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Study register · detail Systematic Review · Safety & Adverse Effects · 2020

Serious adverse effects of cannabidiol (CBD): a review of randomized controlled trials.

Dos Santos et al. ·Expert opinion on drug metabolism & toxicology Impact 4.0
Harm GRADE High 67 citations
SampleSystematische Review
Durationat least 1 week
ControlPlacebo
EndpointSerious adverse events
Blindingunklar
DesignSystematic Review
Cannabinoidcbd
Routeoral
Key finding

Serious adverse effects of CBD are rare, but include increased transaminases, seizures, sedation, lethargy and upper respiratory tract infections, partly related to drug interactions.

Summary

Systematic analysis of serious adverse events (SAEs) in RCTs with oral CBD (≥1 week). SAEs rare; include increased transaminases (interaction with valproate), convulsions, sedation, lethargy, respiratory tract infections (interaction with clobazam). Monitoring recommended with co-medication with antiepileptics.

P
PopulationHealthy volunteers and clinical samples in RCTs with oral CBD (minimum duration 1 week)
I
InterventionOral cannabidiol (CBD), various dosages, at least 1 week
C
ControlPlacebo (from included RCTs)
O
OutcomeSerious adverse events (SAEs) rare: mainly increased transaminases (associated with valproate co-medication), seizures, sedation, lethargy and upper respiratory tract infections (associated with clobazam co-medication)
Confidence in the evidence
High

The highest of four GRADE levels, the effect estimate is very reliable.

Quality profile
Sample size —
Blinding —
Effect size Harm
Citations / year ★★★★★
Authors
Dos Santos RG, Guimaraes FS, Crippa JAS, Hallak JEC, Rossi GN, Rocha JM, Zuardi AW
DOI 10.1080/17425255.2020.1754793↗
Design: Systematic Review
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Abstract
Introduction: Recent trials using cannabidiol (CBD) have shown that most acute and prolonged adverse effects of CBD are mild to moderate, with rare serious adverse effects (SAEs). This review focused on analyzing SAEs of CBD and their possible relation to drug-drug interactions. Areas Covered: We systematically analyzed the SAEs reported in randomized controlled trials (RCTs) involving the administration of oral CBD for at least 1 week in both healthy volunteers and clinical samples. Expert Opinion: SAEs related to CBD in RCT are rare and include mainly elevated transaminases, convulsion, sedation, lethargy, and upper respiratory tract infections. Elevated transaminases are related to concomitant valproate use, while sedation, lethargy, and upper respiratory tract infections are related to concomitant clobazam use. Epileptic patients should be monitored when using CBD concomitantly with these and other antiepileptic drugs for other possible drug-drug interactions.
Indication
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Safety and tolerability of natural and synthetic cannabinoids in adults aged over 50 years: A systematic review and meta-analysis
Mixed Systematische Review + Meta-Analyse

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A Chesney et al. · 2020 · Neuropsychopharmacology
278 citations
Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials
Harm Meta-Analyse

Systematische Review + Meta-Analyse zu CBD-Sicherheit über k=12 doppelblinde RCTs (n=803). CBD vs. Placebo: erhöhtes Risiko für Studienabbruch (OR 2.61, 95% CI 1.38-4.96), schwere unerwünschte Ereignisse (OR 2.30, 95% CI 1.18-4.48), abnorme Leberwerte (OR 11.19, 95% CI 2.09-60.02), Pneumonie (OR 5.37, 95% CI 1.17-24.65), Appetitminderung (OR 3.56, 95% CI 1.94-6.53), Diarrhö (OR 2.61, 95% CI 1.46-4.67), Somnolenz (OR 2.23, 95% CI 1.07-4.64). Leberwert-Anomalien, Somnolenz, Sedierung und Pneumonie limitiert auf kindliche Epilepsie-Studien (Interaktion mit Clobazam/Valproat möglich). Nach Ausschluss kindlicher Epilepsie: nur Diarrhö assoziiert (OR 5.03, 95% CI 1.44-17.61).

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