A public-data reference

What has been reported to FDA about a drug or a device

FDA has received 20,646,523 adverse event reports about drugs and biologics (FAERS, since 2004) and 26,136,888 about medical devices (MAUDE). This site counts them by product, class, reaction and month, and sets each count beside the class, the whole database and FDA's statement of what a report can and cannot show.

Drugs · Classes · Devices · Reactions · Months · Guides

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drugs with most reports

Drug	Reports	12 months
HumiraAdalimumab	639,882	8,749
EnbrelEtanercept	561,339	4,674
DupixentDupilumab	462,188	122,091
RevlimidLenalidomide	354,649	8,112
Zantac	319,639	46
Methotrexate	207,259	11,503
Ranitidine	195,204	269
Prednisone	183,867	15,614
TysabriNatalizumab	173,350	2,471
XeljanzTofacitinib	156,082	3,571
RepathaEvolocumab	155,654	8,546
Rituximab	155,578	15,068

Counts follow how many people take a product and how reports are collected. FDA: the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reactions recorded most often

MedDRA term	Reports	Share
Drug ineffectivethe medicine did not work as expected	1,296,884	6.3%
Off label useused for a purpose or in a way not on the label	856,363	4.2%
Deaththe patient died; cause not stated by this term	847,572	4.1%
Nauseafeeling sick	776,030	3.8%
Fatiguetiredness	765,038	3.7%
Diarrhoealoose or frequent stools	633,344	3.1%
Headachehead pain	616,001	3%
Painpain, site not specified	606,385	2.9%
Dyspnoeashortness of breath	556,535	2.7%
Dizzinesslight-headedness or unsteadiness	489,289	2.4%
Vomitingbeing sick	461,238	2.2%
Malaisegeneral feeling of being unwell	433,298	2.1%

Reports received by month, five years

1,332,454 drug reports in the 12 months to June 2026. FDA releases FAERS quarterly, so the newest months are incomplete. Latest month page: June 2026.

Pharmacologic classes

Tumor necrosis factor blocker 17 drugs · 1,064,042 reports
Opioid agonist 42 drugs · 965,051 reports
Kinase inhibitor 100 drugs · 849,161 reports
Corticosteroid 74 drugs · 808,789 reports
Atypical antipsychotic 37 drugs · 683,680 reports
Nonsteroidal anti-inflammatory drug 47 drugs · 548,672 reports
Thalidomide analog 4 drugs · 516,063 reports
Proton pump inhibitor 22 drugs · 484,090 reports
Interleukin-4 receptor alpha antagonist 2 drugs · 474,914 reports
GLP-1 receptor agonist 18 drugs · 404,853 reports

All 291 classes

Devices with most reports

Dexcom G6 Continuous Glucose Monitoring System 1,339,562 reports
Alaris Pump Module 684,522 reports
Dexcom G7 Continuous Glucose Monitoring System 641,507 reports
t:slim X2 Insulin Pump with Control-IQ Technology 584,236 reports
Alaris System 422,501 reports
Dexcom G5 Mobile Continuous Glucose Monitoring System 332,492 reports
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) 267,716 reports
Pump MMT-1780KPK 670G Pathway Black MG 224,556 reports

All 4,599 device brands and 1,068 device types

How to read this site

FAERS release of 28 Sep 2026, reports received through 30 Jun 2026; MAUDE release of 28 Sep 2026, through 31 Aug 2026. Rebuilt daily.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.