MedDRA preferred term · reduced quality of life

Quality of life decreased: adverse event reports recording this term

13,258 reports to FDA record it, 2007–2026; 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.

13,258
reports recording the term: 0.1% of all reports; 633
reports, 12 months to June 2026: 747 in the 12 months before; 81%
marked serious by the reporter: 57.4% across all reports; 3.9%
record death among outcomes, as reported: 9.1% across all reports

"Quality of life decreased" (in plain words, reduced quality of life) is a MedDRA preferred term recorded in 13,258 adverse event reports received by FDA, 0.1% of the database, from March 2007 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

633 reports recorded it in the 12 months to June 2026, down 15% from 747 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, 81% are marked serious, 3.9% include death among the outcomes and 22.3% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Metoclopramide, OxyContin and Soliris. 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
Metoclopramide	Dopamine-2 receptor antagonist	1,992	8.9%
OxyContin	Opioid agonist	500	0.3%
Soliris	Complement inhibitor	434	0.8%
Oxycodone hydrochloride	Opioid agonist	428	0.4%
Simvastatin	HMG-CoA reductase inhibitor	348	1%
Humira	—	319	0%
Methotrexate	Folate analog metabolic inhibitor	305	0.1%
Prednisone	Corticosteroid	286	0.2%
Dupixent	Interleukin-4 receptor alpha antagonist	273	0.1%
Truvada	Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	246	0.6%
Enbrel	Tumor necrosis factor blocker	213	0%
Hydrocodone bitartrate and acetaminophen	Opioid agonist	212	0.4%
Yasmin	—	205	1%
Yaz	—	204	0.7%
Morphine sulfate	Opioid agonist	185	0.3%
Atripla	—	182	1%
Dilaudid	Opioid agonist	166	0.3%
Adalimumab	Tumor necrosis factor blocker	160	0.4%
Gabapentin	Anti-epileptic agent	158	0.2%
Infliximab	Tumor necrosis factor blocker	157	0.3%
Valsartan	Angiotensin 2 receptor blocker	153	0.9%
Testim	Androgen	146	4.7%
Xolair	Anti-IgE	145	0.2%
Androgel	—	139	0.8%
MS Contin	Opioid agonist	138	0.3%

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 0.1% 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
Opioid agonist	2,221	0.2%	0%
Dopamine-2 receptor antagonist	2,044	5.1%	0.1%
Tumor necrosis factor blocker	826	0.1%	0.1%
Corticosteroid	702	0.1%	0%
Nonsteroidal anti-inflammatory drug	503	0.1%	0%
HMG-CoA reductase inhibitor	477	0.2%	0%
Complement inhibitor	443	0.6%	0.1%
Androgen	395	1.9%	0.5%
Folate analog metabolic inhibitor	365	0.1%	0%
Atypical antipsychotic	327	0%	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%15

2 to 110.9%116

12 to 170.9%122

18 to 4414.9%1,979

45 to 6419.7%2,606

65 to 748.3%1,104

75 and over5.1%680

Age not given50.1%6,636

Patient sex

Female56.4%7,479

Male35.9%4,753

Not given7.7%1,026

Grey bar: all 20,646,523 reports in the database. 72.3% of these reports give the United States as the country.

Questions about "Quality of life decreased"

What does "Quality of life decreased" mean in an adverse event report?

In plain language: reduced quality of life. 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 quality of life decreased?

13,258 reports through June 2026 (0.1% of all reports), 633 of them in the latest 12 months.

Which drugs appear most often in these reports?

Metoclopramide (1,992), OxyContin (500), Soliris (434), Oxycodone hydrochloride (428) and Simvastatin (348). 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.