Reports received by FDA, by month

November 2010: adverse event reports received by FDA

39,725 drug reports (FAERS) and 26,144 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.

39,725
drug reports received: 29,373 a year earlier; 38,228
monthly average, preceding 12 months: 3.9% against the average; 26,144
device reports received: 22,320 a year earlier

FDA received 39,725 drug adverse event reports in November 2010, against 29,373 in the same month a year earlier and a monthly average of 38,228 over the preceding 12 months. The MAUDE device database received 26,144 reports that month (22,320 a year earlier).

The drugs listed most often as suspect products were Tysabri (2,420), Victoza (1,115) and Cimzia (1,068), and the reactions recorded most often were drug ineffective (2,858), death (2,034) and nausea (2,022).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Altace (10.4× its average), Victoza (8.9× its average) and Avodart (7.2× 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 November 2010

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Tysabri	2,420	6.1%
Victoza	1,115	2.8%
Cimzia	1,068	2.7%
BOTOX Cosmetic	963	2.4%
Viagra	864	2.2%
Avandia	785	2%
Simcor	680	1.7%
Avonex	676	1.7%
Remicade	587	1.5%
Dianeal	530	1.3%
Lipitor	455	1.1%
Humira	448	1.1%
Flector	446	1.1%
Enbrel	424	1.1%
Tiotropium bromide	379	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
Altace	172	10.4×
Victoza	1,115	8.9×
Avodart	351	7.2×
Etanercept	104	6.7×
Nuvaring	284	6.6×
Onglyza	215	5.4×
Rapaflo	59	5.1×
Coreg	93	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
Drug ineffectivethe medicine did not work as expected	2,858	7.2%
Deaththe patient died; cause not stated by this term	2,034	5.1%
Nauseafeeling sick	2,022	5.1%
Fatiguetiredness	1,577	4%
Headachehead pain	1,540	3.9%
Vomitingbeing sick	1,256	3.2%
Dyspnoeashortness of breath	1,255	3.2%
Dizzinesslight-headedness or unsteadiness	1,245	3.1%
Diarrhoealoose or frequent stools	1,228	3.1%
Painpain, site not specified	987	2.5%
Astheniaweakness or lack of energy	921	2.3%
Pyrexiafever	873	2.2%
Malaisegeneral feeling of being unwell	856	2.2%
Falla fall	796	2%
Myocardial infarctionheart attack	788	2%

Devices named most often

Brand	Reports	Share of device reports
Animas Insulin Infusion Pump	369	1.4%
Ot Ping Meter	270	1%
Ot Ultralink Meter	260	1%
Perclose Proglide 6f Suture Mediated Closure Smc System	256	1%
Greenlight Addstat	239	0.9%
One Touch Ping Glucose Management System	239	0.9%
Renal - Disposable	228	0.9%
Automated Pd Set W/Cassette4 Prong	208	0.8%
Integrated Apd Set W/Cassette3-Prong	199	0.8%
Inratio	179	0.7%

Questions about November 2010

How many adverse event reports did FDA receive in November 2010?

39,725 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 26,144 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 29,373 drug reports.

Which drugs were listed most often?

Tysabri (2,420), Victoza (1,115), Cimzia (1,068), BOTOX Cosmetic (963) and Viagra (864).

Which reactions were recorded most often?

drug ineffective (2,858), death (2,034), nausea (2,022), fatigue (1,577) and headache (1,540).

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.