Thymoglobulin: adverse event reports filed with FDA

6,283

reports as suspect product

0% of all reports · about 279 a year

308

reports, 12 months to June 2026

384 in the 12 months before

97%

marked serious by the reporter

97.1% across the class

26.8%

record death among outcomes, as reported

1,682 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Thymoglobulin reports recording the termmedian drug in immunoglobulin g

1. Pyrexiafever9.3%586
2. Off label useused for a purpose or in a way not on the label6.3%398
3. Drug ineffectivethe medicine did not work as expected6%374
4. Cytomegalovirus infection5.3%335
5. Transplant rejection5.1%322
6. Febrile neutropeniafever with low white blood cells4.7%298
7. Sepsisa severe body-wide response to infection3.7%234
8. Thrombocytopenialow platelets3.7%231
9. Hypotensionlow blood pressure3.7%230
10. Pneumonialung infection3.4%215
11. Serum sickness3.3%210
12. Acute graft versus host disease3.3%209
13. Pancytopenialow counts of all blood cells3.3%208
14. Product use in unapproved indicationused for a purpose not on the label3.1%196
15. Diarrhoealoose or frequent stools3%191
16. Acute graft versus host disease in skin3%189
17. Cytomegalovirus infection reactivation3%186
18. Acute kidney injurysudden loss of kidney function2.9%185
19. Neutropenialow neutrophils, a type of white blood cell2.9%180
20. BK virus infection2.8%179
21. Epstein-Barr virus infection2.8%174
22. Kidney transplant rejection2.7%172
23. Post transplant lymphoproliferative disorder2.7%167
24. Respiratory failurethe lungs could not supply enough oxygen2.4%152
25. Graft versus host disease2.4%151
26. Renal impairmentreduced kidney function2.4%151
27. Cytomegalovirus viraemia2.4%148
28. Thrombotic microangiopathy2.3%142
29. Leukopenialow white blood cells2.2%140
30. Nauseafeeling sick2.2%139

Top 30 of 1,119 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the immunoglobulin g class; it describes the reports, not the patients. 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."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 8,877 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 37% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 6,283 reports.

Drugs most often listed in the same reports

Other products listed in reports where Thymoglobulin is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."

Other drugs in the immunoglobulin g class

Ordered by report count for navigation only. 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." A brand and its generic are separate rows because reporters name them separately.

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. A report counts here when it lists Thymoglobulin as a suspect or interacting product; reports listing it only as a concomitant medication (1,488) are excluded. 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.