Reports received by FDA, by month

April 2004: adverse event reports received by FDA

10,930 drug reports (FAERS) and 6,811 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.

10,930
drug reports received: —
monthly average, preceding 12 months: 6,811
device reports received: 6,315 a year earlier

FDA received 10,930 drug adverse event reports in April 2004. The MAUDE device database received 6,811 reports that month (6,315 a year earlier).

The drugs listed most often as suspect products were Nuvaring (372), Remicade (283) and Duragesic (205), and the reactions recorded most often were nausea (499), dyspnoea (411) and pyrexia (400).

Drug reports by month, three years to April 2004

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Nuvaring	372	3.4%
Remicade	283	2.6%
Duragesic	205	1.9%
Avonex	170	1.6%
Thalomid	159	1.5%
Methotrexate	141	1.3%
Xolair	113	1%
Morphine sulfate	108	1%
Paxil	108	1%
Zoloft	100	0.9%
Risperdal	99	0.9%
Cyclophosphamide	95	0.9%
Iressa	93	0.9%
Forteo	93	0.9%
Carboplatin	92	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."

Reactions recorded most often

MedDRA term	Reports	Share of the month
Nauseafeeling sick	499	4.6%
Dyspnoeashortness of breath	411	3.8%
Pyrexiafever	400	3.7%
Vomitingbeing sick	378	3.5%
Pharmaceutical product complaint	359	3.3%
Headachehead pain	316	2.9%
Dizzinesslight-headedness or unsteadiness	308	2.8%
Astheniaweakness or lack of energy	295	2.7%
Drug ineffectivethe medicine did not work as expected	294	2.7%
Medication errora mistake in prescribing, dispensing or taking a medicine	287	2.6%
Fatiguetiredness	283	2.6%
Diarrhoealoose or frequent stools	269	2.5%
Drug interactionan interaction between medicines	264	2.4%
Falla fall	263	2.4%
Convulsion	257	2.4%

Devices named most often

Brand	Reports	Share of device reports
One Touch Ultra	433	6.4%
Cypher Sirolimus-Eluting Coronary Stent	250	3.7%
M Series	195	2.9%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	141	2.1%
Fasttake	107	1.6%
Hydroview Intraocular Lens	89	1.3%
Synchromed El	83	1.2%
Colleague Volumetric Infusion Pump	79	1.2%
Elastimide Silicone Posterior Chamber Intraocular Lens	69	1%
Ligaclip Endoscopic Rotating Multiple Clip Applier	65	1%

Questions about April 2004

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

10,930 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 6,811 device reports in the MAUDE release of 28 Sep 2026.

Which drugs were listed most often?

Nuvaring (372), Remicade (283), Duragesic (205), Avonex (170) and Thalomid (159).

Which reactions were recorded most often?

nausea (499), dyspnoea (411), pyrexia (400), vomiting (378) and pharmaceutical product complaint (359).

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.