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Aspirin, acetaminophen and caffeine
This combination analgesic and antipyretic works through multiple pathways: aspirin inhibits cyclooxygenase to reduce prostaglandins, acetaminophen inhibits pain and fever centers in the CNS, and caffeine enhances analgesic efficacy while promoting alertness.
This combination analgesic and antipyretic works through multiple pathways: aspirin inhibits cyclooxygenase to reduce prostaglandins, acetaminophen inhibits pain and fever centers in the CNS, and caffeine enhances analgesic efficacy while promoting alertness. Used for Mild to moderate pain (headache, muscle ache, backache, minor arthritis pain, menstrual cramps, common cold), Fever.
At a glance
| Generic name | Aspirin, acetaminophen and caffeine |
|---|---|
| Sponsor | Novartis |
| Drug class | Combination analgesic/antipyretic |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | FDA-approved |
Mechanism of action
Aspirin irreversibly inhibits COX-1 and COX-2, reducing prostaglandin synthesis and providing anti-inflammatory and analgesic effects. Acetaminophen's exact mechanism remains incompletely understood but involves inhibition of prostaglandin synthesis and modulation of serotonergic and cannabinoid pathways in the central nervous system. Caffeine acts as a CNS stimulant and potentiates the analgesic effects of both aspirin and acetaminophen, likely through adenosine receptor antagonism.
Approved indications
- Mild to moderate pain (headache, muscle ache, backache, minor arthritis pain, menstrual cramps, common cold)
- Fever
Common side effects
- Gastrointestinal upset
- Heartburn
- Nausea
- Jitteriness or nervousness (caffeine-related)
- Sleep disturbance
Key clinical trials
- Assessment of Oral Caffeine Intake in Changing the Severity of Acute Migraine Attack Using VAS Score Among Patients Attending Headache and Neurology Outpatients Clinic of Ainshams University Hospitals (PHASE4)
- Non-cancer Pain and Cognitive Impairment: A Disabling Relationship (PHASE4)
- Prochlorperazine Versus Acetaminophen, Aspirin, and Caffeine for the Treatment of Acute Migraine (PHASE4)
- Acetylsalicylic Acid (ASA) + Paracetamol + Caffeine Combination Compared With ASA + Paracetamol as Well as ASA, Paracetamol, and Caffeine in Headache Patients (PHASE3)
- Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine (PHASE4)
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 |
|---|---|
| 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:
- Aspirin, acetaminophen and caffeine CI brief — competitive landscape report
- Aspirin, acetaminophen and caffeine updates RSS · CI watch RSS
- Novartis portfolio CI