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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

CEMIPLIMAB-RWLC: 1,554 Adverse Event Reports & Safety Profile

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1,554
Total FAERS Reports
323 (20.8%)
Deaths Reported
441
Hospitalizations
1,554
As Primary/Secondary Suspect
90
Life-Threatening
24
Disabilities
Prescription
Status

FDA Application: 761097 ·

First Report: 20121206 · Latest Report: 20250801

What Are the Most Common CEMIPLIMAB-RWLC Side Effects?

#1 Most Reported
Death
128 reports (8.2%)
#2 Most Reported
Disease progression
101 reports (6.5%)
#3 Most Reported
Fatigue
71 reports (4.6%)

All CEMIPLIMAB-RWLC Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Death 128 8.2% 126 13
Disease progression 101 6.5% 29 15
Fatigue 71 4.6% 10 19
Off label use 68 4.4% 12 12
Rash 64 4.1% 2 17
Dyspnoea 55 3.5% 12 25
Pyrexia 52 3.4% 8 41
Pruritus 44 2.8% 1 10
Asthenia 42 2.7% 16 23
Diarrhoea 42 2.7% 5 27
Myocarditis 42 2.7% 19 27
Interstitial lung disease 39 2.5% 3 24
Nausea 38 2.5% 12 26
Drug ineffective 34 2.2% 3 2
Pneumonitis 33 2.1% 3 18
Condition aggravated 31 2.0% 4 10
Acute kidney injury 30 1.9% 6 26
Pneumonia 29 1.9% 13 20
Hypothyroidism 28 1.8% 3 3
General physical health deterioration 27 1.7% 18 10

Who Reports CEMIPLIMAB-RWLC Side Effects? Age & Gender Data

Gender: 40.6% female, 59.4% male. Average age: 70.2 years. Most reports from: US. View detailed demographics →

Is CEMIPLIMAB-RWLC Getting Safer? Reports by Year

YearReportsDeathsHosp.
2012 1 0 1
2016 1 0 0
2018 17 1 4
2019 67 9 25
2020 71 17 34
2021 91 21 48
2022 109 36 46
2023 127 19 61
2024 144 18 62
2025 79 16 32

View full timeline →

What Is CEMIPLIMAB-RWLC Used For?

IndicationReports
Squamous cell carcinoma of skin 370
Product used for unknown indication 348
Squamous cell carcinoma 234
Non-small cell lung cancer 83
Cervix carcinoma recurrent 72
Cervix carcinoma 43
Basal cell carcinoma 42
Metastatic squamous cell carcinoma 42
Lung neoplasm malignant 34
Neoplasm malignant 33

CEMIPLIMAB-RWLC vs Alternatives: Which Is Safer?

CEMIPLIMAB-RWLC vs CENEGERMIN-BKBJ CEMIPLIMAB-RWLC vs CENOBAMATE CEMIPLIMAB-RWLC vs CEPHALEXIN CEMIPLIMAB-RWLC vs CERITINIB CEMIPLIMAB-RWLC vs CERLIPONASE ALFA CEMIPLIMAB-RWLC vs CERTICAN CEMIPLIMAB-RWLC vs CERTOLIZUMAB CEMIPLIMAB-RWLC vs CERTOLIZUMAB PEGOL CEMIPLIMAB-RWLC vs CERTOPARIN CEMIPLIMAB-RWLC vs CETIRIZINE

Official FDA Label for CEMIPLIMAB-RWLC

Official prescribing information from the FDA-approved drug label.