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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.

PROTHIPENDYL: 267 Adverse Event Reports & Safety Profile

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267
Total FAERS Reports
26 (9.7%)
Deaths Reported
167
Hospitalizations
267
As Primary/Secondary Suspect
20
Life-Threatening
6
Disabilities

Active Ingredient: PROTHIPENDYL HYDROCHLORIDE ·

First Report: 20011019 · Latest Report: 20250816

What Are the Most Common PROTHIPENDYL Side Effects?

#1 Most Reported
Fall
32 reports (12.0%)
#2 Most Reported
Off label use
21 reports (7.9%)
#3 Most Reported
Somnolence
20 reports (7.5%)

All PROTHIPENDYL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fall 32 12.0% 0 28
Off label use 21 7.9% 0 21
Somnolence 20 7.5% 0 12
Delirium 19 7.1% 0 17
Syncope 19 7.1% 0 16
Drug interaction 18 6.7% 3 11
Suicide attempt 18 6.7% 0 16
Dizziness 16 6.0% 0 10
Dysphagia 16 6.0% 0 8
General physical health deterioration 16 6.0% 0 16
Pneumonia 16 6.0% 11 10
Galactorrhoea 15 5.6% 0 0
Depression 14 5.2% 0 13
Insomnia 13 4.9% 5 13
Rhabdomyolysis 13 4.9% 0 8
Diarrhoea 12 4.5% 0 12
Sedation 12 4.5% 2 10
Altered state of consciousness 11 4.1% 5 11
Disorientation 11 4.1% 0 8
Drug prescribing error 11 4.1% 0 11

Who Reports PROTHIPENDYL Side Effects? Age & Gender Data

Gender: 60.3% female, 39.7% male. Average age: 51.0 years. Most reports from: DE. View detailed demographics →

Is PROTHIPENDYL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 1
2003 1 0 1
2005 1 0 1
2007 4 0 4
2008 1 0 1
2009 12 0 12
2010 2 0 0
2011 14 7 5
2012 6 0 2
2013 3 0 2
2014 3 0 2
2015 27 0 19
2016 13 0 3
2017 19 1 17
2018 20 0 18
2019 7 0 7
2020 10 0 2
2021 10 0 5
2022 6 0 2
2023 10 0 10
2025 1 0 1

View full timeline →

What Is PROTHIPENDYL Used For?

IndicationReports
Product used for unknown indication 174
Sleep disorder 16
Depression 7
Insomnia 7

PROTHIPENDYL vs Alternatives: Which Is Safer?

PROTHIPENDYL vs PROTIONAMIDE PROTHIPENDYL vs PROTONIX PROTHIPENDYL vs PROTOPIC PROTHIPENDYL vs PROVENGE PROTHIPENDYL vs PROVENTIL PROTHIPENDYL vs PROVERA PROTHIPENDYL vs PROZAC PROTHIPENDYL vs PRUCALOPRIDE PROTHIPENDYL vs PSEUDOEPHEDRINE PROTHIPENDYL vs PSEUDOEPHEDRINE\TRIPROLIDINE

Official FDA Label for PROTHIPENDYL

Official prescribing information from the FDA-approved drug label.