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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.

PRAMIPEXOLE\PRAMIPEXOLE: 335 Adverse Event Reports & Safety Profile

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335
Total FAERS Reports
19 (5.7%)
Deaths Reported
132
Hospitalizations
335
As Primary/Secondary Suspect
14
Life-Threatening
15
Disabilities

Active Ingredient: PRAMIPEXOLE\PRAMIPEXOLE DIHYDROCHLORIDE ·

First Report: 20090101 · Latest Report: 20241209

What Are the Most Common PRAMIPEXOLE\PRAMIPEXOLE Side Effects?

#1 Most Reported
Drug ineffective
62 reports (18.5%)
#2 Most Reported
Constipation
41 reports (12.2%)
#3 Most Reported
Pain
33 reports (9.9%)

All PRAMIPEXOLE\PRAMIPEXOLE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 62 18.5% 0 29
Constipation 41 12.2% 0 20
Hypotension 33 9.9% 0 9
Pain 33 9.9% 1 19
Condition aggravated 29 8.7% 2 16
Suicidal ideation 29 8.7% 0 21
Dizziness 28 8.4% 1 6
Fatigue 28 8.4% 1 19
Gait disturbance 28 8.4% 0 5
Hallucination 26 7.8% 1 9
Off label use 26 7.8% 1 8
Tremor 25 7.5% 0 22
Oedema peripheral 24 7.2% 0 17
Anxiety 23 6.9% 0 4
Asthenia 23 6.9% 0 20
Cough 21 6.3% 0 19
Somnolence 21 6.3% 4 4
Drug hypersensitivity 20 6.0% 0 17
Dyspnoea 20 6.0% 0 17
Balance disorder 19 5.7% 0 2

Who Reports PRAMIPEXOLE\PRAMIPEXOLE Side Effects? Age & Gender Data

Gender: 51.2% female, 48.8% male. Average age: 65.7 years. Most reports from: CA. View detailed demographics →

Is PRAMIPEXOLE\PRAMIPEXOLE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2009 5 0 0
2010 2 0 0
2015 2 2 2
2017 1 0 0
2018 1 0 0
2020 5 0 3
2021 10 0 1
2022 11 7 4
2023 13 0 3
2024 47 0 16

View full timeline →

What Is PRAMIPEXOLE\PRAMIPEXOLE Used For?

IndicationReports
Product used for unknown indication 102
Restless legs syndrome 88
Parkinson's disease 71
Parkinsonism 14
Depression 13
Secondary progressive multiple sclerosis 10
Prostatomegaly 6
Adverse drug reaction 5
Head titubation 5
Resting tremor 5

PRAMIPEXOLE\PRAMIPEXOLE vs Alternatives: Which Is Safer?

PRAMIPEXOLE\PRAMIPEXOLE vs PRAMLINTIDE PRAMIPEXOLE\PRAMIPEXOLE vs PRASTERONE PRAMIPEXOLE\PRAMIPEXOLE vs PRASUGREL PRAMIPEXOLE\PRAMIPEXOLE vs PRAVASTATIN PRAMIPEXOLE\PRAMIPEXOLE vs PRAVASTATIN\PRAVASTATIN PRAMIPEXOLE\PRAMIPEXOLE vs PRAZAXA PRAMIPEXOLE\PRAMIPEXOLE vs PRAZEPAM PRAMIPEXOLE\PRAMIPEXOLE vs PRAZIQUANTEL PRAMIPEXOLE\PRAMIPEXOLE vs PRAZOSIN PRAMIPEXOLE\PRAMIPEXOLE vs PREDNICARBATE

Official FDA Label for PRAMIPEXOLE\PRAMIPEXOLE

Official prescribing information from the FDA-approved drug label.