Reports received by FDA, by month

January 2009: adverse event reports received by FDA

25,832 drug reports (FAERS) and 13,892 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.

25,832
drug reports received: 24,579 a year earlier; 25,798
monthly average, preceding 12 months: 0.1% against the average; 13,892
device reports received: 14,039 a year earlier

FDA received 25,832 drug adverse event reports in January 2009, against 24,579 in the same month a year earlier and a monthly average of 25,798 over the preceding 12 months. The MAUDE device database received 13,892 reports that month (14,039 a year earlier).

The drugs listed most often as suspect products were Prempro (2,240), Abilify (1,696) and Premarin (1,401), and the reactions recorded most often were breast cancer (2,066), completed suicide (1,041) and nausea (929).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Abilify (35.4× its average), Copaxone (15.2× its average) and Prempro (14.9× 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 January 2009

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Prempro	2,240	8.7%
Abilify	1,696	6.6%
Premarin	1,401	5.4%
Provera	1,170	4.5%
Mirena	657	2.5%
Aleve	489	1.9%
Copaxone	456	1.8%
Cycrin	400	1.5%
Tiotropium bromide	357	1.4%
Humira	346	1.3%
Avonex	322	1.2%
Acetaminophen	293	1.1%
Remicade	280	1.1%
Alprazolam	266	1%
Heparin	261	1%

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
Abilify	1,696	35.4×
Copaxone	456	15.2×
Prempro	2,240	14.9×
Cycrin	400	13.6×
Optiray	178	12.5×
Lupron Depot	138	10.8×
Acetaminophen and Hydrocodone Bitartrate	166	8.6×
Provera	1,170	7.8×

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
Breast cancerbreast cancer	2,066	8%
Completed suicidedeath by suicide	1,041	4%
Nauseafeeling sick	929	3.6%
Dyspnoeashortness of breath	863	3.3%
Drug ineffectivethe medicine did not work as expected	745	2.9%
Vomitingbeing sick	704	2.7%
Headachehead pain	671	2.6%
Deaththe patient died; cause not stated by this term	656	2.5%
Dizzinesslight-headedness or unsteadiness	647	2.5%
Diarrhoealoose or frequent stools	625	2.4%
Cardiac arrestthe heart stopped	614	2.4%
Pyrexiafever	542	2.1%
Fatiguetiredness	532	2.1%
Astheniaweakness or lack of energy	524	2%
Painpain, site not specified	477	1.8%

Devices named most often

Brand	Reports	Share of device reports
Ge Oec 9800	231	1.7%
Precision?	168	1.2%
Accu-Chek Comfort Curve Test Strips	157	1.1%
M Series	121	0.9%
Accu-Chek Aviva Test Strips	117	0.8%
Ge Oec 9900	113	0.8%
Heartstream Xl	105	0.8%
Accu-Chek Spirit	99	0.7%
Accu-Chek Compact Test Drum	94	0.7%
Totalcare	88	0.6%

Questions about January 2009

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

25,832 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 13,892 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 24,579 drug reports.

Which drugs were listed most often?

Prempro (2,240), Abilify (1,696), Premarin (1,401), Provera (1,170) and Mirena (657).

Which reactions were recorded most often?

breast cancer (2,066), completed suicide (1,041), nausea (929), dyspnoea (863) and drug ineffective (745).

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.