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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.

INOTERSEN: 1,714 Adverse Event Reports & Safety Profile

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1,714
Total FAERS Reports
127 (7.4%)
Deaths Reported
568
Hospitalizations
1,714
As Primary/Secondary Suspect
24
Life-Threatening
33
Disabilities
Oct 5, 2018
FDA Approved
Discontinued
Status

Active Ingredient: INOTERSEN SODIUM · FDA Application: 211172 ·

Patent Expires: Apr 29, 2031 · First Report: 2013 · Latest Report: 20250826

What Are the Most Common INOTERSEN Side Effects?

#1 Most Reported
Platelet count decreased
334 reports (19.5%)
#2 Most Reported
Protein urine present
269 reports (15.7%)
#3 Most Reported
Glomerular filtration rate decreased
264 reports (15.4%)

All INOTERSEN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Platelet count decreased 334 19.5% 18 86
Protein urine present 269 15.7% 7 48
Glomerular filtration rate decreased 264 15.4% 6 54
Urine protein/creatinine ratio increased 249 14.5% 7 51
Blood creatinine increased 214 12.5% 6 46
Fatigue 198 11.6% 16 78
Bacterial test positive 193 11.3% 5 31
Urine abnormality 184 10.7% 5 30
Nausea 152 8.9% 10 67
Malaise 145 8.5% 14 79
Diarrhoea 135 7.9% 9 60
Asthenia 134 7.8% 15 73
Urinary casts 127 7.4% 3 18
Pain 124 7.2% 7 63
White blood cells urine positive 124 7.2% 3 18
Urine leukocyte esterase positive 123 7.2% 2 18
Chills 121 7.1% 1 43
Haemoglobin decreased 109 6.4% 8 57
Fall 106 6.2% 15 81
Dizziness 103 6.0% 3 50

Who Reports INOTERSEN Side Effects? Age & Gender Data

Gender: 41.7% female, 58.3% male. Average age: 66.9 years. Most reports from: US. View detailed demographics →

Is INOTERSEN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2013 3 0 0
2014 1 0 0
2015 8 0 1
2017 1 0 0
2018 25 2 4
2019 192 13 69
2020 307 25 101
2021 236 16 80
2022 134 17 62
2023 94 12 43
2024 74 7 41
2025 34 3 25

View full timeline →

What Is INOTERSEN Used For?

IndicationReports
Hereditary neuropathic amyloidosis 1,396
Product used for unknown indication 179
Polyneuropathy 62
Familial amyloidosis 52
Amyloidosis 46
Cardiac amyloidosis 12
Acquired attr amyloidosis 10
Amyloidosis senile 7

INOTERSEN vs Alternatives: Which Is Safer?

INOTERSEN vs INOTUZUMAB OZOGAMICIN INOTERSEN vs INSULIN INOTERSEN vs INSULIN ASPART INOTERSEN vs INSULIN ASPART\INSULIN DEGLUDEC INOTERSEN vs INSULIN BEEF INOTERSEN vs INSULIN DEGLUDEC INOTERSEN vs INSULIN DEGLUDEC\LIRAGLUTIDE INOTERSEN vs INSULIN DETEMIR INOTERSEN vs INSULIN GLARGINE INOTERSEN vs INSULIN GLARGINE-YFGN

Official FDA Label for INOTERSEN

Official prescribing information from the FDA-approved drug label.