Thiotepa side effects: what 9,494 FDA adverse event reports show
Brand names
Tepadina
Who reports
9,494 reports · 98% serious · 2,672 with death outcome · 45% female
Used for
TEPADINA (thiotepa) is an alkylating drug indicated: To reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia. (1.1 , 14) For treatment of adenocarcinoma of the breast or ovary.
What it is
TEPADINA (thiotepa) is an alkylating agent. TEPADINA (thiotepa) for injection is supplied as a non-pyrogenic, sterile lyophilized white powder for intravenous, intracavitary, or intravesical use after reconstitution and dilution. TEPADINA is available In a single-dose vial containing 15 mg thiotepa.
Boxed warning
SEVERE MYELOSUPPRESSION and CARCINOGENICITY TEPADINA may cause severe marrow suppression, and high doses may cause marrow ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters. Hema.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 958 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Npm1 gene mutation | 11 | 11,982.0 2,656.2–54,051.6ROR 11,995.9 · χ² 18,472 / p <1e-300 | 437.1 EB05 260.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Pre-engraftment immune reaction | 47 | 3,199.8 2,042.8–5,012.0ROR 3,215.7 · χ² 59,590 / p <1e-300 | 846.3 EB05 662.0 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=47 · ♀ 70% (drug 45%) · 100% clinician | no trial data cached |
| Cytomegalovirus urinary tract infection | 15 | 2,042.4 1,010.0–4,129.9ROR 2,045.6 · χ² 14,760 / p <1e-300 | 448.7 EB05 288.6 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | no trial data cached |
| Autoimmune lymphoproliferative syndrome | 22 | 1,295.4 764.5–2,194.8ROR 1,298.4 · χ² 17,041 / p <1e-300 | 475.3 EB05 330.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Pulmonary arteriopathy | 16 | 1,025.2 566.1–1,856.6ROR 1,026.9 · χ² 10,447 / p <1e-300 | 379.9 EB05 247.9 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=16 | no trial data cached |
| Adenovirus reactivation | 37 | 806.1 553.1–1,174.7ROR 809.2 · χ² 21,132 / p <1e-300 | 450.8 EB05 341.6 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=36 · 100% clinician | no trial data cached |
| Urethral polyp | 10 | 726.2 355.1–1,485.1ROR 726.9 · χ² 4,901 / p <1e-300 | 267.1 EB05 155.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Juvenile melanoma benign | 14 | 598.0 331.2–1,080.0ROR 598.9 · χ² 6,087 / p <1e-300 | 286.1 EB05 181.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Disseminated toxoplasmosis | 24 | 580.9 370.5–911.0ROR 582.4 · χ² 10,516 / p <1e-300 | 335.8 EB05 237.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 23% (drug 45%) · 92% clinician | no trial data cached |
| Viral haemorrhagic cystitis | 144 | 567.3 472.8–680.7ROR 576.0 · χ² 64,138 / p <1e-300 | 424.8 EB05 369.7 · IC025 +7.2 3/3 methods agree | Labeled (related wording) related wording | serious n=144 · 97% clinician | no trial data cached |
| Retinopathy haemorrhagic | 13 | 534.4 291.4–979.8ROR 535.1 · χ² 5,137 / p <1e-300 | 263.3 EB05 163.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Heart failure with midrange ejection fraction | 10 | 518.7 260.3–1,033.5ROR 519.2 · χ² 3,766 / p <1e-300 | 233.1 EB05 135.3 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Engraftment syndrome | 110 | 509.9 414.7–626.9ROR 515.8 · χ² 44,861 / p <1e-300 | 385.6 EB05 328.8 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=109 · ♀ 18% (drug 45%) · 97% clinician | no trial data cached |
| Acute graft versus host disease in intestine | 256 | 494.0 432.0–564.9ROR 507.6 · χ² 102,274 / p <1e-300 | 391.1 EB05 352.5 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious n=256 · ♀ 23% (drug 45%) · 99% clinician | no trial data cached |
| Viruria | 19 | 487.0 296.3–800.5ROR 487.9 · χ² 7,139 / p <1e-300 | 284.3 EB05 192.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Hyperfibrinogenaemia | 12 | 475.3 254.6–887.3ROR 475.9 · χ² 4,281 / p <1e-300 | 241.0 EB05 146.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Anisometropia | 11 | 452.2 236.3–865.3ROR 452.7 · χ² 3,735 / p <1e-300 | 227.2 EB05 135.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Chimerism | 15 | 447.6 256.9–780.0ROR 448.4 · χ² 5,181 / p <1e-300 | 252.3 EB05 162.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Acute graft versus host disease in skin | 448 | 428.8 388.3–473.6ROR 450.0 · χ² 159,431 / p <1e-300 | 353.0 EB05 326.4 · IC025 +7.8 3/3 methods agree | Labeled (related wording) related wording | serious n=448 · 99% clinician | no trial data cached |
| Human herpesvirus 6 infection | 305 | 421.6 373.6–475.8ROR 435.6 · χ² 106,888 / p <1e-300 | 345.7 EB05 314.4 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious n=304 · 97% clinician | no trial data cached |
| Gastroenteritis adenovirus | 25 | 419.0 273.2–642.5ROR 420.1 · χ² 8,395 / p <1e-300 | 277.1 EB05 197.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=25 · 100% clinician | no trial data cached |
| Idiopathic pneumonia syndrome | 46 | 404.1 295.2–553.2ROR 406.0 · χ² 15,264 / p <1e-300 | 298.7 EB05 233.0 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=46 · ♀ 25% (drug 45%) · 100% clinician | no trial data cached |
| Herpes simplex pneumonia | 19 | 386.8 237.6–629.9ROR 387.6 · χ² 5,886 / p <1e-300 | 247.1 EB05 167.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Serratia sepsis | 16 | 378.9 222.9–644.0ROR 379.5 · χ² 4,820 / p <1e-300 | 233.2 EB05 152.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Chronic graft versus host disease in intestine | 26 | 358.5 236.9–542.5ROR 359.5 · χ² 7,655 / p <1e-300 | 251.2 EB05 180.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 21% (drug 45%) · 100% clinician | no trial data cached |
| Radiation interaction | 11 | 332.8 176.5–627.6ROR 333.2 · χ² 2,875 / p <1e-300 | 192.8 EB05 114.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Gastroenteritis astroviral | 10 | 330.1 169.8–641.7ROR 330.4 · χ² 2,570 / p <1e-300 | 185.8 EB05 107.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Meningitis enterococcal | 10 | 320.4 165.0–622.0ROR 320.7 · χ² 2,504 / p <1e-300 | 182.7 EB05 106.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Graft versus host disease in skin | 257 | 292.2 256.9–332.3ROR 300.3 · χ² 65,516 / p <1e-300 | 252.9 EB05 228.0 · IC025 +7.2 3/3 methods agree | Labeled (related wording) related wording | serious n=257 · 98% clinician | no trial data cached |
| Urinary tract infection viral | 12 | 290.5 159.1–530.3ROR 290.8 · χ² 2,804 / p <1e-300 | 182.5 EB05 111.2 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | no trial data cached |
| Medulloblastoma recurrent | 13 | 283.2 159.0–504.6ROR 283.6 · χ² 2,990 / p <1e-300 | 183.6 EB05 114.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Adenovirus infection | 322 | 279.6 249.4–313.4ROR 289.4 · χ² 78,983 / p <1e-300 | 244.3 EB05 222.7 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious n=315 · 99% clinician | no trial data cached |
| Graft versus host disease in gastrointestinal tract | 234 | 273.0 238.7–312.3ROR 279.9 · χ² 56,126 / p <1e-300 | 238.0 EB05 213.5 · IC025 +7.1 3/3 methods agree | Labeled (related wording) related wording | serious n=234 · 97% clinician | no trial data cached |
| Toxic erythema of chemotherapy | 26 | 271.0 180.4–407.2ROR 271.8 · χ² 5,983 / p <1e-300 | 205.0 EB05 147.0 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious n=25 · ♀ 75% (drug 45%) · 100% clinician | no trial data cached |
| Chronic graft versus host disease in skin | 96 | 260.4 211.0–321.5ROR 263.1 · χ² 21,932 / p <1e-300 | 222.5 EB05 187.6 · IC025 +6.4 3/3 methods agree | Labeled (related wording) related wording | serious n=96 · 100% clinician | no trial data cached |
| Central nervous system viral infection | 14 | 252.1 145.0–438.2ROR 252.4 · χ² 2,917 / p <1e-300 | 173.1 EB05 109.6 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | no trial data cached |
| Acute graft versus host disease in liver | 73 | 248.9 195.5–316.8ROR 250.8 · χ² 15,953 / p <1e-300 | 211.2 EB05 173.5 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=73 · 97% clinician | no trial data cached |
| Chronic graft versus host disease in lung | 17 | 246.9 149.6–407.6ROR 247.3 · χ² 3,522 / p <1e-300 | 177.9 EB05 117.6 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious n=17 | no trial data cached |
| Cytomegalovirus infection reactivation | 424 | 243.8 221.0–269.0ROR 255.1 · χ² 92,002 / p <1e-300 | 217.2 EB05 200.4 · IC025 +7.3 3/3 methods agree | Labeled (related wording) related wording | serious n=422 · 99% clinician | no trial data cached |
| Acute graft versus host disease | 458 | 243.4 221.4–267.5ROR 255.6 · χ² 99,241 / p <1e-300 | 217.0 EB05 200.9 · IC025 +7.3 3/3 methods agree | Labeled (related wording) related wording | serious n=457 · 95% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 1,152 | 2.9 2.8–3.1ROR 3.2 · χ² 1,528 / p <1e-300 | 2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 · 96% clinician | no trial data cached |
| Febrile neutropenia | 814 | 27.5 25.7–29.4ROR 30.0 · χ² 20,548 / p <1e-300 | 27.1 EB05 25.6 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.0 · 95% clinician | no trial data cached |
| Mucosal inflammation | 807 | 70.6 66.0–75.5ROR 77.0 · χ² 53,610 / p <1e-300 | 68.3 EB05 64.4 · IC025 +5.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 42.5 · 97% clinician | no trial data cached |
| Product use in unapproved indication | 598 | 5.4 5.0–5.9ROR 5.7 · χ² 2,170 / p <1e-300 | 5.4 EB05 5.0 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 · 99% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 536 | 0.9 0.8–1.0ROR 0.9 · χ² 6 / p 0.006 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.5 · 98% clinician | no trial data cached |
| Cytomegalovirus infection | 533 | 73.1 67.2–79.5ROR 77.4 · χ² 36,636 / p <1e-300 | 70.6 EB05 65.7 · IC025 +5.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 42.2 · 96% clinician | no trial data cached |
| Pyrexia (fever) | 516 | 3.3 3.0–3.6ROR 3.4 · χ² 835 / p 6e-184 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.4 · 96% clinician | no trial data cached |
| Acute graft versus host disease | 458 | 243.4 221.4–267.5ROR 255.6 · χ² 99,241 / p <1e-300 | 217.0 EB05 200.9 · IC025 +7.3 3/3 methods agree | Labeled (related wording) related wording | serious n=457 · 95% clinician | no trial data cached |
| Acute graft versus host disease in skin | 448 | 428.8 388.3–473.6ROR 450.0 · χ² 159,431 / p <1e-300 | 353.0 EB05 326.4 · IC025 +7.8 3/3 methods agree | Labeled (related wording) related wording | serious n=448 · 99% clinician | no trial data cached |
| Cytomegalovirus infection reactivation | 424 | 243.8 221.0–269.0ROR 255.1 · χ² 92,002 / p <1e-300 | 217.2 EB05 200.4 · IC025 +7.3 3/3 methods agree | Labeled (related wording) related wording | serious n=422 · 99% clinician | no trial data cached |
| Infection | 422 | 6.5 5.9–7.1ROR 6.7 · χ² 1,958 / p <1e-300 | 6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.7 · 99% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 412 | 6.7 6.1–7.4ROR 7.0 · χ² 2,013 / p <1e-300 | 6.7 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 97% clinician | no trial data cached |
| Venoocclusive liver disease | 403 | 197.2 178.5–218.0ROR 205.9 · χ² 71,992 / p <1e-300 | 179.4 EB05 165.2 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious n=399 · 98% clinician | no trial data cached |
| Sepsis (blood infection) | 400 | 7.9 7.2–8.7ROR 8.2 · χ² 2,424 / p <1e-300 | 7.9 EB05 7.2 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 · 97% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 394 | 7.8 7.1–8.6ROR 8.1 · χ² 2,344 / p <1e-300 | 7.8 EB05 7.1 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.7 · 98% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Pre-engraftment immune reaction — n=47, PRR 3,199.8
- Autoimmune lymphoproliferative syndrome — n=22, PRR 1,295.4
- Adenovirus reactivation — n=37, PRR 806.1
- Disseminated toxoplasmosis — n=24, PRR 580.9
- Engraftment syndrome — n=110, PRR 509.9
- Acute graft versus host disease in intestine — n=256, PRR 494.0
- Human herpesvirus 6 infection — n=305, PRR 421.6
- Gastroenteritis adenovirus — n=25, PRR 419.0
- Idiopathic pneumonia syndrome — n=46, PRR 404.1
- Chronic graft versus host disease in intestine — n=26, PRR 358.5
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Thiotepa?
In FDA FAERS, the most frequently co-reported reaction terms for Thiotepa are febrile neutropenia, mucosal inflammation, cytomegalovirus infection, pyrexia, acute graft versus host disease, acute graft versus host disease in skin. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Thiotepa have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SEVERE MYELOSUPPRESSION and CARCINOGENICITY TEPADINA may cause severe marrow suppression, and high doses may cause marrow ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters. Hema.
Do FAERS signals prove that Thiotepa causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 559e353c-2dc0-16ba-e054-00144ff8d46c, effective 20260130; matched on
openfda.generic_name.exact:"THIOTEPA") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 998 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.