Reports received by FDA, by month

November 2025: adverse event reports received by FDA

105,351 drug reports (FAERS) and 232,947 device reports (MAUDE).

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.

105,351
drug reports received: 103,824 a year earlier; 108,664
monthly average, preceding 12 months: -3% against the average; 232,947
device reports received: 229,329 a year earlier

FDA received 105,351 drug adverse event reports in November 2025, against 103,824 in the same month a year earlier and a monthly average of 108,664 over the preceding 12 months. The MAUDE device database received 232,947 reports that month (229,329 a year earlier).

The drugs listed most often as suspect products were Dupixent (10,839), Zepbound (3,701) and Mounjaro (2,660), and the reactions recorded most often were off label use (5,944), drug ineffective (5,745) and product dose omission issue (4,219).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Opill (28.4× its average), Polyethylene glycol 3350 (11× its average) and Tirosint (10.6× its average). A jump in one month usually reflects a batch of reports from a manufacturer, a publicised event or a new product, not a change in what happens to patients.

Drug reports by month, three years to November 2025

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Dupixent	10,839	10.3%
Zepbound	3,701	3.5%
Mounjaro	2,660	2.5%
Skyrizi	1,723	1.6%
Mycophenolate mofetil	1,311	1.2%
Rituximab	1,303	1.2%
Nemluvio	1,219	1.2%
Prednisone	1,216	1.2%
Rinvoq	1,192	1.1%
Acetaminophen	1,177	1.1%
Carboplatin	957	0.9%
Cyclophosphamide	952	0.9%
Lenalidomide	944	0.9%
Corticotropin	910	0.9%
Opill	892	0.8%

FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Largest rises against their own average

Drug	Reports this month	Times its 12-month average
Opill	892	28.4×
Polyethylene glycol 3350	534	11×
Tirosint	186	10.6×
Belbuca	241	10.1×
LumaSon	150	9.2×
Nuedexta	129	7.7×
Yeztugo	95	7.3×
NovoLog Mix 70/30	77	7.2×

Drugs with at least 50 reports in the month and an average of at least 10 a month over the preceding year. A rise usually reflects a batch of manufacturer reports, a publicised event or a new product.

Reactions recorded most often

MedDRA term	Reports	Share of the month
Off label useused for a purpose or in a way not on the label	5,944	5.6%
Drug ineffectivethe medicine did not work as expected	5,745	5.5%
Product dose omission issuea dose was missed	4,219	4%
Deaththe patient died; cause not stated by this term	3,889	3.7%
Nauseafeeling sick	3,641	3.5%
Fatiguetiredness	3,395	3.2%
Diarrhoealoose or frequent stools	3,249	3.1%
Pruritusitching	2,921	2.8%
Headachehead pain	2,706	2.6%
Dyspnoeashortness of breath	2,585	2.5%
Rashskin rash	2,487	2.4%
Injection site painpain where the injection was given	2,307	2.2%
Incorrect dose administeredthe wrong dose was given	2,254	2.1%
Vomitingbeing sick	2,251	2.1%
Arthralgiajoint pain	2,128	2%

Devices named most often

Brand	Reports	Share of device reports
Dexcom G7 Continuous Glucose Monitoring System	15,432	6.6%
t:slim X2 Insulin Pump with Control-IQ Technology	10,538	4.5%
Dexcom G6 Continuous Glucose Monitoring System	6,251	2.7%
iLet Bionic Pancreas	3,725	1.6%
t:slim X2 Insulin Pump with Control-IQ+ Technology	3,341	1.4%
BD Pyxis MedStation ES	3,222	1.4%
MiniMed 780G US System BLE Connect 3.0 mg/dL	3,187	1.4%
Alaris System	2,670	1.1%
Omnipod 5 Pods	2,578	1.1%
Endowrist	2,569	1.1%

Questions about November 2025

How many adverse event reports did FDA receive in November 2025?

105,351 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 232,947 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 103,824 drug reports.

Which drugs were listed most often?

Dupixent (10,839), Zepbound (3,701), Mounjaro (2,660), Skyrizi (1,723) and Mycophenolate mofetil (1,311).

Which reactions were recorded most often?

off label use (5,944), drug ineffective (5,745), product dose omission issue (4,219), death (3,889) and nausea (3,641).

Can the count for a month still change?

Yes. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Older months change little.

Does a busy month mean something happened that month?

Not by itself. The date is when FDA received the report, not when the event occurred, and volume follows manufacturer batches, product launches and publicity. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

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