Reports received by FDA, by month

June 2007: adverse event reports received by FDA

17,019 drug reports (FAERS) and 12,412 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.

17,019
drug reports received: 17,792 a year earlier; 19,856
monthly average, preceding 12 months: -14.3% against the average; 12,412
device reports received: 9,411 a year earlier

FDA received 17,019 drug adverse event reports in June 2007, against 17,792 in the same month a year earlier and a monthly average of 19,856 over the preceding 12 months. The MAUDE device database received 12,412 reports that month (9,411 a year earlier).

The drugs listed most often as suspect products were Celebrex (742), Crestor (413) and OxyContin (370), and the reactions recorded most often were cardiovascular disorder (736), drug ineffective (706) and nausea (677).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Atacand (9.8× its average), Opticlik (7.8× its average) and Tamoxifen citrate (7.8× 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 June 2007

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Celebrex	742	4.4%
Crestor	413	2.4%
OxyContin	370	2.2%
Seroquel	366	2.2%
Lantus	302	1.8%
Remicade	262	1.5%
Avonex	229	1.3%
Humalog	222	1.3%
Enbrel	211	1.2%
Humira	206	1.2%
Rhinocort	203	1.2%
Bextra	197	1.2%
Pulmicort Respules	197	1.2%
Vesicare	186	1.1%
Enablex	182	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
Atacand	118	9.8×
Opticlik	94	7.8×
Tamoxifen citrate	118	7.8×
OxyContin	370	7.5×
MultiHance	158	5.8×
Lantus	302	5.8×
Invega	72	5×
Xeloda	161	4.6×

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
Cardiovascular disorder	736	4.3%
Drug ineffectivethe medicine did not work as expected	706	4.1%
Nauseafeeling sick	677	4%
Dyspnoeashortness of breath	581	3.4%
Vomitingbeing sick	536	3.1%
Dizzinesslight-headedness or unsteadiness	501	2.9%
Diarrhoealoose or frequent stools	468	2.7%
Headachehead pain	427	2.5%
Fatiguetiredness	425	2.5%
Pyrexiafever	407	2.4%
Astheniaweakness or lack of energy	363	2.1%
Deaththe patient died; cause not stated by this term	359	2.1%
Blood glucose increasedraised blood sugar reading	350	2.1%
Diabetes mellitusdiabetes	334	2%
Falla fall	333	2%

Devices named most often

Brand	Reports	Share of device reports
Freestyle Flash	811	6.5%
Ge Oec 9800	438	3.5%
Freestyle	254	2%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	213	1.7%
M Series	199	1.6%
Cypher Sirolimus-Eluting Coronary Stent	192	1.5%
Accu-Chek Comfort Curve Test Strips	184	1.5%
Bd Paradigm Link Glucose Monitor	91	0.7%
Ge Oec 9600	82	0.7%
Programming Software	81	0.7%

Questions about June 2007

How many adverse event reports did FDA receive in June 2007?

17,019 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 12,412 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 17,792 drug reports.

Which drugs were listed most often?

Celebrex (742), Crestor (413), OxyContin (370), Seroquel (366) and Lantus (302).

Which reactions were recorded most often?

cardiovascular disorder (736), drug ineffective (706), nausea (677), dyspnoea (581) and vomiting (536).

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.