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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.

IBUDILAST: 73 Adverse Event Reports & Safety Profile

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73
Total FAERS Reports
1 (1.4%)
Deaths Reported
67
Hospitalizations
73
As Primary/Secondary Suspect
1
Life-Threatening

First Report: 20100628 · Latest Report: 20210401

What Are the Most Common IBUDILAST Side Effects?

#1 Most Reported
Poor quality sleep
62 reports (84.9%)
#2 Most Reported
Fatigue
62 reports (84.9%)
#3 Most Reported
Drug ineffective
61 reports (83.6%)

All IBUDILAST Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fatigue 62 84.9% 0 62
Poor quality sleep 62 84.9% 0 62
Drug ineffective 61 83.6% 0 60
Impaired quality of life 55 75.3% 0 55
Impaired work ability 54 74.0% 0 54
Body tinea 45 61.6% 0 45
Bone density decreased 45 61.6% 0 45
Cellulitis 45 61.6% 0 45
Contusion 45 61.6% 0 45
Glucose tolerance impaired 45 61.6% 0 45
Herpes zoster 45 61.6% 0 45
Hyperlipidaemia 45 61.6% 0 45
Hypertension 45 61.6% 0 45
Infection susceptibility increased 45 61.6% 0 45
Insomnia 45 61.6% 0 45
Oral herpes 45 61.6% 0 45
Purpura 45 61.6% 0 45
Skin disorder 45 61.6% 0 45
Weight increased 45 61.6% 0 45
Cataract 44 60.3% 0 44

Who Reports IBUDILAST Side Effects? Age & Gender Data

Gender: 71.6% female, 28.4% male. Average age: 57.2 years. Most reports from: CA. View detailed demographics →

Is IBUDILAST Getting Safer? Reports by Year

YearReportsDeathsHosp.
2010 1 0 1
2011 1 0 1
2014 2 0 1
2019 1 0 0
2021 2 0 0

View full timeline →

What Is IBUDILAST Used For?

IndicationReports
Complex regional pain syndrome 50
Product used for unknown indication 18

Official FDA Label for IBUDILAST

Official prescribing information from the FDA-approved drug label.