ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE: 1,253 Adverse Event Reports & Safety Profile
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1,253
Total FAERS Reports
237 (18.9%)
Deaths Reported
32
Hospitalizations
1,253
As Primary/Secondary Suspect
11
Life-Threatening
8
Disabilities
Active Ingredient: ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE PHOSPHATE ·
First Report: 19930101 · Latest Report: 20221101
What Are the Most Common ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE Side Effects?
#1 Most Reported
Dependence
1,081 reports (86.3%)
#2 Most Reported
Overdose
563 reports (44.9%)
#3 Most Reported
Death
174 reports (13.9%)
All ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Dependence | 1,081 | 86.3% | 160 | 6 |
| Overdose | 563 | 44.9% | 132 | 4 |
| Death | 174 | 13.9% | 174 | 0 |
| Depression | 65 | 5.2% | 12 | 7 |
| Ill-defined disorder | 61 | 4.9% | 10 | 3 |
| Anxiety | 48 | 3.8% | 8 | 4 |
| Withdrawal syndrome | 44 | 3.5% | 1 | 1 |
| Completed suicide | 43 | 3.4% | 42 | 14 |
| Maternal exposure during pregnancy | 25 | 2.0% | 3 | 2 |
| Amnesia | 22 | 1.8% | 4 | 5 |
| Drug ineffective | 21 | 1.7% | 1 | 1 |
| Pain | 21 | 1.7% | 4 | 4 |
| Post-traumatic stress disorder | 21 | 1.7% | 1 | 1 |
| Product prescribing issue | 19 | 1.5% | 3 | 0 |
| Disability | 18 | 1.4% | 2 | 2 |
| Headache | 17 | 1.4% | 5 | 4 |
| Foetal exposure during pregnancy | 16 | 1.3% | 0 | 2 |
| Toxicity to various agents | 15 | 1.2% | 12 | 4 |
| Vomiting | 15 | 1.2% | 4 | 4 |
| Constipation | 14 | 1.1% | 3 | 0 |
Who Reports ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE Side Effects? Age & Gender Data
Gender: 56.8% female, 43.2% male. Average age: 48.0 years. Most reports from: US. View detailed demographics →
Is ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 2 | 0 | 1 |
| 2003 | 2 | 2 | 1 |
| 2009 | 1 | 0 | 1 |
| 2011 | 1 | 0 | 0 |
| 2013 | 2 | 1 | 0 |
| 2014 | 3 | 1 | 0 |
| 2015 | 2 | 0 | 0 |
| 2016 | 12 | 10 | 3 |
| 2017 | 3 | 1 | 0 |
| 2018 | 7 | 7 | 3 |
| 2019 | 3 | 1 | 0 |
| 2022 | 1 | 0 | 0 |
What Is ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 154 |
| Pain | 16 |
| Migraine | 13 |
| Headache | 12 |
ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE vs Alternatives: Which Is Safer?
ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE vs ACETAMINOPHEN\CAFFEINE
ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE vs ACETAMINOPHEN\CAFFEINE\CODEINE
ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE vs ACETAMINOPHEN\CAFFEINE\DIHYDROCODEINE
ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE vs ACETAMINOPHEN\CAFFEINE\OPIUM
ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE vs ACETAMINOPHEN\CAFFEINE\PROPYPHENAZONE
ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE vs ACETAMINOPHEN\CAFFEINE\PYRILAMINE
ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE vs ACETAMINOPHEN\CHLORPHENIRAMINE
ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE vs ACETAMINOPHEN\CHLORPHENIRAMINE\DEXTROMETHORPHAN HYDROBROMIDE
ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE vs ACETAMINOPHEN\CHLORPHENIRAMINE\DEXTROMETHORPHAN HYDROBROMIDE\PHENYLEPHRINE OR ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE\PHENYLEPHRINE OR HOMEOPATHICS
ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE vs ACETAMINOPHEN\CHLORPHENIRAMINE\DEXTROMETHORPHAN\PHENYLEPHRINE
Official FDA Label for ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE
Official prescribing information from the FDA-approved drug label.