Reports received by FDA, by month

November 2005: adverse event reports received by FDA

16,983 drug reports (FAERS) and 10,729 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.

16,983
drug reports received: 15,563 a year earlier; 18,386
monthly average, preceding 12 months: -7.6% against the average; 10,729
device reports received: 7,055 a year earlier

FDA received 16,983 drug adverse event reports in November 2005, against 15,563 in the same month a year earlier and a monthly average of 18,386 over the preceding 12 months. The MAUDE device database received 10,729 reports that month (7,055 a year earlier).

The drugs listed most often as suspect products were Vioxx (1,306), Wellbutrin (646) and Avonex (412), and the reactions recorded most often were myocardial infarction (859), cerebrovascular accident (695) and nausea (690).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Pravachol (10.3× its average), Commit (10.1× its average) and Levaquin (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 November 2005

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Vioxx	1,306	7.7%
Wellbutrin	646	3.8%
Avonex	412	2.4%
Fosamax	335	2%
Lipitor	316	1.9%
Abilify	277	1.6%
Pravachol	275	1.6%
Zetia	260	1.5%
Commit	256	1.5%
Levaquin	254	1.5%
Pegasys	234	1.4%
Remicade	205	1.2%
Raptiva	188	1.1%
Forteo	178	1%
Copegus	177	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
Pravachol	275	10.3×
Commit	256	10.1×
Levaquin	254	6×
Bupropion hcl	66	5.4×
Avodart	112	5.4×
Lyrica	77	5.2×
Fosamax	335	4.9×
Tikosyn	72	4.8×

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
Myocardial infarctionheart attack	859	5.1%
Cerebrovascular accidentstroke	695	4.1%
Nauseafeeling sick	690	4.1%
Drug ineffectivethe medicine did not work as expected	564	3.3%
Dyspnoeashortness of breath	556	3.3%
Dizzinesslight-headedness or unsteadiness	536	3.2%
Vomitingbeing sick	477	2.8%
Deaththe patient died; cause not stated by this term	460	2.7%
Pyrexiafever	460	2.7%
Headachehead pain	454	2.7%
Fatiguetiredness	451	2.7%
Astheniaweakness or lack of energy	445	2.6%
Diarrhoealoose or frequent stools	439	2.6%
Cardiac arrestthe heart stopped	427	2.5%
Completed suicidedeath by suicide	407	2.4%

Devices named most often

Brand	Reports	Share of device reports
One Touch Ultra	547	5.1%
Colleague Cx Volumetric Infusion Pump	480	4.5%
Colleague Volumetric Infusion Pump	474	4.4%
Colleague 3cx Volumetric Infusion Pump	258	2.4%
Colleague 3 Volumetric Infusion Pump	245	2.3%
M Series	187	1.7%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	144	1.3%
Cypher Sirolimus-Eluting Coronary Stent	140	1.3%
Accu-Chek Comfort Curve	118	1.1%
Endotak Reliance	97	0.9%

Questions about November 2005

How many adverse event reports did FDA receive in November 2005?

16,983 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 10,729 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 15,563 drug reports.

Which drugs were listed most often?

Vioxx (1,306), Wellbutrin (646), Avonex (412), Fosamax (335) and Lipitor (316).

Which reactions were recorded most often?

myocardial infarction (859), cerebrovascular accident (695), nausea (690), drug ineffective (564) and dyspnoea (556).

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.