Reports received by FDA, by month

October 2007: adverse event reports received by FDA

22,963 drug reports (FAERS) and 15,124 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.

22,963
drug reports received: 18,944 a year earlier; 21,280
monthly average, preceding 12 months: 7.9% against the average; 15,124
device reports received: 9,446 a year earlier

FDA received 22,963 drug adverse event reports in October 2007, against 18,944 in the same month a year earlier and a monthly average of 21,280 over the preceding 12 months. The MAUDE device database received 15,124 reports that month (9,446 a year earlier).

The drugs listed most often as suspect products were Advair Diskus 100/50 (2,218), Arimidex (590) and Lunesta (506), and the reactions recorded most often were drug ineffective (1,398), nausea (998) and dyspnoea (992).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Advair Diskus 100/50 (49.1× its average), Tekturna (18.9× its average) and Arimidex (16.5× 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 October 2007

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Advair Diskus 100/50	2,218	9.7%
Arimidex	590	2.6%
Lunesta	506	2.2%
Chantix	439	1.9%
Neurontin	334	1.5%
Avonex	333	1.5%
Remicade	328	1.4%
Levemir	310	1.3%
Tekturna	309	1.3%
Tiotropium bromide	290	1.3%
Enbrel	251	1.1%
Celebrex	248	1.1%
Bextra	235	1%
Forteo	217	0.9%
Betaseron	203	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
Advair Diskus 100/50	2,218	49.1×
Tekturna	309	18.9×
Arimidex	590	16.5×
Avapro	166	8.8×
Salmeterol xinafoate	86	5.5×
Mirapex	95	4.9×
Champix	162	4.7×
Tykerb	164	4.1×

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
Drug ineffectivethe medicine did not work as expected	1,398	6.1%
Nauseafeeling sick	998	4.3%
Dyspnoeashortness of breath	992	4.3%
Pharmaceutical product complaint	892	3.9%
Dizzinesslight-headedness or unsteadiness	763	3.3%
Headachehead pain	740	3.2%
Diarrhoealoose or frequent stools	668	2.9%
Vomitingbeing sick	664	2.9%
Fatiguetiredness	631	2.7%
Insomniadifficulty sleeping	546	2.4%
Pyrexiafever	530	2.3%
Depressionlow mood	522	2.3%
Astheniaweakness or lack of energy	510	2.2%
Deaththe patient died; cause not stated by this term	451	2%
Painpain, site not specified	446	1.9%

Devices named most often

Brand	Reports	Share of device reports
Freestyle Flash	1,894	12.5%
Freestyle	496	3.3%
Accu-Chek Comfort Curve Test Strips	312	2.1%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	225	1.5%
Cypher Sirolimus-Eluting Coronary Stent	192	1.3%
Lifevest Wcd 3000 System	166	1.1%
M Series	151	1%
Ge Oec 9800	147	1%
Clearstar Pump	142	0.9%
Polyflux Lr Capillary Dialyzer	110	0.7%

Questions about October 2007

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

22,963 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 15,124 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 18,944 drug reports.

Which drugs were listed most often?

Advair Diskus 100/50 (2,218), Arimidex (590), Lunesta (506), Chantix (439) and Neurontin (334).

Which reactions were recorded most often?

drug ineffective (1,398), nausea (998), dyspnoea (992), pharmaceutical product complaint (892) and dizziness (763).

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.