NABIXIMOLS: 92 Adverse Event Reports & Safety Profile
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92
Total FAERS Reports
3 (3.3%)
Deaths Reported
36
Hospitalizations
92
As Primary/Secondary Suspect
5
Life-Threatening
First Report: 2011 · Latest Report: 20250226
What Are the Most Common NABIXIMOLS Side Effects?
#1 Most Reported
Fatigue
36 reports (39.1%)
#2 Most Reported
Muscle spasticity
33 reports (35.9%)
#3 Most Reported
Off label use
28 reports (30.4%)
All NABIXIMOLS Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Fatigue | 36 | 39.1% | 0 | 24 |
| Muscle spasticity | 33 | 35.9% | 0 | 24 |
| Off label use | 28 | 30.4% | 1 | 20 |
| Fall | 25 | 27.2% | 0 | 18 |
| Covid-19 | 24 | 26.1% | 0 | 17 |
| Vomiting | 23 | 25.0% | 0 | 17 |
| Asthenia | 22 | 23.9% | 0 | 18 |
| Muscular weakness | 21 | 22.8% | 0 | 16 |
| Alopecia | 20 | 21.7% | 0 | 15 |
| Constipation | 20 | 21.7% | 0 | 10 |
| Dyspnoea | 20 | 21.7% | 0 | 16 |
| Headache | 20 | 21.7% | 0 | 16 |
| Pain in extremity | 20 | 21.7% | 0 | 12 |
| Arthralgia | 19 | 20.7% | 0 | 12 |
| Pain | 19 | 20.7% | 0 | 16 |
| Drug ineffective | 17 | 18.5% | 0 | 4 |
| Memory impairment | 16 | 17.4% | 0 | 10 |
| Gait disturbance | 15 | 16.3% | 0 | 8 |
| Muscle spasms | 15 | 16.3% | 0 | 10 |
| Weight increased | 15 | 16.3% | 0 | 13 |
Who Reports NABIXIMOLS Side Effects? Age & Gender Data
Gender: 75.2% female, 24.8% male. Average age: 47.6 years. Most reports from: DE. View detailed demographics →
Is NABIXIMOLS Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 1 | 0 | 0 |
| 2014 | 3 | 1 | 1 |
| 2015 | 4 | 1 | 2 |
| 2016 | 2 | 1 | 1 |
| 2017 | 1 | 0 | 0 |
| 2018 | 7 | 0 | 7 |
| 2019 | 20 | 0 | 9 |
| 2020 | 21 | 0 | 11 |
| 2021 | 4 | 0 | 1 |
| 2022 | 1 | 0 | 0 |
| 2023 | 1 | 0 | 1 |
| 2025 | 2 | 0 | 2 |
What Is NABIXIMOLS Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 29 |
| Muscle spasticity | 22 |
| Multiple sclerosis | 13 |
| Vision blurred | 6 |
| Neuralgia | 5 |
Official FDA Label for NABIXIMOLS
Official prescribing information from the FDA-approved drug label.