Dronedarone
درونادارون
❤️ Cardiovascular SystemAntiarrhythmic
Market / country: 🇺🇸 USA
Multaq (US)
🧮 Dose calculator
Atrial fibrillation / anticoagulation · Regimen source: FDA Multaq · 2
- • Stop class I/III antiarrhythmics and strong CYP3A inhibitors before starting. Exclude pregnancy in women of reproductive potential. FDA Multaq · 2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Permanent AF; symptomatic HF with recent decompensation or NYHA IV; 2nd/3rd-degree AV block or sick sinus without pacemaker; HR <50; strong CYP3A inhibitors and erythromycin; QT-prolonging drugs; QTc >500 or PR >280 ms; prior amiodarone liver or lung toxicity; severe hepatic impairment; hypersensitivity. FDA Multaq · 4
Warnings
- • Boxed warning: doubles the risk of death, stroke and HF in recent decompensated/NYHA IV heart failure and in permanent AF. FDA Multaq · Boxed Warning
Formulations
- 400 mg tablet — tablet 🇺🇸 USA FDA Multaq · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Multaq · 8.1
“Risk Summary MULTAQ may cause fetal harm when administered to a pregnant woman.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Multaq · 8.2
“Because of the potential for serious adverse reactions in breastfed infants from MULTAQ like the adverse effects in adults, (liver injury, and pulmonary toxicity), advise patients not to breastfeed during treatment with MULTAQ and for 5 days (about 6 half-lives) after the last dose.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Multaq · 8.4
“Safety and efficacy in children below the age of 18 years have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Multaq · 8.5
“More than 4500 patients with AF or AFL aged 65 years or above were included in the MULTAQ clinical program (of whom more than 2000 patients were 75 years or older).”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Multaq · 8.3
“Contraception Advise female patients of reproductive potential to use effective contraception during treatment with MULTAQ and for 5 days after the final dose.”
🔗 Reference links
- FDA (approval record)NDA022425
- DailyMed (FDA label)FDA Multaq
- MedlinePlus (NIH)Dronedarone
- WHO ATC/DDDC01BD07
- Darooyab (Iran)Dronedarone
🇮🇷 Registered in Iran Darooyab · G-4725/Dronedarone
Dosage forms with Iranian generic codes, per Darooyab.
- 19067 · DRONEDARON 400MG TAB · قرص دروندارون ۴۰۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Multaq · 3FDA Multaq · 2FDA Multaq · 4FDA Multaq · Boxed WarningFDA Multaq · SPL approval / marketing categoryFDA Multaq · 8.1FDA Multaq · 8.2FDA Multaq · 8.4FDA Multaq · 8.5FDA Multaq · 8.3
- 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 · G-4725/Dronedarone
- Clinical review⚠ Unverified