Reports received by FDA, by month

June 2006: adverse event reports received by FDA

17,792 drug reports (FAERS) and 9,411 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.

17,792
drug reports received: 16,450 a year earlier; 19,732
monthly average, preceding 12 months: -9.8% against the average; 9,411
device reports received: 8,175 a year earlier

FDA received 17,792 drug adverse event reports in June 2006, against 16,450 in the same month a year earlier and a monthly average of 19,732 over the preceding 12 months. The MAUDE device database received 9,411 reports that month (8,175 a year earlier).

The drugs listed most often as suspect products were Byetta (3,472), Boniva (1,062) and Cymbalta (597), and the reactions recorded most often were nausea (1,724), weight decreased (1,274) and blood glucose increased (1,115).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Byetta (9.8× its average), Enablex (7.1× its average) and Boniva (5.7× 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 June 2006

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Byetta	3,472	19.5%
Boniva	1,062	6%
Cymbalta	597	3.4%
Remicade	265	1.5%
Tiotropium bromide	264	1.5%
Avastin	250	1.4%
Avonex	248	1.4%
Duragesic-100	214	1.2%
Enablex	202	1.1%
Vesicare	189	1.1%
Ortho Evra	186	1%
Cialis	181	1%
Bextra	179	1%
Enbrel	164	0.9%
Forteo	150	0.8%

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
Byetta	3,472	9.8×
Enablex	202	7.1×
Boniva	1,062	5.7×
Vesicare	189	3.9×
Ortho Evra	186	3.4×
Xeloda	95	3.2×
Duragesic-100	214	3×
Augmentin '125	90	2.6×

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	1,724	9.7%
Weight decreasedweight loss	1,274	7.2%
Blood glucose increasedraised blood sugar reading	1,115	6.3%
Vomitingbeing sick	819	4.6%
Drug ineffectivethe medicine did not work as expected	796	4.5%
Diarrhoealoose or frequent stools	775	4.4%
Dizzinesslight-headedness or unsteadiness	706	4%
Headachehead pain	666	3.7%
Decreased appetitereduced appetite	547	3.1%
Fatiguetiredness	542	3%
Dyspnoeashortness of breath	540	3%
Astheniaweakness or lack of energy	528	3%
Pyrexiafever	471	2.6%
Blood glucose decreasedlow blood sugar reading	440	2.5%
Condition aggravatedthe condition being treated got worse	373	2.1%

Devices named most often

Brand	Reports	Share of device reports
Accu-Chek Comfort Curve Test Strips	308	3.3%
M Series	211	2.2%
Cypher Sirolimus-Eluting Coronary Stent	157	1.7%
Taxus Express2 Paclitaxel-Eluting Coronary Stent	128	1.4%
Accu-Chek Compact Test Drum	85	0.9%
Ot Ultra Meter	81	0.9%
Coaguchek S System	75	0.8%
Renu With Moistureloc Multi-Purpose Solution	72	0.8%
Acrysof	70	0.7%
Colleague Volumetric Infusion Pump	70	0.7%

Questions about June 2006

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

17,792 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 9,411 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 16,450 drug reports.

Which drugs were listed most often?

Byetta (3,472), Boniva (1,062), Cymbalta (597), Remicade (265) and Tiotropium bromide (264).

Which reactions were recorded most often?

nausea (1,724), weight decreased (1,274), blood glucose increased (1,115), vomiting (819) and drug ineffective (796).

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.