Questions tagged [openfda]

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

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Extracting data from OpenFDA using python to save it locally

I have been looking to extract all data from FDA so I can use it all. I created this code below that works but seems it is too much data it fails. This way it just gives me 25000 records. url = '...
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Well-formatted drug listings sections

I've written an app to search and display ophthalmic medications. When uses select a medication I query the open.fda.gov APIs to get the specific listings for that medication. example API call result ...
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Q1 2021 Drug Event Endpoint Update

It looks like the Q1 2021 FAERS release was posted on 10-May-2021. Does anyone know when openFDA will refresh its Drug Event endpoint to include the new data? I know this typically occurs once a week, ...
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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
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(Drug API with NDC) Drug name with specified strength & NDC Error

Our website is a platform for patients to consult with physicians and specialists on-demand. The doctors will be able to search for the drug name though the database (NDCID drug database integrated in ...
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1answer
33 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....
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Why is my API call for application_number is not working?

#1: https://api.fda.gov/drug/event.json?search=patient.drug.openfda.application_number:ANDA076407 I am trying to make a similar API call to above but for below application# New Drug Application (NDA): ...
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20 views

FDA Press Releases/Announcements

I am looking at the openFDA documentation and I don't see an endpoint to gather all of their press releases/announcements. Can I back into that using the existing api?
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Given the 510k dataset, how do I derive the location of summary PDFs?

Having ingested the 510k dataset, several of the entries have a statement_or_summary value of "Summary" or "Statement" which I understand means a summary/statement is available. ...
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Error retreiving adverse event by country

I was using a query like this one https://api.fda.gov/drug/event.json?search=patient.drug.medicinalproduct.exact:("ELIQUIS")+AND+receivedate:[20110101+TO+20151231]%27+AND+occurcountry:%27fr%...
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35 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, ...
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1answer
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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 ...
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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 ...
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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 ...
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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 ...
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1answer
18 views

Question about total number of drug adverse event reports from 1998-2004

Is there a reason why from 1998-2003 the total number of reports in the FDA Adverse Event Database is 235 but after one year there were suddenly increased by about 100000
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What is the difference between OpenFDA's Drug Label API and DailyMed?

I am interested in downloading and processing structured product label (SPL) data. What is the difference between DailyMed API and OpenFDA's (https://open.fda.gov/apis/drug/label/) API? Is one more ...
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31 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":...
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50 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 ...
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FAERS Quarterly Extracts and openFDA

Does anyone know, on average, how long it takes for openFDA to be updated once the quarterly extracts are released? Is there a way to track this? TIA
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Alignment between openFDA and PV data

I figured it might be worth a shot to pose this question here. We are analyzing adverse event data from openFDA related to a specific product. As an exercise, we looked at specific events over a 10-...
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1answer
32 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 ...
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1answer
31 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 ...
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1answer
27 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 ...
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29 views

Device Endpoint - Brand Name Mismatch

When we Query Maude Website for Report Number "2024168-2020-03898", brand name is displayed as “ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM”. However when we use the device end point and ...
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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 ...
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Device API not returning recent data

Looks like the device end point for adverse events is not returning latest data or I'm missing something. As on today (Sept 16th) when I trigger the below endpoint: https://api.fda.gov/device/event....
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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 ...
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41 views

openFDA API seems to be missing NDCs

I have some NDCs that I want to search for on the openFDA API: 33992-8010-1 50058-100-08 ...etc. So this is what I've tried so far (all with base url api.fda.gov): drug/ndc.json?search=product_ndc:&...
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35 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 ...
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1answer
23 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 ...
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1answer
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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 ...
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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. ...
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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 ...
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1answer
27 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 ...
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1answer
22 views

How to know ATC Class 1-5 of a drug name in OpenFDA data

I am trying to use OpenFDA open-source data so that I can know ATC Class 1-5 of a drug name and the disease it can be used to treat for?
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29 views

Missing whitespace in label text values?

As context for this question, look at the response for NDA211172 (inotersen) from the label.json endpoint: https://api.fda.gov/drug/label.json?search=openfda.application_number.exact:NDA211172 I have ...
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1answer
29 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 ...
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OpenFDA Covid19 Serology Tests missing manufacturer?

-- Missing manfuacturer?: The manufacturer Beckman Coulter, Inc. is not available in the data as can be seen here https://api.fda.gov/device/covid19serology.json?count=manufacturer.exact but it is ...
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What is the best free database to use to get prescription and otc drugs marketed in the U.S. and approved by FDA?

I'm working on a project to build a drug database that provides drug lookup and information (indications/use, side effects, interactions, etc.) and also provides pricing by pharmacy networks. So, ...
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Get product recall information from Open FDA based on the DI or UDI of a product in GUDID

Can UDI or DI codes on product packaging of Medical Devices be used to check for a recall status? Search results from GUDID for product information data, and Open FDA for Recall data, do show some ...
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1answer
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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 ...
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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. ...
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1answer
26 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 ...
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1answer
50 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....
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OpenFDA Medical Device 510(k) other information than summary/statement

Is it possible to identify all 510k records of medical devices were a FDA review or clinical trials is available (e.g. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151502) ...
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Search the summary PDF 510k medical device of openfda

Is it possible to search specific terms within the summary or statement PDF of the 510k records of medical devices using either the API, the dataset or an online database? I found a similar question (...
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1answer
33 views

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 ...
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1answer
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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 ...
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1answer
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Is it possible to search using multiple criteria

Is it possible to search OpenFDA using multiple search fields. Separately both terms work but I can't figure out how to search using both at the same time. This is what I tried that does not work to ...

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