Reports received by FDA, by month

November 2009: adverse event reports received by FDA

29,373 drug reports (FAERS) and 22,320 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.

29,373
drug reports received: 21,099 a year earlier; 27,613
monthly average, preceding 12 months: 6.4% against the average; 22,320
device reports received: 20,144 a year earlier

FDA received 29,373 drug adverse event reports in November 2009, against 21,099 in the same month a year earlier and a monthly average of 27,613 over the preceding 12 months. The MAUDE device database received 22,320 reports that month (20,144 a year earlier).

The drugs listed most often as suspect products were Enbrel (3,370), Dianeal (838) and Mirena (828), and the reactions recorded most often were nausea (1,156), injection site pain (1,045) and death (960).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Savella (14.9× its average), Pletal (10.7× its average) and Cimzia (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 November 2009

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Enbrel	3,370	11.5%
Dianeal	838	2.9%
Mirena	828	2.8%
Cimzia	808	2.8%
Simcor	507	1.7%
Januvia	482	1.6%
Prilosec OTC	409	1.4%
Avonex	403	1.4%
Avandia	400	1.4%
Tysabri	378	1.3%
Tiotropium bromide	377	1.3%
Humira	325	1.1%
Remicade	322	1.1%
Tamiflu	297	1%
Duragesic-100	279	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
Savella	250	14.9×
Pletal	119	10.7×
Cimzia	808	7×
Novolog	178	4.8×
Biaxin	58	4.7×
Coreg	108	4.3×
Tamiflu	297	4×
Kaletra	191	3.9×

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
Nauseafeeling sick	1,156	3.9%
Injection site painpain where the injection was given	1,045	3.6%
Deaththe patient died; cause not stated by this term	960	3.3%
Headachehead pain	929	3.2%
Drug ineffectivethe medicine did not work as expected	927	3.2%
Dyspnoeashortness of breath	896	3.1%
Diarrhoealoose or frequent stools	855	2.9%
Vomitingbeing sick	840	2.9%
Fatiguetiredness	828	2.8%
Dizzinesslight-headedness or unsteadiness	768	2.6%
Painpain, site not specified	745	2.5%
Pyrexiafever	715	2.4%
Injection site erythemaredness where the injection was given	580	2%
Astheniaweakness or lack of energy	573	2%
Arthralgiajoint pain	540	1.8%

Devices named most often

Brand	Reports	Share of device reports
One Touch Ultralink Meter	278	1.2%
Reliance G Active Fix Dual Coil 64cm	197	0.9%
M Series	193	0.9%
One Touch Ping Meter	189	0.8%
Architect I2000sr Analyzer	179	0.8%
Accu-Chek Spirit	160	0.7%
Sprint Fidelis	146	0.7%
Precision?	145	0.6%
Perclose Proglide 6f Suture Mediated Closure Smc System	145	0.6%
Lifevest Wcd 3000 System	135	0.6%

Questions about November 2009

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

29,373 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 22,320 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 21,099 drug reports.

Which drugs were listed most often?

Enbrel (3,370), Dianeal (838), Mirena (828), Cimzia (808) and Simcor (507).

Which reactions were recorded most often?

nausea (1,156), injection site pain (1,045), death (960), headache (929) and drug ineffective (927).

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.