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Butalbital, Aspirin And Caffeine (BUTALBITAL)
Butalbital, Aspirin And Caffeine (generic name: BUTALBITAL) is a Barbiturate [EPC] Small molecule drug developed by Actavis Labs Ut Inc. It is currently FDA-approved (first approved 1976) for Tension-type headache.
At a glance
| Generic name | BUTALBITAL |
|---|---|
| Sponsor | Actavis Labs Ut Inc |
| Drug class | Barbiturate [EPC] |
| Target | GABA-A receptor alpha-1/beta-3/gamma-2 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1976 |
Approved indications
- Tension-type headache
Boxed warnings
- Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
Common side effects
- abuse
- addiction
- anorexia
- anxiety
- allergic reaction
- allergic reactions
- anaphylactic shock
- appetite increased
- aspiration
- cardiac stimulation
- chest pain
- cholangiocarcinoma
Drug interactions
- monoamine oxidase (MAO) inhibitors
- other narcotic analgesics
- alcohol
- general anesthetics
- tranquilizers such as chlordiazepoxide
- sedative-hypnotics
- other CNS depressants
Key clinical trials
- Idiopathic Intracranial Hypertension Treatment Trial (PHASE2,PHASE3)
- TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Butalbital, Aspirin And Caffeine CI brief — competitive landscape report
- Butalbital, Aspirin And Caffeine updates RSS · CI watch RSS
- Actavis Labs Ut Inc portfolio CI
Frequently asked questions about Butalbital, Aspirin And Caffeine
What is Butalbital, Aspirin And Caffeine?
Butalbital, Aspirin And Caffeine (BUTALBITAL) is a Barbiturate [EPC] drug developed by Actavis Labs Ut Inc, indicated for Tension-type headache.
What is Butalbital, Aspirin And Caffeine used for?
Butalbital, Aspirin And Caffeine is indicated for Tension-type headache.
Who makes Butalbital, Aspirin And Caffeine?
Butalbital, Aspirin And Caffeine is developed and marketed by Actavis Labs Ut Inc (see full Actavis Labs Ut Inc pipeline at /company/actavis-labs-ut-inc).
What is the generic name of Butalbital, Aspirin And Caffeine?
BUTALBITAL is the generic (nonproprietary) name of Butalbital, Aspirin And Caffeine.
What drug class is Butalbital, Aspirin And Caffeine in?
Butalbital, Aspirin And Caffeine belongs to the Barbiturate [EPC] class. See all Barbiturate [EPC] drugs at /class/barbiturate-epc.
When was Butalbital, Aspirin And Caffeine approved?
Butalbital, Aspirin And Caffeine was first approved on 1976.
What development phase is Butalbital, Aspirin And Caffeine in?
Butalbital, Aspirin And Caffeine is FDA-approved (marketed).
What are the side effects of Butalbital, Aspirin And Caffeine?
Common side effects of Butalbital, Aspirin And Caffeine include abuse, addiction, anorexia, anxiety, allergic reaction, allergic reactions.
What does Butalbital, Aspirin And Caffeine target?
Butalbital, Aspirin And Caffeine targets GABA-A receptor alpha-1/beta-3/gamma-2 and is a Barbiturate [EPC].
Related
- Drug class: All Barbiturate [EPC] drugs
- Target: All drugs targeting GABA-A receptor alpha-1/beta-3/gamma-2
- Manufacturer: Actavis Labs Ut Inc — full pipeline
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Tension-type headache
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing