Reports received by FDA, by month

August 2005: adverse event reports received by FDA

18,771 drug reports (FAERS) and 8,793 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.

18,771
drug reports received: 15,279 a year earlier; 17,624
monthly average, preceding 12 months: 6.5% against the average; 8,793
device reports received: 7,414 a year earlier

FDA received 18,771 drug adverse event reports in August 2005, against 15,279 in the same month a year earlier and a monthly average of 17,624 over the preceding 12 months. The MAUDE device database received 8,793 reports that month (7,414 a year earlier).

The drugs listed most often as suspect products were Paxil (1,591), Vioxx (1,172) and OxyContin (909), and the reactions recorded most often were nausea (1,026), drug withdrawal syndrome (886) and drug ineffective (862).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were OxyContin (9.1× its average), Tequin (7.4× its average) and Rituxan (5.8× 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 2005

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Paxil	1,591	8.5%
Vioxx	1,172	6.2%
OxyContin	909	4.8%
Avonex	540	2.9%
Wellbutrin	338	1.8%
Abilify	317	1.7%
Zetia	277	1.5%
Commit	271	1.4%
Cialis	247	1.3%
Remicade	234	1.2%
Factive	211	1.1%
Provera	206	1.1%
Premarin	196	1%
Pegasys	179	1%
Byetta	178	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
OxyContin	909	9.1×
Tequin	149	7.4×
Rituxan	150	5.8×
Factive	211	5.8×
Paxil	1,591	4.5×
Zovirax	51	3.8×
Copegus	129	3.6×
Vytorin	77	3.6×

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
Nauseafeeling sick	1,026	5.5%
Drug withdrawal syndromesymptoms on stopping a medicine	886	4.7%
Drug ineffectivethe medicine did not work as expected	862	4.6%
Myocardial infarctionheart attack	845	4.5%
Dizzinesslight-headedness or unsteadiness	771	4.1%
Headachehead pain	676	3.6%
Vomitingbeing sick	671	3.6%
Dyspnoeashortness of breath	652	3.5%
Diarrhoealoose or frequent stools	598	3.2%
Astheniaweakness or lack of energy	572	3%
Depressionlow mood	570	3%
Drug abuser	560	3%
Cerebrovascular accidentstroke	558	3%
Pyrexiafever	551	2.9%
Fatiguetiredness	547	2.9%

Devices named most often

Brand	Reports	Share of device reports
One Touch Ultra	329	3.7%
Colleague Cx Volumetric Infusion Pump	212	2.4%
M Series	187	2.1%
Colleague Volumetric Infusion Pump	158	1.8%
Cypher Sirolimus-Eluting Coronary Stent	155	1.8%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	130	1.5%
Accu-Chek Comfort Curve	105	1.2%
Sterrad 100s Sterilizer	102	1.2%
Colleague 3 Volumetric Infusion Pump	87	1%
Endotak Reliance	85	1%

Questions about August 2005

How many adverse event reports did FDA receive in August 2005?

18,771 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 8,793 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 15,279 drug reports.

Which drugs were listed most often?

Paxil (1,591), Vioxx (1,172), OxyContin (909), Avonex (540) and Wellbutrin (338).

Which reactions were recorded most often?

nausea (1,026), drug withdrawal syndrome (886), drug ineffective (862), myocardial infarction (845) and dizziness (771).

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.