Reports received by FDA, by month

March 2011: adverse event reports received by FDA

41,538 drug reports (FAERS) and 34,130 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.

41,538
drug reports received: 34,048 a year earlier; 42,363
monthly average, preceding 12 months: -1.9% against the average; 34,130
device reports received: 23,917 a year earlier

FDA received 41,538 drug adverse event reports in March 2011, against 34,048 in the same month a year earlier and a monthly average of 42,363 over the preceding 12 months. The MAUDE device database received 34,130 reports that month (23,917 a year earlier).

The drugs listed most often as suspect products were Tysabri (2,180), Pradaxa (1,563) and Mirena (1,276), and the reactions recorded most often were death (1,843), nausea (1,664) and drug ineffective (1,609).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Plan B One-Step (43.4× its average), Reglan (31.5× its average) and Nicorette (12.1× 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 March 2011

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Tysabri	2,180	5.2%
Pradaxa	1,563	3.8%
Mirena	1,276	3.1%
Cimzia	992	2.4%
Avandia	924	2.2%
Revlimid	847	2%
Reglan	735	1.8%
Avonex	645	1.6%
Plan B One-Step	615	1.5%
Remicade	595	1.4%
Cyclophosphamide	594	1.4%
Nicorette	572	1.4%
Yaz	567	1.4%
Yasmin	548	1.3%
Chantix	483	1.2%

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
Plan B One-Step	615	43.4×
Reglan	735	31.5×
Nicorette	572	12.1×
Doxorubicin	196	11×
Prolia	186	10.9×
Pradaxa	1,563	9.8×
Trasylol	173	8.7×
Fentanyl-100	413	7.5×

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
Deaththe patient died; cause not stated by this term	1,843	4.4%
Nauseafeeling sick	1,664	4%
Drug ineffectivethe medicine did not work as expected	1,609	3.9%
Fatiguetiredness	1,462	3.5%
Painpain, site not specified	1,396	3.4%
Dyspnoeashortness of breath	1,364	3.3%
Headachehead pain	1,332	3.2%
Dizzinesslight-headedness or unsteadiness	1,256	3%
Vomitingbeing sick	1,200	2.9%
Diarrhoealoose or frequent stools	1,106	2.7%
Anxietyanxiety	938	2.3%
Malaisegeneral feeling of being unwell	912	2.2%
Depressionlow mood	885	2.1%
Myocardial infarctionheart attack	846	2%
Astheniaweakness or lack of energy	844	2%

Devices named most often

Brand	Reports	Share of device reports
Sprint Fidelis	1,089	3.2%
Precision Xtra	632	1.9%
HomeChoice Automated PD Set with Cassette	498	1.5%
Animas Insulin Infusion Pump	495	1.5%
Ot Ping Meter	471	1.4%
Paradigm Real-Time Insulin Infusion Pump	383	1.1%
Ot Ultralink Meter	361	1.1%
One Touch Ping Glucose Management System	329	1%
Perclose Proglide 6f Suture Mediated Closure Smc System	285	0.8%
Greenlight Addstat	237	0.7%

Questions about March 2011

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

41,538 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 34,130 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 34,048 drug reports.

Which drugs were listed most often?

Tysabri (2,180), Pradaxa (1,563), Mirena (1,276), Cimzia (992) and Avandia (924).

Which reactions were recorded most often?

death (1,843), nausea (1,664), drug ineffective (1,609), fatigue (1,462) and pain (1,396).

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.