Reports received by FDA, by month

August 2008: adverse event reports received by FDA

24,040 drug reports (FAERS) and 18,241 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.

24,040
drug reports received: 26,626 a year earlier; 25,101
monthly average, preceding 12 months: -4.2% against the average; 18,241
device reports received: 17,647 a year earlier

FDA received 24,040 drug adverse event reports in August 2008, against 26,626 in the same month a year earlier and a monthly average of 25,101 over the preceding 12 months. The MAUDE device database received 18,241 reports that month (17,647 a year earlier).

The drugs listed most often as suspect products were Niaspan (1,067), Lioresal (baclofen) (814) and Simcor (794), and the reactions recorded most often were drug ineffective (1,319), nausea (1,119) and flushing (1,058).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Synthroid (37.7× its average), Coumadin (20.3× its average) and Levothyroxine sodium (10.8× 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 2008

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Niaspan	1,067	4.4%
Lioresal (baclofen)	814	3.4%
Simcor	794	3.3%
Mirena	793	3.3%
Coumadin	719	3%
Januvia	711	3%
Synthroid	534	2.2%
Coated Pds	449	1.9%
Remicade	362	1.5%
Chantix	353	1.5%
Tiotropium bromide	323	1.3%
Avonex	287	1.2%
Avandia	287	1.2%
Humira	284	1.2%
Enbrel	253	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
Synthroid	534	37.7×
Coumadin	719	20.3×
Levothyroxine sodium	190	10.8×
Lioresal (baclofen)	814	9.3×
Isentress	66	5.4×
Malarone	69	4.5×
Veramyst	101	3.9×
Zovirax	50	3.7×

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	1,319	5.5%
Nauseafeeling sick	1,119	4.7%
Flushingsudden reddening or warmth of the skin	1,058	4.4%
Dizzinesslight-headedness or unsteadiness	890	3.7%
Headachehead pain	849	3.5%
Pruritusitching	841	3.5%
Dyspnoeashortness of breath	815	3.4%
Fatiguetiredness	688	2.9%
Vomitingbeing sick	681	2.8%
Diarrhoealoose or frequent stools	679	2.8%
Painpain, site not specified	611	2.5%
Astheniaweakness or lack of energy	569	2.4%
Rashskin rash	567	2.4%
Pyrexiafever	558	2.3%
Depressionlow mood	491	2%

Devices named most often

Brand	Reports	Share of device reports
Versacare	1,222	6.7%
Ge Oec 9800	311	1.7%
Contak Renewal 3	271	1.5%
Accu-Chek Comfort Curve Test Strips	233	1.3%
Endotak Reliance G	228	1.2%
Vitality Ds Vr	166	0.9%
Cypher Sirolimus-Eluting Coronary Stent	159	0.9%
Endotak Reliance	148	0.8%
M Series	147	0.8%
One Touch Ultralink Meter	141	0.8%

Questions about August 2008

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

24,040 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 18,241 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 26,626 drug reports.

Which drugs were listed most often?

Niaspan (1,067), Lioresal (baclofen) (814), Simcor (794), Mirena (793) and Coumadin (719).

Which reactions were recorded most often?

drug ineffective (1,319), nausea (1,119), flushing (1,058), dizziness (890) and headache (849).

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.