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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.

AZELNIDIPINE: 126 Adverse Event Reports & Safety Profile

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126
Total FAERS Reports
7 (5.6%)
Deaths Reported
85
Hospitalizations
126
As Primary/Secondary Suspect
18
Life-Threatening
6
Disabilities

First Report: 20091226 · Latest Report: 20240415

What Are the Most Common AZELNIDIPINE Side Effects?

#1 Most Reported
Compartment syndrome
23 reports (18.3%)
#2 Most Reported
Angioedema
23 reports (18.3%)
#3 Most Reported
Hypotension
17 reports (13.5%)

All AZELNIDIPINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Angioedema 23 18.3% 0 22
Compartment syndrome 23 18.3% 0 22
Hypotension 17 13.5% 0 15
Intentional overdose 16 12.7% 0 15
Overdose 13 10.3% 0 12
Acute kidney injury 11 8.7% 0 10
Toxicity to various agents 11 8.7% 0 10
Vomiting 10 7.9% 0 9
Nausea 9 7.1% 0 9
Coma 8 6.4% 0 7
Fall 8 6.4% 1 6
Haemodynamic instability 8 6.4% 0 7
Renal impairment 6 4.8% 0 3
Shock 6 4.8% 0 6
Bradycardia 5 4.0% 0 2
Foetal exposure during pregnancy 5 4.0% 0 0
Oedema peripheral 5 4.0% 0 5

Who Reports AZELNIDIPINE Side Effects? Age & Gender Data

Gender: 64.5% female, 35.5% male. Average age: 64.6 years. Most reports from: JP. View detailed demographics →

Is AZELNIDIPINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2009 1 0 0
2010 1 1 1
2011 1 0 1
2012 3 0 1
2013 2 0 2
2014 1 0 0
2015 9 1 4
2016 4 0 4
2017 3 1 1
2018 7 1 5
2019 1 0 1
2020 2 0 0
2021 1 0 0
2022 5 0 2
2023 1 1 1
2024 2 0 2

View full timeline →

What Is AZELNIDIPINE Used For?

IndicationReports
Product used for unknown indication 56
Hypertension 47

AZELNIDIPINE vs Alternatives: Which Is Safer?

AZELNIDIPINE vs AZILECT AZELNIDIPINE vs AZILSARTAN KAMEDOXOMIL AZELNIDIPINE vs AZILSARTAN KAMEDOXOMIL\CHLORTHALIDONE AZELNIDIPINE vs AZITHROMYCIN AZELNIDIPINE vs AZITHROMYCIN ANHYDROUS AZELNIDIPINE vs AZITHROMYCIN OR METHOTREXATE AZELNIDIPINE vs AZOSEMIDE AZELNIDIPINE vs AZTREONAM AZELNIDIPINE vs AZTREONAM LYSINE AZELNIDIPINE vs BACILLUS CALMETTE-GUERIN ANTIGEN, UNSPECIFIED SUBSTRAIN

Official FDA Label for AZELNIDIPINE

Official prescribing information from the FDA-approved drug label.