Reports received by FDA, by month

April 2009: adverse event reports received by FDA

25,716 drug reports (FAERS) and 17,946 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.

25,716
drug reports received: 25,432 a year earlier; 25,935
monthly average, preceding 12 months: -0.8% against the average; 17,946
device reports received: 12,554 a year earlier

FDA received 25,716 drug adverse event reports in April 2009, against 25,432 in the same month a year earlier and a monthly average of 25,935 over the preceding 12 months. The MAUDE device database received 17,946 reports that month (12,554 a year earlier).

The drugs listed most often as suspect products were Nexium (1,102), Mirena (491) and Remicade (431), and the reactions recorded most often were nausea (1,058), drug ineffective (966) and dyspnoea (945).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Nexium (8.3× its average), Tamoxifen citrate (7.1× its average) and Sensipar (5.5× 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 April 2009

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Nexium	1,102	4.3%
Mirena	491	1.9%
Remicade	431	1.7%
Tiotropium bromide	396	1.5%
Provera	392	1.5%
Vyvanse	379	1.5%
Seroquel	378	1.5%
Avonex	373	1.5%
Premarin	370	1.4%
Humira	357	1.4%
Enbrel	274	1.1%
Prempro	267	1%
Cyclophosphamide	246	1%
Revlimid	243	0.9%
Dianeal	240	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."

Largest rises against their own average

Drug	Reports this month	Times its 12-month average
Nexium	1,102	8.3×
Tamoxifen citrate	107	7.1×
Sensipar	85	5.5×
Sunitinib malate	98	4.7×
Vyvanse	379	4.7×
Advair Hfa	76	4.7×
Toprol-Xl	165	4.6×
Zofran	50	4.3×

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	1,058	4.1%
Drug ineffectivethe medicine did not work as expected	966	3.8%
Dyspnoeashortness of breath	945	3.7%
Deaththe patient died; cause not stated by this term	863	3.4%
Vomitingbeing sick	851	3.3%
Headachehead pain	823	3.2%
Dizzinesslight-headedness or unsteadiness	779	3%
Diarrhoealoose or frequent stools	771	3%
Pyrexiafever	693	2.7%
Fatiguetiredness	646	2.5%
Painpain, site not specified	582	2.3%
Astheniaweakness or lack of energy	578	2.2%
Falla fall	551	2.1%
Malaisegeneral feeling of being unwell	497	1.9%
Depressionlow mood	486	1.9%

Devices named most often

Brand	Reports	Share of device reports
Freestyle Flash	697	3.9%
Freestyle	315	1.8%
One Touch Ultralink Meter	285	1.6%
One Touch Ping Meter	253	1.4%
Architect Reaction Vessel	225	1.3%
Ge Oec 9900	179	1%
Accu-Chek Comfort Curve Test Strips	174	1%
Ge Oec 9800	158	0.9%
M Series	156	0.9%
Cypher Sirolimus-Eluting Coronary Stent	153	0.9%

Questions about April 2009

How many adverse event reports did FDA receive in April 2009?

25,716 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 17,946 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 25,432 drug reports.

Which drugs were listed most often?

Nexium (1,102), Mirena (491), Remicade (431), Tiotropium bromide (396) and Provera (392).

Which reactions were recorded most often?

nausea (1,058), drug ineffective (966), dyspnoea (945), death (863) and vomiting (851).

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.