MedDRA preferred term · a loss of contact with reality

Psychotic disorder: adverse event reports recording this term

29,009 reports to FDA record it, 2004–2026; 0.1% 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.

29,009
reports recording the term: 0.1% of all reports; 1,491
reports, 12 months to June 2026: 1,473 in the 12 months before; 91.7%
marked serious by the reporter: 57.4% across all reports; 4.2%
record death among outcomes, as reported: 9.1% across all reports

"Psychotic disorder" (in plain words, a loss of contact with reality) is a MedDRA preferred term recorded in 29,009 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

1,491 reports recorded it in the 12 months to June 2026, close to the 1,473 of 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, 91.7% are marked serious, 4.2% include death among the outcomes and 52.9% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Clozapine, Olanzapine and Abilify. 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
Clozapine	Atypical antipsychotic	1,705	2.3%
Olanzapine	Atypical antipsychotic	1,428	3%
Abilify	Atypical antipsychotic	1,286	2.4%
Risperidone	Atypical antipsychotic	1,268	2.8%
Clozaril	Atypical antipsychotic	1,252	2.6%
Aripiprazole	Atypical antipsychotic	940	3.1%
Quetiapine	Atypical antipsychotic	797	1.5%
Seroquel	Atypical antipsychotic	688	1.3%
Clonazepam	Benzodiazepine	651	1.7%
Risperdal	Atypical antipsychotic	597	1.1%
Invega Sustenna	Atypical antipsychotic	594	2.5%
Zyprexa	Atypical antipsychotic	588	2.2%
Nuplazid	Atypical antipsychotic	577	1.1%
Chantix	Partial cholinergic nicotinic agonist	537	0.8%
Diazepam	Benzodiazepine	523	1.3%
Prednisone	Corticosteroid	493	0.3%
Abilify Maintena	—	483	5.3%
Lorazepam	Benzodiazepine	441	1.3%
Quetiapine fumarate	Atypical antipsychotic	405	2.1%
Levetiracetam	—	399	0.8%
Sertraline	Serotonin reuptake inhibitor	390	0.9%
Haloperidol	Typical antipsychotic	372	2.6%
Xyrem	Central nervous system depressant	357	0.6%
Risperdal Consta	—	346	2.5%
Mirtazapine	—	330	1%

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 0.1% 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
Atypical antipsychotic	13,981	2%	2.1%
Benzodiazepine	2,276	0.9%	0.5%
Serotonin reuptake inhibitor	1,941	0.7%	0.7%
Anti-epileptic agent	1,733	0.6%	0.4%
Corticosteroid	1,718	0.2%	0%
Opioid agonist	1,224	0.1%	0.1%
Central nervous system stimulant	797	0.7%	0.5%
Serotonin and norepinephrine reuptake inhibitor	793	0.5%	0.4%
Mood stabilizer	708	1.2%	1.3%
Fluoroquinolone antibacterial	572	0.6%	0.5%

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 20.1%20

2 to 111.6%460

12 to 173.5%1,014

18 to 4429.1%8,433

45 to 6418.9%5,497

65 to 745.9%1,724

75 and over4.2%1,229

Age not given36.7%10,632

Patient sex

Female44.3%12,854

Male45.6%13,224

Not given10.1%2,931

Grey bar: all 20,646,523 reports in the database. 46.6% of these reports give the United States as the country.

Questions about "Psychotic disorder"

What does "Psychotic disorder" mean in an adverse event report?

In plain language: a loss of contact with reality. 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 psychotic disorder?

29,009 reports through June 2026 (0.1% of all reports), 1,491 of them in the latest 12 months.

Which drugs appear most often in these reports?

Clozapine (1,705), Olanzapine (1,428), Abilify (1,286), Risperidone (1,268) and Clozaril (1,252). 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.