MedDRA preferred term

Bruxism: adverse event reports recording this term

5,309 reports to FDA record it, 2004–2026; 0% of the database.

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.

5,309
reports recording the term: 0% of all reports; 260
reports, 12 months to June 2026: 327 in the 12 months before; 64.4%
marked serious by the reporter: 57.4% across all reports; 1.3%
record death among outcomes, as reported: 9.1% across all reports

5,309 reports in FDA's adverse event database record the MedDRA term "Bruxism": 0% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

260 reports recorded it in the 12 months to June 2026, down 20% from 327 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 64.4% are marked serious, 1.3% include death among the outcomes and 16.2% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Sertraline, Citalopram and Xyrem. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. 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."

Reports by month, five years

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

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Sertraline	Serotonin reuptake inhibitor	336	0.7%
Citalopram	Serotonin reuptake inhibitor	182	0.6%
Xyrem	Central nervous system depressant	173	0.3%
Abilify	Atypical antipsychotic	148	0.3%
Cymbalta	Serotonin and norepinephrine reuptake inhibitor	139	0.3%
Fosamax	Bisphosphonate	129	0.4%
Latuda	Atypical antipsychotic	93	0.6%
Aripiprazole	Atypical antipsychotic	87	0.3%
Daybue	—	75	1.2%
Quetiapine	Atypical antipsychotic	74	0.1%
Vyvanse	Central nervous system stimulant	70	0.4%
Fluoxetine	Serotonin reuptake inhibitor	66	0.2%
Escitalopram	Serotonin reuptake inhibitor	65	0.3%
Venlafaxine	Serotonin and norepinephrine reuptake inhibitor	65	0.2%
Sertraline hydrochloride	Serotonin reuptake inhibitor	63	0.6%
Zoloft	Serotonin reuptake inhibitor	63	0.3%
Metoclopramide	Dopamine-2 receptor antagonist	60	0.3%
Seroquel	Atypical antipsychotic	60	0.1%
Humira	—	51	0%
Prolia	RANK ligand inhibitor	50	0%
Geodon	Atypical antipsychotic	49	0.6%
Lithium	Mood stabilizer	48	0.4%
Risperidone	Atypical antipsychotic	48	0.1%
Rexulti	Atypical antipsychotic	46	0.4%
Ingrezza	Vesicular monoamine transporter 2 inhibitor	45	0.2%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0% across the whole database. 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."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Serotonin reuptake inhibitor	1,005	0.4%	0.2%
Atypical antipsychotic	868	0.1%	0.1%
Serotonin and norepinephrine reuptake inhibitor	361	0.2%	0.2%
Central nervous system stimulant	254	0.2%	0%
Central nervous system depressant	244	0.3%	0.4%
Bisphosphonate	168	0.2%	0%
Anti-epileptic agent	142	0.1%	0%
Opioid agonist	130	0%	0%
Aminoketone	129	0.2%	0.2%
Benzodiazepine	127	0.1%	0%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.4%22

2 to 113.8%201

12 to 171.4%76

18 to 4426.7%1,420

45 to 6420.9%1,112

65 to 746.4%338

75 and over3.7%198

Age not given36.6%1,942

Patient sex

Female64.3%3,413

Male26.3%1,395

Not given9.4%501

Grey bar: all 20,646,523 reports in the database. 62.2% of these reports give the United States as the country.

Questions about "Bruxism"

What does "Bruxism" mean in an adverse event report?

It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record bruxism?

5,309 reports through June 2026 (0% of all reports), 260 of them in the latest 12 months.

Which drugs appear most often in these reports?

Sertraline (336), Citalopram (182), Xyrem (173), Abilify (148) and Cymbalta (139). Drugs with many reports overall lead almost every term's list. 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."

Does a drug appearing here mean it was responsible for this reaction?

No. 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."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

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. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. 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.