Reports received by FDA, by month

May 2021: adverse event reports received by FDA

150,094 drug reports (FAERS) and 152,598 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.

150,094
drug reports received: 111,653 a year earlier; 121,811
monthly average, preceding 12 months: 23.2% against the average; 152,598
device reports received: 87,448 a year earlier

FDA received 150,094 drug adverse event reports in May 2021, against 111,653 in the same month a year earlier and a monthly average of 121,811 over the preceding 12 months. The MAUDE device database received 152,598 reports that month (87,448 a year earlier).

The drugs listed most often as suspect products were OxyContin (26,351), Oxycodone hydrochloride (20,494) and Zantac (12,045), and the reactions recorded most often were drug dependence (27,468), overdose (11,936) and pain (11,575).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Xyzal Allergy 24HR (32.9× its average), Tymlos (24.7× its average) and Oxy Ir (23.6× 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 May 2021

Drugs listed most often as suspect products

Drug	Reports	Share of the month
OxyContin	26,351	17.6%
Oxycodone hydrochloride	20,494	13.7%
Zantac	12,045	8%
Hydrocodone bitartrate and acetaminophen	9,565	6.4%
Oxycodone and acetaminophen	7,991	5.3%
Ranitidine	7,769	5.2%
Dilaudid	7,751	5.2%
MS Contin	6,929	4.6%
Morphine sulfate	5,551	3.7%
Revlimid	4,131	2.8%
Cimzia	3,177	2.1%
Dupixent	3,055	2%
Tramadol	2,980	2%
Humira	2,478	1.7%
Esbriet	2,297	1.5%

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
Xyzal Allergy 24HR	857	32.9×
Tymlos	1,820	24.7×
Oxy Ir	1,412	23.6×
Acetaminophen Oxycodone Hydrochloride	1,289	17.2×
Hysingla ER	1,774	16.8×
Acetaminophen Oxycodone Hydrochloride Oxycodone Terephthalate	337	15.6×
MS Contin	6,929	13.5×
Tramadol Cr Tablets	1,404	12.8×

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
Drug dependencedependence on a medicine	27,468	18.3%
Overdosea dose above the recommended amount	11,936	8%
Painpain, site not specified	11,575	7.7%
Drug ineffectivethe medicine did not work as expected	9,073	6%
Emotional distressemotional distress	8,469	5.6%
Drug withdrawal syndromesymptoms on stopping a medicine	7,428	4.9%
Off label useused for a purpose or in a way not on the label	6,007	4%
Fatiguetiredness	4,880	3.3%
Deaththe patient died; cause not stated by this term	4,250	2.8%
Nauseafeeling sick	4,126	2.7%
Product dose omission issuea dose was missed	3,595	2.4%
Diarrhoealoose or frequent stools	3,572	2.4%
Headachehead pain	3,411	2.3%
Dyspnoeashortness of breath	3,112	2.1%
Arthralgiajoint pain	3,081	2.1%

Devices named most often

Brand	Reports	Share of device reports
Dexcom G6 Continuous Glucose Monitoring System	20,018	13.1%
t:slim X2 Insulin Pump with Control-IQ Technology	5,353	3.5%
Pump MMT-1780KPK 670G Pathway Black MG	2,386	1.6%
Alaris System	2,111	1.4%
t:slim X2 Insulin Pump with Basal-IQ Technology	1,538	1%
Alaris Pump Module	1,446	0.9%
640G Insulin Pump MMT-1712K	1,227	0.8%
Biohorizons Dental Implant	1,088	0.7%
LifeVest WCD 4000 System	1,043	0.7%
Essure	1,039	0.7%

Questions about May 2021

How many adverse event reports did FDA receive in May 2021?

150,094 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 152,598 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 111,653 drug reports.

Which drugs were listed most often?

OxyContin (26,351), Oxycodone hydrochloride (20,494), Zantac (12,045), Hydrocodone bitartrate and acetaminophen (9,565) and Oxycodone and acetaminophen (7,991).

Which reactions were recorded most often?

drug dependence (27,468), overdose (11,936), pain (11,575), drug ineffective (9,073) and emotional distress (8,469).

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.