Reports received by FDA, by month

April 2005: adverse event reports received by FDA

16,560 drug reports (FAERS) and 7,458 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.

16,560
drug reports received: 10,930 a year earlier; 16,487
monthly average, preceding 12 months: 0.4% against the average; 7,458
device reports received: 6,811 a year earlier

FDA received 16,560 drug adverse event reports in April 2005, against 10,930 in the same month a year earlier and a monthly average of 16,487 over the preceding 12 months. The MAUDE device database received 7,458 reports that month (6,811 a year earlier).

The drugs listed most often as suspect products were Factor ix complex (689), Koate (670) and Konyne (669), and the reactions recorded most often were pharmaceutical product complaint (1,227), nausea (783) and adverse event (705).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Konyne (30.9× its average), Koate (26.9× its average) and Antihemophilic factor (human) (26.7× 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 April 2005

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Factor ix complex	689	4.2%
Koate	670	4%
Konyne	669	4%
Cymbalta	659	4%
Vioxx	656	4%
Rebif	644	3.9%
Antihemophilic factor (human)	578	3.5%
Natalizumab	506	3.1%
Factor Viii	504	3%
Avonex	376	2.3%
Bextra	341	2.1%
Remicade	307	1.9%
Celebrex	196	1.2%
Flovent	160	1%
Methotrexate	154	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
Konyne	669	30.9×
Koate	670	26.9×
Antihemophilic factor (human)	578	26.7×
Factor ix complex	689	26.3×
Rebif	644	8.1×
Cymbalta	659	7.5×
Tamiflu	108	7.3×
Paraplatin	67	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
Pharmaceutical product complaint	1,227	7.4%
Nauseafeeling sick	783	4.7%
Adverse eventan unwanted medical event, type not specified	705	4.3%
Headachehead pain	672	4.1%
Vomitingbeing sick	608	3.7%
Myocardial infarctionheart attack	596	3.6%
Fatiguetiredness	588	3.6%
Dyspnoeashortness of breath	583	3.5%
Astheniaweakness or lack of energy	561	3.4%
Dizzinesslight-headedness or unsteadiness	555	3.4%
Drug ineffectivethe medicine did not work as expected	501	3%
Pyrexiafever	471	2.8%
Cerebrovascular accidentstroke	439	2.7%
Diarrhoealoose or frequent stools	438	2.6%
Painpain, site not specified	417	2.5%

Devices named most often

Brand	Reports	Share of device reports
One Touch Ultra	366	4.9%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	211	2.8%
M Series	180	2.4%
Cypher Sirolimus-Eluting Coronary Stent	179	2.4%
Accu-Chek Comfort Curve	161	2.2%
Minicap Pd Transfer Set Easy-Lock With Twist Clamp	119	1.6%
Colleague Volumetric Infusion Pump	90	1.2%
Guidant 4 5 Mm Heartstring Proximal Seal	86	1.2%
Colleague Cx Volumetric Infusion Pump	72	1%
Synchromed El	61	0.8%

Questions about April 2005

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

16,560 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 7,458 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 10,930 drug reports.

Which drugs were listed most often?

Factor ix complex (689), Koate (670), Konyne (669), Cymbalta (659) and Vioxx (656).

Which reactions were recorded most often?

pharmaceutical product complaint (1,227), nausea (783), adverse event (705), headache (672) and vomiting (608).

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.