Reports received by FDA, by month

December 2009: adverse event reports received by FDA

38,901 drug reports (FAERS) and 21,573 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.

38,901
drug reports received: 40,802 a year earlier; 28,303
monthly average, preceding 12 months: 37.4% against the average; 21,573
device reports received: 16,940 a year earlier

FDA received 38,901 drug adverse event reports in December 2009, against 40,802 in the same month a year earlier and a monthly average of 28,303 over the preceding 12 months. The MAUDE device database received 21,573 reports that month (16,940 a year earlier).

The drugs listed most often as suspect products were Enbrel (8,138), Abilify (2,497) and Crestor (2,313), and the reactions recorded most often were injection site pain (1,634), nausea (1,604) and drug ineffective (1,316).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Nicotine polacrilex (13.2× its average), Abilify (12.7× its average) and Crestor (9.2× 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 December 2009

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Enbrel	8,138	20.9%
Abilify	2,497	6.4%
Crestor	2,313	5.9%
Forteo	803	2.1%
Byetta	754	1.9%
Mirena	620	1.6%
Cymbalta	528	1.4%
Commit	512	1.3%
Remicade	467	1.2%
Avodart	452	1.2%
Zyprexa	405	1%
Tiotropium bromide	396	1%
Pegasys	354	0.9%
Tamiflu	325	0.8%
Humira	309	0.8%

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
Nicotine polacrilex	204	13.2×
Abilify	2,497	12.7×
Crestor	2,313	9.2×
Nuvaring	191	8.3×
Commit	512	8.3×
Pegasys	354	7×
Avodart	452	6.8×
MultiHance	68	6.5×

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
Injection site painpain where the injection was given	1,634	4.2%
Nauseafeeling sick	1,604	4.1%
Drug ineffectivethe medicine did not work as expected	1,316	3.4%
Headachehead pain	1,202	3.1%
Fatiguetiredness	1,099	2.8%
Injection site erythemaredness where the injection was given	1,058	2.7%
Vomitingbeing sick	1,043	2.7%
Dizzinesslight-headedness or unsteadiness	1,036	2.7%
Dyspnoeashortness of breath	1,032	2.7%
Painpain, site not specified	1,018	2.6%
Pain in extremitypain in an arm or leg	972	2.5%
Arthralgiajoint pain	970	2.5%
Diarrhoealoose or frequent stools	963	2.5%
Deaththe patient died; cause not stated by this term	848	2.2%
Pyrexiafever	810	2.1%

Devices named most often

Brand	Reports	Share of device reports
Sculptra	786	3.6%
One Touch Ultralink Meter	438	2%
One Touch Ping Meter	393	1.8%
634 Affinity Bed 405	192	0.9%
M Series	177	0.8%
Accu-Chek Spirit	171	0.8%
Accu-Chek Aviva Test Strips	164	0.8%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	163	0.8%
Taxus Liberte Paclitaxel-Eluting Coronary Stent System	156	0.7%
Precision?	142	0.7%

Questions about December 2009

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

38,901 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 21,573 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 40,802 drug reports.

Which drugs were listed most often?

Enbrel (8,138), Abilify (2,497), Crestor (2,313), Forteo (803) and Byetta (754).

Which reactions were recorded most often?

injection site pain (1,634), nausea (1,604), drug ineffective (1,316), headache (1,202) and fatigue (1,099).

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.