Reports received by FDA, by month

October 2008: adverse event reports received by FDA

24,629 drug reports (FAERS) and 17,481 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.

24,629
drug reports received: 22,963 a year earlier; 25,435
monthly average, preceding 12 months: -3.2% against the average; 17,481
device reports received: 15,124 a year earlier

FDA received 24,629 drug adverse event reports in October 2008, against 22,963 in the same month a year earlier and a monthly average of 25,435 over the preceding 12 months. The MAUDE device database received 17,481 reports that month (15,124 a year earlier).

The drugs listed most often as suspect products were Premarin (1,259), Mirena (939) and Provera (735), and the reactions recorded most often were breast cancer (1,101), nausea (1,042) and dyspnoea (808).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Cycrin (11.7× its average), Vyvanse (11.2× its average) and Premarin (9.3× 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 October 2008

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Premarin	1,259	5.1%
Mirena	939	3.8%
Provera	735	3%
Arimidex	666	2.7%
Avonex	560	2.3%
Tiotropium bromide	385	1.6%
Remicade	364	1.5%
Vyvanse	362	1.5%
Chantix	303	1.2%
Enbrel	290	1.2%
Humira	288	1.2%
Tysabri	274	1.1%
Zometa	243	1%
Forteo	234	1%
Rebif	220	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
Cycrin	182	11.7×
Vyvanse	362	11.2×
Premarin	1,259	9.3×
Medroxyprogesterone	157	9.1×
Avapro	157	9×
Provera	735	7.8×
Metformin hydrochloride	78	7.1×
Arimidex	666	6.9×

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
Breast cancerbreast cancer	1,101	4.5%
Nauseafeeling sick	1,042	4.2%
Dyspnoeashortness of breath	808	3.3%
Vomitingbeing sick	769	3.1%
Drug ineffectivethe medicine did not work as expected	747	3%
Dizzinesslight-headedness or unsteadiness	718	2.9%
Fatiguetiredness	691	2.8%
Diarrhoealoose or frequent stools	684	2.8%
Headachehead pain	673	2.7%
Pyrexiafever	645	2.6%
Deaththe patient died; cause not stated by this term	630	2.6%
Depressionlow mood	568	2.3%
Painpain, site not specified	557	2.3%
Astheniaweakness or lack of energy	533	2.2%
Arthralgiajoint pain	520	2.1%

Devices named most often

Brand	Reports	Share of device reports
Flo-Gard 6201 Volumetric Infusion Pump	458	2.6%
Colleague Cx Volumetric Infusion Pump	374	2.1%
Colleague Volumetric Infusion Pump	248	1.4%
Accu-Chek Comfort Curve Test Strips	217	1.2%
Ge Oec 9800	212	1.2%
Cypher Sirolimus-Eluting Coronary Stent	208	1.2%
Colleague 3cx Volumetric Infusion Pump	194	1.1%
One Touch Ultralink Meter	191	1.1%
M Series	167	1%
Harmonic Ace 36 Cm	153	0.9%

Questions about October 2008

How many adverse event reports did FDA receive in October 2008?

24,629 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 17,481 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 22,963 drug reports.

Which drugs were listed most often?

Premarin (1,259), Mirena (939), Provera (735), Arimidex (666) and Avonex (560).

Which reactions were recorded most often?

breast cancer (1,101), nausea (1,042), dyspnoea (808), vomiting (769) and drug ineffective (747).

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.