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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.

HYDROCHLOROTHIAZIDE\IRBESARTAN: 2,655 Adverse Event Reports & Safety Profile

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2,655
Total FAERS Reports
131 (4.9%)
Deaths Reported
1,280
Hospitalizations
2,655
As Primary/Secondary Suspect
158
Life-Threatening
68
Disabilities

First Report: 1971 · Latest Report: 20250907

What Are the Most Common HYDROCHLOROTHIAZIDE\IRBESARTAN Side Effects?

#1 Most Reported
Acute kidney injury
307 reports (11.6%)
#2 Most Reported
Hyponatraemia
257 reports (9.7%)
#3 Most Reported
Hypotension
138 reports (5.2%)

All HYDROCHLOROTHIAZIDE\IRBESARTAN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Acute kidney injury 307 11.6% 25 265
Hyponatraemia 257 9.7% 0 206
Hypotension 138 5.2% 0 91
Hypertension 130 4.9% 1 42
Hypokalaemia 128 4.8% 0 85
Fall 108 4.1% 0 85
Dyspnoea 105 4.0% 0 62
Dizziness 101 3.8% 0 26
Blood pressure increased 98 3.7% 0 22
Drug ineffective 95 3.6% 3 10
Malaise 92 3.5% 2 52
Nausea 78 2.9% 0 57
Confusional state 77 2.9% 0 63
Vomiting 73 2.8% 0 59
Diarrhoea 70 2.6% 0 54
Headache 67 2.5% 0 14
Lactic acidosis 65 2.5% 21 50
Interstitial lung disease 64 2.4% 23 39
Dehydration 63 2.4% 1 52
Fatigue 63 2.4% 0 28

Who Reports HYDROCHLOROTHIAZIDE\IRBESARTAN Side Effects? Age & Gender Data

Gender: 63.5% female, 36.5% male. Average age: 70.2 years. Most reports from: FR. View detailed demographics →

Is HYDROCHLOROTHIAZIDE\IRBESARTAN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2001 2 0 0
2002 6 0 1
2003 1 0 0
2004 7 0 5
2005 3 0 1
2006 5 0 0
2007 4 0 0
2008 8 0 4
2009 22 1 11
2010 5 0 1
2011 17 1 12
2012 26 0 8
2013 36 2 15
2014 130 14 75
2015 100 4 51
2016 181 4 99
2017 145 2 60
2018 349 21 195
2019 228 22 103
2020 152 0 93
2021 94 14 51
2022 148 2 95
2023 117 0 74
2024 130 9 87
2025 38 1 17

View full timeline →

What Is HYDROCHLOROTHIAZIDE\IRBESARTAN Used For?

IndicationReports
Hypertension 1,668
Product used for unknown indication 433
Essential hypertension 65
Blood pressure measurement 27
Blood pressure abnormal 20
Blood pressure increased 20
Cardiac failure 8
Type 2 diabetes mellitus 7
Blood pressure management 5
Cardiac disorder 5

HYDROCHLOROTHIAZIDE\IRBESARTAN vs Alternatives: Which Is Safer?

HYDROCHLOROTHIAZIDE\IRBESARTAN vs HYDROCHLOROTHIAZIDE\LISINOPRIL HYDROCHLOROTHIAZIDE\IRBESARTAN vs HYDROCHLOROTHIAZIDE\LOSARTAN HYDROCHLOROTHIAZIDE\IRBESARTAN vs HYDROCHLOROTHIAZIDE\METOPROLOL HYDROCHLOROTHIAZIDE\IRBESARTAN vs HYDROCHLOROTHIAZIDE\NEBIVOLOL HYDROCHLOROTHIAZIDE\IRBESARTAN vs HYDROCHLOROTHIAZIDE\OLMESARTAN MEDOXOMIL HYDROCHLOROTHIAZIDE\IRBESARTAN vs HYDROCHLOROTHIAZIDE\QUINAPRIL HYDROCHLOROTHIAZIDE\IRBESARTAN vs HYDROCHLOROTHIAZIDE\RAMIPRIL HYDROCHLOROTHIAZIDE\IRBESARTAN vs HYDROCHLOROTHIAZIDE\SPIRONOLACTONE HYDROCHLOROTHIAZIDE\IRBESARTAN vs HYDROCHLOROTHIAZIDE\TELMISARTAN HYDROCHLOROTHIAZIDE\IRBESARTAN vs HYDROCHLOROTHIAZIDE\TRIAMTERENE

Official FDA Label for HYDROCHLOROTHIAZIDE\IRBESARTAN

Official prescribing information from the FDA-approved drug label.