Indications and usage (truncated)."
+      },
+      "warnings": {
+        "anyOf": [
+          {
+            "type": "string"
+          },
+          {
+            "type": "null"
+          }
+        ],
+        "description": "Warnings (truncated) — boxed warning or warnings_and_cautions for Rx labels, falling back to the OTC-monograph warnings section."
+      }
+    },
+    "required": [
+      "indications",
+      "warnings",
+      "dosage"
+    ],
+    "type": "object"
+  },
+  {
+    "type": "null"
+  }
+]

Changed3 schema fields changedJun 9, 2026

changedOutput schema / properties / identity / properties / generic_name / description

Previous value: -"Canonical generic name (openfda.generic_name) — the key used for fan-out."New value: +"Canonical generic name (openfda.generic_name) — the primary source for meta.fanOutKey."

addedOutput schema / properties / meta / properties / fanOutKey

Added value: +{
+  "description": "Canonical key the structured sub-queries (recall/enforcement, Drugs@FDA approval, shortage) ran against — the resolved generic name, falling back to a brand name, then the input term. The adverse-event sub-query instead keys off the raw input term to match heterogeneous reporter-entered values.",
+  "type": "string"
+}

changedOutput schema / properties / meta / required

Previous value: -[
-  "drug",
-  "resolvedVia"
-]New value: +[
+  "drug",
+  "resolvedVia",
+  "fanOutKey"
+]

AddedJun 5, 2026

TDQS

Score is being calculated.

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