Reports received by FDA, by month

September 2021: adverse event reports received by FDA

131,873 drug reports (FAERS) and 155,130 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.

131,873
drug reports received: 115,803 a year earlier; 128,837
monthly average, preceding 12 months: 2.4% against the average; 155,130
device reports received: 135,630 a year earlier

FDA received 131,873 drug adverse event reports in September 2021, against 115,803 in the same month a year earlier and a monthly average of 128,837 over the preceding 12 months. The MAUDE device database received 155,130 reports that month (135,630 a year earlier).

The drugs listed most often as suspect products were Ranitidine hydrochloride (16,162), Zantac (9,248) and Ranitidine (5,938), and the reactions recorded most often were drug ineffective (7,476), off label use (6,152) and death (5,070).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Rexulti (35.1× its average), Norelgestromin/Ethinyl Estradiol Transdermal System (16.9× its average) and Regen Cov (15.9× 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 September 2021

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Ranitidine hydrochloride	16,162	12.3%
Zantac	9,248	7%
Ranitidine	5,938	4.5%
Revlimid	4,377	3.3%
Dupixent	3,184	2.4%
Humira	2,380	1.8%
Prednisone	1,743	1.3%
Methotrexate	1,509	1.1%
Acetaminophen Oxycodone Hydrochloride	1,487	1.1%
Rituximab	1,448	1.1%
Entresto	1,385	1.1%
Cosentyx	1,360	1%
Enbrel	1,296	1%
Xeljanz	1,245	0.9%
Dexamethasone	1,142	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
Rexulti	796	35.1×
Norelgestromin/Ethinyl Estradiol Transdermal System	187	16.9×
Regen Cov	531	15.9×
Exondys 51	211	14.2×
Praluent	1,075	14×
Qsymia	210	11.5×
SUPREP Bowel Prep	428	10.5×
Matulane	210	8.3×

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
Drug ineffectivethe medicine did not work as expected	7,476	5.7%
Off label useused for a purpose or in a way not on the label	6,152	4.7%
Deaththe patient died; cause not stated by this term	5,070	3.8%
Fatiguetiredness	4,743	3.6%
Prostate cancer	4,622	3.5%
Breast cancerbreast cancer	4,546	3.4%
Nauseafeeling sick	3,988	3%
Product dose omission issuea dose was missed	3,778	2.9%
Painpain, site not specified	3,677	2.8%
Diarrhoealoose or frequent stools	3,571	2.7%
Colorectal cancer	3,371	2.6%
Renal cancer	3,209	2.4%
Dyspnoeashortness of breath	3,162	2.4%
Headachehead pain	3,145	2.4%
Bladder cancer	2,757	2.1%

Devices named most often

Brand	Reports	Share of device reports
Dexcom G6 Continuous Glucose Monitoring System	22,341	14.4%
t:slim X2 Insulin Pump with Control-IQ Technology	6,219	4%
8100 Alaris Pump Module	4,078	2.6%
Alaris System	3,376	2.2%
Pump MMT-1780KPK 670G Pathway Black MG	2,585	1.7%
640G Insulin Pump MMT-1712K	1,680	1.1%
Alaris System Pc Unit	1,398	0.9%
t:slim X2 Insulin Pump with Basal-IQ Technology	1,363	0.9%
Libre 2 Sensor FreeStyle	1,279	0.8%
670G Insulin Pump MMT-1780KL	1,276	0.8%

Questions about September 2021

How many adverse event reports did FDA receive in September 2021?

131,873 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 155,130 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 115,803 drug reports.

Which drugs were listed most often?

Ranitidine hydrochloride (16,162), Zantac (9,248), Ranitidine (5,938), Revlimid (4,377) and Dupixent (3,184).

Which reactions were recorded most often?

drug ineffective (7,476), off label use (6,152), death (5,070), fatigue (4,743) and prostate cancer (4,622).

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.