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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\SPIRONOLACTONE: 185 Adverse Event Reports & Safety Profile

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185
Total FAERS Reports
3 (1.6%)
Deaths Reported
78
Hospitalizations
185
As Primary/Secondary Suspect
13
Life-Threatening

First Report: 1956 · Latest Report: 20241206

What Are the Most Common HYDROCHLOROTHIAZIDE\SPIRONOLACTONE Side Effects?

#1 Most Reported
Ejection fraction decreased
39 reports (21.1%)
#2 Most Reported
Cardiac failure congestive
39 reports (21.1%)
#3 Most Reported
Off label use
38 reports (20.5%)

All HYDROCHLOROTHIAZIDE\SPIRONOLACTONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Cardiac failure congestive 39 21.1% 0 38
Ejection fraction decreased 39 21.1% 0 38
Off label use 38 20.5% 0 31
Fatigue 30 16.2% 0 10
Diabetes mellitus 22 11.9% 0 0
Abdominal distension 21 11.4% 0 4
Oedema peripheral 21 11.4% 0 4
Hypertension 19 10.3% 0 0
Blood pressure decreased 18 9.7% 0 0
Hyperuricaemia 17 9.2% 0 0
Obesity 17 9.2% 0 0
Dehydration 16 8.7% 0 9
Type v hyperlipidaemia 16 8.7% 0 0
Nausea 13 7.0% 0 7
Dizziness 12 6.5% 0 10
Drug hypersensitivity 12 6.5% 0 0
Drug ineffective 12 6.5% 0 5
Malaise 11 6.0% 0 8
Arrhythmia 10 5.4% 0 9
Dyspnoea 10 5.4% 0 9

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

Gender: 42.7% female, 57.3% male. Average age: 66.3 years. Most reports from: US. View detailed demographics →

Is HYDROCHLOROTHIAZIDE\SPIRONOLACTONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2002 2 0 2
2003 1 0 0
2008 1 0 1
2010 1 0 1
2012 1 0 0
2014 12 0 4
2015 2 0 2
2016 6 0 2
2017 3 0 1
2018 5 0 1
2019 2 0 1
2020 2 0 1
2021 3 0 1
2022 2 0 2
2023 1 0 0
2024 4 0 3

View full timeline →

What Is HYDROCHLOROTHIAZIDE\SPIRONOLACTONE Used For?

IndicationReports
Product used for unknown indication 75
Hypertension 27
Diuretic therapy 7
Psoriatic arthropathy 5

HYDROCHLOROTHIAZIDE\SPIRONOLACTONE vs Alternatives: Which Is Safer?

HYDROCHLOROTHIAZIDE\SPIRONOLACTONE vs HYDROCHLOROTHIAZIDE\TELMISARTAN HYDROCHLOROTHIAZIDE\SPIRONOLACTONE vs HYDROCHLOROTHIAZIDE\TRIAMTERENE HYDROCHLOROTHIAZIDE\SPIRONOLACTONE vs HYDROCHLOROTHIAZIDE\VALSARTAN HYDROCHLOROTHIAZIDE\SPIRONOLACTONE vs HYDROCODONE HYDROCHLOROTHIAZIDE\SPIRONOLACTONE vs HYDROCODONE/ACETAMINOPHEN HYDROCHLOROTHIAZIDE\SPIRONOLACTONE vs HYDROCODONE\IBUPROFEN HYDROCHLOROTHIAZIDE\SPIRONOLACTONE vs HYDROCODONE+PARACETAMOL HYDROCHLOROTHIAZIDE\SPIRONOLACTONE vs HYDROCORTISONE HYDROCHLOROTHIAZIDE\SPIRONOLACTONE vs HYDROCORTISONE PROBUTATE HYDROCHLOROTHIAZIDE\SPIRONOLACTONE vs HYDROCORTISONE\HYDROCORTISONE

Official FDA Label for HYDROCHLOROTHIAZIDE\SPIRONOLACTONE

Official prescribing information from the FDA-approved drug label.