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openFDA

Research & AcademiaMisc References

Query every public dataset the US Food and Drug Administration publishes, across drugs, medical devices, food, cosmetics, veterinary medicine and tobacco. Look up a drug by its NDC or read its label; track recalls, shortages, approvals and clearances; search adverse event reports for drugs, devices, food and animals; look up a device by its product code, its UDI or its 510(k); read the letters FDA sends when it refuses an application; and turn any of it into a frequency table. All thirty of openFDA's datasets are covered. No account needed.

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Actions

Steps your workflow can run in openFDA.

Search drug adverse eventsSearch the 20 million adverse event and medication error reports in FDA's FAERS database: what reaction was reported, which drug was suspected, the patient's age and sex, whether the outcome was serious, and who reported it. Filter by reaction, drug, country, patient group and date, and every code the report carries comes back with its meaning beside it. A report is one person's account, not proof the drug caused the reaction. No API key required.

Search drug labelsSearch the prescribing information published for every marketed drug: the boxed warning, indications, dosage, contraindications, adverse reactions, interactions and the rest of the package insert. Choose which sections to return so a step brings back the boxed warning rather than the whole insert, and search inside one section to find, say, every label whose warnings mention a particular risk. No API key required.

Get a drug labelRead one drug's label by its SPL Set ID, the identifier that names a label across every version of it, and the one shown on the product's DailyMed page. Choose which sections to bring back. The step fails if no label carries that ID, so use 'Search drug labels' when you have a name rather than an identifier. No API key required.

Search drug products (NDC directory)Search the National Drug Code directory: every drug product listed with FDA, with its NDC, brand and generic names, labeler, dosage form, route, active ingredients and strengths, package sizes, DEA schedule and marketing dates. This is the action for turning an NDC into a product, or a product into every package it is sold in. No API key required.

Get a drug product by NDCLook up one drug product by its National Drug Code, the number printed on every US drug package. Either the product code or the longer package code works. Returns the brand and generic names, the labeler, the ingredients and strengths, every package it is sold in, and a link to its label. The step fails if the code is not in the directory. No API key required.

Search drug recallsSearch FDA's drug recall enforcement reports: what was recalled, by whom, why, how much of it, where it was distributed, and how dangerous FDA judged it. Filter by hazard class, status, firm, state and date. Run it on a schedule with a date filter to be told about new Class I recalls as they are posted. No API key required.

Search drug approvalsSearch Drugs@FDA: every drug application FDA has acted on, brand-name (NDA), generic (ANDA) and biologic (BLA), with the products approved under it and the full history of submissions and supplements. This is where to look up who sponsors a drug, when it was approved, and what has been filed against the application since. No API key required.

Get a drug approvalRead one Drugs@FDA application by its number: who sponsors it, every product approved under it with its strengths and marketing status, and every submission and supplement filed against it with the date FDA decided each one. The step fails if the number is not in Drugs@FDA. No API key required.

Search drug shortagesSearch FDA's drug shortage database: which drugs are in short supply, in which presentations, why, what the company says about availability, and whether the shortage is current or resolved. Run it on a schedule filtered to your therapeutic categories to be told when something you depend on goes short. No API key required.

Search the Orange BookSearch the Orange Book: FDA's list of approved drug products with their therapeutic equivalence codes, the patents that cover them and the exclusivity periods that keep generics off the market. This is the action for 'which generics are equivalent to this brand', and for when a drug's protection expires. No API key required.

Search device adverse eventsSearch MAUDE, FDA's database of medical device reports: the deaths, injuries and malfunctions reported for a device, with the manufacturer's narrative of what happened, what the patient's outcome was, and what remedial action was taken. Filter by event type, device, manufacturer, specialty and date, or search inside the narratives themselves. A report is not proof the device caused the harm. No API key required.

Search device classificationsSearch FDA's device classification database: what each three-letter product code means, which risk class it is in, which regulation governs it, whether it is implantable or life-sustaining, and what kind of premarket submission it needs. Start here when you have a kind of device and need the product code the other device actions filter by. No API key required.

Get a device classificationRead one device product code in full: what FDA calls that kind of device, its definition, its risk class, the CFR regulation that governs it with a link to the text, and whether it is implantable, life-sustaining or exempt from Good Manufacturing Practice. The step fails if the code does not exist. No API key required.

Search device clearances (510(k))Search 510(k) premarket notifications: the devices FDA has cleared for market because they are substantially equivalent to one already sold. Filter by applicant, device, product code, decision, clearance type, advisory committee or decision date. This is the route most devices reach the market by, so it is the action for tracking a competitor's clearances. No API key required.

Get a device clearanceRead one 510(k) clearance by its K number: the device, the applicant and their address, when FDA received it and when it decided, the decision itself, the product code and the review panel, plus a link to the clearance on FDA's site. The step fails if the number does not exist. No API key required.

Search device approvals (PMA)Search premarket approvals: the highest-risk devices, which have to prove safety and effectiveness rather than equivalence, plus every supplement filed against an approval afterwards. Narrow to original approvals to see new devices only, or include supplements to follow how one device has changed since. No API key required.

Get a device approvalRead one premarket approval by its PMA number, or one of its supplements. Leave the supplement number blank for the original approval. Returns the device, the applicant, the decision and its date, the advisory committee, and FDA's approval-order statement, plus a link to the record on FDA's site. The step fails if the number does not exist. No API key required.

Search device recallsSearch device recalls as FDA's device centre files them, with the root cause it assigned (device design, software, process control, packaging) and the correcting action the firm took. Filter by firm, product code, status, root cause or date. Use 'Search device recall enforcement reports' instead when you want the hazard classification. No API key required.

Search device recall enforcement reportsSearch device recalls in the same enforcement format FDA uses for drugs and food, so they carry the Class I / II / III hazard classification and can be filtered the same way. This is the action for 'every Class I recall this month, whatever kind of product'. Use 'Search device recalls' for the root cause the device centre assigned. No API key required.

Search device establishment registrationsSearch every establishment registered with FDA to make, repack, relabel or import a medical device, and the devices each one lists. Filter by name, registration or FEI number, establishment type, country, state or product code. This is how to find who makes a given device, or everything a given site is registered to make. No API key required.

Search device identifiers (UDI)Search the Global UDI Database: the catalogue entry behind every device identifier, with the brand and model, the company, the sizes it comes in, whether it is sterile, single-use or prescription-only, its MRI safety rating, its storage conditions and the premarket submissions behind it. This is how to turn a barcode on a device into everything FDA knows about it. No API key required.

Search COVID-19 antibody test validationsSearch the independent validation the National Cancer Institute ran on COVID-19 antibody tests for FDA: every sample put through every test, what the test said, what the truth panel said, and whether the two agreed. Filter by manufacturer, test, panel or agreement to compare how different tests performed on the same samples. No API key required.

Search food recallsSearch FDA's food recall enforcement reports: what was recalled, by whom, why (undeclared allergens and contamination are the usual reasons), how much of it, where it was distributed, and how dangerous FDA judged it. Run it on a schedule filtered to Class I and your state to be told about serious local recalls as they are posted. No API key required.

Search food adverse eventsSearch CAERS, the reports FDA collects about foods, dietary supplements and cosmetics: the reaction, the product blamed for it, how serious the outcome was, and the consumer's age and sex. Filter by reaction, outcome, brand or food industry. A report is one person's account, not a finding that the product caused the reaction. No API key required.

Search cosmetic adverse eventsSearch the adverse events reported to FDA about cosmetics: the reaction, the product blamed for it, whether the product was suspected or merely in use at the time, and how serious the outcome was. Filter by reaction, outcome, product or date. A report is one person's account, not a finding that the product caused the reaction. No API key required.

Search animal and veterinary adverse eventsSearch the adverse events reported for animal drugs and devices: which species, what reaction, what happened to the animal, which product was involved and who reported it. Filter by species, reaction, outcome, product or date. Note that people are sometimes the affected party: 'Human' is one of the species in this dataset, for events involving someone handling a veterinary product. No API key required.

Search tobacco problem reportsSearch the problems the public reports to FDA about tobacco products: the health effects (seizures and breathing problems are common with vaping products) and the product defects, such as batteries overheating or foreign material in the product. Filter by product, health problem, product problem or date. No API key required.

Search tobacco prevention ad studiesSearch FDA's Tobacco Rapid Response ad-testing studies: how each prevention advert moved young people's beliefs about addiction, health consequences and harmful constituents, and how much, broken down by risk status, gender, age group and race or ethnicity. Filter by study or advert. No API key required.

Search smokefree.gov traffic researchSearch the traffic measurements FDA publishes for its smokefree.gov quit-smoking resources: page views, completions, session durations and downloads for each tool, split by whether visitors arrived from The Real Cost campaign, from a search engine, or directly. No API key required.

Search tobacco digital ad performanceSearch how FDA's digital tobacco-prevention adverts performed on each channel: views, view-through rate, how long people actually watched, how much of that time they were paying attention, and whether they recognised the advert and the brand afterwards. No API key required.

Search substance registrationsSearch FDA's Global Substance Registration System, the scientific record behind every substance it regulates: its UNII code, every name it goes by, its class, and, for chemicals, its formula, molecular weight and structure. Records are summarised by default because a full one runs to hundreds of kilobytes of structural data. No API key required.

Search UNII codesSearch FDA's Unique Ingredient Identifier list: the ten-character code FDA assigns to every substance, paired with its preferred name and nothing else. Use it to turn a substance name into the UNII the drug and label datasets index by, or a UNII back into a name. No API key required.

Search NSDE package recordsSearch the NSDE file: one row per drug package, with its eleven-digit and hyphenated NDCs, its billing unit, and the dates it started and stopped being marketed. This is the dataset billing systems reconcile against, and it covers packages the NDC directory has already dropped. No API key required.

Search historical FDA documentsSearch FDA's digitised press releases and talk papers, in full text, back through the agency's history. Filter by year, document type or a phrase in the text. Each result carries an excerpt by default and the whole document on request. No API key required.

Search Complete Response LettersSearch the letters FDA sends when it will not approve an application, released in full text with the deficiencies each one cites. Filter by company, application number, letter type, approval status, date, or a phrase in the letter. These are the documents that say, in FDA's own words, why a drug was turned down. No API key required.

Search COVID-19 research samplesSearch the samples in FDA's COVID-19 miRNA and proteomics research: each donor's severity, sex and age, and, on request, the several thousand protein measurements taken from their sample. The measurements are left out by default because one record carries nearly three thousand of them. No API key required.

Count values in a fieldTurn any openFDA dataset into a frequency table: how often each value of one field appears, most common first, without downloading the records. This answers the questions the search actions cannot: the most-reported reactions for a drug, the states with the most recalls, the root causes behind device recalls, recalls per month. Add a query to count within a slice rather than the whole dataset. Choosing a date field gives a time series instead of a breakdown. No API key required.

Run an advanced queryRun a search expression of your own against any openFDA dataset, in openFDA's own query language: 'field:value', AND / OR / NOT, quoted phrases, '[2024-01-01 TO 2024-12-31]' date ranges, and '_exists_:field'. The per-dataset actions cover the filters worth naming; this is the way to ask for something they do not. No API key required.

List openFDA datasetsList every dataset openFDA publishes with how many records it holds, when FDA last exported it, how many bulk download files it comes in, and which of its fields can be sorted and counted. Run it to check a dataset has been refreshed before reading from it, or to see what is available. No API key required.

Get dataset detailsRead one openFDA dataset's record count, export date, sortable and countable fields, and the bulk download files it is published as, each with its size, record count and the period it covers. Use it before a large job to decide between querying the API and downloading the whole file. No API key required.