MedDRA preferred term

Concomitant disease aggravated: adverse event reports recording this term

6,093 reports to FDA record it, 2004–2026; 0% 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.

6,093
reports recording the term: 0% of all reports; 256
reports, 12 months to June 2026: 233 in the 12 months before; 89.8%
marked serious by the reporter: 57.4% across all reports; 13.9%
record death among outcomes, as reported: 9.1% across all reports

"Concomitant disease aggravated" is a MedDRA preferred term recorded in 6,093 adverse event reports received by FDA, 0% of the database, from March 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

256 reports recorded it in the 12 months to June 2026, up 10% from 233 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, 89.8% are marked serious, 13.9% include death among the outcomes and 37.3% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Entresto, Cosentyx and Gilenya. 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
Entresto	Angiotensin 2 receptor blocker	501	0.5%
Cosentyx	Interleukin-17A antagonist	458	0.3%
Gilenya	Sphingosine 1-phosphate receptor modulator	453	0.6%
Opsumit	Endothelin receptor antagonist	267	0.7%
Tracleer	Endothelin receptor antagonist	196	0.6%
Uptravi	Prostacyclin receptor agonist	158	0.9%
Prednisone	Corticosteroid	144	0.1%
Xolair	Anti-IgE	142	0.2%
Methotrexate	Folate analog metabolic inhibitor	133	0.1%
Kisqali	Kinase inhibitor	131	0.5%
Tasigna	Kinase inhibitor	110	0.4%
Afinitor	Kinase inhibitor	108	0.4%
Jakavi	—	106	1.4%
Letrozole	Aromatase inhibitor	100	0.4%
Tepezza	—	96	1.8%
Sandostatin LAR Depot	—	92	0.5%
Aclasta	—	83	0.5%
Metformin	Biguanide	75	0.1%
Cyclophosphamide	Alkylating drug	71	0.1%
Kesimpta	CD20-directed cytolytic antibody	62	0.2%
Prednisolone	Corticosteroid	62	0.1%
Exelon	Cholinesterase inhibitor	59	0.4%
Omalizumab	Anti-IgE	59	0.6%
Ilaris	—	52	0.6%
Fulvestrant	Estrogen receptor antagonist	51	0.4%

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% 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
Angiotensin 2 receptor blocker	639	0.3%	0%
Kinase inhibitor	591	0.1%	0%
Endothelin receptor antagonist	516	0.3%	0.3%
Sphingosine 1-phosphate receptor modulator	497	0.5%	0.1%
Interleukin-17A antagonist	466	0.2%	0.1%
Corticosteroid	330	0%	0%
Anti-IgE	201	0.3%	0.2%
Nonsteroidal anti-inflammatory drug	175	0%	0%
Aromatase inhibitor	169	0.2%	0.2%
Prostacyclin receptor agonist	163	0.8%	0.6%

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 20.8%51

2 to 111.1%70

12 to 171.5%89

18 to 4412.9%788

45 to 6423%1,404

65 to 7414.2%867

75 and over13.6%827

Age not given32.8%1,997

Patient sex

Female55.9%3,409

Male36%2,194

Not given8%490

Grey bar: all 20,646,523 reports in the database. 28.5% of these reports give the United States as the country.

Questions about "Concomitant disease aggravated"

What does "Concomitant disease aggravated" 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 concomitant disease aggravated?

6,093 reports through June 2026 (0% of all reports), 256 of them in the latest 12 months.

Which drugs appear most often in these reports?

Entresto (501), Cosentyx (458), Gilenya (453), Opsumit (267) and Tracleer (196). 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.