Reports received by FDA, by month

December 2010: adverse event reports received by FDA

53,596 drug reports (FAERS) and 31,875 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.

53,596
drug reports received: 38,901 a year earlier; 39,091
monthly average, preceding 12 months: 37.1% against the average; 31,875
device reports received: 21,573 a year earlier

FDA received 53,596 drug adverse event reports in December 2010, against 38,901 in the same month a year earlier and a monthly average of 39,091 over the preceding 12 months. The MAUDE device database received 31,875 reports that month (21,573 a year earlier).

The drugs listed most often as suspect products were Enbrel (18,349), Tracleer (2,669) and Crestor (2,362), and the reactions recorded most often were death (6,264), injection site pain (3,920) and injection site erythema (3,197).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Bosentan Tablet Unknown Us Mg (51.9× its average), Tracleer (29.2× its average) and Remodulin (22.7× 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 December 2010

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Enbrel	18,349	34.2%
Tracleer	2,669	5%
Crestor	2,362	4.4%
Tysabri	1,887	3.5%
Lyrica	1,826	3.4%
Bosentan Tablet Unknown Us Mg	1,285	2.4%
Avonex	540	1%
Remodulin	505	0.9%
Remicade	486	0.9%
Sutent	407	0.8%
Dianeal	397	0.7%
Humira	395	0.7%
Avandia	389	0.7%
Revlimid	361	0.7%
Nicotine polacrilex	335	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
Bosentan Tablet Unknown Us Mg	1,285	51.9×
Tracleer	2,669	29.2×
Remodulin	505	22.7×
Enbrel	18,349	19.2×
Nicotine polacrilex	335	11.1×
Crestor	2,362	8.1×
Novolog	117	7.8×
Flonase	89	6.6×

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	6,264	11.7%
Injection site painpain where the injection was given	3,920	7.3%
Injection site erythemaredness where the injection was given	3,197	6%
Drug ineffectivethe medicine did not work as expected	2,078	3.9%
Headachehead pain	1,951	3.6%
Injection site swellingswelling where the injection was given	1,898	3.5%
Fatiguetiredness	1,712	3.2%
Nauseafeeling sick	1,690	3.2%
Injection site pruritusitching where the injection was given	1,623	3%
Arthralgiajoint pain	1,471	2.7%
Psoriasispsoriasis, a skin condition	1,469	2.7%
Painpain, site not specified	1,415	2.6%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	1,369	2.6%
Injection site haematoma	1,333	2.5%
Dizzinesslight-headedness or unsteadiness	1,320	2.5%

Devices named most often

Brand	Reports	Share of device reports
Capsurefix Novus	871	2.7%
Sprint Quattro Secure	591	1.9%
Ot Ping Meter	356	1.1%
Animas Insulin Infusion Pump	330	1%
Attain Otw	305	1%
Ot Ultralink Meter	301	0.9%
Greenlight Addstat	290	0.9%
One Touch Ping Glucose Management System	255	0.8%
Perclose Proglide 6f Suture Mediated Closure Smc System	227	0.7%
Attain Ability	225	0.7%

Questions about December 2010

How many adverse event reports did FDA receive in December 2010?

53,596 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 31,875 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 38,901 drug reports.

Which drugs were listed most often?

Enbrel (18,349), Tracleer (2,669), Crestor (2,362), Tysabri (1,887) and Lyrica (1,826).

Which reactions were recorded most often?

death (6,264), injection site pain (3,920), injection site erythema (3,197), drug ineffective (2,078) and headache (1,951).

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.