Ospemifeneinteractions
ospemifene 60 MG Oral Tablet [Osphena]
This is the interactions section of this product’s FDA label — what the manufacturer documented for this drug. It is not a check of your medication list, and a drug missing from it has not been cleared: licensed clinical databases list far more interactions than any single label does. Before combining medicines, ask a pharmacist, who can check everything you take at once and will do it for free.
Named on this label
Every name above is printed in the text below. This is not the full set of drugs that interact with this one — it is the set this manufacturer wrote down.
Drug interactions
OSPHENA is primarily metabolized by CYP3A4 and CYP2C9. CYP2C19 and other pathways contribute to the metabolism of ospemifene. Do not use estrogens or estrogen agonist/antagonist concomitantly with OSPHENA. Do not use fluconazole concomitantly with OSPHENA. Fluconazole increases serum concentrations of OSPHENA. Do not use rifampin concomitantly with OSPHENA. Rifampin decreases serum concentration of OSPHENA.
7.1 Estrogens and
Estrogen Agonist/Antagonist Do not use OSPHENA concomitantly with estrogens and estrogen agonists/antagonists. The safety of concomitant use of OSPHENA with estrogens and estrogen agonists/antagonists has not been studied.
7.2 Fluconazole
Do not use OSPHENA concomitantly with fluconazole, a moderate CYP3A / strong CYP2C9 / moderate CYP2C19 inhibitor. Fluconazole increases the systemic exposure of ospemifene by 2.7-fold. Administration of fluconazole with ospemifene may increase the risk of OSPHENA-related adverse reactions.
7.3 Rifampin
Rifampin, a strong CYP3A4 / moderate CYP2C9 / moderate CYP2C19 inducer, decreases the systemic exposure of ospemifene by 58%. Therefore, co-administration of OSPHENA with drugs such as rifampin which induce CYP3A4, CYP2C9 and/or CYP2C19 activity would be expected to decrease the systemic exposure of ospemifene, which may decrease the clinical effect.
7.4 Ketoconazole
Ketoconazole, a strong CYP3A4 inhibitor, increases the systemic exposure of ospemifene by 1.4-fold. Administration of ketoconazole chronically with ospemifene may increase the risk of OSPHENA-related adverse reactions.
7.5 Warfarin
Repeated administration of ospemifene had no effect on the pharmacokinetics of a single 10 mg dose of warfarin. No study was conducted with multiple doses of warfarin. The effect of ospemifene on clotting time such as the International Normalized Ratio (INR) or prothrombin time (PT) was not studied.
7.6 Highly Protein-Bound
Drugs Ospemifene is more than 99% bound to serum proteins and might affect the protein binding of other drugs. Use of OSPHENA with other drug products that are highly protein-bound may lead to increased exposure of either that drug or ospemifene.
7.7 Multiple
Enzyme Inhibition Co-administration of OSPHENA with a drug known to inhibit CYP3A4 and CYP2C9 isoenzymes may increase the risk of OSPHENA-related adverse reactions.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective February 14, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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