nabilone Side Effects
Also known as: Cesamet
Analysis of 1,963 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
1,963
Death-Related
102
5.2% of reports
Hospitalizations
782
39.8% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 102 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 44 |
| CARDIAC ARREST | 12 |
| NAUSEA | 9 |
| ASTHENIA | 8 |
| OFF LABEL USE | 8 |
| ABDOMINAL PAIN | 7 |
| PAIN | 7 |
| DIARRHOEA | 6 |
| COMPLETED SUICIDE | 5 |
| DECREASED APPETITE | 4 |
| DIZZINESS | 4 |
| FATIGUE | 4 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 4 |
| NEOPLASM PROGRESSION | 4 |
| VOMITING | 4 |
| COMA | 3 |
| DRUG INEFFECTIVE | 3 |
| DYSPNOEA | 3 |
| HYPOPHAGIA | 3 |
| LETHARGY | 3 |
Reactions in Hospitalization Reports
Top reactions in 782 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| OFF LABEL USE | 165 |
| DRUG INEFFECTIVE | 141 |
| NAUSEA | 99 |
| INSPIRATORY CAPACITY DECREASED | 97 |
| VOMITING | 76 |
| PAIN | 71 |
| DIARRHOEA | 67 |
| PSYCHOTIC DISORDER | 53 |
| HEADACHE | 52 |
| MALAISE | 52 |
| ABDOMINAL PAIN | 50 |
| DRUG INEFFECTIVE FOR UNAPPROVED INDICATION | 50 |
| THERAPEUTIC RESPONSE SHORTENED | 50 |
| FEBRILE NEUTROPENIA | 48 |
| FATIGUE | 47 |
| DYSPNOEA | 46 |
| ARTHRALGIA | 45 |
| DYSTONIA | 45 |
| ORTHOSTATIC HYPOTENSION | 42 |
| THERAPEUTIC PRODUCT EFFECT INCOMPLETE | 42 |
Nearby — Related Medications
What the FAERS Data Reveals About nabilone Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 1,963 voluntary reports linked to nabilone and its brand equivalents (Cesamet), spanning 2004 through 2025. Of those, 102 (5.2%) listed death as an outcome and 782 (39.8%) 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, 67% were female and 33% male; age distribution skews toward 45-64, with 523 reports in that bracket. The single most reported reaction is pain with 473 submissions, followed by drug ineffective and off label use.
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.
Read our methodology — how this data is sourced, computed, and verified.