Reports received by FDA, by month

September 2009: adverse event reports received by FDA

31,075 drug reports (FAERS) and 18,087 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.

31,075
drug reports received: 25,008 a year earlier; 26,791
monthly average, preceding 12 months: 16% against the average; 18,087
device reports received: 19,885 a year earlier

FDA received 31,075 drug adverse event reports in September 2009, against 25,008 in the same month a year earlier and a monthly average of 26,791 over the preceding 12 months. The MAUDE device database received 18,087 reports that month (19,885 a year earlier).

The drugs listed most often as suspect products were Humira (8,057), Seroquel (3,291) and Mirena (852), and the reactions recorded most often were incorrect dose administered (3,936), diabetes mellitus (1,618) and nausea (1,095).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Seroquel (10.4× its average), Trilipix (10.3× its average) and Sertraline hcl (7.5× 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 2009

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Humira	8,057	25.9%
Seroquel	3,291	10.6%
Mirena	852	2.7%
Avandia	318	1%
Avonex	288	0.9%
Tiotropium bromide	276	0.9%
Trilipix	269	0.9%
Remicade	261	0.8%
Premarin	259	0.8%
Provera	259	0.8%
Enbrel	248	0.8%
Digoxin	230	0.7%
Rebif	214	0.7%
Prempro	203	0.7%
Yaz	201	0.6%

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
Seroquel	3,291	10.4×
Trilipix	269	10.3×
Sertraline hcl	107	7.5×
Humira	8,057	6.8×
Oseltamivir	60	5.3×
Tamiflu	190	4.6×
Zidovudine	75	2.9×
Requip	132	2.8×

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
Incorrect dose administeredthe wrong dose was given	3,936	12.7%
Diabetes mellitusdiabetes	1,618	5.2%
Nauseafeeling sick	1,095	3.5%
Pancreatitisinflammation of the pancreas	1,076	3.5%
Drug ineffectivethe medicine did not work as expected	1,010	3.3%
Drug dose omissiona dose was missed	991	3.2%
Injection site painpain where the injection was given	935	3%
Injection site extravasation	905	2.9%
Fatiguetiredness	869	2.8%
Wrong technique in drug usage processthe medicine was used in the wrong way	842	2.7%
Dyspnoeashortness of breath	829	2.7%
Headachehead pain	821	2.6%
Painpain, site not specified	764	2.5%
Dizzinesslight-headedness or unsteadiness	727	2.3%
Deaththe patient died; cause not stated by this term	690	2.2%

Devices named most often

Brand	Reports	Share of device reports
One Touch Ultralink Meter	292	1.6%
One Touch Ping Meter	225	1.2%
Accu-Chek Spirit	213	1.2%
Accu-Chek Comfort Curve Test Strips	206	1.1%
M Series	192	1.1%
Ge Oec 9800	172	1%
Accu-Chek Aviva Test Strips	169	0.9%
Precision?	158	0.9%
Ge Oec 9900	132	0.7%
Protime Microcoagulation System	115	0.6%

Questions about September 2009

How many adverse event reports did FDA receive in September 2009?

31,075 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 18,087 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 25,008 drug reports.

Which drugs were listed most often?

Humira (8,057), Seroquel (3,291), Mirena (852), Avandia (318) and Avonex (288).

Which reactions were recorded most often?

incorrect dose administered (3,936), diabetes mellitus (1,618), nausea (1,095), pancreatitis (1,076) and drug ineffective (1,010).

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.