ENFORTUMAB VEDOTIN

N/A

Manufactured by SEAGEN INC.

12,251 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ENFORTUMAB VEDOTIN

ENFORTUMAB VEDOTIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by SEAGEN INC.. The most commonly reported adverse reactions for ENFORTUMAB VEDOTIN include RASH, MALIGNANT NEOPLASM PROGRESSION, NEUROPATHY PERIPHERAL, DIARRHOEA, PRURITUS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ENFORTUMAB VEDOTIN.

Top Adverse Reactions

RASH803 reports
MALIGNANT NEOPLASM PROGRESSION693 reports
NEUROPATHY PERIPHERAL688 reports
DIARRHOEA368 reports
PRURITUS362 reports
FATIGUE358 reports
DECREASED APPETITE349 reports
DEATH319 reports
OFF LABEL USE303 reports
ALOPECIA269 reports
NAUSEA238 reports
PYREXIA233 reports
SKIN DISORDER230 reports
TASTE DISORDER218 reports
HYPERGLYCAEMIA217 reports
MALAISE184 reports
WEIGHT DECREASED184 reports
ASTHENIA175 reports
STEVENS JOHNSON SYNDROME165 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION160 reports
INTERSTITIAL LUNG DISEASE151 reports
NEUTROPENIA144 reports
ERYTHEMA139 reports
MYELOSUPPRESSION128 reports
HYPOAESTHESIA123 reports
PAIN122 reports
ANAEMIA121 reports
VOMITING121 reports
TOXIC EPIDERMAL NECROLYSIS119 reports
CONSTIPATION113 reports
ACUTE KIDNEY INJURY108 reports
CONDITION AGGRAVATED102 reports
DISEASE PROGRESSION102 reports
URINARY TRACT INFECTION100 reports
PRODUCT USE ISSUE99 reports
FEBRILE NEUTROPENIA97 reports
DRY SKIN96 reports
DYSPNOEA94 reports
DRY MOUTH92 reports
SEPSIS90 reports
HEPATIC FUNCTION ABNORMAL89 reports
DRUG INEFFECTIVE88 reports
BLISTER87 reports
PNEUMONIA83 reports
THERAPY PARTIAL RESPONDER83 reports
DRY EYE81 reports
SKIN TOXICITY81 reports
GENERAL PHYSICAL HEALTH DETERIORATION79 reports
SKIN EXFOLIATION79 reports
DEHYDRATION78 reports
NEUTROPHIL COUNT DECREASED78 reports
RENAL IMPAIRMENT78 reports
PNEUMONITIS77 reports
DERMATITIS BULLOUS76 reports
RASH PRURITIC74 reports
COLITIS67 reports
FALL63 reports
SKIN REACTION62 reports
OEDEMA PERIPHERAL61 reports
THROMBOCYTOPENIA61 reports
BLOOD GLUCOSE INCREASED60 reports
DRUG ERUPTION60 reports
UNDERDOSE60 reports
PULMONARY TOXICITY59 reports
RASH ERYTHEMATOUS58 reports
BACK PAIN57 reports
DIABETIC KETOACIDOSIS56 reports
METASTASES TO LIVER56 reports
DIZZINESS55 reports
DYSGEUSIA55 reports
HYPOTENSION55 reports
COVID 1954 reports
PARAESTHESIA53 reports
DIABETES MELLITUS50 reports
STOMATITIS50 reports
MUCOSAL INFLAMMATION49 reports
ADRENAL INSUFFICIENCY48 reports
ARTHRALGIA48 reports
HYPONATRAEMIA48 reports
LACRIMATION INCREASED47 reports
RASH MACULO PAPULAR47 reports
BLOOD PRESSURE SYSTOLIC INCREASED46 reports
IMMUNE MEDIATED ENTEROCOLITIS46 reports
INFECTION46 reports
LIVER DISORDER45 reports
VISION BLURRED45 reports
ABDOMINAL PAIN44 reports
SKIN DISCOLOURATION44 reports
DYSPHAGIA43 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME43 reports
PAIN IN EXTREMITY43 reports
SEPTIC SHOCK43 reports
TOXICITY TO VARIOUS AGENTS43 reports
GAIT DISTURBANCE42 reports
HAEMATURIA42 reports
ILEUS42 reports
OEDEMA42 reports
RENAL FAILURE42 reports
WEIGHT INCREASED42 reports
HYPOTHYROIDISM41 reports

Report Outcomes

Out of 5,911 classified reports for ENFORTUMAB VEDOTIN:

Serious 86.0%Non-Serious 14.0%

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

Male4,274 (76.0%)
Female1,351 (24.0%)
Unknown1 (0.0%)

Reports by Age

Age 8456 reports
Age 7182 reports
Age 73176 reports
Age 75173 reports
Age 74169 reports
Age 72156 reports
Age 70155 reports
Age 77155 reports
Age 71145 reports
Age 9139 reports
Age 76138 reports
Age 65136 reports
Age 78134 reports
Age 67130 reports
Age 69116 reports
Age 79112 reports
Age 80111 reports
Age 81102 reports
Age 6697 reports
Age 6892 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 ENFORTUMAB VEDOTIN?

This profile reflects 12,251 FDA FAERS reports that mention ENFORTUMAB VEDOTIN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ENFORTUMAB VEDOTIN?

Frequently reported terms in FAERS include RASH, MALIGNANT NEOPLASM PROGRESSION, NEUROPATHY PERIPHERAL, DIARRHOEA, PRURITUS, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ENFORTUMAB VEDOTIN?

Labeling and FAERS entries often list SEAGEN INC. in connection with ENFORTUMAB VEDOTIN. 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.