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cannabidiol Side Effects

Also known as: Epidiolex

Analysis of 22,227 adverse event reports submitted to the FDA from 2010 to 2025.

Total Reports

22,227

Death-Related

1,726

7.8% of reports

Hospitalizations

6,502

29.3% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

SEIZURE
5,791
OFF LABEL USE
2,199
HOSPITALISATION
2,073
PRODUCT USE IN UNAPPROVED INDICATION
1,792
DIARRHOEA
1,695
DRUG INEFFECTIVE
1,338
SOMNOLENCE
1,242
DEATH
1,204
FATIGUE
1,169
PRODUCT DOSE OMISSION ISSUE
1,122
WEIGHT DECREASED
824
WEIGHT INCREASED
800
VOMITING
707
DECREASED APPETITE
685
NAUSEA
643
CONDITION AGGRAVATED
601
PNEUMONIA
593
PRODUCT ADMINISTRATION INTERRUPTED
524
DRUG INTERACTION
513
INSOMNIA
489

Who Reports Side Effects

Gender Distribution

Female 5,434 (49%)
Male 5,601 (51%)
Unknown 9

Age Distribution

0-17 2,603 (44%)
18-44 1,869 (32%)
45-64 847 (14%)
65-74 361 (6%)
75+ 210 (4%)

Reporting Trend by Year

10
14
15
16
17
18
19
20
21
22
23
24
25

Reactions in Death Reports

Top reactions reported in 1,726 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 1,196
OFF LABEL USE 201
SEIZURE 82
PNEUMONIA 62
CARDIAC ARREST 56
PRODUCT USE IN UNAPPROVED INDICATION 55
RESPIRATORY FAILURE 50
HOSPITALISATION 44
SUDDEN UNEXPLAINED DEATH IN EPILEPSY 40
DRUG ABUSE 33
COMPLETED SUICIDE 27
FATIGUE 26
SEPSIS 25
ANAEMIA 21
COVID-19 21
TOXICITY TO VARIOUS AGENTS 21
PYREXIA 20
THROMBOCYTOPENIA 20
FOETAL DEATH 19
LEUKOCYTOSIS 19

Reactions in Hospitalization Reports

Top reactions in 6,502 reports where hospitalization was an outcome.

Reaction Reports
HOSPITALISATION 2,063
SEIZURE 1,941
OFF LABEL USE 977
PNEUMONIA 471
PRODUCT USE IN UNAPPROVED INDICATION 317
PRODUCT DOSE OMISSION ISSUE 303
DRUG INEFFECTIVE 279
DIARRHOEA 266
VOMITING 256
SOMNOLENCE 246
FATIGUE 223
PRODUCT ADMINISTRATION INTERRUPTED 220
WEIGHT DECREASED 220
EMERGENCY CARE 216
FALL 195
PYREXIA 178
COVID-19 167
URINARY TRACT INFECTION 159
NAUSEA 151
DECREASED APPETITE 144

Nearby — Related Medications

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What the FAERS Data Reveals About cannabidiol Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 22,227 voluntary reports linked to cannabidiol and its brand equivalents (Epidiolex), spanning 2010 through 2025. Of those, 1,726 (7.8%) listed death as an outcome and 6,502 (29.3%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 49% were female and 51% male; age distribution skews toward 0-17, with 2,603 reports in that bracket. The single most reported reaction is seizure with 5,791 submissions, followed by off label use and hospitalisation.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.