Butalbital
Active ingredient
Sold as FIORINAL · TEVA-TECNAL · TRIANAL C½ · TEVA-TECNAL C 1/2
- Drug class
- -
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 2
- Products on record
- 12
- FDA reports (12 mo)
- 427
Overview
Plain-language summary, compiled from the cited regulatory records
Butalbital is an active ingredient used in a combination medication that also contains acetaminophen and caffeine [1]. This combination product is indicated for the relief of tension headaches, also known as muscle contraction headaches [1].
Evidence regarding the effectiveness and safety of this combination for treating multiple recurrent headaches is not available [1]. Caution is advised when considering its use for such conditions, as butalbital has the potential for habit formation and abuse [1].
In the past 12 months, there have been 427 adverse event reports associated with this ingredient [2]. The most frequently reported adverse events include headache, fatigue, nausea, dyspnea, and diarrhea [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 7 | March 6, 2026 |
| CA Canada | Health Canada | 5 | May 8, 2025 |
USUnited States· FDA
7 products
Uses
INDICATIONS AND USAGE
Butalbital, Acetaminophen, and Caffeine capsules, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable.
Caution in this regard is required because butalbital is habit-forming and potentially abusable.
How to take
CACanada· Health Canada
5 products
Uses
AND CLINICAL USE ................................................................................... 3 CONTRAINDICATIONS ................................................................................................... 4 WARNINGS AND PRECAUTIONS.....................................................................................
5 ADVERSE REACTIONS .................................................................................................. 17 DRUG INTERACTIONS..................................................................................................
20 DOSAGE AND ADMINISTRATION ................................................................................. 21 OVERDOSAGE .............................................................................................................
23 ACTION AND CLINICAL PHARMACOLOGY..................................................................... 26 STORAGE AND STABILITY ............................................................................................ 29 DOSAGE FORMS, COMPOSITION AND PACKAGING ......................................................
Drug interactions
Known interactions involving Butalbital. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 446. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]FDA DailyMed · 03475828-eae2-49… · revised March 21, 2025 [PDF]
- [2]Health Canada (DPD) · 00608181 · revised March 22, 2025
- [3]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.