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fda.md

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1# OpenFDA API

OpenFDA API

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3## Base URL

4```

5https://api.fda.gov

6```

Base URL

https://api.fda.gov

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8## Auth

9Optional free API key (240 req/min with or without). Register at https://open.fda.gov/apis/authentication/

10Pass as: `?api_key=YOUR_KEY`

Auth

Optional free API key (240 req/min with or without). Register at https://open.fda.gov/apis/authentication/ Pass as: ?api_key=YOUR_KEY

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12## Key Endpoints

14| Endpoint | Description |

15|----------|-------------|

16| `/drug/event.json` | Drug adverse events (FAERS) |

17| `/drug/label.json` | Drug product labeling (SPL) |

18| `/drug/ndc.json` | NDC directory |

19| `/drug/drugsfda.json` | Drugs@FDA (approvals) |

20| `/drug/enforcement.json` | Drug recalls |

21| `/device/event.json` | Device adverse events |

22| `/device/510k.json` | 510(k) clearances |

23| `/food/event.json` | Food adverse events |

24| `/food/enforcement.json` | Food enforcement |

Key Endpoints

Endpoint	Description
`/drug/event.json`	Drug adverse events (FAERS)
`/drug/label.json`	Drug product labeling (SPL)
`/drug/ndc.json`	NDC directory
`/drug/drugsfda.json`	Drugs@FDA (approvals)
`/drug/enforcement.json`	Drug recalls
`/device/event.json`	Device adverse events
`/device/510k.json`	510(k) clearances
`/food/event.json`	Food adverse events
`/food/enforcement.json`	Food enforcement

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26## Query Parameters

28- `search` — query using OpenFDA syntax

29- `count` — count unique values for a field

30- `limit` — results per request (max 1000)

31- `skip` — pagination offset (max 25000)

Query Parameters

search — query using OpenFDA syntax
count — count unique values for a field
limit — results per request (max 1000)
skip — pagination offset (max 25000)

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33### Search Syntax

34- Field search: `field:"value"`

35- AND: `field1:value1+AND+field2:value2`

36- OR: `field1:value1+OR+field2:value2`

37- Date range: `field:[20230101+TO+20231231]`

38- Wildcards: `field:aspir*`

39- OpenFDA harmonized fields use `openfda.` prefix

Search Syntax

Field search: field:"value"
AND: field1:value1+AND+field2:value2
OR: field1:value1+OR+field2:value2
Date range: field:[20230101+TO+20231231]
Wildcards: field:aspir*
OpenFDA harmonized fields use openfda. prefix

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41## Example Calls

43```

44# Adverse events for aspirin

45/drug/event.json?search=patient.drug.openfda.brand_name:"aspirin"&limit=5

47# Top adverse reactions for a drug

48/drug/event.json?search=patient.drug.openfda.generic_name:"metformin"&count=patient.reaction.reactionmeddrapt.exact

50# Drug labels by generic name

51/drug/label.json?search=openfda.generic_name:"ibuprofen"&limit=3

53# Drug recalls in date range

54/drug/enforcement.json?search=report_date:[20230101+TO+20231231]&limit=10

56# Serious adverse events only

57/drug/event.json?search=patient.drug.openfda.brand_name:"warfarin"+AND+serious:1&limit=10

58```

Example Calls

# Adverse events for aspirin
/drug/event.json?search=patient.drug.openfda.brand_name:"aspirin"&limit=5

# Top adverse reactions for a drug
/drug/event.json?search=patient.drug.openfda.generic_name:"metformin"&count=patient.reaction.reactionmeddrapt.exact

# Drug labels by generic name
/drug/label.json?search=openfda.generic_name:"ibuprofen"&limit=3

# Drug recalls in date range
/drug/enforcement.json?search=report_date:[20230101+TO+20231231]&limit=10

# Serious adverse events only
/drug/event.json?search=patient.drug.openfda.brand_name:"warfarin"+AND+serious:1&limit=10

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60## Rate Limits

61| Tier | Requests/min | Requests/day |

62|------|-------------|-------------|

63| No API key | 240 | 1,000 |

64| With API key (free) | 240 | 120,000 |

66FAERS reports are not incidence estimates or proof that a drug caused an event. Preserve report versions and avoid double-counting follow-ups. OpenFDA harmonization is incomplete; a missing harmonized name is not evidence of absence.

Rate Limits

Tier	Requests/min	Requests/day
No API key	240	1,000
With API key (free)	240	120,000

FAERS reports are not incidence estimates or proof that a drug caused an event. Preserve report versions and avoid double-counting follow-ups. OpenFDA harmonization is incomplete; a missing harmonized name is not evidence of absence.

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