MedDRA preferred term

Therapeutic product effect decreased: adverse event reports recording this term

43,798 reports to FDA record it, 2007–2026; 0.2% 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.

43,798
reports recording the term: 0.2% of all reports; 3,860
reports, 12 months to June 2026: 3,916 in the 12 months before; 50.5%
marked serious by the reporter: 57.4% across all reports; 4.7%
record death among outcomes, as reported: 9.1% across all reports

"Therapeutic product effect decreased" is a MedDRA preferred term recorded in 43,798 adverse event reports received by FDA, 0.2% of the database, from December 2007 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

3,860 reports recorded it in the 12 months to June 2026, close to the 3,916 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, 50.5% are marked serious, 4.7% include death among the outcomes and 16.1% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Humira, Enbrel and Methotrexate. 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
Humira	—	10,648	1.7%
Enbrel	Tumor necrosis factor blocker	8,974	1.6%
Methotrexate	Folate analog metabolic inhibitor	8,560	4.1%
Orencia	Selective T cell costimulation modulator	7,332	6.7%
Actemra	Interleukin-6 receptor antagonist	7,115	8.9%
Sulfasalazine	Aminosalicylate	5,639	13.8%
Rituximab	CD20-directed cytolytic antibody	5,577	3.6%
Remicade	Tumor necrosis factor blocker	5,556	3.6%
Leflunomide	Antirheumatic agent	5,474	14.8%
Simponi	Tumor necrosis factor blocker	5,464	7.8%
Cimzia	Tumor necrosis factor blocker	5,399	6.2%
Arava	Antirheumatic agent	4,947	14.5%
Xeljanz	Janus kinase inhibitor	4,820	3.1%
Prednisone	Corticosteroid	4,612	2.5%
Hydroxychloroquine sulfate	Antimalarial	4,502	18.7%
Hydroxychloroquine	Antimalarial	4,050	10%
Folic acid	Vitamin B12	3,579	14.9%
Desoximetasone	Corticosteroid	3,451	28.3%
Acetaminophen	Nonsteroidal anti-inflammatory drug	3,263	3.8%
Fosamax	Bisphosphonate	2,990	8.6%
Adalimumab	Tumor necrosis factor blocker	2,834	7.2%
Infliximab	Tumor necrosis factor blocker	2,809	5.3%
Cosentyx	Interleukin-17A antagonist	2,745	1.8%
Cetirizine hydrochloride	Histamine-1 receptor antagonist	2,676	14%
Plaquenil	Antimalarial	2,666	12.4%

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 0.2% 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
Tumor necrosis factor blocker	35,178	3.3%	3.6%
Corticosteroid	18,356	2.3%	0.3%
Nonsteroidal anti-inflammatory drug	14,287	2.6%	0%
Antimalarial	11,218	12.2%	0%
Interleukin-6 receptor antagonist	10,812	8.1%	8.1%
Antirheumatic agent	10,421	14.6%	14.7%
Folate analog metabolic inhibitor	9,863	3.2%	0.2%
Selective T cell costimulation modulator	7,859	6%	4.6%
Janus kinase inhibitor	7,646	2.4%	0.8%
CD20-directed cytolytic antibody	7,576	2.4%	0.3%

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%43

2 to 110.7%296

12 to 171.3%564

18 to 4415.2%6,658

45 to 6418.6%8,139

65 to 748.1%3,541

75 and over4.6%2,005

Age not given51.5%22,552

Patient sex

Female56.6%24,773

Male25.4%11,106

Not given18.1%7,919

Grey bar: all 20,646,523 reports in the database. 61.6% of these reports give the United States as the country.

Questions about "Therapeutic product effect decreased"

What does "Therapeutic product effect decreased" mean in an adverse event report?

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 therapeutic product effect decreased?

43,798 reports through June 2026 (0.2% of all reports), 3,860 of them in the latest 12 months.

Which drugs appear most often in these reports?

Humira (10,648), Enbrel (8,974), Methotrexate (8,560), Orencia (7,332) and Actemra (7,115). 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.