What the label lists and what reports show
Thiotepa side effects
Thiotepa's FDA label: “The most common adverse reactions (incidence greater than 10%) are neutropenia, anemia, thrombocytopenia, elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated bilirubin, mucositis, cytomegalovirus infection, hemorrhage, diarrhea …” FAERS holds 9,494 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is febrile neutropenia (814 reports).
- Generic listed
- Boxed warning
Check it at the source: the thiotepa FDA label on DailyMed (effective January 30, 2026, Amneal Pharmaceuticals LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence greater than 10%) are neutropenia, anemia, thrombocytopenia, elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated bilirubin, mucositis, cytomegalovirus infection, hemorrhage, diarrhea, hematuria and rash.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Reaction | Any Grade | Grade 3-5 1 | Any Grade | Grade 3-5 1 |
|---|---|---|---|---|
| Mucositis 2 | 16 (64%) | 4 (16%) | 22 (43%) | 1 (2%) |
| Cytomegalovirus Infection | 12 (48%) | 0 | 15 (29%) | 0 |
| Hemorrhage 3 | 7 (28%) | 2 (8%) | 12 (24%) | 3 (6%) |
| Diarrhea | 6 (24%) | 0 | 7 (14%) | 2 (4%) |
| Hematuria 4 | 5 (20%) | 0 | 10 (20%) | 3 (6%) |
| Rash 5 | 3 (12%) | 0 | 11 (22%) | 0 |
| Intracranial Hemorrhage 6 | 2 (8%) | 1 (4%) | 0 | 0 |
| Pseudomonas Infection | 2 (8%) | 0 | 0 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [ see Warnings and Precautions ( 5.1 ) ] Infection [ see Warnings and Precautions ( 5.1 ) ] Hypersensitivity [ see Warnings and Precautions ( 5.2 ) ] Cutaneous Toxicity [ see Warnings and Precautions ( 5.3 ) ] Hepatic Veno-Occlusive Disease [ see Warnings and Precautions ( 5.5 ) ] Central Nervous System Toxicity [ see Warnings and Precautions (5.6) ] Carcinogenicity [ see Warnings and Precautions (5.7) ] The most common adverse reactions (incidence greater than 10%) are neutropenia, anemia, thrombocytopenia, elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated bilirubin, mucositis, cytomegalovirus infection, hemorrhage, diarrhea, hematuria and rash. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact ADIENNE at 844-668-3940 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Source: FDA drug label, NDA208264 (Adienne Sa), as published by Amneal Pharmaceuticals LLC, effective January 30, 2026 (SPL set 559e353c-2dc0-16ba-e054-00144ff8d46c), via openFDA; the full label on DailyMed
What do FAERS reports show?
9,494 reports list thiotepa among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,672 are coded as a death and 1,813 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Thiotepa: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions