Thiotepa

Common brands: Tepadina, Tepylute, Fludarabine, Cyclophosphamide, Frindovyx

Top reporter: Amneal Pharmaceuticals Llc

Alkylating Drug [EPC]Calcineurin Inhibitor Immunosuppressant [EPC]Folate Analog Metabolic Inhibitor [EPC]Topoisomerase Inhibitor [EPC]Corticosteroid [EPC]
9,259
Total Reports
5,678
Serious Reports
2,618
Death Reports
30
Reported Reactions
Death Report Ratio: High (28.28%)

Patient Demographics

Male
3,544
Female
2,930

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Thiotepa.

# Reaction Reports % of Total
1 OFF LABEL USE 1,109
9.3%
2 FEBRILE NEUTROPENIA 796
6.7%
3 MUCOSAL INFLAMMATION 793
6.6%
4 PRODUCT USE IN UNAPPROVED INDICATION 595
5.0%
5 CYTOMEGALOVIRUS INFECTION 523
4.4%
6 DRUG INEFFECTIVE 521
4.4%
7 PYREXIA 513
4.3%
8 ACUTE GRAFT VERSUS HOST DISEASE 450
3.8%
9 ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 430
3.6%
10 INFECTION 418
3.5%
11 NEUTROPENIA 407
3.4%
12 CYTOMEGALOVIRUS INFECTION REACTIVATION 396
3.3%
13 SEPSIS 394
3.3%
14 VENOOCCLUSIVE LIVER DISEASE 386
3.2%
15 THROMBOCYTOPENIA 382
3.2%
16 GRAFT VERSUS HOST DISEASE 311
2.6%
17 ADENOVIRUS INFECTION 302
2.5%
18 HUMAN HERPESVIRUS 6 INFECTION 298
2.5%
19 HAEMATOTOXICITY 294
2.5%
20 DIARRHOEA 287
2.4%
21 MULTIPLE ORGAN DYSFUNCTION SYNDROME 267
2.2%
22 CHRONIC GRAFT VERSUS HOST DISEASE 261
2.2%
23 THROMBOTIC MICROANGIOPATHY 261
2.2%
24 ACUTE GRAFT VERSUS HOST DISEASE IN INTESTINE 245
2.0%
25 GRAFT VERSUS HOST DISEASE IN SKIN 243
2.0%
26 PNEUMONIA 236
2.0%
27 GRAFT VERSUS HOST DISEASE IN GASTROINTESTINAL TRACT 229
1.9%
28 RESPIRATORY FAILURE 228
1.9%
29 ACUTE KIDNEY INJURY 197
1.6%
30 DISEASE PROGRESSION 193
1.6%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.