Reports received by FDA, by month

August 2004: adverse event reports received by FDA

15,279 drug reports (FAERS) and 7,414 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.

15,279
drug reports received: —
monthly average, preceding 12 months: 7,414
device reports received: 5,676 a year earlier

FDA received 15,279 drug adverse event reports in August 2004. The MAUDE device database received 7,414 reports that month (5,676 a year earlier).

The drugs listed most often as suspect products were Paxil (1,631), Namenda (642) and Provera (490), and the reactions recorded most often were nausea (745), dizziness (711) and drug withdrawal syndrome (635).

Drug reports by month, three years to August 2004

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Paxil	1,631	10.7%
Namenda	642	4.2%
Provera	490	3.2%
Premarin	479	3.1%
Zetia	415	2.7%
Nuvaring	405	2.7%
Cialis	345	2.3%
Wellbutrin	335	2.2%
Abilify	283	1.9%
Prempro	259	1.7%
Raptiva	221	1.4%
Avonex	220	1.4%
Remicade	217	1.4%
Amevive	203	1.3%
Medroxyprogesterone acetate	198	1.3%

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	745	4.9%
Dizzinesslight-headedness or unsteadiness	711	4.7%
Drug withdrawal syndromesymptoms on stopping a medicine	635	4.2%
Drug ineffectivethe medicine did not work as expected	570	3.7%
Headachehead pain	546	3.6%
Vomitingbeing sick	525	3.4%
Fatiguetiredness	460	3%
Astheniaweakness or lack of energy	452	3%
Dyspnoeashortness of breath	438	2.9%
Diarrhoealoose or frequent stools	435	2.8%
Confusional stateconfusion	435	2.8%
Pyrexiafever	408	2.7%
Breast cancer female	370	2.4%
Pharmaceutical product complaint	317	2.1%
Weight increasedweight gain	313	2%

Devices named most often

Brand	Reports	Share of device reports
One Touch Ultra	318	4.3%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	202	2.7%
Cypher Sirolimus-Eluting Coronary Stent	172	2.3%
M Series	165	2.2%
Endotak Reliance	90	1.2%
Easytrak	73	1%
Freestyle	72	1%
Synchromed El	70	0.9%
Elastimide Foldable Silicone Posterior Chamber	61	0.8%
Contak Renewal 3	53	0.7%

Questions about August 2004

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

15,279 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 7,414 device reports in the MAUDE release of 28 Sep 2026.

Which drugs were listed most often?

Paxil (1,631), Namenda (642), Provera (490), Premarin (479) and Zetia (415).

Which reactions were recorded most often?

nausea (745), dizziness (711), drug withdrawal syndrome (635), drug ineffective (570) and headache (546).

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.