Reports received by FDA, by month

September 2005: adverse event reports received by FDA

19,639 drug reports (FAERS) and 9,124 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.

19,639
drug reports received: 21,291 a year earlier; 17,915
monthly average, preceding 12 months: 9.6% against the average; 9,124
device reports received: 7,075 a year earlier

FDA received 19,639 drug adverse event reports in September 2005, against 21,291 in the same month a year earlier and a monthly average of 17,915 over the preceding 12 months. The MAUDE device database received 9,124 reports that month (7,075 a year earlier).

The drugs listed most often as suspect products were Thalomid (3,381), Abreva (1,149) and Humira (1,129), and the reactions recorded most often were death (2,492), drug ineffective (1,292) and disease progression (1,204).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Thalomid (17.4× its average), Coreg (13.6× its average) and Vesicare (10.1× 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 September 2005

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Thalomid	3,381	17.2%
Abreva	1,149	5.9%
Humira	1,129	5.7%
Vioxx	995	5.1%
Strattera	412	2.1%
Avonex	381	1.9%
Boniva	359	1.8%
Tiotropium bromide	347	1.8%
Coreg	313	1.6%
Levitra	252	1.3%
Dexamethasone	238	1.2%
Cyclophosphamide	230	1.2%
Topamax	227	1.2%
Velcade	179	0.9%
Lipitor	178	0.9%

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
Thalomid	3,381	17.4×
Coreg	313	13.6×
Vesicare	126	10.1×
Adriamycin Pfs	113	6.9×
Topamax	227	6×
Requip	78	5.8×
Dexamethasone	238	5×
Stadol	64	4.9×

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
Deaththe patient died; cause not stated by this term	2,492	12.7%
Drug ineffectivethe medicine did not work as expected	1,292	6.6%
Disease progressionthe disease advanced	1,204	6.1%
Nauseafeeling sick	727	3.7%
Myocardial infarctionheart attack	712	3.6%
Dyspnoeashortness of breath	685	3.5%
Dizzinesslight-headedness or unsteadiness	570	2.9%
Cerebrovascular accidentstroke	547	2.8%
Fatiguetiredness	544	2.8%
Headachehead pain	538	2.7%
Vomitingbeing sick	531	2.7%
Pyrexiafever	531	2.7%
Astheniaweakness or lack of energy	505	2.6%
Pneumonialung infection	445	2.3%
Chest painchest pain	445	2.3%

Devices named most often

Brand	Reports	Share of device reports
Colleague Cx Volumetric Infusion Pump	345	3.8%
One Touch Ultra	326	3.6%
Colleague Volumetric Infusion Pump	294	3.2%
M Series	192	2.1%
Colleague 3cx Volumetric Infusion Pump	167	1.8%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	166	1.8%
Minicap Pd Transfer Set Easy-Lock With Twist Clamp	164	1.8%
Colleague 3 Volumetric Infusion Pump	158	1.7%
Cypher Sirolimus-Eluting Coronary Stent	153	1.7%
Aed Plus	77	0.8%

Questions about September 2005

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

19,639 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 9,124 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 21,291 drug reports.

Which drugs were listed most often?

Thalomid (3,381), Abreva (1,149), Humira (1,129), Vioxx (995) and Strattera (412).

Which reactions were recorded most often?

death (2,492), drug ineffective (1,292), disease progression (1,204), nausea (727) and myocardial infarction (712).

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.