Reports received by FDA, by month

June 2024: adverse event reports received by FDA

99,229 drug reports (FAERS) and 199,432 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.

99,229
drug reports received: 110,059 a year earlier; 111,530
monthly average, preceding 12 months: -11% against the average; 199,432
device reports received: 208,308 a year earlier

FDA received 99,229 drug adverse event reports in June 2024, against 110,059 in the same month a year earlier and a monthly average of 111,530 over the preceding 12 months. The MAUDE device database received 199,432 reports that month (208,308 a year earlier).

The drugs listed most often as suspect products were Dupixent (5,241), Repatha (2,247) and Mounjaro (1,581), and the reactions recorded most often were off label use (8,229), drug ineffective (5,802) and fatigue (3,987).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Alectinib (56.2× its average), Phesgo (47.5× its average) and Vabysmo (18.7× 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 June 2024

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Dupixent	5,241	5.3%
Repatha	2,247	2.3%
Mounjaro	1,581	1.6%
Vabysmo	1,538	1.5%
Phesgo	1,442	1.5%
Humira	1,376	1.4%
Revlimid	1,365	1.4%
Prednisone	1,343	1.4%
Skyrizi	1,144	1.2%
Rituximab	1,133	1.1%
Rinvoq	1,086	1.1%
Methotrexate	1,046	1.1%
Eliquis	1,017	1%
Lenalidomide	961	1%
Cyclophosphamide	899	0.9%

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
Alectinib	716	56.2×
Phesgo	1,442	47.5×
Vabysmo	1,538	18.7×
Brixadi	223	17.2×
Nirogacestat	236	15.3×
Apokyn	257	14.8×
Bimzelx	276	13.9×
Alecensa	786	13.8×

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	8,229	8.3%
Drug ineffectivethe medicine did not work as expected	5,802	5.8%
Fatiguetiredness	3,987	4%
Deaththe patient died; cause not stated by this term	3,758	3.8%
Diarrhoealoose or frequent stools	3,341	3.4%
Nauseafeeling sick	3,312	3.3%
Product dose omission issuea dose was missed	3,271	3.3%
No adverse eventno adverse event was reported	2,641	2.7%
Headachehead pain	2,605	2.6%
Painpain, site not specified	2,540	2.6%
Dyspnoeashortness of breath	2,393	2.4%
Pruritusitching	2,228	2.2%
Rashskin rash	2,162	2.2%
Dizzinesslight-headedness or unsteadiness	2,148	2.2%
Arthralgiajoint pain	2,147	2.2%

Devices named most often

Brand	Reports	Share of device reports
Dexcom G6 Continuous Glucose Monitoring System	13,667	6.9%
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)	13,019	6.5%
Dexcom G7 Continuous Glucose Monitoring System	11,519	5.8%
t:slim X2 Insulin Pump with Control-IQ Technology	2,956	1.5%
Alaris System	2,765	1.4%
Autosoft Xc	2,598	1.3%
DreamStation Auto CPAP	2,474	1.2%
MiniMed 780G US System BLE Connect 3.0 mg/dL	2,376	1.2%
Omnipod 5 Pod	2,302	1.2%
BioHorizons Inc.	1,998	1%

Questions about June 2024

How many adverse event reports did FDA receive in June 2024?

99,229 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 199,432 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 110,059 drug reports.

Which drugs were listed most often?

Dupixent (5,241), Repatha (2,247), Mounjaro (1,581), Vabysmo (1,538) and Phesgo (1,442).

Which reactions were recorded most often?

off label use (8,229), drug ineffective (5,802), fatigue (3,987), death (3,758) and diarrhoea (3,341).

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.