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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.

ENALAPRIL\HYDROCHLOROTHIAZIDE: 616 Adverse Event Reports & Safety Profile

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616
Total FAERS Reports
28 (4.5%)
Deaths Reported
385
Hospitalizations
616
As Primary/Secondary Suspect
34
Life-Threatening
8
Disabilities

Active Ingredient: ENALAPRIL MALEATE\HYDROCHLOROTHIAZIDE ·

First Report: 20030725 · Latest Report: 20250613

What Are the Most Common ENALAPRIL\HYDROCHLOROTHIAZIDE Side Effects?

#1 Most Reported
Acute kidney injury
88 reports (14.3%)
#2 Most Reported
Hyponatraemia
81 reports (13.1%)
#3 Most Reported
Dizziness
55 reports (8.9%)

All ENALAPRIL\HYDROCHLOROTHIAZIDE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Acute kidney injury 88 14.3% 9 86
Hyponatraemia 81 13.2% 6 68
Dizziness 55 8.9% 0 20
Fall 54 8.8% 1 23
Drug interaction 53 8.6% 1 40
Headache 50 8.1% 0 9
Hypotension 45 7.3% 2 29
Insomnia 45 7.3% 0 8
Drug ineffective 35 5.7% 3 6
Somnolence 34 5.5% 0 8
Fatigue 33 5.4% 1 8
Hypokalaemia 31 5.0% 6 25
Depression 29 4.7% 2 2
Bradycardia 27 4.4% 0 15
Pain in extremity 26 4.2% 1 3
Syncope 26 4.2% 2 13
Vomiting 25 4.1% 0 11
Treatment noncompliance 23 3.7% 0 1
Hyperkalaemia 19 3.1% 2 18
Depressed level of consciousness 18 2.9% 0 18

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

Gender: 54.1% female, 45.9% male. Average age: 72.4 years. Most reports from: ES. View detailed demographics →

Is ENALAPRIL\HYDROCHLOROTHIAZIDE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 1 1 0
2004 1 0 0
2005 1 0 1
2007 1 0 0
2008 1 0 1
2009 5 0 5
2011 5 0 1
2012 2 0 1
2013 9 1 1
2014 35 1 23
2015 26 1 18
2016 75 2 32
2017 55 1 36
2018 82 6 57
2019 49 0 28
2020 24 1 19
2021 27 0 23
2022 9 0 8
2023 30 0 24
2024 17 0 14
2025 9 0 9

View full timeline →

What Is ENALAPRIL\HYDROCHLOROTHIAZIDE Used For?

IndicationReports
Hypertension 281
Product used for unknown indication 212
Blood pressure abnormal 14
Cardiac failure chronic 12
Intentional self-injury 9
Essential hypertension 6
Drug abuse 5

ENALAPRIL\HYDROCHLOROTHIAZIDE vs Alternatives: Which Is Safer?

ENALAPRIL\HYDROCHLOROTHIAZIDE vs ENALAPRIL\LERCANIDIPINE ENALAPRIL\HYDROCHLOROTHIAZIDE vs ENASIDENIB ENALAPRIL\HYDROCHLOROTHIAZIDE vs ENBREL ENALAPRIL\HYDROCHLOROTHIAZIDE vs ENCORAFENIB ENALAPRIL\HYDROCHLOROTHIAZIDE vs ENDOXAN ENALAPRIL\HYDROCHLOROTHIAZIDE vs ENDOXAN BAXTER ENALAPRIL\HYDROCHLOROTHIAZIDE vs ENDOXAN , POUDRE POUR ENALAPRIL\HYDROCHLOROTHIAZIDE vs ENFORTUMAB VEDOTIN ENALAPRIL\HYDROCHLOROTHIAZIDE vs ENFORTUMAB VEDOTIN-EJFV ENALAPRIL\HYDROCHLOROTHIAZIDE vs ENFORTUMAB VEDOTIN\ENFORTUMAB VEDOTIN-EJFV

Official FDA Label for ENALAPRIL\HYDROCHLOROTHIAZIDE

Official prescribing information from the FDA-approved drug label.