Skip to content
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\VALSARTAN: 4,446 Adverse Event Reports & Safety Profile

Lower Your Cholesterol — The Natural Way

The Oxidized Cholesterol Strategy: a science-backed plan for heart health.

See the Strategy
4,446
Total FAERS Reports
464 (10.4%)
Deaths Reported
1,277
Hospitalizations
4,446
As Primary/Secondary Suspect
257
Life-Threatening
134
Disabilities

Active Ingredient: AMLODIPINE BESYLATE\VALSARTAN ·

First Report: 19850101 · Latest Report: 20250917

What Are the Most Common AMLODIPINE\VALSARTAN Side Effects?

#1 Most Reported
Blood pressure increased
450 reports (10.1%)
#2 Most Reported
Malaise
322 reports (7.2%)
#3 Most Reported
Drug ineffective
314 reports (7.1%)

All AMLODIPINE\VALSARTAN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Blood pressure increased 450 10.1% 7 122
Malaise 322 7.2% 17 96
Drug ineffective 314 7.1% 7 59
Hypertension 305 6.9% 12 84
Dizziness 283 6.4% 3 89
Diabetes mellitus 251 5.7% 6 41
Death 212 4.8% 212 13
Wrong technique in product usage process 206 4.6% 10 50
Fall 197 4.4% 16 81
Headache 197 4.4% 2 56
Peripheral swelling 187 4.2% 4 56
Cerebrovascular accident 173 3.9% 20 58
Fatigue 160 3.6% 5 52
Hypotension 151 3.4% 7 68
Feeling abnormal 150 3.4% 2 37
Off label use 145 3.3% 14 48
Blood pressure decreased 142 3.2% 5 42
Memory impairment 137 3.1% 2 33
Dyspnoea 136 3.1% 12 60
Pain 116 2.6% 7 38

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

Gender: 54.0% female, 46.0% male. Average age: 67.7 years. Most reports from: COUNTRY NOT SPECIFIED. View detailed demographics →

Is AMLODIPINE\VALSARTAN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 2 0 0
2002 1 0 0
2004 1 0 0
2005 5 0 1
2006 6 2 2
2007 3 0 1
2008 11 0 2
2009 14 0 3
2010 20 5 10
2011 26 2 12
2012 32 3 9
2013 104 11 33
2014 203 26 97
2015 196 27 76
2016 159 21 67
2017 211 20 108
2018 225 19 96
2019 182 18 88
2020 182 32 55
2021 196 33 55
2022 128 12 48
2023 95 5 33
2024 90 0 39
2025 35 0 16

View full timeline →

What Is AMLODIPINE\VALSARTAN Used For?

IndicationReports
Hypertension 2,315
Product used for unknown indication 1,563
Blood pressure abnormal 116
Blood pressure increased 94
Blood pressure measurement 51
Cardiac disorder 47
Suicide attempt 23
Arrhythmia 16
Essential hypertension 16
Blood pressure management 11

AMLODIPINE\VALSARTAN vs Alternatives: Which Is Safer?

AMLODIPINE\VALSARTAN vs AMMONIUM AMLODIPINE\VALSARTAN vs AMNESTEEM AMLODIPINE\VALSARTAN vs AMOXAPINE AMLODIPINE\VALSARTAN vs AMOXICILLIN AMLODIPINE\VALSARTAN vs AMOXICILLIN\CLARITHROMYCIN\ESOMEPRAZOLE AMLODIPINE\VALSARTAN vs AMOXICILLIN\CLARITHROMYCIN\LANSOPRAZOLE AMLODIPINE\VALSARTAN vs AMOXICILLIN\CLAVULANATE AMLODIPINE\VALSARTAN vs AMOXICILLIN\CLAVULANIC ACID AMLODIPINE\VALSARTAN vs AMOXICILLIN\OMEPRAZOLE\RIFABUTIN AMLODIPINE\VALSARTAN vs AMPHETAMINE

Official FDA Label for AMLODIPINE\VALSARTAN

Official prescribing information from the FDA-approved drug label.