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OpenFDA
Data by U.S. Food and Drug Administration
Access U.S. FDA public health data including drug adverse events, drug labels, medical device reports, and recalls.
healthcare, fda, drugs, medical-devices, recalls
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Tools (10)
- searchDeviceAdverseEventsSearch U.S. medical device adverse event reports (MAUDE/MDR database). Returns reports of device malfunctions, injuries, and deaths associated with medical devices.1 credit
- getDrugAdverseEventCountsFrequency-ranked counts of FAERS (U.S. FDA) adverse-event reports for a drug. Use this, not searchDrugAdverseEvents, for quantitative 'how many / breakdown' questions.Free
- searchNdcDirectorySearch the U.S. National Drug Code (NDC) directory for drug product information including brand/generic names, dosage forms, routes, and active ingredients.1 credit
- searchDrugAdverseEventsSearch U.S. FDA Adverse Event Reporting System (FAERS) for drug safety reports. Returns adverse events associated with drugs including reactions, patient demographics, and seriousness.1 credit
- getDrugReactionDisproportionalityFAERS (U.S. FDA) disproportionality signal screen for a drug: reactions ranked by signal strength with ROR, 95% CI, PRR and SDR flag. Use this, not getDrugAdverseEventCounts, when the question is whether a reaction is reported MORE than expected (a signal), not merely how many.Free
- searchFoodRecallsSearch U.S. food enforcement reports and recalls. Find food product recalls by product, company, reason (e.g., salmonella, undeclared allergen), or classification.1 credit
- searchDrugRecallsSearch U.S. drug enforcement reports and recalls. Find drug product recalls by product, company, reason, or classification.1 credit
- searchDrugApprovalsSearch Drugs@FDA, the FDA's official registry of approved drug applications (NDA, BLA, ANDA). Returns approval dates, application numbers, sponsors, marketing status, and submission history. Use this for FDA approval dates and regulatory status; prefer searchDrugLabels for prescribing information.Free
- searchDevice510kSearch U.S. 510(k) premarket notification clearances for medical devices. Find devices that have been cleared by FDA as substantially equivalent to predicate devices.1 credit
- searchDrugLabelsSearch U.S. FDA drug labeling (SPL) including prescribing information, warnings, indications, and dosage. Returns structured product labels for prescription and OTC drugs.1 credit