MedDRA preferred term

Transplant rejection: adverse event reports recording this term

7,880 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.

7,880
reports recording the term: 0% of all reports; 477
reports, 12 months to June 2026: 559 in the 12 months before; 99.2%
marked serious by the reporter: 57.4% across all reports; 13.6%
record death among outcomes, as reported: 9.1% across all reports

"Transplant rejection" is a MedDRA preferred term recorded in 7,880 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

477 reports recorded it in the 12 months to June 2026, down 15% from 559 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, 99.2% are marked serious, 13.6% include death among the outcomes and 35.2% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Tacrolimus, Mycophenolate mofetil and Prednisone. 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
Tacrolimus	Calcineurin inhibitor immunosuppressant	3,591	3.8%
Mycophenolate mofetil	Antimetabolite immunosuppressant	3,022	3.7%
Prednisone	Corticosteroid	1,339	0.7%
Prednisolone	Corticosteroid	1,023	1.2%
Methylprednisolone	Corticosteroid	860	1.7%
Prograf	Calcineurin inhibitor immunosuppressant	785	3.8%
Cyclosporine	Calcineurin inhibitor immunosuppressant	546	1.4%
Rapamune	—	540	8.5%
Neoral	Calcineurin inhibitor immunosuppressant	530	4.7%
Basiliximab	Interleukin-2 receptor blocking antibody	527	7.8%
CellCept	Antimetabolite immunosuppressant	461	2.6%
Enbrel	Tumor necrosis factor blocker	421	0.1%
Rituximab	CD20-directed cytolytic antibody	408	0.3%
Daclizumab	—	385	30%
Remicade	Tumor necrosis factor blocker	382	0.2%
Mycophenolic acid	Antimetabolite immunosuppressant	362	2.6%
Thymoglobulin	Immunoglobulin G	322	5.1%
Sirolimus	Kinase inhibitor	315	3.2%
Antithymocyte Immunoglobulin	—	295	9.1%
Azathioprine	Purine antimetabolite	259	0.8%
Everolimus	Kinase inhibitor	258	1.9%
Envarsus	Calcineurin inhibitor immunosuppressant	223	5.9%
Myfortic	Antimetabolite immunosuppressant	178	2.3%
Sulfasalazine	Aminosalicylate	177	0.4%
Valganciclovir	Cytomegalovirus nucleoside analog DNA polymerase inhibitor	157	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% 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
Calcineurin inhibitor immunosuppressant	5,704	2.8%	1.4%
Antimetabolite immunosuppressant	4,023	3.3%	2.6%
Corticosteroid	3,387	0.4%	0%
Tumor necrosis factor blocker	938	0.1%	0%
Interleukin-2 receptor blocking antibody	674	7.9%	8.3%
Kinase inhibitor	596	0.1%	0%
CD20-directed cytolytic antibody	423	0.1%	0%
Immunoglobulin G	408	4.6%	3.8%
Cytomegalovirus nucleoside analog DNA polymerase inhibitor	319	2.3%	1.7%
Purine antimetabolite	264	0.5%	0.1%

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 21.1%88

2 to 113.9%310

12 to 173.4%266

18 to 4424.1%1,901

45 to 6430.2%2,383

65 to 746%474

75 and over0.9%69

Age not given30.3%2,389

Patient sex

Female37.8%2,981

Male43.3%3,410

Not given18.9%1,489

Grey bar: all 20,646,523 reports in the database. 35.9% of these reports give the United States as the country.

Questions about "Transplant rejection"

What does "Transplant rejection" 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 transplant rejection?

7,880 reports through June 2026 (0% of all reports), 477 of them in the latest 12 months.

Which drugs appear most often in these reports?

Tacrolimus (3,591), Mycophenolate mofetil (3,022), Prednisone (1,339), Prednisolone (1,023) and Methylprednisolone (860). 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.