Reports received by FDA, by month

February 2008: adverse event reports received by FDA

22,882 drug reports (FAERS) and 15,264 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.

22,882
drug reports received: 20,336 a year earlier; 22,734
monthly average, preceding 12 months: 0.7% against the average; 15,264
device reports received: 11,987 a year earlier

FDA received 22,882 drug adverse event reports in February 2008, against 20,336 in the same month a year earlier and a monthly average of 22,734 over the preceding 12 months. The MAUDE device database received 15,264 reports that month (11,987 a year earlier).

The drugs listed most often as suspect products were Paxil (946), Chantix (686) and Valtrex (552), and the reactions recorded most often were nausea (1,042), drug ineffective (1,034) and drug exposure during pregnancy (991).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Valtrex (8.3× its average), Paxil (7.1× its average) and Angiomax (6.6× 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 February 2008

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Paxil	946	4.1%
Chantix	686	3%
Valtrex	552	2.4%
Januvia	525	2.3%
Mirena	449	2%
Heparin sodium	422	1.8%
Nicorette	412	1.8%
Tiotropium bromide	304	1.3%
Avonex	281	1.2%
Remicade	278	1.2%
Enbrel	266	1.2%
Isotretinoin	257	1.1%
Humira	243	1.1%
Avelox	243	1.1%
Imitrex	240	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
Valtrex	552	8.3×
Paxil	946	7.1×
Angiomax	89	6.6×
Tysabri	69	6.5×
Altabax	80	6.4×
Isotretinoin	257	5.5×
Mirena	449	5.4×
Botox	54	5.1×

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
Nauseafeeling sick	1,042	4.6%
Drug ineffectivethe medicine did not work as expected	1,034	4.5%
Drug exposure during pregnancythe medicine was taken during pregnancy	991	4.3%
Dizzinesslight-headedness or unsteadiness	769	3.4%
Deaththe patient died; cause not stated by this term	754	3.3%
Dyspnoeashortness of breath	711	3.1%
Vomitingbeing sick	705	3.1%
Congenital anomalya condition present at birth	689	3%
Headachehead pain	667	2.9%
Pharmaceutical product complaint	568	2.5%
Diarrhoealoose or frequent stools	563	2.5%
Fatiguetiredness	517	2.3%
Painpain, site not specified	509	2.2%
Depressionlow mood	482	2.1%
Rashskin rash	449	2%

Devices named most often

Brand	Reports	Share of device reports
Accu-Chek Comfort Curve Test Strips	249	1.6%
Contak Renewal 3	239	1.6%
Cypher Sirolimus-Eluting Coronary Stent	212	1.4%
Vitality Ds Vr	209	1.4%
Endotak Reliance G	194	1.3%
Vitality Vr	170	1.1%
Vitality Ds	157	1%
Ge Oec 9800	149	1%
M Series	144	0.9%
Endotak Reliance	144	0.9%

Questions about February 2008

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

22,882 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 15,264 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 20,336 drug reports.

Which drugs were listed most often?

Paxil (946), Chantix (686), Valtrex (552), Januvia (525) and Mirena (449).

Which reactions were recorded most often?

nausea (1,042), drug ineffective (1,034), drug exposure during pregnancy (991), dizziness (769) and death (754).

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.