Caffeine
Active ingredient · 2 therapeutic classes
Sold as Vivarin · Stay Awake · Alertness Aid · Uplift Chewable · Peyona (previously Nymusa)
- Drug class
- Xanthine Derivatives
- Availability
- Over-the-counter
- Routes
- Oral, Intravenous
- Markets covered
- 4
- Products on record
- 57
- FDA reports (12 mo)
- 1,979
Overview
Plain-language summary, compiled from the cited regulatory records
Caffeine is a stimulant that belongs to the drug class of Other Dermatologicals (D11AX) [1]. It is approved for use to help restore mental alertness or wakefulness when experiencing fatigue or drowsiness [1].
This active ingredient is available under various brand names, including Vivarin and Stay Awake [1]. In the past 12 months, there have been 1,979 adverse event reports associated with caffeine [2]. The most frequently reported reactions include off-label use, the drug being ineffective, dyspnoea, nausea, and headache [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 41 | May 29, 2026 |
| US United States | FDA | 12 | October 15, 2025 |
| CA Canada | Health Canada | 3 | December 18, 2025 |
| EU European Union | EMA | 1 | September 18, 2024 |
GBUnited Kingdom· MHRA
41 products
Uses
Symptomatic treatment of mild to moderate pain and/or fever in adults and children aged 16 years or over.
How to take
USUnited States· FDA
12 products
Uses
Uses temporarily relieves minor aches and pains due to: ○ headache ○ minor arthritis pain ○ muscle aches ○ menstrual cramps ○ backache temporarily reduces fever
How to take
CACanada· Health Canada
3 products
Uses
Caffeine Citrate Injection USP, 20 mg / mL solution for infusion and oral use, is indicated: for the short-term treatment of primary apnea of premature newborns. Treatment must be initiated under the supervision of a physician experienced in neonatal intensive care.
Caffeine Citrate Injection USP is for use in Neonatal Intensive Care Units only. Measurement of baseline caffeine levels, monitoring of plasma concentrations as well as dose adjustments during therapy is advisable. Healthcare professionals should pay special attention to dosage recommendations, contraindications, warnings and precautions for use.
1 Pediatrics Based on the data submitted and reviewed by Health Canada, the safety and efficacy of caffeine citrate in preterm newborn infants is presented. Caffeine Citrate Injection USP is not indicated in other age groups. 2 Geriatrics Caffeine Citrate Injection USP is only indicated in preterm infants.
EUEuropean Union· EMA
1 product
Uses
Treatment of primary apnoea of premature newborns.
How to take
Drug interactions
Known interactions involving Caffeine. Select one for details. This list is informational and not a complete interaction checker.
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]MHRA (UK) · PL179070305 · revised May 29, 2026
- [2]FDA DailyMed · 065bd10c-3bcf-48… · revised October 15, 2025 [PDF]
- [3]Health Canada (DPD) · 02526778 · revised December 18, 2025
- [4]European Medicines Agency · EMEA/H/C/001014 · revised September 18, 2024
- [5]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.