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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.

CASIMERSEN: 767 Adverse Event Reports & Safety Profile

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767
Total FAERS Reports
7 (0.9%)
Deaths Reported
87
Hospitalizations
767
As Primary/Secondary Suspect
3
Life-Threatening
Feb 25, 2021
FDA Approved
Sarepta Therapeutics, Inc.
Manufacturer
Prescription
Status

Drug Class: Antisense Oligonucleotide [EPC] · Manufacturer: Sarepta Therapeutics, Inc. · FDA Application: 213026 ·

Patent Expires: Nov 12, 2030 · First Report: 20190227 · Latest Report: 20250801

What Are the Most Common CASIMERSEN Side Effects?

#1 Most Reported
Product dose omission issue
253 reports (33.0%)
#2 Most Reported
No adverse event
166 reports (21.6%)
#3 Most Reported
Poor venous access
101 reports (13.2%)

All CASIMERSEN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Product dose omission issue 253 33.0% 0 2
No adverse event 166 21.6% 0 0
Poor venous access 101 13.2% 0 5
Device issue 76 9.9% 0 1
Intentional dose omission 74 9.7% 0 0
Malaise 36 4.7% 0 1
Pyrexia 31 4.0% 1 4
Covid-19 29 3.8% 0 2
Influenza 18 2.4% 0 2
Pneumonia 17 2.2% 0 15
Product distribution issue 17 2.2% 0 0
Dehydration 15 2.0% 0 2
Cough 14 1.8% 0 0
Illness 14 1.8% 0 1
Exposure to sars-cov-2 12 1.6% 0 0
Fall 12 1.6% 1 7
Catheter site pain 10 1.3% 0 1
Infusion site extravasation 10 1.3% 0 0
Underdose 10 1.3% 0 0
Device dislocation 9 1.2% 0 0

Who Reports CASIMERSEN Side Effects? Age & Gender Data

Gender: 0.4% female, 99.6% male. Average age: 14.0 years. Most reports from: US. View detailed demographics →

Is CASIMERSEN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2019 1 0 0
2021 60 0 2
2022 188 0 16
2023 207 2 15
2024 122 1 19
2025 62 2 12

View full timeline →

What Is CASIMERSEN Used For?

IndicationReports
Duchenne muscular dystrophy 406
Product used for unknown indication 342
Muscular dystrophy 17

CASIMERSEN vs Alternatives: Which Is Safer?

CASIMERSEN vs CASIRIVIMAB CASIMERSEN vs CASIRIVIMAB\IMDEVIMAB CASIMERSEN vs CASPOFUNGIN CASIMERSEN vs CATEQUENTINIB CASIMERSEN vs CC-4047 CASIMERSEN vs CEDAZURIDINE\DECITABINE CASIMERSEN vs CEDIRANIB CASIMERSEN vs CEFACLOR CASIMERSEN vs CEFADROXIL CASIMERSEN vs CEFAZOLIN

Other Drugs in Same Class: Antisense Oligonucleotide [EPC]

NUSINERSEN (7,043) ETEPLIRSEN (2,079) GOLODIRSEN (406) TOFERSEN (366) EPLONTERSEN (250) View all → Class side effects → Compare in class →

Official FDA Label for CASIMERSEN

Official prescribing information from the FDA-approved drug label.