Reports received by FDA, by month

September 2004: adverse event reports received by FDA

21,291 drug reports (FAERS) and 7,075 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.

21,291
drug reports received: —
monthly average, preceding 12 months: 7,075
device reports received: 6,047 a year earlier

FDA received 21,291 drug adverse event reports in September 2004. The MAUDE device database received 7,075 reports that month (6,047 a year earlier).

The drugs listed most often as suspect products were Ortho Evra (2,432), Thalomid (1,737) and Forteo (1,737), and the reactions recorded most often were death (1,578), nausea (1,150) and metrorrhagia (825).

Drug reports by month, three years to September 2004

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Ortho Evra	2,432	11.4%
Thalomid	1,737	8.2%
Forteo	1,737	8.2%
Humira	1,481	7%
Crestor	954	4.5%
Strattera	934	4.4%
Advair Diskus 100/50	488	2.3%
Provera	339	1.6%
Premarin	331	1.6%
Salmeterol xinafoate	320	1.5%
Tiotropium bromide	312	1.5%
Coumadin	291	1.4%
Avonex	247	1.2%
Bextra	236	1.1%
OxyContin	215	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."

Reactions recorded most often

MedDRA term	Reports	Share of the month
Deaththe patient died; cause not stated by this term	1,578	7.4%
Nauseafeeling sick	1,150	5.4%
Metrorrhagia	825	3.9%
Drug ineffectivethe medicine did not work as expected	804	3.8%
Dizzinesslight-headedness or unsteadiness	771	3.6%
Headachehead pain	723	3.4%
Fatiguetiredness	692	3.3%
Vomitingbeing sick	660	3.1%
Dyspnoeashortness of breath	639	3%
Astheniaweakness or lack of energy	613	2.9%
Pharmaceutical product complaint	547	2.6%
Feeling abnormalfeeling odd or not right	512	2.4%
Injection site haemorrhagebleeding where the injection was given	476	2.2%
Pyrexiafever	447	2.1%
Rashskin rash	421	2%

Devices named most often

Brand	Reports	Share of device reports
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	296	4.2%
One Touch Ultra	288	4.1%
Cypher Sirolimus-Eluting Coronary Stent	206	2.9%
M Series	146	2.1%
Accu-Chek Comfort Curve	89	1.3%
Colleague Volumetric Infusion Pump	65	0.9%
Elastimide Foldable Silicone Posterior Chamber	62	0.9%
Excluder Bifurcated Endoprosthesis	61	0.9%
Freestyle	55	0.8%
Ultracision Surgical Device Curved Shears Endo	49	0.7%

Questions about September 2004

How many adverse event reports did FDA receive in September 2004?

21,291 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 7,075 device reports in the MAUDE release of 28 Sep 2026.

Which drugs were listed most often?

Ortho Evra (2,432), Thalomid (1,737), Forteo (1,737), Humira (1,481) and Crestor (954).

Which reactions were recorded most often?

death (1,578), nausea (1,150), metrorrhagia (825), drug ineffective (804) and dizziness (771).

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.