Reports received by FDA, by month

March 2005: adverse event reports received by FDA

19,968 drug reports (FAERS) and 7,662 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.

19,968
drug reports received: 14,823 a year earlier; 16,059
monthly average, preceding 12 months: 24.3% against the average; 7,662
device reports received: 7,204 a year earlier

FDA received 19,968 drug adverse event reports in March 2005, against 14,823 in the same month a year earlier and a monthly average of 16,059 over the preceding 12 months. The MAUDE device database received 7,662 reports that month (7,204 a year earlier).

The drugs listed most often as suspect products were Humira (1,391), Forteo (1,346) and Vioxx (796), and the reactions recorded most often were drug ineffective (941), nausea (876) and pharmaceutical product complaint (774).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Valtrex (21× its average), Aleve (11× its average) and Peg-Intron (8.2× 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 March 2005

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Humira	1,391	7%
Forteo	1,346	6.7%
Vioxx	796	4%
Strattera	641	3.2%
Tiotropium bromide	531	2.7%
Crestor	444	2.2%
Neurontin	386	1.9%
Valtrex	372	1.9%
Zetia	289	1.4%
Peg-Intron	251	1.3%
Monistat	240	1.2%
Aleve	232	1.2%
Celebrex	231	1.2%
Konyne	231	1.2%
Factor ix complex	220	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
Valtrex	372	21×
Aleve	232	11×
Peg-Intron	251	8.2×
Alimta	75	5.8×
Warfarin	63	5.8×
Trileptal	113	5.7×
Neulasta	93	5.6×
Tiotropium bromide	531	5.3×

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
Drug ineffectivethe medicine did not work as expected	941	4.7%
Nauseafeeling sick	876	4.4%
Pharmaceutical product complaint	774	3.9%
Dizzinesslight-headedness or unsteadiness	771	3.9%
Dyspnoeashortness of breath	697	3.5%
Headachehead pain	669	3.4%
Astheniaweakness or lack of energy	629	3.2%
Fatiguetiredness	596	3%
Vomitingbeing sick	586	2.9%
Myocardial infarctionheart attack	547	2.7%
Diarrhoealoose or frequent stools	542	2.7%
Feeling abnormalfeeling odd or not right	485	2.4%
Painpain, site not specified	470	2.4%
Rashskin rash	469	2.3%
Pyrexiafever	460	2.3%

Devices named most often

Brand	Reports	Share of device reports
One Touch Ultra	328	4.3%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	247	3.2%
Cypher Sirolimus-Eluting Coronary Stent	164	2.1%
M Series	150	2%
Colleague Volumetric Infusion Pump	118	1.5%
Accu-Chek Comfort Curve	112	1.5%
Colleague Cx Volumetric Infusion Pump	104	1.4%
Minicap Pd Transfer Set Easy-Lock With Twist Clamp	84	1.1%
Synchromed El	71	0.9%
Colleague 3cx Volumetric Infusion Pump	60	0.8%

Questions about March 2005

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

19,968 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 7,662 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 14,823 drug reports.

Which drugs were listed most often?

Humira (1,391), Forteo (1,346), Vioxx (796), Strattera (641) and Tiotropium bromide (531).

Which reactions were recorded most often?

drug ineffective (941), nausea (876), pharmaceutical product complaint (774), dizziness (771) and dyspnoea (697).

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.