What the FDA labels say about taking them together
Darunavir and simvastatin
Darunavir's FDA label of August 29, 2025 names simvastatin in its contraindications section, and simvastatin's label names darunavir too. The darunavir label: “Co-administration is contraindicated due to potential for serious reactions such as myopathy including rhabdomyolysis.”
Check it at the source: the darunavir FDA label on DailyMed (effective August 29, 2025, Janssen Products LP); the simvastatin FDA label on DailyMed (effective March 28, 2025, Organon LLC).
What does the darunavir label say about simvastatin?
Darunavir label, contraindicationsSt. John's wort ( Hypericum perforatum ) Hepatitis C direct acting antiviral: elbasvir/grazoprevir Lipid modifying agents: lomitapide, lovastatin, simvastatin Opioid Antagonist: naloxegol PDE-5 inhibitor: sildenafil when used for treatment of pulmonary arterial hypertension Sedatives/hypnotics: orally administered midazolam, triazolam Co-administration of PREZISTA/ritonavir is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index).
Darunavir label, drug interactionsConcomitant Drug Class Drug Name Examples: lovastatin, simvastatin; Effect on Concentration of Darunavir Or Concomitant Drug: ↑ lovastatin ↑ simvastatin; Clinical Comment: Co-administration is contraindicated due to potential for serious reactions such as myopathy including rhabdomyolysis.
Source: FDA drug label (PREZISTA), Janssen Products LP, effective August 29, 2025 (SPL set 814301f9-c990-46a5-b481-2879a521a16f), via openFDA; the full label on DailyMed
What does the simvastatin label say about darunavir?
Simvastatin label, drug interactionsStrong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with ZOCOR increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher ZOCOR dosages. … (e.g., erythromycin and clarithromycin), select HIV protease inhibitors (e.g., nelfinavir, ritonavir, and darunavir/ritonavir), select HCV protease inhibitors (e.g., boceprevir and telaprevir), cobicistat-containing products, and nefazodone.
Source: FDA drug label (ZOCOR), Organon LLC, effective March 28, 2025 (SPL set 8f55d5de-5a4f-4a39-8c84-c53976dd6af9), via openFDA; the full label on DailyMed
These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.
Both medicines on the record
| Darunavir | Simvastatin | |
|---|---|---|
| Labeled for | HIV | Heart attack and coronary artery disease, High cholesterol, High triglycerides |
| Boxed warning | No | No |
| Pharmacy cost (NADAC) | $1.16 per tablet 600 mg tablet | $0.0321 per tablet 20 mg tablet |
| Shortage now | No current entry | No current entry |
Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)
What next?
- Check more medicines together
- up to five at once