Reports received by FDA, by month

January 2008: adverse event reports received by FDA

24,579 drug reports (FAERS) and 14,039 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.

24,579
drug reports received: 17,486 a year earlier; 22,143
monthly average, preceding 12 months: 11% against the average; 14,039
device reports received: 10,384 a year earlier

FDA received 24,579 drug adverse event reports in January 2008, against 17,486 in the same month a year earlier and a monthly average of 22,143 over the preceding 12 months. The MAUDE device database received 14,039 reports that month (10,384 a year earlier).

The drugs listed most often as suspect products were Byetta (2,374), Revlimid (1,711) and Prempro (777), and the reactions recorded most often were nausea (1,552), blood glucose increased (1,359) and vomiting (853).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Yaz (22.7× its average), Revlimid (14.2× its average) and Prempro (11.4× 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 2008

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Byetta	2,374	9.7%
Revlimid	1,711	7%
Prempro	777	3.2%
Plavix	609	2.5%
Chantix	579	2.4%
Premarin	506	2.1%
Tiotropium bromide	396	1.6%
Yaz	379	1.5%
Provera	378	1.5%
Remicade	313	1.3%
Aspirin	303	1.2%
Bupropion hydrochloride	302	1.2%
Avonex	283	1.2%
Acetaminophen	277	1.1%
Enbrel	268	1.1%

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
Yaz	379	22.7×
Revlimid	1,711	14.2×
Prempro	777	11.4×
Omnicef	112	10.2×
Alprazolam	205	8.8×
Copaxone	229	8.6×
Provera	378	7.2×
Premarin	506	7.1×

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	1,552	6.3%
Blood glucose increasedraised blood sugar reading	1,359	5.5%
Vomitingbeing sick	853	3.5%
Dizzinesslight-headedness or unsteadiness	853	3.5%
Drug ineffectivethe medicine did not work as expected	802	3.3%
Weight decreasedweight loss	797	3.2%
Fatiguetiredness	792	3.2%
Diarrhoealoose or frequent stools	762	3.1%
Headachehead pain	732	3%
Completed suicidedeath by suicide	728	3%
Dyspnoeashortness of breath	723	2.9%
Breast cancerbreast cancer	588	2.4%
Astheniaweakness or lack of energy	566	2.3%
Deaththe patient died; cause not stated by this term	553	2.2%
Pyrexiafever	516	2.1%

Devices named most often

Brand	Reports	Share of device reports
Sprint Fidelis	562	4%
Accu-Chek Comfort Curve Test Strips	343	2.4%
Cypher Sirolimus-Eluting Coronary Stent	207	1.5%
Cell-Dyn Wbc Reagent A	184	1.3%
Ge Oec 9800	172	1.2%
M Series	154	1.1%
Mesh - Composix Kugel	150	1.1%
Accu-Chek Aviva Test Strips	144	1%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	121	0.9%
Accu-Chek Compact Test Drum	118	0.8%

Questions about January 2008

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

24,579 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 14,039 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 17,486 drug reports.

Which drugs were listed most often?

Byetta (2,374), Revlimid (1,711), Prempro (777), Plavix (609) and Chantix (579).

Which reactions were recorded most often?

nausea (1,552), blood glucose increased (1,359), vomiting (853), dizziness (853) and drug ineffective (802).

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.