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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.

AMLODIPINE\HYDROCHLOROTHIAZIDE\VALSARTAN: 2,450 Adverse Event Reports & Safety Profile

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2,450
Total FAERS Reports
344 (14.0%)
Deaths Reported
518
Hospitalizations
2,450
As Primary/Secondary Suspect
126
Life-Threatening
70
Disabilities

Active Ingredient: AMLODIPINE BESYLATE\HYDROCHLOROTHIAZIDE\VALSARTAN ·

First Report: 1988 · Latest Report: 20250722

What Are the Most Common AMLODIPINE\HYDROCHLOROTHIAZIDE\VALSARTAN Side Effects?

#1 Most Reported
Blood pressure increased
306 reports (12.5%)
#2 Most Reported
Wrong technique in product usage process
222 reports (9.1%)
#3 Most Reported
Death
199 reports (8.1%)

All AMLODIPINE\HYDROCHLOROTHIAZIDE\VALSARTAN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Blood pressure increased 306 12.5% 3 74
Wrong technique in product usage process 222 9.1% 12 46
Death 199 8.1% 199 7
Hypertension 170 6.9% 9 32
Diabetes mellitus 167 6.8% 5 22
Off label use 162 6.6% 14 32
Malaise 161 6.6% 3 41
Drug ineffective 144 5.9% 3 26
Blood pressure decreased 139 5.7% 1 34
Dizziness 119 4.9% 0 31
Headache 115 4.7% 1 14
Feeling abnormal 113 4.6% 3 21
Peripheral swelling 113 4.6% 0 17
Deafness 97 4.0% 1 1
Cerebrovascular accident 96 3.9% 7 21
Fall 90 3.7% 5 31
Visual impairment 90 3.7% 0 15
Gait disturbance 86 3.5% 1 15
Fatigue 78 3.2% 1 15
Infarction 76 3.1% 15 26

Who Reports AMLODIPINE\HYDROCHLOROTHIAZIDE\VALSARTAN Side Effects? Age & Gender Data

Gender: 60.1% female, 39.9% male. Average age: 67.2 years. Most reports from: COUNTRY NOT SPECIFIED. View detailed demographics →

Is AMLODIPINE\HYDROCHLOROTHIAZIDE\VALSARTAN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2005 2 0 0
2006 1 0 0
2007 3 0 0
2008 3 0 1
2009 1 0 0
2010 3 0 2
2011 9 2 2
2012 22 2 7
2013 45 4 8
2014 76 8 33
2015 79 8 17
2016 77 8 23
2017 83 16 16
2018 101 11 28
2019 95 13 28
2020 134 41 46
2021 139 16 27
2022 91 10 26
2023 77 9 23
2024 31 0 11
2025 13 0 6

View full timeline →

What Is AMLODIPINE\HYDROCHLOROTHIAZIDE\VALSARTAN Used For?

IndicationReports
Hypertension 1,297
Product used for unknown indication 877
Blood pressure increased 91
Blood pressure abnormal 63
Cardiac disorder 28
Blood pressure measurement 25
Essential hypertension 11
Diabetes mellitus 8
Coronary artery disease 6
Foetal exposure during pregnancy 6

AMLODIPINE\HYDROCHLOROTHIAZIDE\VALSARTAN vs Alternatives: Which Is Safer?

AMLODIPINE\HYDROCHLOROTHIAZIDE\VALSARTAN vs AMLODIPINE\INDAPAMIDE\PERINDOPRIL AMLODIPINE\HYDROCHLOROTHIAZIDE\VALSARTAN vs AMLODIPINE\INDAPAMIDE\PERINDOPRIL ARGININE AMLODIPINE\HYDROCHLOROTHIAZIDE\VALSARTAN vs AMLODIPINE\OLMESARTAN MEDOXOMIL AMLODIPINE\HYDROCHLOROTHIAZIDE\VALSARTAN vs AMLODIPINE\PERINDOPRIL AMLODIPINE\HYDROCHLOROTHIAZIDE\VALSARTAN vs AMLODIPINE\PERINDOPRIL ARGININE AMLODIPINE\HYDROCHLOROTHIAZIDE\VALSARTAN vs AMLODIPINE\RAMIPRIL AMLODIPINE\HYDROCHLOROTHIAZIDE\VALSARTAN vs AMLODIPINE\TELMISARTAN AMLODIPINE\HYDROCHLOROTHIAZIDE\VALSARTAN vs AMLODIPINE\VALSARTAN AMLODIPINE\HYDROCHLOROTHIAZIDE\VALSARTAN vs AMMONIUM AMLODIPINE\HYDROCHLOROTHIAZIDE\VALSARTAN vs AMNESTEEM

Official FDA Label for AMLODIPINE\HYDROCHLOROTHIAZIDE\VALSARTAN

Official prescribing information from the FDA-approved drug label.