Reports received by FDA, by month

May 2005: adverse event reports received by FDA

16,335 drug reports (FAERS) and 8,157 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.

16,335
drug reports received: 10,684 a year earlier; 16,957
monthly average, preceding 12 months: -3.7% against the average; 8,157
device reports received: 6,577 a year earlier

FDA received 16,335 drug adverse event reports in May 2005, against 10,684 in the same month a year earlier and a monthly average of 16,957 over the preceding 12 months. The MAUDE device database received 8,157 reports that month (6,577 a year earlier).

The drugs listed most often as suspect products were Zometa (615), Vioxx (427) and Wellbutrin (418), and the reactions recorded most often were nausea (698), pharmaceutical product complaint (684) and dizziness (579).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Aredia (17.2× its average), Factive (16.2× its average) and Zometa (16.2× 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 May 2005

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Zometa	615	3.8%
Vioxx	427	2.6%
Wellbutrin	418	2.6%
Zetia	328	2%
Bextra	319	2%
Abilify	288	1.8%
Zyprexa	269	1.6%
Avonex	266	1.6%
Ketek	264	1.6%
Namenda	260	1.6%
Factive	249	1.5%
Celebrex	243	1.5%
Provera	209	1.3%
Lovenox	208	1.3%
Proplex T	205	1.3%

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
Aredia	201	17.2×
Factive	249	16.2×
Zometa	615	16.2×
Lovenox	208	6.6×
Depo-Provera	172	5.5×
Ketek	264	5.3×
Avandamet	150	4.7×
Melphalan	51	4×

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	698	4.3%
Pharmaceutical product complaint	684	4.2%
Dizzinesslight-headedness or unsteadiness	579	3.5%
Osteonecrosis	559	3.4%
Dyspnoeashortness of breath	549	3.4%
Vomitingbeing sick	521	3.2%
Drug ineffectivethe medicine did not work as expected	500	3.1%
Headachehead pain	482	3%
Pyrexiafever	467	2.9%
Diarrhoealoose or frequent stools	447	2.7%
Astheniaweakness or lack of energy	446	2.7%
Rashskin rash	438	2.7%
Fatiguetiredness	419	2.6%
Condition aggravatedthe condition being treated got worse	389	2.4%
Convulsion	388	2.4%

Devices named most often

Brand	Reports	Share of device reports
One Touch Ultra	374	4.6%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	194	2.4%
Accu-Chek Comfort Curve	184	2.3%
M Series	164	2%
Cypher Sirolimus-Eluting Coronary Stent	128	1.6%
Colleague Volumetric Infusion Pump	103	1.3%
Colleague Cx Volumetric Infusion Pump	96	1.2%
Endotak Reliance	95	1.2%
Minicap Pd Transfer Set Easy-Lock With Twist Clamp	58	0.7%
Colleague 3cx Volumetric Infusion Pump	58	0.7%

Questions about May 2005

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

16,335 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 8,157 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 10,684 drug reports.

Which drugs were listed most often?

Zometa (615), Vioxx (427), Wellbutrin (418), Zetia (328) and Bextra (319).

Which reactions were recorded most often?

nausea (698), pharmaceutical product complaint (684), dizziness (579), osteonecrosis (559) and dyspnoea (549).

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.