Reports received by FDA, by month

June 2018: adverse event reports received by FDA

133,424 drug reports (FAERS) and 94,370 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.

133,424
drug reports received: 101,638 a year earlier; 112,238
monthly average, preceding 12 months: 18.9% against the average; 94,370
device reports received: 79,533 a year earlier

FDA received 133,424 drug adverse event reports in June 2018, against 101,638 in the same month a year earlier and a monthly average of 112,238 over the preceding 12 months. The MAUDE device database received 94,370 reports that month (79,533 a year earlier).

The drugs listed most often as suspect products were Sensipar (11,093), Prolia (8,001) and Proactiv Solution Daily Protection Plus Sunscreen Spf 30 (7,044), and the reactions recorded most often were off label use (9,776), drug dose omission (7,819) and drug ineffective (7,691).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Sensipar (128.1× its average), Proactiv Solution Daily Protection Plus Sunscreen Spf 30 (22.9× its average) and Defitelio (13.5× 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 June 2018

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Sensipar	11,093	8.3%
Prolia	8,001	6%
Proactiv Solution Daily Protection Plus Sunscreen Spf 30	7,044	5.3%
Enbrel	3,397	2.5%
Humira	2,457	1.8%
Cosentyx	2,250	1.7%
Revlimid	1,953	1.5%
Actemra	1,821	1.4%
Docetaxel	1,580	1.2%
Neulasta	1,577	1.2%
Methotrexate	1,548	1.2%
Repatha	1,523	1.1%
Otezla	1,459	1.1%
Xeljanz	1,298	1%
Taxotere	1,196	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
Sensipar	11,093	128.1×
Proactiv Solution Daily Protection Plus Sunscreen Spf 30	7,044	22.9×
Defitelio	274	13.5×
Apokyn	521	13.4×
Ambien	367	12.1×
Septocaine and Epinephrine	85	8.4×
Kybella	195	8×
Provenge	488	7.7×

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
Off label useused for a purpose or in a way not on the label	9,776	7.3%
Drug dose omissiona dose was missed	7,819	5.9%
Drug ineffectivethe medicine did not work as expected	7,691	5.8%
Nauseafeeling sick	4,559	3.4%
Fatiguetiredness	4,448	3.3%
Deaththe patient died; cause not stated by this term	4,382	3.3%
Erythemaskin redness	3,562	2.7%
Diarrhoealoose or frequent stools	3,555	2.7%
Headachehead pain	3,375	2.5%
Painpain, site not specified	3,237	2.4%
Dry skindry skin	3,166	2.4%
Dyspnoeashortness of breath	3,061	2.3%
Rashskin rash	2,971	2.2%
Alopeciahair loss	2,852	2.1%
Malaisegeneral feeling of being unwell	2,778	2.1%

Devices named most often

Brand	Reports	Share of device reports
Dexcom G5 Mobile Continuous Glucose Monitoring System	11,157	11.8%
Pump MMT-1780KPK 670G Pathway Black MG	1,886	2%
T Slim G5 System	1,850	2%
Animas Vibe	1,752	1.9%
Reservoir 3ml	1,197	1.3%
Reservoir 3ML MMT-332A	1,112	1.2%
630G Insulin PUMP MMT-1715K 630G BLACK MG	1,043	1.1%
Sensor Mmt-7020a Enlite3 5pk Us	904	1%
640G Insulin Pump MMT-1712K	862	0.9%
640G Insulin Pump MMT-1711K	860	0.9%

Questions about June 2018

How many adverse event reports did FDA receive in June 2018?

133,424 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 94,370 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 101,638 drug reports.

Which drugs were listed most often?

Sensipar (11,093), Prolia (8,001), Proactiv Solution Daily Protection Plus Sunscreen Spf 30 (7,044), Enbrel (3,397) and Humira (2,457).

Which reactions were recorded most often?

off label use (9,776), drug dose omission (7,819), drug ineffective (7,691), nausea (4,559) and fatigue (4,448).

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.