Reports received by FDA, by month

August 2007: adverse event reports received by FDA

26,626 drug reports (FAERS) and 17,647 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.

26,626
drug reports received: 17,607 a year earlier; 20,134
monthly average, preceding 12 months: 32.2% against the average; 17,647
device reports received: 12,137 a year earlier

FDA received 26,626 drug adverse event reports in August 2007, against 17,607 in the same month a year earlier and a monthly average of 20,134 over the preceding 12 months. The MAUDE device database received 17,647 reports that month (12,137 a year earlier).

The drugs listed most often as suspect products were Alli (7,529), Januvia (957) and Wellbutrin (601), and the reactions recorded most often were drug ineffective (1,993), constipation (1,286) and gastrointestinal disorder (1,275).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Lioresal (baclofen) (27.1× its average), Lucentis (11.3× its average) and Flomax (7.1× 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 August 2007

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Alli	7,529	28.3%
Januvia	957	3.6%
Wellbutrin	601	2.3%
Lioresal (baclofen)	562	2.1%
Paxil	400	1.5%
Celebrex	345	1.3%
Remicade	286	1.1%
Avonex	278	1%
Rozerem	278	1%
Chantix	232	0.9%
Enbrel	223	0.8%
Tiotropium bromide	222	0.8%
Humira	220	0.8%
Lucentis	217	0.8%
Imitrex	208	0.8%

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
Lioresal (baclofen)	562	27.1×
Lucentis	217	11.3×
Flomax	110	7.1×
Januvia	957	6.8×
Paroxetine	73	6.7×
Wellbutrin	601	6.2×
Malarone	79	6×
Imitrex	208	5.7×

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
Drug ineffectivethe medicine did not work as expected	1,993	7.5%
Constipationconstipation	1,286	4.8%
Gastrointestinal disorder	1,275	4.8%
Nauseafeeling sick	1,140	4.3%
Headachehead pain	1,074	4%
Diarrhoealoose or frequent stools	983	3.7%
Weight increasedweight gain	867	3.3%
Dizzinesslight-headedness or unsteadiness	838	3.1%
Flatulencewind	753	2.8%
Vomitingbeing sick	698	2.6%
Fatiguetiredness	691	2.6%
Dyspnoeashortness of breath	680	2.6%
Pharmaceutical product complaint	653	2.5%
Abdominal distensiona bloated abdomen	609	2.3%
Abdominal pain upperupper stomach pain	545	2%

Devices named most often

Brand	Reports	Share of device reports
Freestyle Flash	1,868	10.6%
Freestyle	514	2.9%
Ge Oec 9800	437	2.5%
Accu-Chek Comfort Curve Test Strips	356	2%
Contak Renewal 3	254	1.4%
Cypher Sirolimus-Eluting Coronary Stent	205	1.2%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	173	1%
Flextend Is-1 Bi Positive Fix	152	0.9%
Contak Renewal	150	0.9%
Endotak Reliance G	147	0.8%

Questions about August 2007

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

26,626 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 17,647 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 17,607 drug reports.

Which drugs were listed most often?

Alli (7,529), Januvia (957), Wellbutrin (601), Lioresal (baclofen) (562) and Paxil (400).

Which reactions were recorded most often?

drug ineffective (1,993), constipation (1,286), gastrointestinal disorder (1,275), nausea (1,140) and headache (1,074).

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.