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Is Milk Thistle Safe with Tacrolimus?

⛔ CRITICAL SEVERITY
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Tacrolimus Milk Thistle
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Free · No account · based on published sources including NIH ODS, FDA drug labels, and peer-reviewed literature

WHAT YOU NEED TO KNOW

Avoid concurrent use without specialist supervision. If use is unavoidable, intensive therapeutic drug monitoring of tacrolimus trough levels is required. Any signs of nephrotoxicity or neurotoxicity should be reported immediately.

Why this interaction occurs

Silymarin inhibits CYP3A4 and P-glycoprotein, both critical to tacrolimus metabolism and efflux. Inhibition can significantly increase tacrolimus bioavailability and systemic exposure, leading to dose-dependent toxicities including nephrotoxicity and neurotoxicity. Case reports document clinically significant tacrolimus level elevations with co-administration.

Evidence

Evidence level: moderate.

Data source

PubMed: PMID 22139684, PMID 15916450

Reported safety data

The FDA’s adverse event reporting system (FAERS) has received 130,929 reports mentioning Tacrolimus. This reflects reported cases involving the medication in general — not confirmed causation, and not specific to the Tacrolimus + supplement combination on this page.

FAERS reports are voluntary and cannot prove that a drug caused an event. Do not use report counts to assess the safety of this specific drug-supplement pair.

Frequently asked questions

Can I take Milk Thistle with Tacrolimus?
Avoid unless your doctor or pharmacist directs otherwise. Avoid concurrent use without specialist supervision. If use is unavoidable, intensive therapeutic drug monitoring of tacrolimus trough levels is required. Any signs of nephrotoxicity or neurotoxicity should be reported immediately.
Does Milk Thistle affect how well Tacrolimus works?
Silymarin inhibits CYP3A4 and P-glycoprotein, both critical to tacrolimus metabolism and efflux. Inhibition can significantly increase tacrolimus bioavailability and systemic exposure, leading to dose-dependent toxicities including nephrotoxicity and neurotoxicity. Case reports document clinically significant tacrolimus level elevations with co-administration.

Related interactions

All Milk Thistle interactions →  ·  All Tacrolimus interactions →

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Educational only — not medical advice.
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