FDA Study: 5.6% of Healthy Adults on CBD Developed Significant Liver Enzyme Elevations | Research

The takeaway

In a rigorous FDA-conducted trial, 5.6% of healthy adults taking a consumer-relevant CBD dose for 28 days developed liver enzyme elevations more than 3 times the normal limit.

CBD consumers; healthcare providers advising on CBD; regulators.

5.6% developed liver enzyme elevations >3x normal in just 28 days

What the researchers found

8 of 143 participants (5.6%) taking CBD at 5 mg/kg/day developed ALT or AST elevations >3x ULN, vs 0 of 58 on placebo. Seven met withdrawal criteria for potential drug-induced liver injury, detected at days 21-28. No endocrine hormone changes observed.

Why it matters

This is the first rigorous trial testing CBD liver safety at doses consumers actually use. The 5.6% incidence in healthy people over just 4 weeks is a notable safety signal.

The numbers in context

201 participants (median age 36, 44% female). CBD: 8/143 (5.6%, 95% CI 1.8-9.3%) with ALT/AST >3x ULN. Placebo: 0/58. 7 met DILI criteria. No endocrine changes.

How the study worked

Randomized double-blind placebo-controlled trial by FDA researchers. 201 healthy adults, CBD 5 mg/kg/day vs placebo for 28 days. Weekly liver enzyme monitoring.

What this study cannot tell us

Only 28 days. Pharmaceutical-grade CBD. Per protocol analysis. Healthy adults only. Relatively small sample.

How to read the evidence

Randomized, double-blind, placebo-controlled trial by FDA researchers with objective lab measurements.

When this study was published

2025 study

The bigger picture

Millions of consumers use unregulated CBD products without liver monitoring. This trial suggests a small but meaningful percentage may develop liver injury at commonly used doses.

Questions still open

What is the risk with longer use? Are certain people genetically predisposed? Should routine liver monitoring be recommended for CBD users?

Common questions

What dose of CBD was used?

Participants took 5 mg/kg/day, within the range consumers commonly use. For a 150-pound person, that is about 340 mg/day.

Should I get my liver checked if I use CBD?

Liver enzyme elevations appeared at weeks 3-4. The study authors called for further investigation of long-term effects.

Read the original research

Cannabidiol and Liver Enzyme Level Elevations in Healthy Adults: A Randomized Clinical Trial.

JAMA internal medicine, 185(9), 1070-1078

View on PubMed ↗Publisher’s paper ↗

Citation

Florian, Jeffry; Salcedo, Pablo; Burkhart, Keith; Shah, Aanchal; Chekka, Lakshmi Manasa S; Keshishi, Dro; Patel, Vikram; Yang, ShanChao; Fein, Melanie; DePalma, Ryan; Matta, Murali; Strauss, David G; Rouse, Rodney. (2025). Cannabidiol and Liver Enzyme Level Elevations in Healthy Adults: A Randomized Clinical Trial.. JAMA internal medicine, 185(9), 1070-1078. https://doi.org/10.1001/jamainternmed.2025.2366