Reports received by FDA, by month

July 2007: adverse event reports received by FDA

26,259 drug reports (FAERS) and 13,694 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.

26,259
drug reports received: 22,154 a year earlier; 19,792
monthly average, preceding 12 months: 32.7% against the average; 13,694
device reports received: 8,693 a year earlier

FDA received 26,259 drug adverse event reports in July 2007, against 22,154 in the same month a year earlier and a monthly average of 19,792 over the preceding 12 months. The MAUDE device database received 13,694 reports that month (8,693 a year earlier).

The drugs listed most often as suspect products were Celebrex (3,059), Byetta (2,482) and Ortho Evra (1,406), and the reactions recorded most often were myocardial infarction (2,181), nausea (1,707) and blood glucose increased (1,494).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Ortho Evra (28.7× its average), Kineret (15.8× its average) and Thymoglobulin (11.6× 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 July 2007

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Celebrex	3,059	11.6%
Byetta	2,482	9.5%
Ortho Evra	1,406	5.4%
Vioxx	1,053	4%
Lunesta	676	2.6%
Avandia	640	2.4%
Bextra	483	1.8%
Tykerb	388	1.5%
Nicorette	380	1.4%
Procrit	328	1.2%
Remicade	302	1.2%
Enbrel	299	1.1%
Avonex	289	1.1%
Avelox	287	1.1%
Levemir	259	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."

Largest rises against their own average

Drug	Reports this month	Times its 12-month average
Ortho Evra	1,406	28.7×
Kineret	165	15.8×
Thymoglobulin	129	11.6×
Vioxx	1,053	10.2×
Celebrex	3,059	10×
Champix	74	5.9×
Avelox	287	5.9×
Avandia	640	5.5×

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
Myocardial infarctionheart attack	2,181	8.3%
Nauseafeeling sick	1,707	6.5%
Blood glucose increasedraised blood sugar reading	1,494	5.7%
Cerebrovascular accidentstroke	1,204	4.6%
Drug ineffectivethe medicine did not work as expected	950	3.6%
Diarrhoealoose or frequent stools	930	3.5%
Vomitingbeing sick	910	3.5%
Pulmonary embolisma blood clot in the lung	847	3.2%
Weight decreasedweight loss	834	3.2%
Dizzinesslight-headedness or unsteadiness	785	3%
Dyspnoeashortness of breath	769	2.9%
Fatiguetiredness	752	2.9%
Deep vein thrombosisa blood clot in a deep vein	706	2.7%
Headachehead pain	705	2.7%
Astheniaweakness or lack of energy	578	2.2%

Devices named most often

Brand	Reports	Share of device reports
Freestyle Flash	1,512	11%
Freestyle	557	4.1%
Accu-Chek Comfort Curve Test Strips	308	2.2%
Sprint Fidelis	256	1.9%
Cypher Sirolimus-Eluting Coronary Stent	236	1.7%
Ge Oec 9800	195	1.4%
M Series	179	1.3%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	140	1%
Tendril Sdx	115	0.8%
Accu-Chek Compact Test Drum	80	0.6%

Questions about July 2007

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

26,259 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 13,694 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 22,154 drug reports.

Which drugs were listed most often?

Celebrex (3,059), Byetta (2,482), Ortho Evra (1,406), Vioxx (1,053) and Lunesta (676).

Which reactions were recorded most often?

myocardial infarction (2,181), nausea (1,707), blood glucose increased (1,494), cerebrovascular accident (1,204) and drug ineffective (950).

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.