Reports received by FDA, by month

July 2008: adverse event reports received by FDA

26,560 drug reports (FAERS) and 16,792 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.

26,560
drug reports received: 26,259 a year earlier; 25,076
monthly average, preceding 12 months: 5.9% against the average; 16,792
device reports received: 13,694 a year earlier

FDA received 26,560 drug adverse event reports in July 2008, against 26,259 in the same month a year earlier and a monthly average of 25,076 over the preceding 12 months. The MAUDE device database received 16,792 reports that month (13,694 a year earlier).

The drugs listed most often as suspect products were Byetta (2,096), Mirena (785) and Avonex (753), and the reactions recorded most often were nausea (1,814), blood glucose increased (1,256) and dizziness (1,125).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Levoxyl (12.2× its average), Kineret (7.6× its average) and Zantac (7.2× 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 July 2008

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Byetta	2,096	7.9%
Mirena	785	3%
Avonex	753	2.8%
Digoxin	503	1.9%
Avandia	480	1.8%
Remicade	416	1.6%
Tiotropium bromide	410	1.5%
Chantix	409	1.5%
Nicorette	319	1.2%
Magnevist	302	1.1%
Humira	284	1.1%
Enbrel	277	1%
Procrit	271	1%
Imitrex	256	1%
Aleve	240	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
Levoxyl	210	12.2×
Kineret	154	7.6×
Zantac	77	7.2×
Magnevist	302	6.4×
Procrit	271	6.1×
Epogen	87	5.7×
Imitrex	256	5.1×
Avandia	480	4.7×

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	1,814	6.8%
Blood glucose increasedraised blood sugar reading	1,256	4.7%
Dizzinesslight-headedness or unsteadiness	1,125	4.2%
Vomitingbeing sick	1,027	3.9%
Dyspnoeashortness of breath	1,004	3.8%
Drug ineffectivethe medicine did not work as expected	985	3.7%
Fatiguetiredness	890	3.4%
Weight decreasedweight loss	863	3.2%
Headachehead pain	855	3.2%
Diarrhoealoose or frequent stools	826	3.1%
Astheniaweakness or lack of energy	735	2.8%
Malaisegeneral feeling of being unwell	703	2.6%
Pyrexiafever	673	2.5%
Pharmaceutical product complaint	599	2.3%
Falla fall	591	2.2%

Devices named most often

Brand	Reports	Share of device reports
Ge Oec 9800	405	2.4%
Cypher Sirolimus-Eluting Coronary Stent	212	1.3%
Accu-Chek Comfort Curve Test Strips	212	1.3%
M Series	177	1.1%
Polyflux Lr Capillary Dialyzer	163	1%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	155	0.9%
One Touch Ultralink Meter	138	0.8%
Ge Oec 9600	137	0.8%
Ge Oec 9900	134	0.8%
Sprint Quattro Secure	111	0.7%

Questions about July 2008

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

26,560 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 16,792 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 26,259 drug reports.

Which drugs were listed most often?

Byetta (2,096), Mirena (785), Avonex (753), Digoxin (503) and Avandia (480).

Which reactions were recorded most often?

nausea (1,814), blood glucose increased (1,256), dizziness (1,125), vomiting (1,027) and dyspnoea (1,004).

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.