Reports received by FDA, by month

June 2005: adverse event reports received by FDA

16,450 drug reports (FAERS) and 8,175 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.

16,450
drug reports received: 16,996 a year earlier; 17,427
monthly average, preceding 12 months: -5.6% against the average; 8,175
device reports received: 6,717 a year earlier

FDA received 16,450 drug adverse event reports in June 2005, against 16,996 in the same month a year earlier and a monthly average of 17,427 over the preceding 12 months. The MAUDE device database received 8,175 reports that month (6,717 a year earlier).

The drugs listed most often as suspect products were Humira (1,137), Natalizumab (751) and Cymbalta (674), and the reactions recorded most often were drug ineffective (799), nausea (696) and headache (673).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Accutane (19.8× its average), Natalizumab (16.4× its average) and Augmentin (6× 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 2005

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Humira	1,137	6.9%
Natalizumab	751	4.6%
Cymbalta	674	4.1%
Accutane	545	3.3%
Avonex	542	3.3%
Vioxx	531	3.2%
Tiotropium bromide	526	3.2%
Cialis	301	1.8%
Levitra	295	1.8%
Celebrex	254	1.5%
Remicade	206	1.3%
Bextra	174	1.1%
Isotretinoin	163	1%
Avastin	140	0.9%
Hemofil	139	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
Accutane	545	19.8×
Natalizumab	751	16.4×
Augmentin	89	6×
Proplex T	135	5.9×
Hemofil	139	5.3×
Duragesic-100	109	5.2×
Cymbalta	674	4.5×
Levitra	295	4.4×

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
Drug ineffectivethe medicine did not work as expected	799	4.9%
Nauseafeeling sick	696	4.2%
Headachehead pain	673	4.1%
Dyspnoeashortness of breath	625	3.8%
Fatiguetiredness	594	3.6%
Dizzinesslight-headedness or unsteadiness	561	3.4%
Astheniaweakness or lack of energy	522	3.2%
Vomitingbeing sick	515	3.1%
Pyrexiafever	511	3.1%
Diarrhoealoose or frequent stools	467	2.8%
Pharmaceutical product complaint	446	2.7%
Depressionlow mood	420	2.6%
Painpain, site not specified	401	2.4%
Pregnancypregnancy	400	2.4%
Drug exposure during pregnancythe medicine was taken during pregnancy	394	2.4%

Devices named most often

Brand	Reports	Share of device reports
One Touch Ultra	265	3.2%
Colleague Cx Volumetric Infusion Pump	210	2.6%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	187	2.3%
Cypher Sirolimus-Eluting Coronary Stent	177	2.2%
Colleague Volumetric Infusion Pump	174	2.1%
M Series	173	2.1%
Accu-Chek Comfort Curve	142	1.7%
Guidant 4 5 Mm Heartstring Proximal Seal	136	1.7%
Colleague 3cx Volumetric Infusion Pump	103	1.3%
Colleague 3 Volumetric Infusion Pump	83	1%

Questions about June 2005

How many adverse event reports did FDA receive in June 2005?

16,450 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 8,175 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 16,996 drug reports.

Which drugs were listed most often?

Humira (1,137), Natalizumab (751), Cymbalta (674), Accutane (545) and Avonex (542).

Which reactions were recorded most often?

drug ineffective (799), nausea (696), headache (673), dyspnoea (625) and fatigue (594).

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.