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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.

RILMENIDINE: 899 Adverse Event Reports & Safety Profile

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899
Total FAERS Reports
103 (11.5%)
Deaths Reported
536
Hospitalizations
899
As Primary/Secondary Suspect
178
Life-Threatening
21
Disabilities

First Report: 20050101 · Latest Report: 20250410

What Are the Most Common RILMENIDINE Side Effects?

#1 Most Reported
Acute kidney injury
214 reports (23.8%)
#2 Most Reported
Lactic acidosis
121 reports (13.5%)
#3 Most Reported
Fall
120 reports (13.3%)

All RILMENIDINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Acute kidney injury 214 23.8% 12 139
Lactic acidosis 121 13.5% 28 46
Fall 120 13.4% 0 107
Hyperkalaemia 86 9.6% 5 54
Hypotension 85 9.5% 4 75
Hypoglycaemia 59 6.6% 0 21
Diarrhoea 49 5.5% 5 30
Bradycardia 45 5.0% 0 14
Rhabdomyolysis 44 4.9% 0 17
Drug ineffective 41 4.6% 0 32
Dyspnoea 39 4.3% 11 29
Hyponatraemia 37 4.1% 0 26
Oedema peripheral 36 4.0% 5 24
Confusional state 32 3.6% 0 30
Fatigue 32 3.6% 0 22
Off label use 31 3.5% 15 6
Somnolence 31 3.5% 4 26
Tachycardia 31 3.5% 4 21
Pemphigoid 30 3.3% 0 22
Angioedema 29 3.2% 0 1

Who Reports RILMENIDINE Side Effects? Age & Gender Data

Gender: 65.3% female, 34.7% male. Average age: 73.4 years. Most reports from: FR. View detailed demographics →

Is RILMENIDINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 2 0 0
2008 1 0 1
2009 1 0 1
2011 4 3 4
2012 10 0 2
2013 13 1 9
2014 31 1 28
2015 37 4 34
2016 59 6 44
2017 97 4 42
2018 116 1 54
2019 119 25 66
2020 76 11 47
2021 47 0 25
2022 58 7 42
2023 14 0 4
2024 53 24 17
2025 14 0 14

View full timeline →

What Is RILMENIDINE Used For?

IndicationReports
Hypertension 661
Product used for unknown indication 126
Poisoning deliberate 11
Medication error 10
Drug administration error 7
Essential hypertension 6
Suicide attempt 5

RILMENIDINE vs Alternatives: Which Is Safer?

RILMENIDINE vs RILONACEPT RILMENIDINE vs RILPIVIRINE RILMENIDINE vs RILUZOLE RILMENIDINE vs RIMABOTULINUMTOXINB RILMENIDINE vs RIMEGEPANT RILMENIDINE vs RIOCIGUAT RILMENIDINE vs RIPRETINIB RILMENIDINE vs RISANKIZUMAB RILMENIDINE vs RISANKIZUMAB-RZAA RILMENIDINE vs RISDIPLAM

Official FDA Label for RILMENIDINE

Official prescribing information from the FDA-approved drug label.