Reports received by FDA, by month

January 2006: adverse event reports received by FDA

19,416 drug reports (FAERS) and 8,624 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.

19,416
drug reports received: 19,286 a year earlier; 18,891
monthly average, preceding 12 months: 2.8% against the average; 8,624
device reports received: 6,426 a year earlier

FDA received 19,416 drug adverse event reports in January 2006, against 19,286 in the same month a year earlier and a monthly average of 18,891 over the preceding 12 months. The MAUDE device database received 8,624 reports that month (6,426 a year earlier).

The drugs listed most often as suspect products were Vioxx (2,197), Lunesta (1,408) and Clozapine (928), and the reactions recorded most often were drug ineffective (1,257), myocardial infarction (1,242) and cerebrovascular accident (964).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Lyrica (30.6× its average), Clozapine (13.3× its average) and Tarceva (12.3× 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 January 2006

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Vioxx	2,197	11.3%
Lunesta	1,408	7.3%
Clozapine	928	4.8%
Lyrica	849	4.4%
Avonex	418	2.2%
Plavix	408	2.1%
Bupropion hydrochloride	390	2%
Tarceva	318	1.6%
Prempro	311	1.6%
Levitra	311	1.6%
Remicade	221	1.1%
Premarin	194	1%
Provera	177	0.9%
Lipitor	172	0.9%
Ketek	153	0.8%

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
Lyrica	849	30.6×
Clozapine	928	13.3×
Tarceva	318	12.3×
Copaxone	127	12×
Lunesta	1,408	7.4×
Plavix	408	5.2×
Levitra	311	4.6×
Glucophage	150	4.6×

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
Drug ineffectivethe medicine did not work as expected	1,257	6.5%
Myocardial infarctionheart attack	1,242	6.4%
Cerebrovascular accidentstroke	964	5%
Insomniadifficulty sleeping	744	3.8%
Nauseafeeling sick	733	3.8%
Dyspnoeashortness of breath	706	3.6%
Dizzinesslight-headedness or unsteadiness	675	3.5%
Dysgeusiaaltered taste	668	3.4%
Chest painchest pain	627	3.2%
Vomitingbeing sick	597	3.1%
Headachehead pain	564	2.9%
Diarrhoealoose or frequent stools	554	2.9%
Depressionlow mood	530	2.7%
Hypertensionhigh blood pressure	511	2.6%
Pyrexiafever	511	2.6%

Devices named most often

Brand	Reports	Share of device reports
Colleague Cx Volumetric Infusion Pump	492	5.7%
Colleague Volumetric Infusion Pump	401	4.6%
Colleague 3cx Volumetric Infusion Pump	253	2.9%
Colleague 3 Volumetric Infusion Pump	205	2.4%
M Series	152	1.8%
One Touch Ultra	146	1.7%
Cypher Sirolimus-Eluting Coronary Stent	141	1.6%
Accu-Chek Comfort Curve	121	1.4%
Taxus Express2 Paclitaxel-Eluting Coronary Stent	103	1.2%
Homechoice Automated Pd Set W/Cassette 4-Prong	70	0.8%

Questions about January 2006

How many adverse event reports did FDA receive in January 2006?

19,416 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 8,624 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 19,286 drug reports.

Which drugs were listed most often?

Vioxx (2,197), Lunesta (1,408), Clozapine (928), Lyrica (849) and Avonex (418).

Which reactions were recorded most often?

drug ineffective (1,257), myocardial infarction (1,242), cerebrovascular accident (964), insomnia (744) and nausea (733).

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.