FDA Study: 5.6% of Healthy Adults on CBD Developed Significant Liver Enzyme Elevations
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.
Quick Facts
What This Study 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.
Key Numbers
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 They Did This
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.
Why This Research 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 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.
What This Study Doesn't Tell Us
Only 28 days. Pharmaceutical-grade CBD. Per protocol analysis. Healthy adults only. Relatively small sample.
Questions This Raises
- ?What is the risk with longer use?
- ?Are certain people genetically predisposed?
- ?Should routine liver monitoring be recommended for CBD users?
Trust & Context
- Key Stat:
- 5.6% developed liver enzyme elevations >3x normal in just 28 days
- Evidence Grade:
- Randomized, double-blind, placebo-controlled trial by FDA researchers with objective lab measurements.
- Study Age:
- 2025 study
- Original Title:
- Cannabidiol and Liver Enzyme Level Elevations in Healthy Adults: A Randomized Clinical Trial.
- Published In:
- JAMA internal medicine, 185(9), 1070-1078 (2025)
- Authors:
- 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
- Database ID:
- RTHC-06471
Evidence Hierarchy
Participants are randomly assigned to treatment or placebo groups to test cause and effect.
What do these levels mean? →Frequently Asked 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.
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Cite This Study
https://rethinkthc.com/research/RTHC-06471APA
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
MLA
Florian, Jeffry, et al. "Cannabidiol and Liver Enzyme Level Elevations in Healthy Adults: A Randomized Clinical Trial.." JAMA internal medicine, 2025. https://doi.org/10.1001/jamainternmed.2025.2366
RethinkTHC
RethinkTHC Research Database. "Cannabidiol and Liver Enzyme Level Elevations in Healthy Adu..." RTHC-06471. Retrieved from https://rethinkthc.com/research/florian-2025-cannabidiol-and-liver-enzyme
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkTHC research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.