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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.

OTILONIUM: 44 Adverse Event Reports & Safety Profile

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44
Total FAERS Reports
0
Deaths Reported
16
Hospitalizations
44
As Primary/Secondary Suspect
1
Life-Threatening
1
Disabilities

Active Ingredient: OTILONIUM BROMIDE ·

First Report: 2004 · Latest Report: 20250313

What Are the Most Common OTILONIUM Side Effects?

#1 Most Reported
Haematoma
23 reports (52.3%)
#2 Most Reported
Headache
18 reports (40.9%)
#3 Most Reported
Weight increased
17 reports (38.6%)

All OTILONIUM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Haematoma 23 52.3% 0 6
Headache 18 40.9% 0 1
Choking sensation 17 38.6% 0 0
Depression 17 38.6% 0 0
Malaise 17 38.6% 0 1
Secretion discharge 17 38.6% 0 0
Suicidal ideation 17 38.6% 0 0
Weight increased 17 38.6% 0 0
Contusion 16 36.4% 0 0
Drug ineffective 16 36.4% 0 0
Asphyxia 15 34.1% 0 0
Cough 15 34.1% 0 0
Pyrexia 7 15.9% 0 7
Drug interaction 6 13.6% 0 6
Eyelid oedema 6 13.6% 0 6
Periorbital oedema 6 13.6% 0 6
Pruritus 6 13.6% 0 6
Rash generalised 6 13.6% 0 6
Skin lesion 6 13.6% 0 6
Skin plaque 6 13.6% 0 6

Who Reports OTILONIUM Side Effects? Age & Gender Data

Gender: 52.4% female, 47.6% male. Average age: 60.1 years. Most reports from: ES. View detailed demographics →

Is OTILONIUM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2004 1 0 0
2016 1 0 1
2018 8 0 6
2021 16 0 0
2022 1 0 1
2024 1 0 1
2025 4 0 0

View full timeline →

What Is OTILONIUM Used For?

IndicationReports
Product used for unknown indication 29

Official FDA Label for OTILONIUM

Official prescribing information from the FDA-approved drug label.