What the label lists and what reports show

Aspirin and butalbital and caffeine side effects

Aspirin and butalbital and caffeine's FDA label lists its adverse reactions in its own words. FAERS holds 162 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (17 reports).

Generic listed
DEA Schedule III

Check it at the source: the aspirin and butalbital and caffeine FDA label on DailyMed (effective December 2, 2024, Sandoz Inc); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions
The most frequent adverse reactions are drowsiness and dizziness. Less frequent adverse reactions are lightheadedness and gastrointestinal disturbances including nausea, vomiting, and flatulence. A single incidence of bone marrow suppression has been reported with the use of butalbital, aspirin, and caffeine capsules. Several cases of dermatological reactions including toxic epidermal necrolysis and erythema multiforme have been reported. Butalbital, aspirin, and caffeine capsules may also cause exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and fixed drug eruption (FDE) ( see WARNINGS ).

Source: FDA drug label, Sandoz Inc, effective December 2, 2024 (SPL set 0e5e3842-fc6c-4a24-8e5c-522701f7c291), via openFDA; the full label on DailyMed

What do FAERS reports show?

162 reports list aspirin and butalbital and caffeine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 42 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

Headache (a use or a product term, not a reaction)18
Nausea (named in the label)17
Fatigue13
Dizziness (named in the label)12
Dyspnoea12
Vomiting (named in the label)12
Drug Hypersensitivity11
Diarrhoea10
Drug Ineffective (a use or a product term, not a reaction)10
Pain10
Anxiety9
Weight Decreased9
Asthenia8
Illness8
Product Dose Omission Issue (a use or a product term, not a reaction)8
Weight Increased8
Arthralgia7
Fall7
Migraine7
Pruritus7
Death (an outcome recorded in the report)6
Gait Disturbance6
Oedema Peripheral6
Rash (named in the label)6
Asthma5

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Aspirin and butalbital and caffeine: the full record: label, generics, price, shortages, recalls
Report a side effect to the FDA: MedWatch
Side effects hub: the most reported medicines and reactions