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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.

PIRIBEDIL: 137 Adverse Event Reports & Safety Profile

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137
Total FAERS Reports
6 (4.4%)
Deaths Reported
83
Hospitalizations
137
As Primary/Secondary Suspect
6
Life-Threatening
7
Disabilities

First Report: 19961101 · Latest Report: 20250101

What Are the Most Common PIRIBEDIL Side Effects?

#1 Most Reported
Fall
39 reports (28.5%)
#2 Most Reported
Malaise
26 reports (19.0%)
#3 Most Reported
Nausea
21 reports (15.3%)

All PIRIBEDIL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fall 39 28.5% 0 20
Malaise 26 19.0% 0 12
Confusional state 21 15.3% 0 16
Nausea 21 15.3% 0 18
Agitation 14 10.2% 0 14
Condition aggravated 12 8.8% 0 7
Drug ineffective 11 8.0% 0 7
Vomiting 11 8.0% 0 11
Anxiety 10 7.3% 0 7
Dyskinesia 10 7.3% 0 9
Facial bones fracture 9 6.6% 0 0
Insomnia 9 6.6% 0 7
Mental disorder 9 6.6% 0 8
Overdose 9 6.6% 0 8
Tremor 9 6.6% 0 8
Abnormal behaviour 8 5.8% 0 7
Apathy 8 5.8% 0 7
Depression 8 5.8% 0 6
Fatigue 8 5.8% 0 6
Hypertension 8 5.8% 0 8

Who Reports PIRIBEDIL Side Effects? Age & Gender Data

Gender: 47.7% female, 52.3% male. Average age: 72.0 years. Most reports from: FR. View detailed demographics →

Is PIRIBEDIL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 4 0 4
2006 1 0 0
2007 3 0 3
2009 2 0 1
2011 3 0 2
2012 3 0 3
2013 2 0 2
2014 6 3 4
2015 13 0 13
2016 5 0 2
2017 8 0 5
2018 17 0 12
2019 14 0 0
2020 5 0 4
2021 1 0 1
2022 5 0 3
2024 7 0 7
2025 1 0 1

View full timeline →

What Is PIRIBEDIL Used For?

IndicationReports
Parkinson's disease 80
Product used for unknown indication 26
Tremor 8
Restless legs syndrome 7

PIRIBEDIL vs Alternatives: Which Is Safer?

PIRIBEDIL vs PIRITRAMIDE PIRIBEDIL vs PIROXICAM PIRIBEDIL vs PIRTOBRUTINIB PIRIBEDIL vs PIT VIPER IMMUNE GLOBULIN ANTIVENIN PIRIBEDIL vs PITAVASTATIN PIRIBEDIL vs PITOLISANT PIRIBEDIL vs PIXANTRONE PIRIBEDIL vs PIZOTYLINE PIRIBEDIL vs PLACEBO PIRIBEDIL vs PLAN B ONE-STEP

Official FDA Label for PIRIBEDIL

Official prescribing information from the FDA-approved drug label.