Table 4.
Adverse events reported in clinical trials of cannabidiol (Epidiolex).
| Adverse Events | Frequency a | Other Medications with Similar ADE | |
|---|---|---|---|
| Cannabidiol | Placebo | ||
| Transaminase elevation | 8%, 16% | 3% | Alcohol, acetaminophen, sulfonamides, antifungals, ACE inhibitors, antipsychotics |
| Somnolence, sedation, lethargy, fatigue | 41%, 51% | 15% | Benzodiazepines, opioids, antidepressants, antiepileptics, antihistamines |
| Decreased appetite | 16%, 22% | 5% | Stimulants, antibiotics, chemotherapies, antiretrovirals, some antidepressants |
| Diarrhea | 9%, 20% | 9% | Metformin, antibiotics, chemotherapy, proton pump inhibitors, antidepressants |
| Weight decreased | 3%, 5% | 1% | Stimulants, antibiotics, chemotherapies, antiretrovirals, some antidepressants |
| Insomnia, sleep disturbance | 11%, 5% | 4% | Antidepressants, dopamine agonists, stimulants, antiepileptics, steroids, diuretics, and beta-blockers |
| Gait disturbance | 3%, 2% | <1% | Benzodiazepines, opioids, antidepressants, antiepileptics, antihistamines, antihypertensives, antiarrhythmics, sedatives/hypnotics, anticholinergics |
| Infections | 41%, 40% | 31% | Corticosteroids, tumor necrosis factor inhibitors, non-steroidal anti-inflammatory drugs, chemotherapy |
| Pneumonia | 8%, 5% | 1% | |
| Viral | 7%, 11% | 6% | |
| Suicidal thoughts or behaviors | Relative risk 1.8 to 3.5 b | 1.0 | Antihypertensives, antidepressants, hormones, anxiolytics, analgesics, respiratory agents, and anticonvulsants |
a Reported respectively for Epidiolex doses of 10 mg/kg/day and 20 mg/kg/day. b Relative risk reported for all anti-epileptic drugs in a pooled meta-analysis. Highest (3.5) in patients with epilepsy indications.