Reports received by FDA, by month

August 2006: adverse event reports received by FDA

17,607 drug reports (FAERS) and 12,137 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.

17,607
drug reports received: 18,771 a year earlier; 20,092
monthly average, preceding 12 months: -12.4% against the average; 12,137
device reports received: 8,793 a year earlier

FDA received 17,607 drug adverse event reports in August 2006, against 18,771 in the same month a year earlier and a monthly average of 20,092 over the preceding 12 months. The MAUDE device database received 12,137 reports that month (8,793 a year earlier).

The drugs listed most often as suspect products were Coumadin (695), Paxil (594) and Procrit (352), and the reactions recorded most often were drug ineffective (946), nausea (810) and vomiting (618).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Coumadin (14.6× its average), Procrit (10.6× its average) and Nicorette (9.7× 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 August 2006

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Coumadin	695	3.9%
Paxil	594	3.4%
Procrit	352	2%
Wellbutrin	348	2%
Remicade	339	1.9%
Nicorette	331	1.9%
Avonex	282	1.6%
Bextra	269	1.5%
Tiotropium bromide	242	1.4%
Forteo	224	1.3%
Erbitux	219	1.2%
Enablex	209	1.2%
Paroxetine hydrochloride	208	1.2%
Zyprexa	207	1.2%
Humira	196	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
Coumadin	695	14.6×
Procrit	352	10.6×
Nicorette	331	9.7×
Exjade	98	8.2×
Nicotine polacrilex	176	7.2×
Malarone	67	6.3×
Aranesp	121	5.4×
Epogen	56	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
Drug ineffectivethe medicine did not work as expected	946	5.4%
Nauseafeeling sick	810	4.6%
Vomitingbeing sick	618	3.5%
Dyspnoeashortness of breath	618	3.5%
Dizzinesslight-headedness or unsteadiness	616	3.5%
Headachehead pain	579	3.3%
Diarrhoealoose or frequent stools	562	3.2%
Pyrexiafever	527	3%
Fatiguetiredness	521	3%
Astheniaweakness or lack of energy	500	2.8%
Drug exposure during pregnancythe medicine was taken during pregnancy	410	2.3%
Condition aggravatedthe condition being treated got worse	399	2.3%
Rashskin rash	359	2%
Malaisegeneral feeling of being unwell	358	2%
Pharmaceutical product complaint	352	2%

Devices named most often

Brand	Reports	Share of device reports
Silicone Advance Optic Lens	307	2.5%
Accu-Chek Comfort Curve Test Strips	231	1.9%
Vitality 2 Vr	185	1.5%
Soflex Three-Piece Foldable Lens	150	1.2%
Flextend Is-1 Bi Positive Fix	143	1.2%
Cypher Sirolimus-Eluting Coronary Stent	142	1.2%
M Series	134	1.1%
Accu-Chek Comfort Curve	132	1.1%
Taxus Express2 Paclitaxel-Eluting Coronary Stent	131	1.1%
Ultracision Harmonic Ace	113	0.9%

Questions about August 2006

How many adverse event reports did FDA receive in August 2006?

17,607 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 12,137 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 18,771 drug reports.

Which drugs were listed most often?

Coumadin (695), Paxil (594), Procrit (352), Wellbutrin (348) and Remicade (339).

Which reactions were recorded most often?

drug ineffective (946), nausea (810), vomiting (618), dyspnoea (618) and dizziness (616).

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.