Reports received by FDA, by month

January 2005: adverse event reports received by FDA

19,286 drug reports (FAERS) and 6,426 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.

19,286
drug reports received: 5,716 a year earlier; 14,155
monthly average, preceding 12 months: 36.2% against the average; 6,426
device reports received: 5,774 a year earlier

FDA received 19,286 drug adverse event reports in January 2005, against 5,716 in the same month a year earlier and a monthly average of 14,155 over the preceding 12 months. The MAUDE device database received 6,426 reports that month (5,774 a year earlier).

The drugs listed most often as suspect products were Forteo (2,070), Strattera (1,073) and Vioxx (767), and the reactions recorded most often were nausea (1,071), dizziness (845) and drug ineffective (830).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Rebif (30.8× its average), Imitrex (11.6× its average) and Glucophage (10.6× 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 January 2005

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Forteo	2,070	10.7%
Strattera	1,073	5.6%
Vioxx	767	4%
Rebif	700	3.6%
Crestor	594	3.1%
Prempro	580	3%
Bupropion hydrochloride	336	1.7%
Provera	280	1.5%
Plavix	276	1.4%
Celebrex	256	1.3%
Imitrex	255	1.3%
Avonex	245	1.3%
Serzone	221	1.1%
Premarin	209	1.1%
Remicade	204	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
Rebif	700	30.8×
Imitrex	255	11.6×
Glucophage	175	10.6×
Ketek	201	8.6×
Plavix	276	8.3×
Atorvastatin	99	8×
Forteo	2,070	5.1×
Mifepristone Tablets 200 Mg	81	5.1×

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	1,071	5.6%
Dizzinesslight-headedness or unsteadiness	845	4.4%
Drug ineffectivethe medicine did not work as expected	830	4.3%
Pharmaceutical product complaint	794	4.1%
Astheniaweakness or lack of energy	710	3.7%
Fatiguetiredness	708	3.7%
Headachehead pain	692	3.6%
Vomitingbeing sick	635	3.3%
Feeling abnormalfeeling odd or not right	633	3.3%
Dyspnoeashortness of breath	604	3.1%
Diarrhoealoose or frequent stools	522	2.7%
Pyrexiafever	514	2.7%
Painpain, site not specified	505	2.6%
Myocardial infarctionheart attack	487	2.5%
Pain in extremitypain in an arm or leg	468	2.4%

Devices named most often

Brand	Reports	Share of device reports
One Touch Ultra	347	5.4%
M Series	184	2.9%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	184	2.9%
Cypher Sirolimus-Eluting Coronary Stent	134	2.1%
Accu-Chek Comfort Curve	109	1.7%
Colleague Volumetric Infusion Pump	60	0.9%
Synchromed El	59	0.9%
Profix	57	0.9%
Ultracision Surg Dev Curved Shears Endo	55	0.9%
Colleague Cx Volumetric Infusion Pump	50	0.8%

Questions about January 2005

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

19,286 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 6,426 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 5,716 drug reports.

Which drugs were listed most often?

Forteo (2,070), Strattera (1,073), Vioxx (767), Rebif (700) and Crestor (594).

Which reactions were recorded most often?

nausea (1,071), dizziness (845), drug ineffective (830), pharmaceutical product complaint (794) and asthenia (710).

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.