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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.

ASPIRIN\BUTALBITAL\CAFFEINE: 175 Adverse Event Reports & Safety Profile

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175
Total FAERS Reports
17 (9.7%)
Deaths Reported
22
Hospitalizations
175
As Primary/Secondary Suspect
6
Life-Threatening
2
Disabilities

First Report: 2006 · Latest Report: 20241203

What Are the Most Common ASPIRIN\BUTALBITAL\CAFFEINE Side Effects?

#1 Most Reported
Drug hypersensitivity
36 reports (20.6%)
#2 Most Reported
Drug ineffective
28 reports (16.0%)
#3 Most Reported
Headache
22 reports (12.6%)

All ASPIRIN\BUTALBITAL\CAFFEINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug hypersensitivity 36 20.6% 0 0
Drug ineffective 28 16.0% 0 0
Headache 22 12.6% 0 1
Cataract 13 7.4% 0 0
Breast mass 12 6.9% 0 0
Eye disorder 12 6.9% 0 0
Eye haemorrhage 12 6.9% 0 0
Incision site impaired healing 12 6.9% 0 0
Nasal congestion 12 6.9% 0 0
Nausea 12 6.9% 0 1
Sinus disorder 12 6.9% 0 0
Vaginal haemorrhage 12 6.9% 0 0
Blindness unilateral 9 5.1% 0 0
Toxicity to various agents 9 5.1% 9 0
Delirium 8 4.6% 0 8
Completed suicide 7 4.0% 7 3
Dizziness 7 4.0% 0 1
Off label use 7 4.0% 1 0
Vomiting 7 4.0% 0 1
Cardio-respiratory arrest 6 3.4% 6 0

Who Reports ASPIRIN\BUTALBITAL\CAFFEINE Side Effects? Age & Gender Data

Gender: 76.6% female, 23.4% male. Average age: 63.3 years. Most reports from: US. View detailed demographics →

Is ASPIRIN\BUTALBITAL\CAFFEINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 1 0 1
2008 1 0 0
2009 1 0 0
2010 1 0 0
2011 1 0 0
2014 10 0 4
2015 1 0 0
2016 5 2 1
2017 7 2 1
2018 2 0 0
2019 3 0 0
2020 8 0 0
2021 1 0 0
2022 3 0 0
2023 2 0 1
2024 1 0 0

View full timeline →

What Is ASPIRIN\BUTALBITAL\CAFFEINE Used For?

IndicationReports
Product used for unknown indication 67
Migraine 37
Headache 19
Pain 5

ASPIRIN\BUTALBITAL\CAFFEINE vs Alternatives: Which Is Safer?

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Official FDA Label for ASPIRIN\BUTALBITAL\CAFFEINE

Official prescribing information from the FDA-approved drug label.