Reports received by FDA, by month

July 2010: adverse event reports received by FDA

66,895 drug reports (FAERS) and 24,259 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.

66,895
drug reports received: 28,323 a year earlier; 31,648
monthly average, preceding 12 months: 111.4% against the average; 24,259
device reports received: 19,114 a year earlier

FDA received 66,895 drug adverse event reports in July 2010, against 28,323 in the same month a year earlier and a monthly average of 31,648 over the preceding 12 months. The MAUDE device database received 24,259 reports that month (19,114 a year earlier).

The drugs listed most often as suspect products were Chantix (27,040), Lipitor (3,204) and Celebrex (2,921), and the reactions recorded most often were nausea (9,311), drug ineffective (3,661) and headache (3,305).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Chantix (239.5× its average), Celebrex (66.8× its average) and Lipitor (22.8× 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 2010

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Chantix	27,040	40.4%
Lipitor	3,204	4.8%
Celebrex	2,921	4.4%
Tysabri	2,369	3.5%
Avandia	1,315	2%
Zoloft	945	1.4%
Avonex	767	1.1%
Neurontin	736	1.1%
Synthroid	661	1%
Norvasc	567	0.8%
Remicade	530	0.8%
Dianeal	473	0.7%
Humira	427	0.6%
Enbrel	397	0.6%
Vioxx	390	0.6%

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
Chantix	27,040	239.5×
Celebrex	2,921	66.8×
Lipitor	3,204	22.8×
Neurontin	736	19.5×
Zoloft	945	18.5×
Norvasc	567	17.3×
Zithromax	327	15×
Opcon-A	126	11.3×

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	9,311	13.9%
Drug ineffectivethe medicine did not work as expected	3,661	5.5%
Headachehead pain	3,305	4.9%
Vomitingbeing sick	3,172	4.7%
Insomniadifficulty sleeping	3,055	4.6%
Abnormal dreamsunusual dreams	2,957	4.4%
Depressionlow mood	2,899	4.3%
Fatiguetiredness	2,898	4.3%
Dizzinesslight-headedness or unsteadiness	2,481	3.7%
Malaisegeneral feeling of being unwell	2,361	3.5%
Myocardial infarctionheart attack	2,238	3.3%
Feeling abnormalfeeling odd or not right	1,999	3%
Anxietyanxiety	1,983	3%
Diarrhoealoose or frequent stools	1,842	2.8%
Dyspnoeashortness of breath	1,679	2.5%

Devices named most often

Brand	Reports	Share of device reports
Endotak Reliance	329	1.4%
Ot Ultralink Meter	324	1.3%
Veriflex Liberte Coronary Stent Delivery System	284	1.2%
Ot Ping Meter	273	1.1%
Animas Insulin Infusion Pump	208	0.9%
Colleague Cxe Volumetricinfusion Pump	201	0.8%
M Series	189	0.8%
Contak Renewal	189	0.8%
Vitality 2	189	0.8%
Integrated Apd Set W/Cassette3-Prong	187	0.8%

Questions about July 2010

How many adverse event reports did FDA receive in July 2010?

66,895 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 24,259 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 28,323 drug reports.

Which drugs were listed most often?

Chantix (27,040), Lipitor (3,204), Celebrex (2,921), Tysabri (2,369) and Avandia (1,315).

Which reactions were recorded most often?

nausea (9,311), drug ineffective (3,661), headache (3,305), vomiting (3,172) and insomnia (3,055).

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.