Reports received by FDA, by month

June 2004: adverse event reports received by FDA

16,996 drug reports (FAERS) and 6,717 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.

16,996
drug reports received: —
monthly average, preceding 12 months: 6,717
device reports received: 6,240 a year earlier

FDA received 16,996 drug adverse event reports in June 2004. The MAUDE device database received 6,717 reports that month (6,240 a year earlier).

The drugs listed most often as suspect products were Ortho Evra (2,582), Humira (1,336) and OxyContin (881), and the reactions recorded most often were nausea (810), metrorrhagia (809) and drug ineffective (650).

Drug reports by month, three years to June 2004

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Ortho Evra	2,582	15.2%
Humira	1,336	7.9%
OxyContin	881	5.2%
Advair Hfa	530	3.1%
Zetia	439	2.6%
Abilify	325	1.9%
Amevive	311	1.8%
Premarin	275	1.6%
Provera	274	1.6%
Bextra	219	1.3%
Levitra	206	1.2%
Prempro	193	1.1%
Remicade	179	1.1%
Avonex	177	1%
Spectracef	149	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
Nauseafeeling sick	810	4.8%
Metrorrhagia	809	4.8%
Drug ineffectivethe medicine did not work as expected	650	3.8%
Headachehead pain	531	3.1%
Vomitingbeing sick	527	3.1%
Dyspnoeashortness of breath	512	3%
Drug abuser	512	3%
Diarrhoealoose or frequent stools	428	2.5%
Pharmaceutical product complaint	425	2.5%
Dizzinesslight-headedness or unsteadiness	418	2.5%
Medication errora mistake in prescribing, dispensing or taking a medicine	414	2.4%
Pyrexiafever	409	2.4%
Astheniaweakness or lack of energy	378	2.2%
Application site reactiona reaction where the product was applied	342	2%
Fatiguetiredness	333	2%

Devices named most often

Brand	Reports	Share of device reports
One Touch Ultra	328	4.9%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	163	2.4%
M Series	159	2.4%
Cypher Sirolimus-Eluting Coronary Stent	155	2.3%
Elastimide Silicone Posterior Chamber Intraocular Lens	90	1.3%
Accu-Chek Comfort Curve	80	1.2%
Bd Paradigm Link Blood Glucose Monitor	72	1.1%
Colleague Volumetric Infusion Pump	68	1%
Synchromed El	64	1%
Guidant 4 5 Mm Heartstring Proximal Seal	51	0.8%

Questions about June 2004

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

16,996 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 6,717 device reports in the MAUDE release of 28 Sep 2026.

Which drugs were listed most often?

Ortho Evra (2,582), Humira (1,336), OxyContin (881), Advair Hfa (530) and Zetia (439).

Which reactions were recorded most often?

nausea (810), metrorrhagia (809), drug ineffective (650), headache (531) and vomiting (527).

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.