Questions tagged [openfda]

Questions and answers surrounding the U.S. Food and Drug Administration's OpenFDA program.

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Is there an API for drug approval packages from the FDA?

I am building an application where we'd like to reuse information from drug approval packages (Example). The FDA API does not have a query interface for drug approval packages. Is there an ...
pwalsh's user avatar
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3 votes
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.How can I get the list of drugs that interact with a particular drug in openFDA

I am trying to get a list of ingredients/drugs that might interact with a particular drug or check if a list of drugs might interact with each other. How can I achieve it using openFDA API.
Angersmash's user avatar
2 votes
1 answer
82 views

openfda: query to obtain links to 510(k) summaries

Using the api for the 510(k) database in openfda, I can search the statement_or_summary field and find all the rows (i.e. devices) with summaries. But in the download, the api just produces the ...
Brad Thompson's user avatar
2 votes
1 answer
39 views

OpenFDA Covid19 Serology Tests DB Created_On/Updated_On Fields?

We are looking to monitor data that is added/changed within the DB on a daily basis. When looking at the results returned from the OpenFDA Covid19 Serology Tests API, it appears that in the metadata ...
Arv's user avatar
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2 votes
1 answer
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Incorrect Product Code in OpenFDA Recalls Database

I noticed that when I look at product recall "Z-1973-2012" in the OpenFDA Recalls database, it returns with a result containing Product Code "CGA". However the same recall number on FDA's Recall ...
Niranjan Maharajh's user avatar
2 votes
1 answer
181 views

Mapping of drug names to generics

Dataset: Obtained from FDA AERS I would like to map the drug names to its generic name. Example: Arthritis Pain, Aspir 81, Aspir-Low, Bayer Childrens Aspirin etc would be mapped to aspirin Is there ...
Jerry's user avatar
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2 votes
1 answer
90 views

Q: Boolean Structure

I'm looking for help to construct a search with multiple parameters. Is this possible? I'm basically performing this search to try to catch reports that may have been labeled with the incorrect ...
LeapingMarmoset's user avatar
2 votes
0 answers
44 views

Retrieve Import Alerts published by FDA

The FDA publishes lists of Import Alerts in HTML format, such as, for example, on this page. This is in FDA site under Industry > Import > Program Actions & Enforcement > Import Alerts. ...
Luis's user avatar
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2 votes
0 answers
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Discrepancy between OpenFDA and FAERS

I noticed there are discrepancies in counts of events for a given drug when querying OpenFDA for a given quarter (I tried q1 2014) and trying to get a matching answer from the downloadable FAERS ...
jymaze's user avatar
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2 votes
0 answers
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Inconsistent fields

This question is related to https://stackoverflow.com/questions/32363315/gson-fields-that-sometimes-are-strings-and-others-arrays I'm parsing json with Gson but I'm struggling with the data I'm ...
javydreamercsw's user avatar
2 votes
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Problem displaying charts in clone of open.fda.gov

I have cloned the open.fda.gov repository and followed instructions to get the site running on my machine. I've been meticulous to install all the ruby and nodejs dependencies, however when jekyll is ...
Razi Khaja's user avatar
2 votes
0 answers
51 views

OpenFDA API: Why do some recalled items have UPCs listed and others don't, and is that something that would likely get improved?

I know that UPCs are optional. But I'm curious why when a company recalls all codes, those codes aren't listed. It would make it easier for apps to alert consumers accurately if more UPC codes were ...
Dwayne Martin's user avatar
2 votes
0 answers
25 views

OPEN FDA beta - 2 Letter Codes for device attribute - "manufacturer_country"

what are the 2 letter codes for the device attribute - "manufacturer_country" based on? are these fips codes or so-3166 alpha 2 codes or some other coding scheme? it seems there are multiple codes ...
primetime's user avatar
2 votes
0 answers
32 views

Timing/schedule for new datasets

Is there a target schedule for making additional datasets available via OpenFDA? For example, the data in Drugs@FDA database, or the PostMarketing Reqs and Commitements database data?
Shawn's user avatar
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1 vote
1 answer
99 views

The openFDA API supports searching by range in date not working?

I would like to create an URL, that shows me all reports from the MAUDE database from December with the product key 'MQB'. I created the this URL as an attempt: https://api.fda.gov/device/recall.json?...
Steve's user avatar
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1 vote
1 answer
97 views

How to format openFDA API results?

I am able to retrieve the results for a drug from the openFDA via PHP; however the results are just strings of text without any indicators for formatting such as html tags or splitting them up into ...
Aristocles's user avatar
1 vote
1 answer
41 views

Why are the results of two search statements inconsistent?

https://api.fda.gov/drug/event.json?search=(receivedate:[20040108+TO+20210401])+AND+patient.drug.medicinalproduct:%22IBUPROFEN%22&count=patient.reaction.reactionmeddrapt.exact Using the above ...
phar_lee's user avatar
1 vote
1 answer
120 views

How can I list FDA approved drugs in a year?

I am trying to list all of the approved drugs in a particular year, (e.g. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-...
Jagadeesh Samatham's user avatar
1 vote
1 answer
254 views

Can I use openFDA API for Drugs side effects?

Is there any way to get Drugs side effect for specific drug name like Paxil from openFDA API. I read the documentation but don't really understand
cem sezeroglu's user avatar
1 vote
1 answer
67 views

How to know which drug product is a reference listed drug (RLD)?

I trying to figure out how to know which drug product is a reference listed drug (RLD). Let's take for an example following spl_set_id: https://api.fda.gov/drug/drugsfda.json?search=products....
Jasmin Besic's user avatar
1 vote
1 answer
98 views

is there a way to fetch only the updated documents in openFDA?

I am using a query like the following one https://api.fda.gov/drug/label.json?search=effective_time:[20110601+TO+20121231]&limit=1 to search for all records with effective_time between Jun 01, ...
Ivan's user avatar
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1 vote
1 answer
111 views

Getting newly approved drugs from any of the Drug API Endpoints

I am looking to build and maintain a database of newly approved oncology drugs from the FDA. I need something similar to their "What's new" or "Novel Drug Approvals" section on ...
nearsighted3's user avatar
1 vote
1 answer
29 views

Question RE Safety Report ID

I'm seeing the following in the drug event endpoint: On a "conceptual" level, it would appear that these are the same person, however, they appear in the drug event endpoint repeatedly, so ...
Steve's user avatar
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1 vote
2 answers
55 views

How to inquire about adverse events of aspirin in the open FDA?

I want to check the adverse events of aspirin drugs in the open fda data within the specified date I have tried many times and it keeps getting an error display Where did I go wrong ? How can I query ...
user26423's user avatar
1 vote
0 answers
29 views

Local instance setup instructions

I'd like step by step instructions for setting up OpenFDA in my lab. The goal is to have the available pipelines populate and update the data in Elasticsearch so that I can make use of Kibana for ...
Mariano Mattei's user avatar
1 vote
1 answer
54 views

Existing record (spl_id) now showing not found

We are storing spl_id in our DB and using it as primary key in the API. But after some time, when we search it via the API, we get the following response: { "error": { "code":...
nwtdev's user avatar
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1 vote
2 answers
97 views

OpenFDA NDC endpoint has multiple RXCUI values for a single product NDC

I'm currently operating under the assumption that any two NDCs with the same RxCUI value are pharmaceutical equivalents. Hopefully that's correct. When querying the NDC data from OpenFDA, I noticed ...
Travesty3's user avatar
  • 111
1 vote
1 answer
53 views

OpenFda data seems to grow lot each quarter

Why the data we get from openfda seems to grow a lot each quarter? The 2020Q2 openfda csv file we create is 2.3GB vs the 2019Q2 data which is 1.3GB. On the other hand, the FAERS data only changed from ...
Lediona's user avatar
  • 21
1 vote
1 answer
49 views

Are weekly CRON jobs possbile for for openFDA, new indications_and_usage inquiries?

How would I track new FDA drug indications or other major changes each month? Example Dupixent expanded its atopic dermatitis indication from 12 years + to 6 years + in May 2020. How could I set up a ...
Az PharmD's user avatar
1 vote
1 answer
65 views

Total Product Life Cycle API?

I am unable to find any endpoint(s) to fetch TPLC related details in the OpenFDA website or may be i've overlooked. Is there is an API or other ways to retrieve TPLC related details, could you pls ...
Sandeep's user avatar
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1 vote
1 answer
41 views

Device Endpoint - Brand Name Mismatch

When we Query Maude Website for Report Number "2024168-2020-03898", the brand name is displayed as “ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM”. However, when we use the device endpoint ...
Sandeep's user avatar
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1 vote
1 answer
64 views

openFDA API query including "\"

I came across a question. Some of the generic_name contains backward slash sign, for example, CYCLOPHOSPHAMIDE\PREDNISONE\VINCRISTINE. How to construct the API query that can include backward slash ...
Meng Liu's user avatar
1 vote
0 answers
52 views

Crosswalk / Equivalence Mapping from HCPCS (Devices) to FDA Product Code

Is there any available mapping between the HCPCS-II codes associated with medical devices and the 3-letter FDA "Product Code"? So to be excruciatingly obvious... The FDA Product Code for ...
Jay Stevens's user avatar
1 vote
1 answer
96 views

openFDA decision_code field in PMA device API endpoint

I downloaded the PMA devices dataset from here https://download.open.fda.gov/device/pma/device-pma-0001-of-0001.json.zip However, It seems like the denied filings were not included since the ...
user25679's user avatar
1 vote
1 answer
31 views

Need help for Constructing Query String - device/event.json endpoint

I'm trying to get all the filters working for Maude DB via the device/event.json endpoint. URL The Filter in the website Brand Name matches to device.brand_name in the API. Similarly, Need help to ...
Sandeep's user avatar
  • 43
1 vote
1 answer
24 views

Missing pma_number in classification endpoint Aug2020 release

I downloaded the device classification dataset from here Despite being listed in the searchable fields in the documentation, the openFDA field "pma_number" appears to be missing (at least in ...
user25679's user avatar
1 vote
1 answer
52 views

How would one leverage the OpenFDA API to obtain listing of all recalls associated with a specific CIED?

How would one leverage the OpenFDA API to obtain listing of all recalls associated with a specific CIED? We have limited info on each device such as the model of implanted device and serial number. ...
Sophie Sallow's user avatar
1 vote
1 answer
69 views

API returns code not found

For a number of codes found in the National Drug Code directory the API returns code not found. https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm I have reviewed the API documentation and ...
Elli's user avatar
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1 vote
1 answer
84 views

Does OpenFDA have duplicate reports?

In an answer of this specific question on stack exchange: What does some reports have the same safetyreportid? It is stated that openfda has duplicates: 'Duplicate and incomplete reports are in the ...
Lediona's user avatar
  • 21
1 vote
1 answer
67 views

What does the searchable field safetyreportid mean in openFDA drug adverse event api

In the openFDA website(https://open.fda.gov/apis/drug/event/searchable-fields), it said safetyreportid is "The 8-digit Safety Report ID number, also known as the case report number or case ID. ...
kk133's user avatar
  • 53
1 vote
1 answer
69 views

How can I import your database downloads into Elasticsearch?

I spent several hours unsuccessfully trying to import the drug json files that you have available in the downloads section into the latest release of elasticseach (7.8.0). The download files don't ...
marieke zacher's user avatar
1 vote
1 answer
67 views

What does some reports have the same safetyreportid?

I thought that safetyreportid is the unique identity of a report, but I found that some safetyreportid like "5390497-5" has two or three reports in openFDA when I search by API: https://api....
kk133's user avatar
  • 53
1 vote
1 answer
45 views

Is "event_key" meant to be empty?

If you review the raw data documentation and any accompanying research papers, you will be informed that "event_key" is meant to be an important field. Master Event Data: A distinct master event data ...
user2364697's user avatar
1 vote
0 answers
42 views

Do we need to consider a duplicate report in openFDA adverse event database? (like patient and doctor both submitted reports)

I am trying to search data with the drug name Hydroxychloroquine from the URL here from OpenFDA api https://api.fda.gov/drug/event.json?search=patient.drug.medicinalproduct:%22hydroxychloroquine%22+...
kk133's user avatar
  • 53
1 vote
1 answer
119 views

NDC - SETID Mapping

I am interested in connecting the NDC data (brand_name, labeler etc.) to the FDA Label data (SET_ID). However, I'm struggling to find a dataset that would contain the mapping between the NDC code and ...
user25015's user avatar
1 vote
1 answer
330 views

MAUDE data frontend vs API

I am trying to use the openfda API to get a view of the data in the front end. This is an example of a front-end search: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?...
Wee King Yo's user avatar
1 vote
1 answer
88 views

What characters are allowed in the search parameter of the NDC OpenFDA API request?

I'm having an issue where the NDC API returns errors when special characters are submitted in the search parameter. I working on a product that contains a search box that allows the user to lookup ...
Mathew Borum's user avatar
1 vote
0 answers
29 views

Looking for an endpoint to retrieve warning letters

You can search for warning letters https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters
Kenneth Toley's user avatar
1 vote
0 answers
33 views

Where can I find FDA approval SPL drug data?

I am doing a study on approval label drug data for prescription drugs and want to get a a large dataset of the approval label for a drug. I will be then comparing this with later versions of the drug ...
Damon Ross's user avatar
1 vote
0 answers
82 views

OpenFDA End Point Updates

With respect to the US Food and Drug Administration's API, I haven't seen the endpoints updated since 8/12/19. Did something change or is this common? I've noticed the endpoints refreshed fairly ...
rdt454's user avatar
  • 11