Reports received by FDA, by month

February 2005: adverse event reports received by FDA

18,175 drug reports (FAERS) and 7,130 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.

18,175
drug reports received: 8,897 a year earlier; 15,285
monthly average, preceding 12 months: 18.9% against the average; 7,130
device reports received: 6,664 a year earlier

FDA received 18,175 drug adverse event reports in February 2005, against 8,897 in the same month a year earlier and a monthly average of 15,285 over the preceding 12 months. The MAUDE device database received 7,130 reports that month (6,664 a year earlier).

The drugs listed most often as suspect products were Paxil (1,603), Lamictal (1,436) and Excedrin (708), and the reactions recorded most often were drug ineffective (1,028), drug withdrawal syndrome (961) and nausea (845).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Lamictal (31.8× its average), Paxil (6.9× its average) and Mirena (6.1× 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 February 2005

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Paxil	1,603	8.8%
Lamictal	1,436	7.9%
Excedrin	708	3.9%
Vioxx	574	3.2%
Wellbutrin	361	2%
Celebrex	333	1.8%
Cialis	304	1.7%
Namenda	279	1.5%
Zocor	277	1.5%
Abilify	246	1.4%
Remicade	219	1.2%
Avonex	188	1%
Taxol	182	1%
Bextra	174	1%
Methotrexate	158	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
Lamictal	1,436	31.8×
Paxil	1,603	6.9×
Mirena	144	6.1×
Copegus	104	5.9×
Avelox	90	4.6×
Pegasys	137	4.2×
Zocor	277	4×
Keppra	76	3.9×

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	1,028	5.7%
Drug withdrawal syndromesymptoms on stopping a medicine	961	5.3%
Nauseafeeling sick	845	4.6%
Rashskin rash	808	4.4%
Dizzinesslight-headedness or unsteadiness	693	3.8%
Pharmaceutical product complaint	614	3.4%
Dyspnoeashortness of breath	582	3.2%
Headachehead pain	563	3.1%
Vomitingbeing sick	526	2.9%
Pyrexiafever	483	2.7%
Myocardial infarctionheart attack	466	2.6%
Fatiguetiredness	460	2.5%
Astheniaweakness or lack of energy	444	2.4%
Convulsion	429	2.4%
Diarrhoealoose or frequent stools	421	2.3%

Devices named most often

Brand	Reports	Share of device reports
One Touch Ultra	231	3.2%
M Series	166	2.3%
Cypher Sirolimus-Eluting Coronary Stent	147	2.1%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	143	2%
Colleague Volumetric Infusion Pump	108	1.5%
Ultracision Surg Dev Curved Shears Endo	101	1.4%
Colleague Cx Volumetric Infusion Pump	96	1.3%
Endotak Reliance	80	1.1%
Cidex Opa Solution	67	0.9%
Synchromed El	60	0.8%

Questions about February 2005

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

18,175 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 7,130 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 8,897 drug reports.

Which drugs were listed most often?

Paxil (1,603), Lamictal (1,436), Excedrin (708), Vioxx (574) and Wellbutrin (361).

Which reactions were recorded most often?

drug ineffective (1,028), drug withdrawal syndrome (961), nausea (845), rash (808) and dizziness (693).

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.