Reports received by FDA, by month

July 2006: adverse event reports received by FDA

22,154 drug reports (FAERS) and 8,693 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.

22,154
drug reports received: 19,186 a year earlier; 19,844
monthly average, preceding 12 months: 11.6% against the average; 8,693
device reports received: 7,825 a year earlier

FDA received 22,154 drug adverse event reports in July 2006, against 19,186 in the same month a year earlier and a monthly average of 19,844 over the preceding 12 months. The MAUDE device database received 8,693 reports that month (7,825 a year earlier).

The drugs listed most often as suspect products were Byetta (3,090), Lyrica (946) and Lunesta (929), and the reactions recorded most often were nausea (1,757), blood glucose increased (1,470) and weight decreased (1,450).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Procrit (12.5× its average), Nexavar (12.4× its average) and Avandia (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 July 2006

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Byetta	3,090	13.9%
Lyrica	946	4.3%
Lunesta	929	4.2%
Avandia	832	3.8%
Celebrex	790	3.6%
Clozapine	589	2.7%
Risperdal	422	1.9%
Provera	394	1.8%
Premarin	324	1.5%
Forteo	280	1.3%
Imitrex	274	1.2%
Medroxyprogesterone acetate	253	1.1%
Remicade	250	1.1%
Avonex	243	1.1%
Tarceva	240	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
Procrit	214	12.5×
Nexavar	228	12.4×
Avandia	832	8×
Avelox	198	7.1×
Risperdal	422	6.3×
Zantac	104	5.7×
Herceptin	142	5.7×
Metformin	145	5.6×

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	1,757	7.9%
Blood glucose increasedraised blood sugar reading	1,470	6.6%
Weight decreasedweight loss	1,450	6.5%
Drug ineffectivethe medicine did not work as expected	1,222	5.5%
Vomitingbeing sick	919	4.1%
Dizzinesslight-headedness or unsteadiness	778	3.5%
Diarrhoealoose or frequent stools	761	3.4%
Headachehead pain	734	3.3%
Dyspnoeashortness of breath	695	3.1%
Astheniaweakness or lack of energy	649	2.9%
Fatiguetiredness	641	2.9%
Insomniadifficulty sleeping	560	2.5%
Pyrexiafever	551	2.5%
Granulocytopenia	540	2.4%
Decreased appetitereduced appetite	529	2.4%

Devices named most often

Brand	Reports	Share of device reports
Accu-Chek Comfort Curve Test Strips	220	2.5%
Silicone Advance Optic Lens	124	1.4%
M Series	122	1.4%
Cypher Sirolimus-Eluting Coronary Stent	115	1.3%
Accu-Chek Comfort Curve	103	1.2%
Soflex Three-Piece Foldable Lens	97	1.1%
Tendril Sdx	97	1.1%
Ultracision Harmonic Ace	89	1%
Ot Ultra Meter	86	1%
Accu-Chek Compact Test Drum	83	1%

Questions about July 2006

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

22,154 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 8,693 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 19,186 drug reports.

Which drugs were listed most often?

Byetta (3,090), Lyrica (946), Lunesta (929), Avandia (832) and Celebrex (790).

Which reactions were recorded most often?

nausea (1,757), blood glucose increased (1,470), weight decreased (1,450), drug ineffective (1,222) and vomiting (919).

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.