Pharmacologic class (EPC) · 19 drug pages

Benzodiazepine: adverse event reports filed with FDA

244,289 reports list a drug in this class as a suspect or interacting product, 2004–2026.

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.

244,289
reports across the class: 1.2% of all reports; 14,536
reports, 12 months to June 2026: 16,412 in the 12 months before; 88.1%
marked serious by the reporter: 57.4% across all reports; 19
drugs with a page: brand and generic names counted separately

Benzodiazepine is a pharmacologic class (an FDA Established Pharmacologic Class) with 19 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 244,289 adverse event reports received by FDA, 1.2% of the database, from January 2004 to June 2026.

14,536 reports arrived in the 12 months to June 2026, down 11% from 16,412 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 88.1% of the class's reports are marked serious, 29.7% record death among the outcomes and 34.6% record hospitalisation, as reported.

Across the class the reactions recorded most often are toxicity to various agents (12.7%), drug abuse (11.2%) and drug ineffective (9.4%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Alprazolam	generic	48,263	2,271	90.4%	Drug abuse
Diazepam	generic	40,060	2,762	94.8%	Toxicity to various agents
Clonazepam	generic	37,432	2,530	86.7%	Completed suicide
Lorazepam	generic	33,307	2,010	90%	Drug ineffective
XanaxAlprazolam	brand	17,444	520	78.2%	Drug abuse
Midazolam	generic	11,299	872	92.6%	Drug ineffective
Oxazepam	generic	10,709	1,200	99.1%	Toxicity to various agents
ValiumDiazepam	brand	9,650	477	84%	Drug abuse
Clobazam	generic	8,005	712	89.1%	Drug ineffective
Temazepam	generic	7,422	308	90.7%	Toxicity to various agents
KlonopinClonazepam	brand	5,832	56	56.5%	Drug ineffective
AtivanLorazepam	brand	5,318	255	77.8%	Anxiety
OnfiClobazam	brand	3,543	41	57.5%	Seizure
Midazolam hydrochloride	generic	1,731	125	88.6%	Drug ineffective
Triazolam	generic	1,479	66	84.3%	Drug abuse
RestorilTemazepam	brand	1,018	66	79.8%	Headache
Clorazepate dipotassium	generic	753	108	87.6%	Intentional overdose
NayzilamMidazolam	brand	517	95	72.9%	Seizure
Estazolam	generic	507	62	93.3%	Toxicity to various agents

Ordered by report count for navigation only. 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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Toxicity to various agentspoisoning or toxic effect of one or more substances12.7%31,141
Drug abusemisuse of a medicine11.2%27,280
Drug ineffectivethe medicine did not work as expected9.4%22,876
Completed suicidedeath by suicide8.8%21,481
Somnolencedrowsiness5.6%13,704
Overdosea dose above the recommended amount5.3%12,886
Drug interactionan interaction between medicines5.2%12,652
Off label useused for a purpose or in a way not on the label4.9%12,026
Deaththe patient died; cause not stated by this term4%9,714
Intentional overdosea deliberate overdose3.8%9,227
Anxietyanxiety3.7%9,129
Coma3.7%9,081
Suicide attempta suicide attempt3.7%8,966
Drug dependencedependence on a medicine3.5%8,521
Hypotensionlow blood pressure3.2%7,796
Cardiac arrestthe heart stopped3.1%7,648
Fatiguetiredness3%7,438
Falla fall3%7,340
Headachehead pain2.9%7,073
Nauseafeeling sick2.8%6,912
Painpain, site not specified2.8%6,910
Vomitingbeing sick2.8%6,791
Insomniadifficulty sleeping2.8%6,741
Cardio-respiratory arrestthe heart and breathing stopped2.7%6,713
Depressionlow mood2.7%6,575

Solid bar: share of all class reports. Hollow bar: the median share across the 19 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death29.7%72,474

Life-threatening8.3%20,282

Hospitalisation (initial or prolonged)34.6%84,634

Disability2.1%5,034

Congenital anomaly1%2,527

Other serious48.5%118,470

Not serious11.9%29,028

Patient age

Under 21.1%2,769

2 to 112%4,825

12 to 172.6%6,255

18 to 4430.8%75,359

45 to 6424.4%59,532

65 to 747.5%18,259

75 and over6.6%16,116

Age not given25%61,174

Who reported

Physician32.4%79,216

Pharmacist11.1%27,226

Other health professional31.3%76,533

Lawyer0.5%1,155

Consumer or non-health professional21.3%52,010

Not given3.3%8,149

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Benzodiazepine reports

Which drugs are in the Benzodiazepine class on this site?

Alprazolam, Diazepam, Clonazepam, Lorazepam, Xanax and Midazolam and 13 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

244,289 reports through June 2026, 14,536 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

toxicity to various agents (12.7%), drug abuse (11.2%), drug ineffective (9.4%), completed suicide (8.8%) and somnolence (5.6%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.