ACETAMINOPHEN\BUTALBITAL: 134 Adverse Event Reports & Safety Profile

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134

Total FAERS Reports

60 (44.8%)

Deaths Reported

Hospitalizations

134

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 1997 · Latest Report: 20240721

What Are the Most Common ACETAMINOPHEN\BUTALBITAL Side Effects?

#1 Most Reported

Drug ineffective

58 reports (43.3%)

#2 Most Reported

Wound

52 reports (38.8%)

#3 Most Reported

Fatigue

52 reports (38.8%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Drug ineffective	58	43.3%	15	41
Fatigue	52	38.8%	37	44
Wound	52	38.8%	37	44
Joint swelling	50	37.3%	35	42
Pyrexia	50	37.3%	36	43
Road traffic accident	49	36.6%	46	45
Sleep disorder	49	36.6%	36	42
Malaise	48	35.8%	41	41
Dyspnoea	47	35.1%	12	40
Folliculitis	47	35.1%	39	46
Rheumatoid arthritis	47	35.1%	38	45
Sciatica	47	35.1%	46	46
Stomatitis	47	35.1%	39	46
Systemic lupus erythematosus	47	35.1%	38	45
Duodenal ulcer perforation	46	34.3%	38	45
Helicobacter infection	46	34.3%	38	45
Hepatic enzyme increased	46	34.3%	36	43
Hypersensitivity	46	34.3%	37	44
Ill-defined disorder	46	34.3%	38	45
Impaired healing	46	34.3%	38	45

Gender: 68.8% female, 31.2% male. Average age: 51.9 years. Most reports from: CA. View detailed demographics →

Year	Reports	Deaths	Hosp.
2003	1	0	1
2010	2	0	2
2012	2	1	1
2013	1	0	1
2014	1	0	0
2017	5	3	1
2018	1	0	1
2019	1	0	0
2020	2	0	1
2024	1	0	0

Indication	Reports
Product used for unknown indication	66
Rheumatoid arthritis	33
Pain	11
Pyrexia	8
Arthralgia	6
Headache	6

Official prescribing information from the FDA-approved drug label.