Reports received by FDA, by month

February 2004: adverse event reports received by FDA

8,897 drug reports (FAERS) and 6,664 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.

8,897
drug reports received: —
monthly average, preceding 12 months: 6,664
device reports received: 6,663 a year earlier

FDA received 8,897 drug adverse event reports in February 2004. The MAUDE device database received 6,664 reports that month (6,663 a year earlier).

The drugs listed most often as suspect products were Remicade (331), Avonex (142) and Heparin sodium (125), and the reactions recorded most often were pyrexia (392), nausea (367) and dyspnoea (355).

Drug reports by month, three years to February 2004

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Remicade	331	3.7%
Avonex	142	1.6%
Heparin sodium	125	1.4%
Paxil	121	1.4%
Methotrexate	115	1.3%
Thalomid	110	1.2%
Abciximab	106	1.2%
Eptifibatide	102	1.1%
Vioxx	96	1.1%
Wellbutrin	95	1.1%
Zocor	94	1.1%
Duragesic	90	1%
Lipitor	86	1%
Prednisone	84	0.9%
Bupropion hydrochloride	80	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."

Reactions recorded most often

MedDRA term	Reports	Share of the month
Pyrexiafever	392	4.4%
Nauseafeeling sick	367	4.1%
Dyspnoeashortness of breath	355	4%
Vomitingbeing sick	340	3.8%
Dizzinesslight-headedness or unsteadiness	322	3.6%
Astheniaweakness or lack of energy	306	3.4%
Headachehead pain	261	2.9%
Drug interactionan interaction between medicines	256	2.9%
Pharmaceutical product complaint	256	2.9%
Falla fall	237	2.7%
Condition aggravatedthe condition being treated got worse	232	2.6%
Diarrhoealoose or frequent stools	229	2.6%
Fatiguetiredness	229	2.6%
Pneumonialung infection	228	2.6%
Myocardial infarctionheart attack	227	2.6%

Devices named most often

Brand	Reports	Share of device reports
One Touch Ultra	438	6.6%
Cypher Sirolimus-Eluting Coronary Stent	247	3.7%
M Series	178	2.7%
Minimed Infusion Pump	155	2.3%
Guidant 4 5 Mm Heartstring Proximal Seal	100	1.5%
Fasttake	90	1.4%
Colleague Volumetric Infusion Pump	78	1.2%
Synchromed El	67	1%
Endotak Reliance	65	1%
One Touch Basic Enhanced	56	0.8%

Questions about February 2004

How many adverse event reports did FDA receive in February 2004?

8,897 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 6,664 device reports in the MAUDE release of 28 Sep 2026.

Which drugs were listed most often?

Remicade (331), Avonex (142), Heparin sodium (125), Paxil (121) and Methotrexate (115).

Which reactions were recorded most often?

pyrexia (392), nausea (367), dyspnoea (355), vomiting (340) and dizziness (322).

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.