Icosapent ethyl
ایکوزاپنت اتیل (امگا-۳ خالص EPA)
❤️ Cardiovascular SystemEPA ethyl ester
Market / country: 🇺🇸 USA
Vascepa (US)
🧮 Dose calculator
Hypertriglyceridaemia · Regimen source: FDA Vascepa · 2.2
- • Swallow whole. Continue diet and exercise. FDA Vascepa · 2.2FDA Vascepa · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to icosapent ethyl. FDA Vascepa · 4
Warnings
- • Atrial fibrillation/flutter; bleeding (especially with anticoagulants); caution with fish allergy. FDA Vascepa · 5
Formulations
- 1 g capsule (also 0.5 g) — capsule 🇺🇸 USA FDA Vascepa · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Vascepa · 8.1
“Risk Summary The available data from published case reports and the pharmacovigilance database on the use of VASCEPA in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Vascepa · 8.2
“Risk Summary Published studies have detected omega-3 fatty acids, including EPA, in human milk.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Vascepa · 8.4
“Safety and effectiveness in pediatric patients have not been established.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Vascepa · 8.5
“No overall differences in safety or effectiveness were observed between these patients and younger groups.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA202057
- DailyMed (FDA label)FDA Vascepa
- MedlinePlus (NIH)Icosapent Ethyl
- WHO ATC/DDDC10AX06
- Darooyab (Iran)❌ None
🇮🇷 Not found in Iran list Darooyab · search
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Vascepa · 3FDA Vascepa · 2.2FDA Vascepa · 2.1FDA Vascepa · 4FDA Vascepa · 5FDA Vascepa · SPL approval / marketing categoryFDA Vascepa · 8.1FDA Vascepa · 8.2FDA Vascepa · 8.4FDA Vascepa · 8.5
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · search
- Clinical review⚠ Unverified