Psychological trauma 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 December 2008 to June 2026, FDA received 8,628 adverse event reports that record the MedDRA preferred term Psychological trauma. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 87 reports in the 12 months to June 2026 and 80 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 1,374 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, 87 (under 0.1%) record this term. Reports for female patients were 88.9% of the reports that record this term and 52.7% 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 75 drug pages with 5 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 Psychological trauma name as a suspect product, in order of name
Drug	Class	Reports with this term
Abilify	Atypical antipsychotic	8
Acetaminophen Oxycodone Hydrochloride		19
Acetaminophen Oxycodone Hydrochloride Oxycodone Terephthalate		6
Amlodipine	Calcium channel blocker	6
Amlodipine besylate	Dihydropyridine calcium channel blocker	5
Aripiprazole	Atypical antipsychotic	5
Beyaz		15
Bilastine		11
Buprenorphine Transdermal Patch		19
Butrans	Partial opioid agonist	11
Capecitabine	Nucleoside metabolic inhibitor	19
Certolizumab pegol	Tumor necrosis factor blocker	9
Cetirizine hydrochloride	Histamine-1 receptor antagonist	10
Ciprofloxacin	Fluoroquinolone antibacterial	7
Citalopram	Serotonin reuptake inhibitor	12
Cytoxan		6
Daytrana	Central nervous system stimulant	6
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	8
Dilaudid	Opioid agonist	38
Docetaxel	Microtubule inhibitor	778
Drospirenone and ethinyl estradiol		47
Escitalopram	Serotonin reuptake inhibitor	21
Fentanyl	Opioid agonist	40
Fluoxetine	Serotonin reuptake inhibitor	8
Gianvi		22
Heroin		7
Hydrocodone bitartrate	Opioid agonist	14
Hydrocodone bitartrate and acetaminophen	Opioid agonist	104
Hydromorphone Tablets		14
Lamictal	Anti-epileptic agent	6
Latuda	Atypical antipsychotic	8
Levetiracetam		19
Levothyroxine		6
Lortab		10
Lumryz	Central nervous system depressant	6
Mesalamine	Aminosalicylate	8
Methadone	Opioid agonist	30
Methotrexate	Folate analog metabolic inhibitor	9
Mirena	Progestin	102
Morphine sulfate	Opioid agonist	52
MS Contin	Opioid agonist	34
Norco	Opioid agonist	10
Ocella		89
Olanzapine	Atypical antipsychotic	5
Oxy Ir		6
Oxycodone	Opioid agonist	7
Oxycodone and acetaminophen	Opioid agonist	89
Oxycodone hydrochloride	Opioid agonist	203
OxyContin	Opioid agonist	180
Oxyfast		7
Oxyir		9
Pantoprazole	Proton pump inhibitor	15
ParaGard T 380A	Copper-containing intrauterine device	81
Percocet	Opioid agonist	11
Plavix	P2Y12 platelet inhibitor	41
Quetiapine	Atypical antipsychotic	6
Risperdal	Atypical antipsychotic	6
Ryzolt		6
Sandostatin LAR Depot		5
Spravato		5
Suboxone	Opioid antagonist	18
Sulfasalazine	Aminosalicylate	10
Sunosi		6
Taxotere		6,203
Tramadol		49
Tramadol Cr Tablets		26
Trastuzumab	HER2/neu receptor antagonist	19
Trasylol		39
Trikafta		5
Tukysa	Kinase inhibitor	18
Vicodin		17
Yasmin		382
Yaz		457
Zantac		22
Zoloft	Serotonin reuptake inhibitor	8

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 29 pharmacologic classes with 5 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 Psychological trauma name, in order of name
Class	Reports with this term
Aminosalicylate	18
Angiotensin 2 receptor blocker	7
Anti-epileptic agent	10
Atypical antipsychotic	47
Calcium channel blocker	6
Central nervous system depressant	12
Central nervous system stimulant	6
Copper-containing intrauterine device	81
Corticosteroid	7
Dihydropyridine calcium channel blocker	5
Fluoroquinolone antibacterial	7
Folate analog metabolic inhibitor	11
HER2/neu receptor antagonist	22
Histamine-1 receptor antagonist	10
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	6
Interferon beta	5
Kinase inhibitor	21
Microtubule inhibitor	778
Nonsteroidal anti-inflammatory drug	11
Nucleoside metabolic inhibitor	19
Opioid agonist	827
Opioid antagonist	18
P2Y12 platelet inhibitor	41
Partial opioid agonist	14
Progestin	106
Proton pump inhibitor	15
Serotonin and norepinephrine reuptake inhibitor	7
Serotonin reuptake inhibitor	53
Tumor necrosis factor blocker	18

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

Reports by month

Reports that record Psychological trauma, 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 Psychological trauma
Age	Reports	Share
Under 2	4	under 0.1%
2 to 11	15	0.2%
12 to 17	34	0.4%
18 to 44	2,032	23.6%
45 to 64	4,492	52.1%
65 to 74	727	8.4%
75 and over	95	1.1%
Age not given	1,229	14.2%

Sex of the patient in the reports that record Psychological trauma
Sex	Reports	Share
Female	7,671	88.9%
Male	364	4.2%
Unknown or not given	593	6.9%

Age and sex are as the report gives them. 96.2% 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. Psychological trauma: adverse event reports that record this term. https://reportedreactions.com/reaction/psychological-trauma/ 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 Psychological trauma 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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