Drug safety summary with 0-100 concern score & verdict (openFDA) API

Pharmacovigilance safety read on a single drug, fusing three distinct openFDA datasets into one decision-oriented summary: top adverse-event reactions plus the total FAERS report count (/drug/event), recall/enforcement history with the most-recent recall and worst classification (/drug/enforcement), and boxed-warning presence plus key warning text from the official label (/drug/label). Collapses them into a derived 0-100 concernScore, a four-level verdict (LOW | MODERATE | ELEVATED | HIGH), the top machine-readable safety signals (e.g. FDA_BOXED_WARNING, CLASS_I_RECALL_HISTORY, MULTIPLE_SERIOUS_REACTIONS), the serious reaction terms detected, and an honest coverage note for any dataset that returned nothing. Answers 'Is this drug safe?', 'Does this drug have a black box warning?', 'What are the most-reported side effects of this drug?', 'Has this drug been recalled by the FDA?'. INFORMATIONAL ONLY — not medical advice.

Price$0.2per request

MethodPOST

Route/v1/health/drug-safety

StatusLive

MIME typeapplication/json

Rate limit60/minute

Cache86400s public

healthdrugsafetypharmacovigilanceopenfdafdaadverse-eventsrecallboxed-warningside-effects

API URLhttps://x402.hexl.dev/v1/health/drug-safety

Integration docs

Example request

{
  "drug": "warfarin"
}

Example response

{
  "drug": "warfarin",
  "concernScore": 84,
  "concern": "HIGH",
  "verdict": "High-concern profile for \"warfarin\": carries an FDA boxed (black box) warning; 12 FDA recalls on record (worst: Class I); 133,630 adverse-event reports. Informational only — confirm with the official label and a clinician.",
  "topSignals": [
    "FDA_BOXED_WARNING",
    "CLASS_I_RECALL_HISTORY",
    "SERIOUS_REACTIONS_REPORTED",
    "HIGH_REPORT_VOLUME"
  ],
  "boxedWarning": {
    "present": true,
    "text": "WARNING: BLEEDING RISK Warfarin sodium can cause major or fatal bleeding. Perform regular monitoring of INR in all treated patients."
  },
  "keyWarnings": "Tissue necrosis and/or gangrene, calciphylaxis, systemic atheroemboli and cholesterol microemboli...",
  "adverseEvents": {
    "totalReports": 133630,
    "topReactions": [
      {
        "term": "INTERNATIONAL NORMALISED RATIO INCREASED",
        "count": 11107
      },
      {
        "term": "DYSPNOEA",
        "count": 8852
      },
      {
        "term": "DRUG INTERACTION",
        "count": 6726
      }
    ],
    "seriousReactionTerms": [
      "HAEMORRHAGE",
      "GASTROINTESTINAL HAEMORRHAGE",
      "DEATH"
    ],
    "available": true
  },
  "recalls": {
    "total": 12,
    "worstClassification": "Class I",
    "mostRecent": {
      "date": "2014-01-22",
      "classification": "Class II",
      "reason": "Labeling: Label Mixup; WARFARIN SODIUM Tablet may be potentially mislabeled."
    },
    "available": true
  },
  "coverage": {
    "datasetsQueried": [
      "drug/event",
      "drug/enforcement",
      "drug/label"
    ],
    "datasetsUnavailable": []
  },
  "disclaimer": "INFORMATIONAL ONLY. This is an automated heuristic summary of public openFDA data (FAERS adverse-event reports, recall/enforcement records, and label text) and is NOT medical advice, NOT a clinical risk assessment, and NOT a substitute for a licensed clinician or the drug's official FDA label. FAERS reports are voluntary, unvalidated, and do NOT establish that the drug caused the event; report volume largely tracks how widely a drug is used. The concernScore is a non-clinical heuristic. Never make medical decisions based on this output — consult a healthcare professional and the official label."
}

Input schema

{
  "type": "object",
  "required": [
    "drug"
  ],
  "properties": {
    "drug": {
      "type": "string",
      "minLength": 2,
      "maxLength": 80,
      "description": "Drug name (generic or brand), e.g. \"ibuprofen\" or \"warfarin\"."
    }
  },
  "examples": [
    {
      "drug": "warfarin"
    },
    {
      "drug": "ibuprofen"
    }
  ]
}

Output schema

{
  "type": "object",
  "additionalProperties": true
}