Reports received by FDA, by month

July 2009: adverse event reports received by FDA

28,323 drug reports (FAERS) and 19,114 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.

28,323
drug reports received: 26,560 a year earlier; 26,038
monthly average, preceding 12 months: 8.8% against the average; 19,114
device reports received: 16,792 a year earlier

FDA received 28,323 drug adverse event reports in July 2009, against 26,560 in the same month a year earlier and a monthly average of 26,038 over the preceding 12 months. The MAUDE device database received 19,114 reports that month (16,792 a year earlier).

The drugs listed most often as suspect products were Mirena (1,052), Avandia (961) and Coumadin (884), and the reactions recorded most often were nausea (1,121), dyspnoea (985) and death (922).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Flovent (14.6× its average), Coumadin (9.7× its average) and Bystolic (6.6× 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 2009

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Mirena	1,052	3.7%
Avandia	961	3.4%
Coumadin	884	3.1%
Avonex	717	2.5%
Seroquel	605	2.1%
Tysabri	459	1.6%
Humira	368	1.3%
Tiotropium bromide	344	1.2%
Remicade	343	1.2%
Provera	290	1%
Enbrel	287	1%
Premarin	285	1%
Revlimid	269	0.9%
Yaz	269	0.9%
Dianeal	253	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
Flovent	152	14.6×
Coumadin	884	9.7×
Bystolic	119	6.6×
Phosphosoda Flavor Not Specified	81	6×
Procrit	209	5.5×
Mifepristone Tablets 200 Mg	55	5.3×
Tykerb	163	5.1×
Avandia	961	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	1,121	4%
Dyspnoeashortness of breath	985	3.5%
Deaththe patient died; cause not stated by this term	922	3.3%
Dizzinesslight-headedness or unsteadiness	846	3%
Fatiguetiredness	841	3%
Drug ineffectivethe medicine did not work as expected	813	2.9%
Vomitingbeing sick	801	2.8%
Diarrhoealoose or frequent stools	781	2.8%
Headachehead pain	781	2.8%
Pyrexiafever	760	2.7%
Astheniaweakness or lack of energy	652	2.3%
Painpain, site not specified	619	2.2%
Falla fall	537	1.9%
Convulsion	536	1.9%
Depressionlow mood	520	1.8%

Devices named most often

Brand	Reports	Share of device reports
FreeStyle Lite	424	2.2%
Ge Oec 9800	276	1.4%
One Touch Ping Meter	235	1.2%
One Touch Ultralink Meter	230	1.2%
Accu-Chek Spirit	201	1.1%
M Series	175	0.9%
Ge Oec 9900	156	0.8%
Accu-Chek Comfort Curve Test Strips	139	0.7%
Totalcare	133	0.7%
Precision?	121	0.6%

Questions about July 2009

How many adverse event reports did FDA receive in July 2009?

28,323 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 19,114 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 26,560 drug reports.

Which drugs were listed most often?

Mirena (1,052), Avandia (961), Coumadin (884), Avonex (717) and Seroquel (605).

Which reactions were recorded most often?

nausea (1,121), dyspnoea (985), death (922), dizziness (846) and fatigue (841).

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.