Questions tagged [openfda]

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

98 questions with no upvoted or accepted answers
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152 views

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 ...
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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.
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1answer
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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
30 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 ...
2
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1answer
44 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 ...
2
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1answer
95 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 ...
2
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0answers
34 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. ...
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0answers
73 views

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 ...
2
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0answers
37 views

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 ...
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0answers
34 views

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 ...
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48 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 ...
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0answers
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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 ...
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31 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?
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1answer
46 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-...
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1answer
67 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
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1answer
43 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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1answer
31 views

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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1answer
20 views

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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1answer
51 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
62 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 ...
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1answer
20 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 ...
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2answers
27 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 ...
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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
36 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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1answer
55 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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1answer
29 views

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
37 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
37 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
42 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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1answer
36 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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1answer
37 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 ...
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1answer
26 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 ...
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1answer
50 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
26 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
15 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 ...
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1answer
38 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. ...
1
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1answer
32 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
25 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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2answers
108 views

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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0answers
27 views

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
54 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 ...
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1answer
55 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. ...
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1answer
34 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
55 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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1answer
35 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 ...
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0answers
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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+...
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1answer
67 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 ...
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1answer
89 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?...
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1answer
50 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 ...
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0answers
23 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