TRIFLURIDINE

N/A

Manufactured by Sandoz Inc

1,094 FDA adverse event reports analyzed

Last updated: 2026-04-15

About TRIFLURIDINE

TRIFLURIDINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Sandoz Inc. The most commonly reported adverse reactions for TRIFLURIDINE include DIARRHOEA, DRUG INEFFECTIVE, DEATH, COLORECTAL CANCER METASTATIC, NEUTROPENIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TRIFLURIDINE.

Top Adverse Reactions

DIARRHOEA45 reports
DRUG INEFFECTIVE44 reports
DEATH38 reports
COLORECTAL CANCER METASTATIC31 reports
NEUTROPENIA30 reports
NAUSEA26 reports
EYE PAIN25 reports
FATIGUE25 reports
THERAPY PARTIAL RESPONDER22 reports
DISEASE PROGRESSION20 reports
ANAEMIA19 reports
EYE IRRITATION19 reports
PAIN19 reports
VOMITING19 reports
CONDITION AGGRAVATED18 reports
NEUROPATHY PERIPHERAL18 reports
PALMAR PLANTAR ERYTHRODYSAESTHESIA SYNDROME18 reports
DRUG RESISTANCE17 reports
COVID 1916 reports
HYPERTENSION16 reports
OFF LABEL USE16 reports
RENAL FAILURE15 reports
CHRONIC KIDNEY DISEASE14 reports
DIZZINESS12 reports
GENERAL PHYSICAL HEALTH DETERIORATION12 reports
INSOMNIA12 reports
MALIGNANT NEOPLASM PROGRESSION12 reports
NEUROTOXICITY12 reports
EYE SWELLING11 reports
METASTASES TO LIVER11 reports
PARONYCHIA11 reports
PRODUCT STORAGE ERROR11 reports
DECREASED APPETITE10 reports
HALLUCINATION10 reports
METASTASES TO LUNG10 reports
OCULAR HYPERAEMIA10 reports
PNEUMONIA10 reports
VISION BLURRED10 reports
WEIGHT DECREASED10 reports
LEUKOPENIA9 reports
PATHOGEN RESISTANCE9 reports
PHOTOSENSITIVITY REACTION9 reports
POLYNEUROPATHY9 reports
ABDOMINAL PAIN8 reports
ACNE8 reports
ADENOCARCINOMA OF COLON8 reports
ANXIETY8 reports
CONSTIPATION8 reports
DEPRESSION8 reports
MUCOSAL INFLAMMATION8 reports
OPHTHALMIC HERPES SIMPLEX8 reports
PRODUCT DOSE OMISSION ISSUE8 reports
PRODUCT LEAKAGE8 reports
THERAPY NON RESPONDER8 reports
THROMBOCYTOPENIA8 reports
TOXICITY TO VARIOUS AGENTS8 reports
ASTHENIA7 reports
DEHYDRATION7 reports
FEBRILE NEUTROPENIA7 reports
HAEMATOTOXICITY7 reports
HERPES ZOSTER7 reports
MYELOSUPPRESSION7 reports
PHOTOPHOBIA7 reports
POOR QUALITY DRUG ADMINISTERED7 reports
ACUTE KIDNEY INJURY6 reports
BACK PAIN6 reports
CHEST PAIN6 reports
CLOSTRIDIUM DIFFICILE INFECTION6 reports
EMOTIONAL DISTRESS6 reports
EYE DISCHARGE6 reports
GASTROINTESTINAL TOXICITY6 reports
GASTROOESOPHAGEAL REFLUX DISEASE6 reports
HEADACHE6 reports
INCORRECT PRODUCT STORAGE6 reports
PRODUCT USE IN UNAPPROVED INDICATION6 reports
PYREXIA6 reports
RASH6 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE6 reports
TRANSIENT ISCHAEMIC ATTACK6 reports
ASCITES5 reports
ATRIAL FIBRILLATION5 reports
CONJUNCTIVITIS5 reports
DERMATITIS ACNEIFORM5 reports
DERMATITIS CONTACT5 reports
DRY SKIN5 reports
DYSPNOEA5 reports
FALL5 reports
HYPERSENSITIVITY5 reports
HYPOAESTHESIA5 reports
INCORRECT DOSE ADMINISTERED5 reports
PERITONSILLAR ABSCESS5 reports
PRESCRIBED OVERDOSE5 reports
PROTEINURIA5 reports
RASH PUSTULAR5 reports
RENAL IMPAIRMENT5 reports
SKIN FISSURES5 reports
SKIN TOXICITY5 reports
STOMATITIS5 reports
TRAUMATIC FRACTURE5 reports
ACCIDENTAL EXPOSURE TO PRODUCT4 reports

Report Outcomes

Out of 407 classified reports for TRIFLURIDINE:

Serious 69.8%Non-Serious 30.2%

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

Male198 (55.3%)
Female159 (44.4%)
Unknown1 (0.3%)

Reports by Age

Age 4314 reports
Age 6614 reports
Age 5911 reports
Age 6110 reports
Age 6710 reports
Age 7910 reports
Age 529 reports
Age 688 reports
Age 718 reports
Age 577 reports
Age 707 reports
Age 727 reports
Age 636 reports
Age 485 reports
Age 515 reports
Age 565 reports
Age 655 reports
Age 745 reports
Age 775 reports
Age 835 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 TRIFLURIDINE?

This profile reflects 1,094 FDA FAERS reports that mention TRIFLURIDINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TRIFLURIDINE?

Frequently reported terms in FAERS include DIARRHOEA, DRUG INEFFECTIVE, DEATH, COLORECTAL CANCER METASTATIC, NEUTROPENIA, NAUSEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures TRIFLURIDINE?

Labeling and FAERS entries often list Sandoz Inc in connection with TRIFLURIDINE. 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.