THIOTEPA

N/A

Manufactured by Amneal Pharmaceuticals LLC

18,516 FDA adverse event reports analyzed

Last updated: 2026-04-14

About THIOTEPA

THIOTEPA is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. The most commonly reported adverse reactions for THIOTEPA include OFF LABEL USE, FEBRILE NEUTROPENIA, MUCOSAL INFLAMMATION, PRODUCT USE IN UNAPPROVED INDICATION, CYTOMEGALOVIRUS INFECTION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for THIOTEPA.

Top Adverse Reactions

OFF LABEL USE1,050 reports
FEBRILE NEUTROPENIA782 reports
MUCOSAL INFLAMMATION765 reports
PRODUCT USE IN UNAPPROVED INDICATION573 reports
CYTOMEGALOVIRUS INFECTION519 reports
DRUG INEFFECTIVE507 reports
PYREXIA501 reports
ACUTE GRAFT VERSUS HOST DISEASE431 reports
ACUTE GRAFT VERSUS HOST DISEASE IN SKIN417 reports
NEUTROPENIA405 reports
INFECTION403 reports
SEPSIS385 reports
VENOOCCLUSIVE LIVER DISEASE382 reports
THROMBOCYTOPENIA381 reports
CYTOMEGALOVIRUS INFECTION REACTIVATION372 reports
ADENOVIRUS INFECTION296 reports
HUMAN HERPESVIRUS 6 INFECTION293 reports
GRAFT VERSUS HOST DISEASE292 reports
HAEMATOTOXICITY288 reports
DIARRHOEA270 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME259 reports
CHRONIC GRAFT VERSUS HOST DISEASE256 reports
THROMBOTIC MICROANGIOPATHY244 reports
ACUTE GRAFT VERSUS HOST DISEASE IN INTESTINE240 reports
GRAFT VERSUS HOST DISEASE IN SKIN240 reports
PNEUMONIA229 reports
RESPIRATORY FAILURE226 reports
GRAFT VERSUS HOST DISEASE IN GASTROINTESTINAL TRACT225 reports
ACUTE KIDNEY INJURY192 reports
ANAEMIA190 reports
EPSTEIN BARR VIRUS INFECTION190 reports
DISEASE PROGRESSION189 reports
SEPTIC SHOCK179 reports
VENOOCCLUSIVE DISEASE172 reports
BK VIRUS INFECTION171 reports
DEATH166 reports
PANCYTOPENIA166 reports
VOMITING160 reports
HYPERTENSION151 reports
CYTOMEGALOVIRUS VIRAEMIA150 reports
CYSTITIS HAEMORRHAGIC134 reports
VIRAL HAEMORRHAGIC CYSTITIS133 reports
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION131 reports
NAUSEA131 reports
RENAL FAILURE128 reports
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME126 reports
STOMATITIS114 reports
BONE MARROW FAILURE110 reports
NEUROTOXICITY110 reports
PRODUCT USE ISSUE105 reports
ENGRAFTMENT SYNDROME104 reports
ACUTE RESPIRATORY DISTRESS SYNDROME103 reports
HEPATOTOXICITY103 reports
TOXICITY TO VARIOUS AGENTS101 reports
BACTERAEMIA100 reports
STAPHYLOCOCCAL INFECTION97 reports
INTENTIONAL PRODUCT USE ISSUE95 reports
HEPATIC FAILURE91 reports
ASCITES90 reports
CLOSTRIDIUM DIFFICILE COLITIS90 reports
HYPOTENSION90 reports
PERICARDIAL EFFUSION90 reports
BRONCHOPULMONARY ASPERGILLOSIS89 reports
CHRONIC GRAFT VERSUS HOST DISEASE IN SKIN88 reports
DISEASE RECURRENCE87 reports
ENCEPHALITIS VIRAL86 reports
ABDOMINAL PAIN85 reports
ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT85 reports
VIRAEMIA85 reports
SEIZURE84 reports
PLEURAL EFFUSION83 reports
PULMONARY ARTERIAL HYPERTENSION82 reports
POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER81 reports
COVID 1980 reports
BACTERIAL SEPSIS79 reports
TRANSPLANT FAILURE79 reports
APLASTIC ANAEMIA78 reports
FUNGAL INFECTION78 reports
RASH77 reports
RESPIRATORY DISTRESS77 reports
LEUKOPENIA76 reports
AUTOIMMUNE HAEMOLYTIC ANAEMIA74 reports
CYTOKINE RELEASE SYNDROME73 reports
MYELOSUPPRESSION73 reports
PNEUMONIA CYTOMEGALOVIRAL71 reports
GASTROINTESTINAL TOXICITY69 reports
MALIGNANT NEOPLASM PROGRESSION69 reports
CARDIAC FAILURE68 reports
RENAL IMPAIRMENT68 reports
ACUTE GRAFT VERSUS HOST DISEASE IN LIVER66 reports
CYTOPENIA66 reports
NEPHROPATHY TOXIC66 reports
PSEUDOMONAS INFECTION66 reports
GRAFT VERSUS HOST DISEASE IN LIVER65 reports
PNEUMOCYSTIS JIROVECII PNEUMONIA65 reports
PNEUMONITIS65 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION64 reports
HEADACHE64 reports
BACTERIAL INFECTION61 reports
MULTI ORGAN FAILURE61 reports

Report Outcomes

Out of 8,972 classified reports for THIOTEPA:

Serious 97.9%Non-Serious 2.1%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male3,457 (54.0%)
Female2,816 (44.0%)
Unknown131 (2.0%)

Reports by Age

Age 3248 reports
Age 4240 reports
Age 5237 reports
Age 8213 reports
Age 11192 reports
Age 7166 reports
Age 10162 reports
Age 6161 reports
Age 12159 reports
Age 9151 reports
Age 1150 reports
Age 16143 reports
Age 14141 reports
Age 2135 reports
Age 15122 reports
Age 1799 reports
Age 1995 reports
Age 1392 reports
Age 6489 reports
Age 1888 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with THIOTEPA?

This profile reflects 18,516 FDA FAERS reports that mention THIOTEPA. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for THIOTEPA?

Frequently reported terms in FAERS include OFF LABEL USE, FEBRILE NEUTROPENIA, MUCOSAL INFLAMMATION, PRODUCT USE IN UNAPPROVED INDICATION, CYTOMEGALOVIRUS INFECTION, DRUG INEFFECTIVE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures THIOTEPA?

Labeling and FAERS entries often list Amneal Pharmaceuticals LLC in connection with THIOTEPA. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.