Psychiatric symptom adverse event reports that record this term

Kind of term: MedDRA preferred term

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From January 2004 to June 2026, FDA received 7,268 adverse event reports that record the MedDRA preferred term Psychiatric symptom. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 360 reports in the 12 months to June 2026 and 350 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

By reports in the 12 months to June 2026, this term was number 1,154 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 360 (under 0.1%) record this term. Reports for patients aged 18 to 44 were 21.3% of the reports that record this term and 12.3% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 92 drug pages with 25 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Drugs that the reports with the term Psychiatric symptom name as a suspect product, in order of name
Drug	Class	Reports with this term
Abilify	Atypical antipsychotic	170
Abilify Maintena		62
Alprazolam	Benzodiazepine	45
Androgel		78
Aripiprazole	Atypical antipsychotic	106
Avonex	Interferon beta	28
Carbamazepine	Mood stabilizer	33
Carbidopa levodopa	Aromatic amino acid	62
Champix		26
Chantix	Partial cholinergic nicotinic agonist	111
Ciprofloxacin	Fluoroquinolone antibacterial	39
Citalopram	Serotonin reuptake inhibitor	38
Clonazepam	Benzodiazepine	36
Clozapine	Atypical antipsychotic	139
Clozaril	Atypical antipsychotic	70
Cymbalta		49
Desvenlafaxine succinate	Serotonin and norepinephrine reuptake inhibitor	45
Dexamethasone	Corticosteroid	34
Dilaudid	Opioid agonist	25
Disulfiram		42
Duodopa		37
Dupixent	Interleukin-4 receptor alpha antagonist	111
Effexor	Serotonin and norepinephrine reuptake inhibitor	125
Enbrel	Tumor necrosis factor blocker	41
Entresto	Angiotensin 2 receptor blocker	32
Escitalopram	Serotonin reuptake inhibitor	32
Euthyrox		44
Finasteride	5-alpha reductase inhibitor	50
Fluoxetine	Serotonin reuptake inhibitor	44
Gabapentin	Anti-epileptic agent	27
Gilenya	Sphingosine 1-phosphate receptor modulator	40
Humira		187
Hydrocodone bitartrate and acetaminophen	Opioid agonist	28
Hydrocortisone	Corticosteroid	25
Ibrance	Kinase inhibitor	66
Ingrezza	Vesicular monoamine transporter 2 inhibitor	64
Invega	Atypical antipsychotic	39
Keppra		25
Lamotrigine	Anti-epileptic agent	48
Latuda	Atypical antipsychotic	40
Lenalidomide	Thalidomide analog	28
Levetiracetam		117
Lorazepam	Benzodiazepine	43
Lyrica		55
Methotrexate	Folate analog metabolic inhibitor	51
Methotrexate sodium	Folate analog metabolic inhibitor	25
Methylprednisolone	Corticosteroid	29
Mirena	Progestin	28
Montelukast	Leukotriene receptor antagonist	28
Morphine sulfate	Opioid agonist	38
Novothyrox		125
Nuplazid	Atypical antipsychotic	27
Olanzapine	Atypical antipsychotic	81
Omeprazole	Proton pump inhibitor	45
Oxycodone and acetaminophen	Opioid agonist	25
Oxycodone hydrochloride	Opioid agonist	81
OxyContin	Opioid agonist	76
Pantoprazole	Proton pump inhibitor	62
Paroxetine	Serotonin reuptake inhibitor	31
Paroxetine hydrochloride	Serotonin reuptake inhibitor	59
Paxil	Serotonin reuptake inhibitor	82
Prednisolone	Corticosteroid	70
Prednisone	Corticosteroid	74
Propecia	5-alpha reductase inhibitor	32
Quetiapine	Atypical antipsychotic	107
Rexulti	Atypical antipsychotic	25
Ribavirin	Nucleoside analog antiviral	33
Risperdal	Atypical antipsychotic	58
Risperidone	Atypical antipsychotic	93
Sandostatin	Somatostatin analog	34
Sandostatin LAR Depot		55
Seroquel	Atypical antipsychotic	63
Seroxat		33
Sertraline	Serotonin reuptake inhibitor	70
Simvastatin	HMG-CoA reductase inhibitor	264
Tacrolimus	Calcineurin inhibitor immunosuppressant	35
Tamiflu	Neuraminidase inhibitor	27
Topiramate		26
Tramadol		29
Trasylol		42
Tysabri	Integrin receptor antagonist	36
Valproate sodium	Anti-epileptic agent	37
Valproic acid	Anti-epileptic agent	29
Valtrex	Herpes simplex virus nucleoside analog DNA polymerase inhibitor	63
Venlafaxine	Serotonin and norepinephrine reuptake inhibitor	27
Venlafaxine hydrochloride	Serotonin and norepinephrine reuptake inhibitor	42
Xeljanz	Janus kinase inhibitor	43
Xeplion		43
Yaz		27
Zoloft	Serotonin reuptake inhibitor	218
Zopiclone		25
Zyprexa	Atypical antipsychotic	66

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 50 pharmacologic classes with 25 or more reports that record this term. The rows are in order of name.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pharmacologic classes of the drugs that the reports with the term Psychiatric symptom name, in order of name
Class	Reports with this term
5-alpha reductase inhibitor	82
Aminoketone	29
Angiotensin 2 receptor blocker	69
Anti-epileptic agent	188
Anti-IgE	27
Antimetabolite immunosuppressant	29
Antirheumatic agent	27
Aromatase inhibitor	26
Aromatic amino acid	62
Atypical antipsychotic	1,185
Azole antifungal	39
Benzodiazepine	189
beta-Adrenergic blocker	36
Calcineurin inhibitor immunosuppressant	38
CD20-directed cytolytic antibody	36
Central nervous system stimulant	54
Corticosteroid	316
Echinocandin antifungal	33
Estrogen	83
Fluoroquinolone antibacterial	48
Folate analog metabolic inhibitor	76
Herpes simplex virus nucleoside analog DNA polymerase inhibitor	67
HMG-CoA reductase inhibitor	309
Integrin receptor antagonist	45
Interferon beta	39
Interleukin-4 receptor alpha antagonist	111
Interleukin-6 receptor antagonist	29
Janus kinase inhibitor	73
Kinase inhibitor	146
Leukotriene receptor antagonist	57
Mood stabilizer	71
Neuraminidase inhibitor	30
Nonsteroidal anti-inflammatory drug	54
Nucleoside analog antiviral	33
Opioid agonist	381
Partial cholinergic nicotinic agonist	117
Progestin	53
Proteasome inhibitor	28
Proton pump inhibitor	135
Retinoid	34
Rifamycin antibacterial	26
Serotonin and norepinephrine reuptake inhibitor	266
Serotonin reuptake inhibitor	623
Somatostatin analog	47
Sphingosine 1-phosphate receptor modulator	42
Tetracycline-class drug	35
Thalidomide analog	43
Tumor necrosis factor blocker	120
Typical antipsychotic	31
Vesicular monoamine transporter 2 inhibitor	68

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Psychiatric symptom, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Patients in these reports

Age of the patient in the reports that record Psychiatric symptom
Age	Reports	Share
Under 2	12	0.2%
2 to 11	89	1.2%
12 to 17	138	1.9%
18 to 44	1,550	21.3%
45 to 64	1,655	22.8%
65 to 74	684	9.4%
75 and over	433	6%
Age not given	2,707	37.2%

Sex of the patient in the reports that record Psychiatric symptom
Sex	Reports	Share
Female	3,893	53.6%
Male	2,646	36.4%
Unknown or not given	729	10%

Age and sex are as the report gives them. 43% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Psychiatric symptom: adverse event reports that record this term. https://reportedreactions.com/reaction/psychiatric-symptom/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

The count has the reports with each spelling of one MedDRA preferred term. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

What does Psychiatric symptom mean in an adverse event report?

It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.
Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on 2 Oct 2026.

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