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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.

BUTALBITAL: 448 Adverse Event Reports & Safety Profile

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448
Total FAERS Reports
337 (75.2%)
Deaths Reported
75
Hospitalizations
448
As Primary/Secondary Suspect
4
Life-Threatening
2
Disabilities

First Report: 20020101 · Latest Report: 20250721

What Are the Most Common BUTALBITAL Side Effects?

#1 Most Reported
Toxicity to various agents
152 reports (33.9%)
#2 Most Reported
Completed suicide
127 reports (28.3%)
#3 Most Reported
Drug abuse
97 reports (21.7%)

All BUTALBITAL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Toxicity to various agents 152 33.9% 140 31
Completed suicide 127 28.4% 127 35
Drug abuse 97 21.7% 85 3
Death 57 12.7% 57 2
Cardio-respiratory arrest 21 4.7% 21 13
Overdose 21 4.7% 16 5
Intentional overdose 18 4.0% 14 6
Intentional product misuse 16 3.6% 14 0
Migraine 15 3.4% 1 8
Drug ineffective 14 3.1% 0 0
Pain 14 3.1% 1 6
Cardiac arrest 13 2.9% 11 3
Respiratory arrest 13 2.9% 11 3
Drug dependence 12 2.7% 4 1
Exposure via ingestion 12 2.7% 8 0
Drug interaction 11 2.5% 6 2
Drug hypersensitivity 10 2.2% 0 4
Intentional drug misuse 9 2.0% 9 0
Nausea 8 1.8% 0 3
Poisoning 8 1.8% 6 0

Who Reports BUTALBITAL Side Effects? Age & Gender Data

Gender: 80.1% female, 19.9% male. Average age: 46.4 years. Most reports from: US. View detailed demographics →

Is BUTALBITAL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2002 1 0 0
2009 2 0 2
2011 2 2 0
2012 32 28 0
2013 15 12 3
2014 16 13 4
2015 3 3 0
2016 7 5 3
2017 15 15 1
2019 2 1 0
2020 19 19 1
2021 10 6 4
2022 1 1 0
2024 3 0 1
2025 1 0 1

View full timeline →

What Is BUTALBITAL Used For?

IndicationReports
Product used for unknown indication 300
Migraine 18
Headache 8
Completed suicide 5
Drug abuse 5
Suicide attempt 5

BUTALBITAL vs Alternatives: Which Is Safer?

BUTALBITAL vs BUTENAFINE BUTALBITAL vs BUTORPHANOL BUTALBITAL vs BUTRANS BUTALBITAL vs BUTYLSCOPOLAMINE BUTALBITAL vs BYETTA BUTALBITAL vs BYETTA PEN DISPOSABLE BUTALBITAL vs CABAZITAXEL BUTALBITAL vs CABERGOLINE BUTALBITAL vs CABOTEGRAVIR BUTALBITAL vs CABOTEGRAVIR\RILPIVIRINE

Official FDA Label for BUTALBITAL

Official prescribing information from the FDA-approved drug label.