Reports received by FDA, by month

August 2011: adverse event reports received by FDA

54,310 drug reports (FAERS) and 44,711 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.

54,310
drug reports received: 49,862 a year earlier; 43,949
monthly average, preceding 12 months: 23.6% against the average; 44,711
device reports received: 25,661 a year earlier

FDA received 54,310 drug adverse event reports in August 2011, against 49,862 in the same month a year earlier and a monthly average of 43,949 over the preceding 12 months. The MAUDE device database received 44,711 reports that month (25,661 a year earlier).

The drugs listed most often as suspect products were Niaspan (7,309), Mirena (4,332) and Tysabri (2,420), and the reactions recorded most often were flushing (4,100), pain (3,066) and anxiety (2,275).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Zoledronoc Acid (12.1× its average), Kadian (10.7× its average) and Lioresal (baclofen) (10.3× 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 August 2011

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Niaspan	7,309	13.5%
Mirena	4,332	8%
Tysabri	2,420	4.5%
Metoclopramide	1,429	2.6%
Victoza	1,253	2.3%
Lioresal (baclofen)	966	1.8%
Avandia	911	1.7%
Pradaxa	887	1.6%
Remicade	848	1.6%
Dianeal	792	1.5%
Avonex	709	1.3%
Yaz	628	1.2%
Humira	621	1.1%
Plan B One-Step	530	1%
Revlimid	517	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
Zoledronoc Acid	229	12.1×
Kadian	171	10.7×
Lioresal (baclofen)	966	10.3×
Niaspan	7,309	10.2×
Provigil	127	8.8×
Vimovo	99	8.7×
Mirena	4,332	8.3×
Dronedarone hydrochloride	97	6.1×

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
Flushingsudden reddening or warmth of the skin	4,100	7.5%
Painpain, site not specified	3,066	5.6%
Anxietyanxiety	2,275	4.2%
Pruritusitching	2,198	4%
Device expulsionthe device came out	2,164	4%
Nauseafeeling sick	2,129	3.9%
Deaththe patient died; cause not stated by this term	1,960	3.6%
Fatiguetiredness	1,685	3.1%
Drug ineffectivethe medicine did not work as expected	1,628	3%
Emotional distressemotional distress	1,584	2.9%
Headachehead pain	1,580	2.9%
Tardive dyskinesiainvoluntary repetitive movements	1,522	2.8%
Dizzinesslight-headedness or unsteadiness	1,451	2.7%
Anhedonia	1,414	2.6%
Fear	1,411	2.6%

Devices named most often

Brand	Reports	Share of device reports
Colleague Pre P1 7	2,923	6.5%
Colleague	2,013	4.5%
Asku	763	1.7%
Ot Ping Meter	763	1.7%
Ot Ultralink Meter	726	1.6%
Capsurefix Novus	699	1.6%
HomeChoice Automated PD Set with Cassette	550	1.2%
Carelink	500	1.1%
Onetouchping Glucosemgmtsystem	492	1.1%
Access	473	1.1%

Questions about August 2011

How many adverse event reports did FDA receive in August 2011?

54,310 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 44,711 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 49,862 drug reports.

Which drugs were listed most often?

Niaspan (7,309), Mirena (4,332), Tysabri (2,420), Metoclopramide (1,429) and Victoza (1,253).

Which reactions were recorded most often?

flushing (4,100), pain (3,066), anxiety (2,275), pruritus (2,198) and device expulsion (2,164).

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.