Reports received by FDA, by month

March 2008: adverse event reports received by FDA

26,011 drug reports (FAERS) and 13,123 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.

26,011
drug reports received: 17,666 a year earlier; 22,946
monthly average, preceding 12 months: 13.4% against the average; 13,123
device reports received: 13,446 a year earlier

FDA received 26,011 drug adverse event reports in March 2008, against 17,666 in the same month a year earlier and a monthly average of 22,946 over the preceding 12 months. The MAUDE device database received 13,123 reports that month (13,446 a year earlier).

The drugs listed most often as suspect products were Mirena (3,768), Humira (2,655) and Aleve (1,896), and the reactions recorded most often were intra-uterine contraceptive device expelled (1,310), nausea (1,058) and drug ineffective (890).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Aleve (42.7× its average), Mirena (42.4× its average) and Erbitux (11× 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 2008

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Mirena	3,768	14.5%
Humira	2,655	10.2%
Aleve	1,896	7.3%
Chantix	412	1.6%
Erbitux	379	1.5%
Requip	365	1.4%
Tiotropium bromide	270	1%
Singulair	254	1%
Remicade	241	0.9%
Avelox	237	0.9%
Enbrel	233	0.9%
Avonex	231	0.9%
Heparin sodium	223	0.9%
Lyrica	211	0.8%
Neulasta	179	0.7%

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
Aleve	1,896	42.7×
Mirena	3,768	42.4×
Erbitux	379	11×
Neupro	106	9.2×
Altace	175	8.6×
Humira	2,655	8.2×
Singulair	254	7.9×
Symbicort	138	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
Intra-uterine contraceptive device expelled	1,310	5%
Nauseafeeling sick	1,058	4.1%
Drug ineffectivethe medicine did not work as expected	890	3.4%
Dyspnoeashortness of breath	807	3.1%
Headachehead pain	765	2.9%
Dizzinesslight-headedness or unsteadiness	741	2.8%
Vomitingbeing sick	713	2.7%
Abdominal painstomach or belly pain	646	2.5%
Painpain, site not specified	621	2.4%
Rashskin rash	611	2.3%
Depressionlow mood	573	2.2%
Diarrhoealoose or frequent stools	569	2.2%
Fatiguetiredness	567	2.2%
Pyrexiafever	549	2.1%
Deaththe patient died; cause not stated by this term	512	2%

Devices named most often

Brand	Reports	Share of device reports
Icy Hot Heat Therapy Patch	335	2.6%
Embrace Pump	324	2.5%
Accu-Chek Comfort Curve Test Strips	292	2.2%
Cypher Sirolimus-Eluting Coronary Stent	225	1.7%
M Series	140	1.1%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	137	1%
Ge Oec 9800	135	1%
Precision Xtra/Optium	121	0.9%
Bravo	109	0.8%
Accu-Chek Aviva Test Strips	107	0.8%

Questions about March 2008

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

26,011 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 13,123 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 17,666 drug reports.

Which drugs were listed most often?

Mirena (3,768), Humira (2,655), Aleve (1,896), Chantix (412) and Erbitux (379).

Which reactions were recorded most often?

intra-uterine contraceptive device expelled (1,310), nausea (1,058), drug ineffective (890), dyspnoea (807) and headache (765).

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.