MIROGABALIN: 84 Adverse Event Reports & Safety Profile
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84
Total FAERS Reports
3 (3.6%)
Deaths Reported
37
Hospitalizations
84
As Primary/Secondary Suspect
1
Life-Threatening
Active Ingredient: MIROGABALIN BESYLATE ·
First Report: 20190423 · Latest Report: 20250424
What Are the Most Common MIROGABALIN Side Effects?
#1 Most Reported
Drug ineffective
11 reports (13.1%)
#2 Most Reported
Off label use
8 reports (9.5%)
#3 Most Reported
Altered state of consciousness
8 reports (9.5%)
All MIROGABALIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 11 | 13.1% | 0 | 2 |
| Altered state of consciousness | 8 | 9.5% | 0 | 7 |
| Off label use | 8 | 9.5% | 0 | 4 |
| Cognitive disorder | 7 | 8.3% | 0 | 0 |
| Psychotic disorder | 7 | 8.3% | 0 | 0 |
| Somnolence | 7 | 8.3% | 0 | 2 |
| Dizziness | 6 | 7.1% | 1 | 3 |
| Nausea | 6 | 7.1% | 0 | 4 |
| Neuropathy peripheral | 6 | 7.1% | 1 | 1 |
| Product use in unapproved indication | 6 | 7.1% | 0 | 0 |
| Acute kidney injury | 5 | 6.0% | 0 | 5 |
| Inappropriate schedule of product administration | 5 | 6.0% | 0 | 4 |
| Substance-induced psychotic disorder | 5 | 6.0% | 0 | 0 |
Who Reports MIROGABALIN Side Effects? Age & Gender Data
Gender: 70.8% female, 29.2% male. Average age: 71.8 years. Most reports from: JP. View detailed demographics →
Is MIROGABALIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2019 | 6 | 0 | 5 |
| 2020 | 2 | 0 | 0 |
| 2021 | 10 | 3 | 7 |
| 2022 | 11 | 0 | 6 |
| 2023 | 4 | 0 | 2 |
| 2024 | 9 | 0 | 6 |
| 2025 | 3 | 0 | 1 |
What Is MIROGABALIN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 22 |
| Neuralgia | 13 |
| Neuropathy peripheral | 11 |
| Back pain | 5 |
| Pain in extremity | 5 |
Official FDA Label for MIROGABALIN
Official prescribing information from the FDA-approved drug label.