Questions tagged [openfda]

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

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Parsing the Original Files from Maude-Website (DEVICE_EVENT_KEY)

Because sadly OpenFDA is lagging behind currently with the device-events i want to parse the Data directly from FDA-Maude Website ZIP-Files from following Files: https://www.fda.gov/medical-devices/...
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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 ...
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MAUDE Device Events are not present past 4/29/2022

I would like to ask what the cause is for no updates to MAUDE events past 4/29/2022. In the past there has been some delay in new data, but in recent history, it has never lagged by more than a month.
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How can I list FDA approved drugs in a year? asked again

Does anyone figur this out? How can I list FDA approved drugs in a year? The answer stated the example for the year of 1981, and that call contains [1981-01-01+TO+1981-12-31]. So, I assumed that I ...
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Device Events for 2022 Q2 are missing

I want to ask why the Maude-Device-Event Files for Q2 are currently not available in the downloads. See: https://open.fda.gov/data/downloads/ It states last updated on 2022-06-23.
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How do I find NDC-level therapeutic equivalency (TE) codes (Orange Book)

FDA Orange Book data contains a column for strength, but it is formatted so differently from the strength columns available in other FDA data (i.e. NDC catalog). Therapeutic equivalency codes (TE ...
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Why is my API call for drug.active_ingredients.name.exact not working? (Animal and Veterinary endpoint)

I am trying to look up data on the ingredient milbemycin oxime, and I want results that contain only milbemycin oxime as the active ingredient. https://api.fda.gov/animalandveterinary/event.json?...
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How do I modularize openFDA API requests?

I'm trying to iterate through an excel sheet and find the NDC of a drug from its generic name in each cell in a column so that I don't have to manually type in each generic name. This is what I have ...
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Is passing an "&" as a string character possible using the openFDA API? If no, is there a way to access data with manufacturer name containing "&"?

I am using the openFDA NDC API. Searching and counting using the "manufacture_name.exact" field results in a status 400 bad request when passing the character "&" as part of ...
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Which API to use to find the information based on NDC code?

I found out that there are two ways to find drug information based on NDC code but I am not quite sure which one to choose. Here is an example NDC API - https://api.fda.gov/drug/ndc.json?search=...
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Search via NDC api and brand name outputs different results

I was trying to search information about Advil so I tried two ways Search by drug name: https://api.fda.gov/drug/event.json?search=patient.drug.openfda.brand_name:advil Search by ndc code: https://api....
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Is it possible to have 2 drugs with same NDA number

I am facing a very peculiar issue with the USFDA database. There is one NDA number 050790 corresponding to 2 different drug names viz. Restasis and Restasis multidose! Both the drugs have different ...
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frequency of data updates in source system

Is the source database for OpenFDA APIs updated on real time with the updates released by FDA? If not, what is the ideal update frequency, particularly for medical devices recalls and classification.
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Cant Search By NDC String

Hello I know this may be a dumb question but I would like to search for a drug by the NDC like this https://api.fda.gov/drug/ndc.json?search=product_ndc:"54868-4517"&limit=100 but I get ...
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FDA Cosmetics Data

I see that open.fda.gov has data for drugs, food, etc, but I can't find anything about cosmetics (makeup, shampoo etc) recalls. Any ideas?
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Device recalls - difference between date entry was created in openFDA database and date manufacturer informed about recall

I am using the recalls database to always be aware of the recalls for some specific vendors and products. This is the call I am doing: https://api.fda.gov/device/recall.json?search=recalling_firm:(&...
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The difference between exact with suffix and without suffix

Can you help me explain the difference between exact with suffix and without suffix? I'm a little confused
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1 answer
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how to modify time range in interactive chat?

Deadlines are always up to date in interactive chat ,for example:i want to query time range between 2015/01/01-2020/01/01.how to modify?
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1 answer
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FDA Api Issue with Brackets

When I'm making what seems like a working query: https://api.fda.gov/food/enforcement.json?api_key=123&search=report_date:[2021111+TO+20211112] I get an error: [token_mgr_error] token_mgr_error: ...
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https://openfda.shinyapps.io/RR_D/ can not work

https://openfda.shinyapps.io/RR_D/ can not work ,error:Peer certificate cannot be authenticated with given CA certificates How do I make this site work?
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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 ...
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1 answer
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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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How to obtain ROR and PRR of an adverse drug event using openFDA

I am writing a paper on adverse reaction mining, and I need to calculate ROR and PRR values of all adverse reactions of a drug. May I ask how to use openFDA to build query statements?
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Filtering pma dataset for only new PMA decisions (that is, no supplmements)

All - admittedly, a beginner question. I'm looking at the most recent pma json dataset from OpenFDA to understand trends in new applications over time and by geographic location. My first look at ...
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1 answer
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New Indications via OpenFDA API

Is it possible to access new indication submissions or approvals via the OpenFDA API? I can see the information that I am looking for via the the Drugs@FDA website. For example, the page for Jakafi ...
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Uniquely Identify Items in OpenFDA (MAUDE)

Im downloading and processing the complete data of OpenFDA as described in: https://open.fda.gov/apis/downloads/ https://api.fda.gov/download.json But i could not find a way to uniquely identify the ...
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Is there an identifier that might indicate 505(b)(1) vs 505(b)(2) filing?

I'm skimming through the Drugs@FDA dataset, and I'm wondering if any of the identifiers would tell me which pathway the application went through. Of the options, SubmissionClassCodeID seems most ...
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No inactive_ingredient field when query for drug substance in Drug Label API

I am looking for the inactive ingredients for a dozen of different drugs. However when querying in the Label API, most results return without an "inactive_ingredient" field. The field only ...
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OpenFDA - Parsing Indications and Dosage Variables

I have a question about parsing two specific variables from the Product Labeling Endpoint on OpenFDA: indications_and_usage dosage_and_administration Ideally I would like to: Extract each ...
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Combined search query of openfda.generic_name and inactive ingredients only provides info for OTC products?

I think the title explains the question. Im trying to run a query that pull specified legend drug name and specified inactive ingredient. The results only seem to have an inactive ingredient ...
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1 answer
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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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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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1 answer
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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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1 answer
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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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1 answer
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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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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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1 answer
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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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1 answer
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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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1 answer
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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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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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