Reports received by FDA, by month

November 2006: adverse event reports received by FDA

18,181 drug reports (FAERS) and 12,541 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.

18,181
drug reports received: 16,983 a year earlier; 19,196
monthly average, preceding 12 months: -5.3% against the average; 12,541
device reports received: 10,729 a year earlier

FDA received 18,181 drug adverse event reports in November 2006, against 16,983 in the same month a year earlier and a monthly average of 19,196 over the preceding 12 months. The MAUDE device database received 12,541 reports that month (10,729 a year earlier).

The drugs listed most often as suspect products were Zyprexa (808), Wellbutrin (563) and Coreg (527), and the reactions recorded most often were completed suicide (705), nausea (699) and drug ineffective (642).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Coreg (32.6× its average), Acetaminophen and Hydrocodone Bitartrate (8.9× its average) and Quetiapine fumarate (7.9× 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 2006

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Zyprexa	808	4.4%
Wellbutrin	563	3.1%
Coreg	527	2.9%
Lipitor	394	2.2%
Fosamax	361	2%
Celebrex	358	2%
Bextra	318	1.7%
Levaquin	297	1.6%
Avonex	250	1.4%
Rozerem	247	1.4%
Vioxx	242	1.3%
Remicade	242	1.3%
Symlin	226	1.2%
Lyrica	203	1.1%
Enbrel	188	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
Coreg	527	32.6×
Acetaminophen and Hydrocodone Bitartrate	96	8.9×
Quetiapine fumarate	89	7.9×
Bupropion hcl	109	6.9×
Rozerem	247	5.5×
Levaquin	297	5.2×
Zyprexa	808	5×
Ethanol	82	4.7×

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
Completed suicidedeath by suicide	705	3.9%
Nauseafeeling sick	699	3.8%
Drug ineffectivethe medicine did not work as expected	642	3.5%
Dizzinesslight-headedness or unsteadiness	562	3.1%
Vomitingbeing sick	561	3.1%
Dyspnoeashortness of breath	524	2.9%
Diabetes mellitusdiabetes	504	2.8%
Diarrhoealoose or frequent stools	483	2.7%
Pyrexiafever	472	2.6%
Fatiguetiredness	462	2.5%
Headachehead pain	458	2.5%
Astheniaweakness or lack of energy	434	2.4%
Cardiac arrestthe heart stopped	417	2.3%
Drug exposure during pregnancythe medicine was taken during pregnancy	412	2.3%
Hypertensionhigh blood pressure	400	2.2%

Devices named most often

Brand	Reports	Share of device reports
Accu-Chek Comfort Curve Test Strips	321	2.6%
M Series	198	1.6%
Freestyle Flash	192	1.5%
Cypher Sirolimus-Eluting Coronary Stent	185	1.5%
Contak Renewal	144	1.1%
Flextend Is-1 Bi Positive Fix	136	1.1%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	132	1.1%
Vitality Avt	121	1%
Coaguchek S System	113	0.9%
Sprint Fidelis	112	0.9%

Questions about November 2006

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

18,181 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 12,541 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 16,983 drug reports.

Which drugs were listed most often?

Zyprexa (808), Wellbutrin (563), Coreg (527), Lipitor (394) and Fosamax (361).

Which reactions were recorded most often?

completed suicide (705), nausea (699), drug ineffective (642), dizziness (562) and vomiting (561).

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.