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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.

ALISKIREN: 1,593 Adverse Event Reports & Safety Profile

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1,593
Total FAERS Reports
414 (26.0%)
Deaths Reported
746
Hospitalizations
1,593
As Primary/Secondary Suspect
229
Life-Threatening
125
Disabilities

First Report: 20000320 · Latest Report: 20241127

What Are the Most Common ALISKIREN Side Effects?

#1 Most Reported
Fall
341 reports (21.4%)
#2 Most Reported
Asthenia
333 reports (20.9%)
#3 Most Reported
Blood pressure increased
303 reports (19.0%)

All ALISKIREN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fall 341 21.4% 176 156
Asthenia 333 20.9% 163 159
Blood pressure increased 303 19.0% 168 79
Nausea 293 18.4% 125 163
Headache 271 17.0% 166 75
Malaise 268 16.8% 160 91
Vomiting 240 15.1% 142 90
Cough 237 14.9% 165 62
Fatigue 236 14.8% 148 73
Pyrexia 234 14.7% 149 87
Dyspnoea 221 13.9% 176 34
Dizziness 212 13.3% 168 21
Syncope 204 12.8% 157 40
Diarrhoea 195 12.2% 172 14
Cerebrovascular accident 194 12.2% 1 181
Tachycardia 194 12.2% 183 3
Haemorrhagic stroke 185 11.6% 185 0
Myalgia 185 11.6% 164 0
Cardio-respiratory arrest 183 11.5% 178 7
Decreased appetite 183 11.5% 167 9

Who Reports ALISKIREN Side Effects? Age & Gender Data

Gender: 65.6% female, 34.4% male. Average age: 64.1 years. Most reports from: CA. View detailed demographics →

Is ALISKIREN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 9 0 9
2004 1 0 1
2005 1 0 0
2007 2 1 0
2008 2 0 2
2009 18 2 12
2010 129 24 100
2011 96 17 74
2012 65 15 45
2013 46 11 37
2014 81 12 56
2015 51 10 31
2016 42 0 20
2017 25 3 13
2018 48 2 28
2019 14 0 1
2020 5 0 1
2021 2 0 2
2022 6 0 4
2023 1 0 0
2024 2 1 1

View full timeline →

What Is ALISKIREN Used For?

IndicationReports
Product used for unknown indication 582
Hypertension 546
Cardiac failure 227
Microalbuminuria 82
Foetal exposure during pregnancy 54
Off label use 49
Cardiac failure chronic 48
Cardiovascular disorder 25
Blood pressure increased 18
Blood pressure abnormal 11

ALISKIREN vs Alternatives: Which Is Safer?

ALISKIREN vs ALISKIREN HEMIFUMARATE ALISKIREN vs ALISKIREN\HYDROCHLOROTHIAZIDE ALISKIREN vs ALIZAPRIDE ALISKIREN vs ALLANTOIN ALISKIREN vs ALLEGRA ALISKIREN vs ALLEGRA 24 HOUR ALISKIREN vs ALLEGRA D ALISKIREN vs ALLERGENIC EXTRACT- PEANUT ARACHIS HYPOGAEA ALISKIREN vs ALLERGENIC EXTRACTS ALISKIREN vs ALLI

Official FDA Label for ALISKIREN

Official prescribing information from the FDA-approved drug label.