Reports received by FDA, by month

May 2007: adverse event reports received by FDA

21,169 drug reports (FAERS) and 17,854 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.

21,169
drug reports received: 18,266 a year earlier; 19,614
monthly average, preceding 12 months: 7.9% against the average; 17,854
device reports received: 11,562 a year earlier

FDA received 21,169 drug adverse event reports in May 2007, against 18,266 in the same month a year earlier and a monthly average of 19,614 over the preceding 12 months. The MAUDE device database received 17,854 reports that month (11,562 a year earlier).

The drugs listed most often as suspect products were Byetta (3,176), Estradiol (1,150) and Zyprexa (1,139), and the reactions recorded most often were nausea (1,624), blood glucose increased (1,561) and weight decreased (1,462).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Estradiol (75.4× its average), Januvia (16.8× its average) and Lotrel (8× 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 May 2007

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Byetta	3,176	15%
Estradiol	1,150	5.4%
Zyprexa	1,139	5.4%
Januvia	944	4.5%
Remicade	301	1.4%
Rozerem	291	1.4%
Zelnorm	271	1.3%
Avonex	249	1.2%
Enbrel	243	1.1%
Chantix	232	1.1%
Bextra	214	1%
Rebif	207	1%
Celebrex	179	0.8%
Tramadol hcl	171	0.8%
Lyrica	168	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
Estradiol	1,150	75.4×
Januvia	944	16.8×
Lotrel	81	8×
Zelnorm	271	7.3×
Tamiflu	164	6.5×
Diovan HCT	59	5.5×
Tramadol hcl	171	5.4×
Zyprexa	1,139	5.1×

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	1,624	7.7%
Blood glucose increasedraised blood sugar reading	1,561	7.4%
Weight decreasedweight loss	1,462	6.9%
Breast cancer female	1,165	5.5%
Vomitingbeing sick	859	4.1%
Diabetes mellitusdiabetes	730	3.4%
Drug ineffectivethe medicine did not work as expected	714	3.4%
Dizzinesslight-headedness or unsteadiness	709	3.3%
Diarrhoealoose or frequent stools	668	3.2%
Dyspnoeashortness of breath	615	2.9%
Headachehead pain	613	2.9%
Decreased appetitereduced appetite	551	2.6%
Fatiguetiredness	526	2.5%
Pancreatitisinflammation of the pancreas	506	2.4%
Blood glucose decreasedlow blood sugar reading	498	2.4%

Devices named most often

Brand	Reports	Share of device reports
Freestyle Flash	1,752	9.8%
Freestyle	760	4.3%
Ge Oec 9800	472	2.6%
Accu-Chek Comfort Curve Test Strips	348	1.9%
Sprint Fidelis	261	1.5%
Cypher Sirolimus-Eluting Coronary Stent	244	1.4%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	165	0.9%
Contak Renewal	163	0.9%
Coaguchek S System	163	0.9%
Flextend Is-1 Bi Positive Fix	160	0.9%

Questions about May 2007

How many adverse event reports did FDA receive in May 2007?

21,169 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 17,854 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 18,266 drug reports.

Which drugs were listed most often?

Byetta (3,176), Estradiol (1,150), Zyprexa (1,139), Januvia (944) and Remicade (301).

Which reactions were recorded most often?

nausea (1,624), blood glucose increased (1,561), weight decreased (1,462), breast cancer female (1,165) and vomiting (859).

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.