Reports received by FDA, by month

October 2005: adverse event reports received by FDA

22,584 drug reports (FAERS) and 8,015 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.

22,584
drug reports received: 15,286 a year earlier; 17,778
monthly average, preceding 12 months: 27% against the average; 8,015
device reports received: 6,718 a year earlier

FDA received 22,584 drug adverse event reports in October 2005, against 15,286 in the same month a year earlier and a monthly average of 17,778 over the preceding 12 months. The MAUDE device database received 8,015 reports that month (6,718 a year earlier).

The drugs listed most often as suspect products were Vioxx (3,413), Advair Diskus 100/50 (2,341) and Lunesta (1,318), and the reactions recorded most often were myocardial infarction (2,124), drug ineffective (1,661) and cerebrovascular accident (1,651).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Advair Diskus 100/50 (108.5× its average), Lunesta (16.5× its average) and Salmeterol xinafoate (16.4× 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 October 2005

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Vioxx	3,413	15.1%
Advair Diskus 100/50	2,341	10.4%
Lunesta	1,318	5.8%
Premarin	488	2.2%
Avonex	368	1.6%
Zyprexa	314	1.4%
Remicade	243	1.1%
Provera	243	1.1%
Neurontin	239	1.1%
Salmeterol xinafoate	183	0.8%
Celebrex	182	0.8%
Forteo	180	0.8%
Zometa	171	0.8%
Avapro	169	0.7%
Lipitor	165	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
Advair Diskus 100/50	2,341	108.5×
Lunesta	1,318	16.5×
Salmeterol xinafoate	183	16.4×
Avapro	169	16×
Acetaminophen and Hydrocodone Bitartrate	80	4.8×
Carisoprodol	52	4.6×
Quetiapine fumarate	54	4.3×
Diltiazem	70	3.9×

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	2,124	9.4%
Drug ineffectivethe medicine did not work as expected	1,661	7.4%
Cerebrovascular accidentstroke	1,651	7.3%
Pharmaceutical product complaint	981	4.3%
Dyspnoeashortness of breath	945	4.2%
Cardiovascular disorder	917	4.1%
Hypertensionhigh blood pressure	873	3.9%
Arrhythmia	803	3.6%
Angina pectoris	793	3.5%
Dysgeusiaaltered taste	753	3.3%
Nauseafeeling sick	731	3.2%
Insomniadifficulty sleeping	698	3.1%
Completed suicidedeath by suicide	693	3.1%
Dizzinesslight-headedness or unsteadiness	644	2.9%
Vomitingbeing sick	575	2.5%

Devices named most often

Brand	Reports	Share of device reports
Colleague Cx Volumetric Infusion Pump	338	4.2%
Colleague Volumetric Infusion Pump	212	2.6%
One Touch Ultra	199	2.5%
M Series	175	2.2%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	155	1.9%
Accu-Chek Comfort Curve	141	1.8%
Colleague 3cx Volumetric Infusion Pump	127	1.6%
Colleague 3 Volumetric Infusion Pump	112	1.4%
Coaguchek Pt Test Strips	98	1.2%
Cypher Sirolimus-Eluting Coronary Stent	95	1.2%

Questions about October 2005

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

22,584 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 8,015 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 15,286 drug reports.

Which drugs were listed most often?

Vioxx (3,413), Advair Diskus 100/50 (2,341), Lunesta (1,318), Premarin (488) and Avonex (368).

Which reactions were recorded most often?

myocardial infarction (2,124), drug ineffective (1,661), cerebrovascular accident (1,651), pharmaceutical product complaint (981) and dyspnoea (945).

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.