Reports received by FDA, by month

October 2022: adverse event reports received by FDA

131,961 drug reports (FAERS) and 183,142 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.

131,961
drug reports received: 109,560 a year earlier; 123,465
monthly average, preceding 12 months: 6.9% against the average; 183,142
device reports received: 166,828 a year earlier

FDA received 131,961 drug adverse event reports in October 2022, against 109,560 in the same month a year earlier and a monthly average of 123,465 over the preceding 12 months. The MAUDE device database received 183,142 reports that month (166,828 a year earlier).

The drugs listed most often as suspect products were Humira (7,930), Zantac (7,781) and Dilaudid (4,804), and the reactions recorded most often were drug ineffective (7,784), off label use (7,307) and pain (6,866).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Qulipta (14.2× its average), Sublocade (12.9× its average) and Addyi (12.8× 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 October 2022

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Humira	7,930	6%
Zantac	7,781	5.9%
Dilaudid	4,804	3.6%
Skyrizi	4,663	3.5%
Dupixent	4,395	3.3%
Imbruvica	2,855	2.2%
Hydrocodone bitartrate and acetaminophen	2,437	1.8%
Rinvoq	2,064	1.6%
Revlimid	2,058	1.6%
Oxycodone hydrochloride	1,763	1.3%
Paxlovid	1,637	1.2%
Acetaminophen Oxycodone Hydrochloride	1,535	1.2%
Anticoagulant Sodium Citrate	1,531	1.2%
Rituximab	1,396	1.1%
Entresto	1,383	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
Qulipta	776	14.2×
Sublocade	257	12.9×
Addyi	345	12.8×
Mounjaro	1,328	12.5×
Krystexxa	165	12.1×
Skyrizi	4,663	9.9×
Linzess	711	9.3×
Vraylar	424	8.3×

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
Drug ineffectivethe medicine did not work as expected	7,784	5.9%
Off label useused for a purpose or in a way not on the label	7,307	5.5%
Painpain, site not specified	6,866	5.2%
Drug dependencedependence on a medicine	6,113	4.6%
Fatiguetiredness	5,114	3.9%
Nauseafeeling sick	4,929	3.7%
Covid-19COVID-19 infection	4,778	3.6%
Deaththe patient died; cause not stated by this term	4,642	3.5%
Diarrhoealoose or frequent stools	4,001	3%
Headachehead pain	3,560	2.7%
Dizzinesslight-headedness or unsteadiness	3,456	2.6%
Emotional distressemotional distress	3,365	2.5%
Overdosea dose above the recommended amount	3,219	2.4%
Arthralgiajoint pain	3,109	2.4%
Product dose omission issuea dose was missed	3,091	2.3%

Devices named most often

Brand	Reports	Share of device reports
Dexcom G6 Continuous Glucose Monitoring System	21,251	11.6%
Alaris System	15,350	8.4%
t:slim X2 Insulin Pump with Control-IQ Technology	11,465	6.3%
DreamStation Auto CPAP	1,779	1%
Medfusion 3500 Syringe Infusion Pump	1,495	0.8%
Assurity Mri	1,360	0.7%
Biohorizons Dental Implant	1,355	0.7%
Libre 2 Sensor FreeStyle	1,304	0.7%
t:slim X2 Insulin Pump with Basal-IQ Technology	1,198	0.7%
Alaris Pump Module	1,174	0.6%

Questions about October 2022

How many adverse event reports did FDA receive in October 2022?

131,961 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 183,142 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 109,560 drug reports.

Which drugs were listed most often?

Humira (7,930), Zantac (7,781), Dilaudid (4,804), Skyrizi (4,663) and Dupixent (4,395).

Which reactions were recorded most often?

drug ineffective (7,784), off label use (7,307), pain (6,866), drug dependence (6,113) and fatigue (5,114).

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.