Darunavir and cobicistat and Flibanserin interaction

Darunavir and cobicistat and Flibanserin: 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 Flibanserin (ADDYI) label · effective 2025-12-22

Major

Contraindicated with Strong or Moderate CYP3A4 Inhibitors The concomitant use of ADDYI and moderate or strong CYP3A4 inhibitors increases flibanserin concentrations, which can cause severe hypotension and syncope [see Warnings and Precautions (5.2) ] .

Boxed warningby drug classView label on DailyMed
Major

Therefore, the use of moderate or strong CYP3A4 inhibitors is contraindicated in patients taking ADDYI [see Contraindications (4) ] .

Boxed warningby drug classView label on DailyMed
Major

• Severe hypotension and syncope can occur when ADDYI is used with moderate or strong CYP3A4 inhibitors or in patients with hepatic impairment; therefore, ADDYI use in these settings is contraindicated.

Boxed warningby drug classView label on DailyMed
Major

ADDYI is contraindicated in patients: • Using concomitant moderate or strong CYP3A4 inhibitors [see Boxed Warning and Warnings and Precautions (5.2) ] .

Contraindicationsby drug classView label on DailyMed
Major

The concomitant use of ADDYI with a moderate or strong CYP3A4 inhibitor is contraindicated.

Warnings and precautionsby drug classView label on DailyMed

From the Darunavir and cobicistat (PREZCOBIX) label · effective 2026-02-01

Major

…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 PREZCOBIX or PREZCOBIX PED is contraindicated in patients receiving certain co-administered drugs for which altered plasma…

Contraindicationsby drug classView label on DailyMed
Major

Sedatives/hypnotics: orally administered midazolam, triazolam ↑ midazolam ↑ triazolam Co-administration is contraindicated due to potential for serious and/or life-threatening reactions such as prolonged or increased sedation or respiratory depression.

Drug interactionsby drug classView label on DailyMed
Moderate

…midazolam with PREZCOBIX or PREZCOBIX PED may cause large increases in the concentrations of these benzodiazepines. metabolized by CYP3A: e.g. buspirone, diazepam, estazolam, zolpidem ↑ sedatives/hypnotics With concomitant use, titration is recommended with sedatives/hypnotics metabolized by CYP3A and a lower dose of the sedatives/hypnotics should be considered with…

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.