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Butalbital Side Effects

The most commonly reported side effects of butalbital include headache, nausea, and fatigue, based on 16,323 FDA adverse event reports from 2004 to 2025. 6.7% of reports found the drug to be ineffective.

Butalbital side effects

Percentages show how often each reaction appears relative to total reports for butalbital.

1
Headache8.9%1,458
2
Nausea7.0%1,137
3
Drug Ineffective6.7%1,089
4
Fatigue6.5%1,060
5
Pain5.6%921
6
Migraine5.5%904
7
Diarrhoea4.3%700
8
Dizziness4.0%654
9
Vomiting3.4%555
10
Dyspnoea3.2%526
11
Fall3.1%499
12
Off Label Use3.0%495
13
Malaise3.0%495
14
Anxiety3.0%485
15
Arthralgia2.9%478

These are voluntary reports and do not establish that butalbital caused these reactions.

Report severity

58.3%Serious9,521 reports
24.9%Hospitalizations4,067 reports
9.8%Fatal1,599 reports

Seriousness is determined by the reporter, not by OpenClaim.

Butalbital drug interactions

Other drugs that appear in adverse event reports alongside butalbital. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Acetaminophen11.8%1,927
2
Caffeine11.6%1,895
3
Sodium-oxybate7.9%1,291
4
Codeine5.8%953
5
Adalimumab4.3%695
6
Aspirin3.1%504
7
Oxycodone3.0%486
8
Pregabalin2.4%395
9
Treprostinil2.1%340
10
Ethinyl-estradiol2.0%329
11
Gabapentin2.0%320
12
Hydrocodone1.9%310
13
Erenumab-aooe1.9%303
14
Ibuprofen1.8%298
15
Dupilumab1.8%287

Taken alongside

1
Acetaminophen69.6%11,358
2
Caffeine69.3%11,314
3
Codeine49.6%8,100
4
Aspirin21.4%3,487
5
Ergocalciferol18.5%3,014
6
Gabapentin16.0%2,614
7
Albuterol15.4%2,510
8
Levothyroxine-sodium15.0%2,455
9
Ondansetron13.7%2,235
10
Omeprazole12.9%2,107
11
Fluticasone12.3%2,002
12
Oxycodone11.6%1,898
13
Hydrocodone11.1%1,814
14
Alprazolam10.8%1,761
15
Ibuprofen10.8%1,759

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports butalbital side effects

78.8% of butalbital adverse event reports involve female patients and 15.4% involve male patients. The largest age group is adult at 77%. These figures reflect who reports side effects, not underlying risk.

Sex

Female78.8%
Male15.4%
Unknown5.8%

Age group

< 20.7%
2–110.2%
12–170.9%
18–6476.6%
65+21.5%

What is butalbital used for

Conditions and purposes for which patients were taking butalbital when the adverse event was reported.

Abdominal PainAbdominal Pain LowerAbdominal Pain UpperAccident At WorkAccidental ExposureAcute Coronary SyndromeAcute LeukaemiaAnaemiaAnalgesiaAnalgesic TherapyAneurysmAnticoagulant TherapyAntiplatelet TherapyAnxietyArthralgia

Showing 15 of 228 indications

Butalbital brand names and reporting trend

Butalbital is sold under the brand name Triad.

Brand names

Triad2,887

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking butalbital with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.