Reports received by FDA, by month

January 2011: adverse event reports received by FDA

46,519 drug reports (FAERS) and 31,574 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.

46,519
drug reports received: 28,744 a year earlier; 40,315
monthly average, preceding 12 months: 15.4% against the average; 31,574
device reports received: 16,184 a year earlier

FDA received 46,519 drug adverse event reports in January 2011, against 28,744 in the same month a year earlier and a monthly average of 40,315 over the preceding 12 months. The MAUDE device database received 31,574 reports that month (16,184 a year earlier).

The drugs listed most often as suspect products were Humira (12,318), Tysabri (1,787) and Pradaxa (799), and the reactions recorded most often were death (2,669), injection site pain (2,127) and drug ineffective (2,053).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Pradaxa (25.4× its average), Humira (17× its average) and Lovaza (11.8× 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 January 2011

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Humira	12,318	26.5%
Tysabri	1,787	3.8%
Pradaxa	799	1.7%
Restasis	775	1.7%
Avandia	732	1.6%
Avonex	591	1.3%
Remodulin	563	1.2%
Lovaza	541	1.2%
Dianeal	489	1.1%
Remicade	460	1%
Acetaminophen	450	1%
Enbrel	433	0.9%
Lipitor	420	0.9%
Alprazolam	406	0.9%
Revlimid	390	0.8%

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
Pradaxa	799	25.4×
Humira	12,318	17×
Lovaza	541	11.8×
Restasis	775	11.3×
Remodulin	563	8.8×
Amitriptyline	67	6.4×
Diltiazem	93	6.3×
Fludara	97	5.7×

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	2,669	5.7%
Injection site painpain where the injection was given	2,127	4.6%
Drug ineffectivethe medicine did not work as expected	2,053	4.4%
Nauseafeeling sick	1,762	3.8%
Fatiguetiredness	1,659	3.6%
Headachehead pain	1,565	3.4%
Painpain, site not specified	1,565	3.4%
Dyspnoeashortness of breath	1,412	3%
Arthralgiajoint pain	1,277	2.7%
Diarrhoealoose or frequent stools	1,248	2.7%
Vomitingbeing sick	1,127	2.4%
Dizzinesslight-headedness or unsteadiness	1,125	2.4%
Completed suicidedeath by suicide	1,117	2.4%
Pyrexiafever	1,111	2.4%
Rashskin rash	1,008	2.2%

Devices named most often

Brand	Reports	Share of device reports
Precision Test Strips	2,532	8%
Precision Xtra	934	3%
Endotak Reliance	689	2.2%
Ot Ping Meter	471	1.5%
Vitality 2	382	1.2%
Ot Ultralink Meter	372	1.2%
Teligen	348	1.1%
Renal - Disposable	322	1%
Cognis	312	1%
Medisense Optium	297	0.9%

Questions about January 2011

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

46,519 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 31,574 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 28,744 drug reports.

Which drugs were listed most often?

Humira (12,318), Tysabri (1,787), Pradaxa (799), Restasis (775) and Avandia (732).

Which reactions were recorded most often?

death (2,669), injection site pain (2,127), drug ineffective (2,053), nausea (1,762) and fatigue (1,659).

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.