Reports received by FDA, by month

December 2005: adverse event reports received by FDA

22,758 drug reports (FAERS) and 9,457 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.

22,758
drug reports received: 18,113 a year earlier; 18,504
monthly average, preceding 12 months: 23% against the average; 9,457
device reports received: 7,188 a year earlier

FDA received 22,758 drug adverse event reports in December 2005, against 18,113 in the same month a year earlier and a monthly average of 18,504 over the preceding 12 months. The MAUDE device database received 9,457 reports that month (7,188 a year earlier).

The drugs listed most often as suspect products were Nicoderm Cq (3,017), Byetta (1,668) and Vioxx (1,520), and the reactions recorded most often were nausea (1,923), drug ineffective (1,075) and dizziness (1,025).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Byetta (67.2× its average), Boniva (22.1× its average) and Symlin (16.9× 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 December 2005

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Nicoderm Cq	3,017	13.3%
Byetta	1,668	7.3%
Vioxx	1,520	6.7%
Humira	941	4.1%
Cymbalta	795	3.5%
Boniva	763	3.4%
OxyContin	508	2.2%
Flonase	422	1.9%
Avonex	417	1.8%
Bextra	401	1.8%
Effexor	297	1.3%
Enbrel	288	1.3%
Cialis	258	1.1%
Viagra	212	0.9%
Remicade	210	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
Byetta	1,668	67.2×
Boniva	763	22.1×
Symlin	196	16.9×
Flonase	422	12.8×
Vesicare	191	8.1×
Tequin	165	6.8×
Augmentin	88	5.7×
Effexor	297	5.2×

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
Nauseafeeling sick	1,923	8.4%
Drug ineffectivethe medicine did not work as expected	1,075	4.7%
Dizzinesslight-headedness or unsteadiness	1,025	4.5%
Myocardial infarctionheart attack	1,020	4.5%
Vomitingbeing sick	932	4.1%
Headachehead pain	857	3.8%
Application site erythemaredness where the product was applied	772	3.4%
Cerebrovascular accidentstroke	771	3.4%
Weight decreasedweight loss	724	3.2%
Application site pruritusitching where the product was applied	721	3.2%
Blood glucose increasedraised blood sugar reading	711	3.1%
Diarrhoealoose or frequent stools	685	3%
Dyspnoeashortness of breath	639	2.8%
Astheniaweakness or lack of energy	623	2.7%
Fatiguetiredness	578	2.5%

Devices named most often

Brand	Reports	Share of device reports
Colleague Cx Volumetric Infusion Pump	550	5.8%
One Touch Ultra	472	5%
Colleague Volumetric Infusion Pump	457	4.8%
Colleague 3cx Volumetric Infusion Pump	278	2.9%
Colleague 3 Volumetric Infusion Pump	226	2.4%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	155	1.6%
M Series	131	1.4%
Accu-Chek Comfort Curve	130	1.4%
Cypher Sirolimus-Eluting Coronary Stent	117	1.2%
Harmonic Scalpel Hand Piece	97	1%

Questions about December 2005

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

22,758 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 9,457 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 18,113 drug reports.

Which drugs were listed most often?

Nicoderm Cq (3,017), Byetta (1,668), Vioxx (1,520), Humira (941) and Cymbalta (795).

Which reactions were recorded most often?

nausea (1,923), drug ineffective (1,075), dizziness (1,025), myocardial infarction (1,020) and vomiting (932).

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.