Reports received by FDA, by month

January 2007: adverse event reports received by FDA

17,486 drug reports (FAERS) and 10,384 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.

17,486
drug reports received: 19,416 a year earlier; 20,289
monthly average, preceding 12 months: -13.8% against the average; 10,384
device reports received: 8,624 a year earlier

FDA received 17,486 drug adverse event reports in January 2007, against 19,416 in the same month a year earlier and a monthly average of 20,289 over the preceding 12 months. The MAUDE device database received 10,384 reports that month (8,624 a year earlier).

The drugs listed most often as suspect products were Abilify (1,047), Lunesta (726) and Acetaminophen (482), and the reactions recorded most often were drug ineffective (895), nausea (728) and death (688).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Abilify (26.5× its average), MultiHance (10.1× its average) and Arixtra (8.7× 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 2007

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Abilify	1,047	6%
Lunesta	726	4.2%
Acetaminophen	482	2.8%
Paxil	394	2.3%
Remicade	385	2.2%
Bupropion hydrochloride	359	2.1%
Avonex	285	1.6%
Seroquel	210	1.2%
Bextra	208	1.2%
Prempro	208	1.2%
Forteo	197	1.1%
Humira	193	1.1%
Enbrel	187	1.1%
Copaxone	163	0.9%
Zyprexa	157	0.9%

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
Abilify	1,047	26.5×
MultiHance	104	10.1×
Arixtra	120	8.7×
Copaxone	163	8.5×
Acetaminophen	482	7.7×
Chantix	97	5.5×
Ethanol	88	4.9×
Bupropion hydrochloride	359	4.6×

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
Drug ineffectivethe medicine did not work as expected	895	5.1%
Nauseafeeling sick	728	4.2%
Deaththe patient died; cause not stated by this term	688	3.9%
Vomitingbeing sick	648	3.7%
Intentional overdosea deliberate overdose	613	3.5%
Dyspnoeashortness of breath	534	3.1%
Insomniadifficulty sleeping	512	2.9%
Headachehead pain	503	2.9%
Dizzinesslight-headedness or unsteadiness	478	2.7%
Diarrhoealoose or frequent stools	445	2.5%
Pyrexiafever	444	2.5%
Fatiguetiredness	404	2.3%
Astheniaweakness or lack of energy	393	2.2%
Convulsion	375	2.1%
Somnolencedrowsiness	361	2.1%

Devices named most often

Brand	Reports	Share of device reports
Accu-Chek Comfort Curve Test Strips	332	3.2%
Freestyle Flash	306	2.9%
Coaguchek S System	218	2.1%
Cypher Sirolimus-Eluting Coronary Stent	204	2%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	190	1.8%
M Series	189	1.8%
Sprint Fidelis	148	1.4%
Freestyle	137	1.3%
Accu-Chek Compact Test Drum	101	1%
Tendril Sdx	98	0.9%

Questions about January 2007

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

17,486 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 10,384 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 19,416 drug reports.

Which drugs were listed most often?

Abilify (1,047), Lunesta (726), Acetaminophen (482), Paxil (394) and Remicade (385).

Which reactions were recorded most often?

drug ineffective (895), nausea (728), death (688), vomiting (648) and intentional overdose (613).

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.