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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.

LEVOSULPIRIDE: 177 Adverse Event Reports & Safety Profile

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177
Total FAERS Reports
8 (4.5%)
Deaths Reported
73
Hospitalizations
177
As Primary/Secondary Suspect
10
Life-Threatening
4
Disabilities

First Report: 20111128 · Latest Report: 20250609

What Are the Most Common LEVOSULPIRIDE Side Effects?

#1 Most Reported
Drug abuse
37 reports (20.9%)
#2 Most Reported
Intentional self-injury
24 reports (13.6%)
#3 Most Reported
Sopor
20 reports (11.3%)

All LEVOSULPIRIDE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug abuse 37 20.9% 0 31
Intentional self-injury 24 13.6% 0 4
Condition aggravated 20 11.3% 7 8
Sopor 20 11.3% 0 9
Galactorrhoea 19 10.7% 0 0
Intentional overdose 18 10.2% 0 17
Disorganised speech 14 7.9% 0 14
Serotonin syndrome 14 7.9% 0 14
Cerebellar syndrome 13 7.3% 0 13
Hyperprolactinaemia 13 7.3% 0 0
Asthenia 12 6.8% 7 2
Parkinsonism 10 5.7% 0 1
Weight decreased 10 5.7% 7 1
Depressed mood 9 5.1% 7 0
Anal incontinence 8 4.5% 7 0
Blood lactic acid increased 8 4.5% 0 8
Extrapyramidal disorder 8 4.5% 0 5
Respiratory failure 8 4.5% 7 1
Sedation 8 4.5% 0 8
Toxicity to various agents 8 4.5% 0 8

Who Reports LEVOSULPIRIDE Side Effects? Age & Gender Data

Gender: 57.4% female, 42.6% male. Average age: 57.3 years. Most reports from: IT. View detailed demographics →

Is LEVOSULPIRIDE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2011 1 0 0
2013 2 0 0
2015 16 0 14
2016 8 0 2
2017 9 0 4
2018 14 0 4
2019 21 0 10
2020 26 0 16
2021 2 0 2
2022 7 0 4
2023 9 0 6
2024 5 0 0
2025 1 0 1

View full timeline →

What Is LEVOSULPIRIDE Used For?

IndicationReports
Product used for unknown indication 77
Major depression 13
Dyspepsia 9
Drug abuse 8
Gastrooesophageal reflux disease 7
Intentional self-injury 6
Abdominal pain upper 5
Antidepressant therapy 5
Bipolar ii disorder 5

LEVOSULPIRIDE vs Alternatives: Which Is Safer?

LEVOSULPIRIDE vs LEVOTHYROXINE LEVOSULPIRIDE vs LEVOTHYROXINE\LEVOTHYROXINE LEVOSULPIRIDE vs LEVOTHYROXINE\LIOTHYRONINE LEVOSULPIRIDE vs LEVOXYL LEVOSULPIRIDE vs LEXAPRO LEVOSULPIRIDE vs LEXISCAN LEVOSULPIRIDE vs LIALDA LEVOSULPIRIDE vs LIDOCAINE LEVOSULPIRIDE vs LIDOCAINE\MENTHOL LEVOSULPIRIDE vs LIDOCAINE\PRILOCAINE

Official FDA Label for LEVOSULPIRIDE

Official prescribing information from the FDA-approved drug label.