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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.

AMILORIDE\HYDROCHLOROTHIAZIDE: 563 Adverse Event Reports & Safety Profile

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563
Total FAERS Reports
17 (3.0%)
Deaths Reported
342
Hospitalizations
563
As Primary/Secondary Suspect
64
Life-Threatening
6
Disabilities

Active Ingredient: AMILORIDE HYDROCHLORIDE\HYDROCHLOROTHIAZIDE ·

First Report: 1999 · Latest Report: 20250622

What Are the Most Common AMILORIDE\HYDROCHLOROTHIAZIDE Side Effects?

#1 Most Reported
Hyponatraemia
118 reports (21.0%)
#2 Most Reported
Acute kidney injury
67 reports (11.9%)
#3 Most Reported
Hyperkalaemia
61 reports (10.8%)

All AMILORIDE\HYDROCHLOROTHIAZIDE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Hyponatraemia 118 21.0% 0 107
Acute kidney injury 67 11.9% 4 39
Hyperkalaemia 61 10.8% 0 33
Lactic acidosis 39 6.9% 0 14
Hypokalaemia 33 5.9% 0 25
Syncope 31 5.5% 0 29
Hypotension 29 5.2% 0 20
Malaise 29 5.2% 1 18
Headache 28 5.0% 0 7
Fall 24 4.3% 3 23
Nausea 24 4.3% 1 8
Dizziness 23 4.1% 1 13
Drug interaction 22 3.9% 0 13
Drug ineffective 21 3.7% 1 2
Atrial fibrillation 20 3.6% 0 11
Confusional state 20 3.6% 0 13
Fatigue 20 3.6% 1 11
Arthralgia 19 3.4% 0 2
Hypomagnesaemia 19 3.4% 0 19
Diarrhoea 18 3.2% 0 3

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

Gender: 71.3% female, 28.7% male. Average age: 74.7 years. Most reports from: IT. View detailed demographics →

Is AMILORIDE\HYDROCHLOROTHIAZIDE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2002 1 0 1
2005 2 0 1
2006 2 0 2
2007 2 0 1
2008 3 0 1
2009 2 0 2
2010 6 0 1
2011 7 0 4
2012 7 0 0
2013 13 0 9
2014 35 0 24
2015 34 0 30
2016 36 0 23
2017 43 8 21
2018 97 5 64
2019 53 1 19
2020 21 0 17
2021 20 0 17
2022 26 0 13
2023 1 0 1
2024 5 0 5
2025 3 0 2

View full timeline →

What Is AMILORIDE\HYDROCHLOROTHIAZIDE Used For?

IndicationReports
Hypertension 281
Product used for unknown indication 115
Diuretic therapy 11
Blood pressure abnormal 8
Blood pressure management 5

AMILORIDE\HYDROCHLOROTHIAZIDE vs Alternatives: Which Is Safer?

AMILORIDE\HYDROCHLOROTHIAZIDE vs AMINO ACIDS AMILORIDE\HYDROCHLOROTHIAZIDE vs AMINO ACIDS, SOURCE UNSPECIFIED AMILORIDE\HYDROCHLOROTHIAZIDE vs AMINO ACIDS\ANHYDROUS DEXTROSE\CALCIUM\MAGNESIUM HEPTAHYDRATE\POTASSIUM\SODIUM\SODIUM GLYCEROPHOSPHATE ANHYDROUS\SOYBEAN OIL AMILORIDE\HYDROCHLOROTHIAZIDE vs AMINO ACIDS\DEXTROSE\ELECTROLYTES NOS\SOYBEAN OIL AMILORIDE\HYDROCHLOROTHIAZIDE vs AMINO ACIDS\DEXTROSE\ELECTROLYTES NOS\SOYBEAN OIL\VITAMINS AMILORIDE\HYDROCHLOROTHIAZIDE vs AMINOBENZOIC ACID AMILORIDE\HYDROCHLOROTHIAZIDE vs AMINOCAPROIC ACID AMILORIDE\HYDROCHLOROTHIAZIDE vs AMINOLEVULINIC ACID AMILORIDE\HYDROCHLOROTHIAZIDE vs AMINOPHYLLINE AMILORIDE\HYDROCHLOROTHIAZIDE vs AMINOSALICYLATE

Official FDA Label for AMILORIDE\HYDROCHLOROTHIAZIDE

Official prescribing information from the FDA-approved drug label.