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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.

LEVAMISOLE: 505 Adverse Event Reports & Safety Profile

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505
Total FAERS Reports
299 (59.2%)
Deaths Reported
141
Hospitalizations
505
As Primary/Secondary Suspect
43
Life-Threatening
4
Disabilities
Jun 18, 1990
FDA Approved
Discontinued
Status

FDA Application: 020035 ·

First Report: 199102 · Latest Report: 20250519

What Are the Most Common LEVAMISOLE Side Effects?

#1 Most Reported
Toxicity to various agents
193 reports (38.2%)
#2 Most Reported
Drug abuse
133 reports (26.3%)
#3 Most Reported
Drug use disorder
64 reports (12.7%)

All LEVAMISOLE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Toxicity to various agents 193 38.2% 161 48
Drug abuse 133 26.3% 83 57
Drug use disorder 64 12.7% 0 28
Substance use disorder 58 11.5% 4 22
Overdose 50 9.9% 18 20
Death 47 9.3% 47 4
Intentional product misuse 41 8.1% 31 8
Coma 36 7.1% 0 13
Completed suicide 35 6.9% 35 4
Miosis 34 6.7% 0 18
Poisoning 31 6.1% 27 4
Drug interaction 25 5.0% 25 0
Accidental death 24 4.8% 24 0
Asphyxia 23 4.6% 23 0
Accidental overdose 22 4.4% 22 0
Vomiting 22 4.4% 10 1
Adulterated product 20 4.0% 18 2
Agitation 20 4.0% 0 9
Cardiac arrest 20 4.0% 20 5
Off label use 19 3.8% 0 9

Who Reports LEVAMISOLE Side Effects? Age & Gender Data

Gender: 32.5% female, 67.5% male. Average age: 38.9 years. Most reports from: US. View detailed demographics →

Is LEVAMISOLE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 1 0 1
2009 2 1 1
2012 14 14 0
2013 2 1 1
2015 1 1 0
2016 12 6 8
2017 9 9 0
2018 2 1 1
2020 2 0 2
2021 3 2 2
2022 23 17 1
2023 31 14 12
2024 46 0 20
2025 3 0 0

View full timeline →

What Is LEVAMISOLE Used For?

IndicationReports
Product used for unknown indication 364
Nephrotic syndrome 21
Drug abuse 17
Adenocarcinoma of colon 7
Accidental exposure to product 5
Overdose 5

LEVAMISOLE vs Alternatives: Which Is Safer?

LEVAMISOLE vs LEVAQUIN LEVAMISOLE vs LEVEMIR LEVAMISOLE vs LEVETIRACETAM LEVAMISOLE vs LEVOBUNOLOL LEVAMISOLE vs LEVOBUPIVACAINE LEVAMISOLE vs LEVOCARNITINE LEVAMISOLE vs LEVOCETIRIZINE LEVAMISOLE vs LEVODOPA LEVAMISOLE vs LEVOFLOXACIN LEVAMISOLE vs LEVOKETOCONAZOLE

Official FDA Label for LEVAMISOLE

Official prescribing information from the FDA-approved drug label.