MedDRA preferred term · emotional distress

Emotional distress: adverse event reports recording this term

119,584 reports to FDA record it, 2004–2026; 0.6% 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.

119,584
reports recording the term: 0.6% of all reports; 3,246
reports, 12 months to June 2026: 2,050 in the 12 months before; 88.5%
marked serious by the reporter: 57.4% across all reports; 3.3%
record death among outcomes, as reported: 9.1% across all reports

119,584 reports in FDA's adverse event database record the MedDRA term "Emotional distress" (in plain words, emotional distress): 0.6% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

3,246 reports recorded it in the 12 months to June 2026, up 58% from 2,050 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, 88.5% are marked serious, 3.3% include death among the outcomes and 13.9% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are OxyContin, Oxycodone hydrochloride and Dilaudid. 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
OxyContin	Opioid agonist	44,930	30.7%
Oxycodone hydrochloride	Opioid agonist	21,962	19.4%
Dilaudid	Opioid agonist	17,089	26.6%
MS Contin	Opioid agonist	13,958	26.8%
Hydrocodone bitartrate and acetaminophen	Opioid agonist	10,645	18%
Morphine sulfate	Opioid agonist	6,905	11.5%
Taxotere	—	6,536	21.4%
Truvada	Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	6,332	16.4%
Acetaminophen Oxycodone Hydrochloride	—	5,280	16.3%
Yaz	—	4,714	17.1%
Butrans	Partial opioid agonist	4,448	7.4%
Yasmin	—	4,396	20.4%
Hydrocodone bitartrate	Opioid agonist	4,340	37.8%
Atripla	—	4,271	23.7%
Acetaminophen Oxycodone Hydrochloride Oxycodone Terephthalate	—	4,168	70.5%
Docetaxel	Microtubule inhibitor	3,606	6.1%
Hysingla ER	Opioid agonist	3,509	11.4%
Tramadol	—	3,179	6.7%
Oxycodone and acetaminophen	Opioid agonist	3,042	12.2%
Risperdal	Atypical antipsychotic	2,916	5.4%
ParaGard T 380A	Copper-containing intrauterine device	2,886	6.9%
Mirena	Progestin	2,864	2.2%
Viread	Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	2,851	12.9%
Vicodin	—	2,678	22.4%
Fentanyl	Opioid agonist	2,285	4.3%

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 0.6% 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
Opioid agonist	138,963	14.4%	1.3%
Atypical antipsychotic	7,867	1.2%	0.2%
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	7,727	9.5%	0.1%
Partial opioid agonist	5,777	6.1%	0.1%
Microtubule inhibitor	3,615	2.5%	0%
Progestin	2,971	1%	0.1%
Copper-containing intrauterine device	2,886	6.7%	3.5%
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	2,875	4%	0%
Cytochrome P450 3A inhibitor	1,866	4%	0.2%
Opioid antagonist	1,836	5.9%	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 20.1%87

2 to 110.9%1,106

12 to 171%1,205

18 to 4412.6%15,052

45 to 6411.4%13,617

65 to 742.8%3,344

75 and over1.3%1,585

Age not given69.9%83,588

Patient sex

Female48.5%58,040

Male43.7%52,274

Not given7.8%9,270

Grey bar: all 20,646,523 reports in the database. 93.9% of these reports give the United States as the country.

Questions about "Emotional distress"

What does "Emotional distress" mean in an adverse event report?

In plain language: emotional distress. 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 emotional distress?

119,584 reports through June 2026 (0.6% of all reports), 3,246 of them in the latest 12 months.

Which drugs appear most often in these reports?

OxyContin (44,930), Oxycodone hydrochloride (21,962), Dilaudid (17,089), MS Contin (13,958) and Hydrocodone bitartrate and acetaminophen (10,645). 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.