Reports received by FDA, by month

March 2007: adverse event reports received by FDA

17,666 drug reports (FAERS) and 13,446 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.

17,666
drug reports received: 19,072 a year earlier; 19,947
monthly average, preceding 12 months: -11.4% against the average; 13,446
device reports received: 10,283 a year earlier

FDA received 17,666 drug adverse event reports in March 2007, against 19,072 in the same month a year earlier and a monthly average of 19,947 over the preceding 12 months. The MAUDE device database received 13,446 reports that month (10,283 a year earlier).

The drugs listed most often as suspect products were Nicorette (509), Requip (441) and Plavix (433), and the reactions recorded most often were nausea (749), drug ineffective (718) and dyspnoea (683).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Neulasta (10.4× its average), Aleve (8.7× its average) and Nicorette (8.1× 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 2007

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Nicorette	509	2.9%
Requip	441	2.5%
Plavix	433	2.5%
Tiotropium bromide	346	2%
Avastin	303	1.7%
Rebif	295	1.7%
Avonex	286	1.6%
Lamictal	260	1.5%
Remicade	236	1.3%
Aleve	234	1.3%
Bextra	233	1.3%
Nicotine polacrilex	228	1.3%
Enbrel	223	1.3%
Neulasta	211	1.2%
Celebrex	208	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
Neulasta	211	10.4×
Aleve	234	8.7×
Nicorette	509	8.1×
Rebif	295	6×
Nicotine polacrilex	228	5.9×
Plavix	433	5.9×
Requip	441	5.8×
MultiHance	95	4.9×

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
Nauseafeeling sick	749	4.2%
Drug ineffectivethe medicine did not work as expected	718	4.1%
Dyspnoeashortness of breath	683	3.9%
Vomitingbeing sick	560	3.2%
Dizzinesslight-headedness or unsteadiness	513	2.9%
Pyrexiafever	489	2.8%
Deaththe patient died; cause not stated by this term	458	2.6%
Headachehead pain	453	2.6%
Intentional drug misuse	453	2.6%
Diarrhoealoose or frequent stools	428	2.4%
Fatiguetiredness	425	2.4%
Rashskin rash	381	2.2%
Pharmaceutical product complaint	374	2.1%
Myocardial infarctionheart attack	372	2.1%
Falla fall	339	1.9%

Devices named most often

Brand	Reports	Share of device reports
Freestyle Flash	962	7.2%
Freestyle	639	4.8%
Accu-Chek Comfort Curve Test Strips	255	1.9%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	222	1.7%
Cypher Sirolimus-Eluting Coronary Stent	184	1.4%
Sprint Fidelis	181	1.3%
M Series	149	1.1%
Tendril Sdx	125	0.9%
Harmonic Ace 36 Cm	117	0.9%
Starclose Vascular Closure System	96	0.7%

Questions about March 2007

How many adverse event reports did FDA receive in March 2007?

17,666 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 13,446 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 19,072 drug reports.

Which drugs were listed most often?

Nicorette (509), Requip (441), Plavix (433), Tiotropium bromide (346) and Avastin (303).

Which reactions were recorded most often?

nausea (749), drug ineffective (718), dyspnoea (683), vomiting (560) and dizziness (513).

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.