Reports received by FDA, by month

May 2008: adverse event reports received by FDA

20,254 drug reports (FAERS) and 17,744 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.

20,254
drug reports received: 21,169 a year earlier; 24,214
monthly average, preceding 12 months: -16.4% against the average; 17,744
device reports received: 17,854 a year earlier

FDA received 20,254 drug adverse event reports in May 2008, against 21,169 in the same month a year earlier and a monthly average of 24,214 over the preceding 12 months. The MAUDE device database received 17,744 reports that month (17,854 a year earlier).

The drugs listed most often as suspect products were Digoxin (903), Chantix (502) and Mirena (469), and the reactions recorded most often were nausea (1,079), dizziness (915) and pharmaceutical product complaint (820).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Digoxin (34.8× its average), Veramyst (6.8× its average) and Albuterol sulfate (6.5× 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 2008

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Digoxin	903	4.5%
Chantix	502	2.5%
Mirena	469	2.3%
Tiotropium bromide	427	2.1%
Remicade	320	1.6%
Ultravist	300	1.5%
Enbrel	269	1.3%
Avonex	250	1.2%
Rebif	228	1.1%
Singulair	204	1%
Prempro	199	1%
Avelox	194	1%
Premarin	191	0.9%
Humira	188	0.9%
Lyrica	186	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
Digoxin	903	34.8×
Veramyst	109	6.8×
Albuterol sulfate	92	6.5×
Ultravist	300	5.7×
Valproic acid	94	4.7×
Magnevist	124	3.9×
Altabax	71	3.6×
Su-011 248	65	3×

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	1,079	5.3%
Dizzinesslight-headedness or unsteadiness	915	4.5%
Pharmaceutical product complaint	820	4%
Dyspnoeashortness of breath	806	4%
Vomitingbeing sick	803	4%
Fatiguetiredness	648	3.2%
Deaththe patient died; cause not stated by this term	640	3.2%
Drug ineffectivethe medicine did not work as expected	615	3%
Diarrhoealoose or frequent stools	609	3%
Headachehead pain	589	2.9%
Astheniaweakness or lack of energy	566	2.8%
Depressionlow mood	507	2.5%
Hypotensionlow blood pressure	485	2.4%
Pyrexiafever	464	2.3%
Painpain, site not specified	458	2.3%

Devices named most often

Brand	Reports	Share of device reports
Sprint Fidelis	754	4.2%
Contak Renewal 3	253	1.4%
Vitality Ds Vr	241	1.4%
Endotak Reliance G	227	1.3%
Accu-Chek Comfort Curve Test Strips	223	1.3%
Cypher Sirolimus-Eluting Coronary Stent	205	1.2%
Endotak Reliance	163	0.9%
Vitality Vr	135	0.8%
Polyflux Lr Capillary Dialyzer	134	0.8%
M Series	129	0.7%

Questions about May 2008

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

20,254 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 17,744 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 21,169 drug reports.

Which drugs were listed most often?

Digoxin (903), Chantix (502), Mirena (469), Tiotropium bromide (427) and Remicade (320).

Which reactions were recorded most often?

nausea (1,079), dizziness (915), pharmaceutical product complaint (820), dyspnoea (806) and vomiting (803).

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.