Reports received by FDA, by month

October 2009: adverse event reports received by FDA

28,431 drug reports (FAERS) and 18,232 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.

28,431
drug reports received: 24,629 a year earlier; 27,296
monthly average, preceding 12 months: 4.2% against the average; 18,232
device reports received: 17,481 a year earlier

FDA received 28,431 drug adverse event reports in October 2009, against 24,629 in the same month a year earlier and a monthly average of 27,296 over the preceding 12 months. The MAUDE device database received 18,232 reports that month (17,481 a year earlier).

The drugs listed most often as suspect products were Arimidex (1,070), Exjade (948) and Mirena (911), and the reactions recorded most often were death (1,841), nausea (1,132) and dyspnoea (1,043).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Exjade (16.5× its average), Tylenol (13.9× its average) and Arimidex (11.2× 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 October 2009

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Arimidex	1,070	3.8%
Exjade	948	3.3%
Mirena	911	3.2%
Avonex	496	1.7%
Humira	437	1.5%
Tiotropium bromide	437	1.5%
Remicade	416	1.5%
Revlimid	400	1.4%
Seroquel	387	1.4%
Latisse	355	1.2%
Yaz	329	1.2%
Tylenol	320	1.1%
Enbrel	310	1.1%
Avandia	309	1.1%
Simvastatin	286	1%

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
Exjade	948	16.5×
Tylenol	320	13.9×
Arimidex	1,070	11.2×
Avapro	150	8.7×
Mifepristone Tablets 200 Mg	74	6.1×
Depo-Provera	82	6×
Advair Diskus 100/50	94	5.2×
Lupron Depot	221	4.9×

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
Deaththe patient died; cause not stated by this term	1,841	6.5%
Nauseafeeling sick	1,132	4%
Dyspnoeashortness of breath	1,043	3.7%
Vomitingbeing sick	851	3%
Drug ineffectivethe medicine did not work as expected	846	3%
Fatiguetiredness	836	2.9%
Diarrhoealoose or frequent stools	829	2.9%
Dizzinesslight-headedness or unsteadiness	826	2.9%
Headachehead pain	819	2.9%
Pyrexiafever	730	2.6%
Painpain, site not specified	661	2.3%
Astheniaweakness or lack of energy	627	2.2%
Malaisegeneral feeling of being unwell	590	2.1%
Falla fall	585	2.1%
Pneumonialung infection	562	2%

Devices named most often

Brand	Reports	Share of device reports
Accu-Chek Comfort Curve Test Strips	320	1.8%
One Touch Ultralink Meter	229	1.3%
M Series	208	1.1%
One Touch Ping Meter	187	1%
Accu-Chek Aviva Test Strips	182	1%
Ge Oec 9800	160	0.9%
Precision?	148	0.8%
Ge Oec 9900	128	0.7%
Accu-Chek Spirit	128	0.7%
Taxus Liberte Paclitaxel-Eluting Coronary Stent System	118	0.6%

Questions about October 2009

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

28,431 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 18,232 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 24,629 drug reports.

Which drugs were listed most often?

Arimidex (1,070), Exjade (948), Mirena (911), Avonex (496) and Humira (437).

Which reactions were recorded most often?

death (1,841), nausea (1,132), dyspnoea (1,043), vomiting (851) and drug ineffective (846).

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.