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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\OLMESARTAN: 142 Adverse Event Reports & Safety Profile

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142
Total FAERS Reports
12 (8.5%)
Deaths Reported
86
Hospitalizations
142
As Primary/Secondary Suspect
6
Life-Threatening
3
Disabilities

First Report: 20150316 · Latest Report: 20250518

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

#1 Most Reported
Hyponatraemia
16 reports (11.3%)
#2 Most Reported
Drug ineffective
10 reports (7.0%)
#3 Most Reported
Dyspnoea
9 reports (6.3%)

All AMLODIPINE\HYDROCHLOROTHIAZIDE\OLMESARTAN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Hyponatraemia 16 11.3% 1 15
Drug ineffective 10 7.0% 0 1
Acute kidney injury 9 6.3% 1 8
Dyspnoea 9 6.3% 0 7
Completed suicide 8 5.6% 8 3
Fall 8 5.6% 0 7
Fatigue 8 5.6% 0 6
Syncope 8 5.6% 0 7
Dizziness 7 4.9% 0 5
Drug interaction 7 4.9% 0 5
Oedema peripheral 7 4.9% 0 7
Renal impairment 7 4.9% 0 5
Product prescribing error 6 4.2% 0 6
Haematemesis 5 3.5% 0 4
Hyperkalaemia 5 3.5% 0 3

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

Gender: 64.8% female, 35.2% male. Average age: 70.2 years. Most reports from: US. View detailed demographics →

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

YearReportsDeathsHosp.
2015 5 0 3
2016 7 2 6
2017 10 0 8
2018 9 0 5
2019 11 1 6
2020 16 1 12
2021 3 0 1
2022 8 1 7
2023 8 1 7
2024 4 0 1
2025 6 0 3

View full timeline →

What Is AMLODIPINE\HYDROCHLOROTHIAZIDE\OLMESARTAN Used For?

IndicationReports
Hypertension 67
Product used for unknown indication 42

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

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

Official FDA Label for AMLODIPINE\HYDROCHLOROTHIAZIDE\OLMESARTAN

Official prescribing information from the FDA-approved drug label.