Dronedarone and Simvastatin interaction

Dronedarone and Simvastatin: both prescribing labels flag this combination with the strongest language, such as a contraindication, a boxed warning, or an instruction to avoid it.

Major

Do not combine without a prescriber's guidance. The label language below is the strongest FDA uses.

What the FDA labels say

From the Dronedarone (Multaq) label · effective 2026-01-27

Major

• Statins: Avoid simvastatin doses greater than 10 mg daily.

Drug interactionsnames SimvastatinView label on DailyMed
Major

Avoid doses greater than 10 mg once daily of simvastatin [see Clinical Pharmacology (12.3) ] .

Drug interactionsnames SimvastatinView label on DailyMed
Moderate

Effects of Dronedarone on Other Drugs Simvastatin Dronedarone increased simvastatin/simvastatin acid exposure.

Drug interactionsnames SimvastatinView label on DailyMed
Minor

Follow label recommendations for concomitant use of other statins with a CYP3A and P-gp inhibitor like dronedarone.

Drug interactionsby drug classView label on DailyMed
Minor

Other Statins Because of multiple mechanisms of interaction with statins (CYPs and transporters), follow statin label recommendations for use with CYP3A and P-gp inhibitors such as dronedarone.

Drug interactionsby drug classView label on DailyMed

From the Simvastatin (ZOCOR) label · effective 2025-03-28

Major

ZOCOR is contraindicated in the following conditions: Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications, and nefazodone) [see Drug Interactions (7.1) ] .

Contraindicationsby drug classView label on DailyMed
Major

Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications, and nefazodone) ( 4 , 7.1 )

Contraindicationsby drug classView label on DailyMed
Major

Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis The concomitant use of strong CYP3A4 inhibitors with ZOCOR is contraindicated.

Warnings and precautionsby drug classView label on DailyMed
Major

Intervention: Concomitant use of strong CYP3A4 inhibitors with ZOCOR is contraindicated [see Contraindications (4) ] .

Drug interactionsby drug classView label on DailyMed
Major

If treatment with a CYP3A4 inhibitor is unavoidable, suspend ZOCOR during the course of strong CYP3A4 inhibitor treatment.

Drug interactionsby drug classView label on DailyMed

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Not medical advice. Interaction Checker quotes FDA label text and NIH fact sheets. Whether an interaction matters for you depends on doses, timing, kidney and liver function, and other conditions. Confirm with a pharmacist or prescriber.