Reports received by FDA, by month

December 2006: adverse event reports received by FDA

34,683 drug reports (FAERS) and 9,185 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.

34,683
drug reports received: 22,758 a year earlier; 19,296
monthly average, preceding 12 months: 79.7% against the average; 9,185
device reports received: 9,457 a year earlier

FDA received 34,683 drug adverse event reports in December 2006, against 22,758 in the same month a year earlier and a monthly average of 19,296 over the preceding 12 months. The MAUDE device database received 9,185 reports that month (9,457 a year earlier).

The drugs listed most often as suspect products were Enbrel (6,849), Byetta (3,501) and Nicoderm Cq (2,979), and the reactions recorded most often were nausea (2,686), weight decreased (1,774) and blood glucose increased (1,698).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Crestor (52.6× its average), Enbrel (40.6× its average) and Avodart (23.6× 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 2006

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Enbrel	6,849	19.7%
Byetta	3,501	10.1%
Nicoderm Cq	2,979	8.6%
Crestor	1,946	5.6%
Commit	1,341	3.9%
Seroquel	870	2.5%
Bextra	791	2.3%
Cymbalta	719	2.1%
Iressa	611	1.8%
Avodart	383	1.1%
Flonase	348	1%
Ortho Evra	266	0.8%
Vesicare	265	0.8%
Celebrex	246	0.7%
Tiotropium bromide	234	0.7%

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
Crestor	1,946	52.6×
Enbrel	6,849	40.6×
Avodart	383	23.6×
Iressa	611	22.6×
Equate Nts 21mg	153	13.1×
Avandamet	174	12×
Nicoderm Cq	2,979	11.6×
Seroquel	870	9.1×

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	2,686	7.7%
Weight decreasedweight loss	1,774	5.1%
Blood glucose increasedraised blood sugar reading	1,698	4.9%
Drug ineffectivethe medicine did not work as expected	1,454	4.2%
Dizzinesslight-headedness or unsteadiness	1,325	3.8%
Condition aggravatedthe condition being treated got worse	1,204	3.5%
Headachehead pain	1,181	3.4%
Vomitingbeing sick	1,123	3.2%
Injection site painpain where the injection was given	1,115	3.2%
Injection site reactiona reaction where the injection was given	1,031	3%
Fatiguetiredness	964	2.8%
Diarrhoealoose or frequent stools	950	2.7%
Application site erythemaredness where the product was applied	806	2.3%
Astheniaweakness or lack of energy	760	2.2%
Malaisegeneral feeling of being unwell	759	2.2%

Devices named most often

Brand	Reports	Share of device reports
Cypher Sirolimus-Eluting Coronary Stent	365	4%
Freestyle Flash	282	3.1%
Accu-Chek Comfort Curve Test Strips	278	3%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	167	1.8%
M Series	163	1.8%
Coaguchek S System	132	1.4%
Synchromed El	82	0.9%
Accu-Chek Compact Test Drum	74	0.8%
Freestyle	60	0.7%
Ortho Summit Sample Handling System	55	0.6%

Questions about December 2006

How many adverse event reports did FDA receive in December 2006?

34,683 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 9,185 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 22,758 drug reports.

Which drugs were listed most often?

Enbrel (6,849), Byetta (3,501), Nicoderm Cq (2,979), Crestor (1,946) and Commit (1,341).

Which reactions were recorded most often?

nausea (2,686), weight decreased (1,774), blood glucose increased (1,698), drug ineffective (1,454) and dizziness (1,325).

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.