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Norgesic (caffeine)
Norgesic (caffeine) is a central nervous system stimulant originally developed by Novartis and currently owned by Hikma. It targets the adenosine receptor A2a and is used to treat various conditions including allergic rhinitis, cluster headaches, and common cold. Norgesic has been FDA-approved since 1948 and is available as a generic medication. It has a high bioavailability of 98% and a half-life of 4.9 hours. As an off-patent medication, it is no longer protected by active patents.
At a glance
| Generic name | caffeine |
|---|---|
| Sponsor | Hikma |
| Drug class | Central Nervous System Stimulant [EPC] |
| Target | Adenosine receptor A2a |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1948 |
Approved indications
- Allergic rhinitis
- Apnea in the newborn
- Backache
- Cluster Headache Prevention
- Cluster headache syndrome
- Common cold
- Dysmenorrhea
- Headache disorder
- Influenza-like symptoms
- Joint pain
- Migraine
- Nasal congestion
- Nasal discharge
- Pain
- Sinus headache
- Spasticity
- Tension-type headache
- Vascular headache
Common side effects
- Drowsiness
- Lightheadedness
- Dizziness
- Sedation
- Shortness of breath
- Nausea
- Vomiting
- Abdominal pain
- Intoxicated feeling
- Headache
- Shaky feeling
- Tingling
Serious adverse events
- Seizure
- Toxic epidermal necrolysis
- Erythema multiforme
- Thrombocytopenia
- Agranulocytosis
- Nephrotoxicity
- Mental confusion
- Depression
- Allergic reactions
- Cardiac stimulation
Key clinical trials
- Caracterization of the Combined Alterations in Respiration and aROUSal in Patients With Drug-resistant EpiLepsy (NA)
- Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart Failure (NYHA Class III-IV) (PHASE3)
- SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid (NA)
- Lenvatinib or Regorafenib for Advanced Hepatocellular Carcinoma After Immunotherapy (REVIVE) (PHASE2)
- Effects of Different Caffeine Forms on Aerobic and Anaerobic Exercise Performance (NA)
- Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa (PHASE4)
- Improving Preterm Kidney Outcomes With Caffeine (PHASE2)
- Tritordeum-based Foods for IBS Symptoms (NA)
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 |